Radnostix, Inc. Reports FY2026 2nd Quarter and Six Months Results - Completes Execution of FDA 483 & Recall Actions, Restores Capsule Inventory, Completes Lucerno Dynamics Asset Acquisition

IDAHO FALLS, Idaho, Aug. 13, 2026 /PRNewswire/ -- Radnostix, Inc. (formerly International Isotopes Inc.) (OTCQB: INIS) ("Radnostix" or the "Company"), a manufacturer of radioisotope-focused technologies for medical, industrial, and research applications, today announced its financial results for the second quarter and six months ended June 30, 2026 and the filing of its Quarterly Report on Form 10-Q with the U.S. Securities and Exchange Commission.

Second Quarter and First Half 2026 Financial and Operational Summary

• Total revenue for the three months ended June 30, 2026 was $2.67 million, a 27% decrease from $3.66 million in the prior-year period. Revenue for the six months ended June 30, 2026 was $5.05 million, also down 27% from $6.89 million in the first half of 2025. The declines were driven primarily by residual effects of two voluntary product recalls for Theranostics Products initiated in the first quarter and Cobalt Products shutdown.
• Gross profit for the quarter was $1.36 million (51% margin) compared with $2.14 million (59% margin) in Q2 2025. Six-month gross profit was $2.51 million (50% margin) versus $4.17 million (61% margin) in the prior-year period.
• Net loss for the quarter was $0.88 million compared with $0.16 million in Q2 2025. Six-month net loss was $2.23 million versus $0.27 million in the first half of 2025.
• Cash and cash equivalents were $1.20 million at June 30, 2026.
• FDA Recall and regulatory remediation actions: Capsule inventory was fully restored by the end of June 2026. Customer volumes returned and sales normalized in July 2026. Both voluntary recalls have been fully executed, with all required documentation submitted to the FDA in June 2026; the Company is awaiting formal recall close-out. In response to the FDA Form 483 issued in April 2025, all planned corrective and preventive actions were completed, and a request for inspection close-out was submitted on June 19, 2026.
• Cobalt-60 hot-cell rehabilitation (completed in Q1) delivered improved margins and eliminated significant prior-year radiological waste costs in the second quarter.
• The Company acquired the Lucerno Dynamics' assets, including the Lara System technology platform and Ellexa Explorer Software, on June 25, 2026, expanding the Medical Devices segment portfolio.

Shahe Bagerdjian, President and Chief Executive Officer, commented: "The second quarter continued to reflect the temporary but significant impact of the voluntary recalls that originated from issues spanning prior years, specifically capsule specifications for lots manufactured between 2022 and 2025. We treated these as opportunities to clean up longstanding operational and regulatory items. We fully restored capsule inventory by the end of June, submitted all required FDA documentation, completed our corrective actions related to the 2025 Form 483, and saw sales begin to normalize in July. With the Cobalt hot-cell work behind us and delivering lower waste costs, and with the reformulation of our PET/CT calibration products, our focus for the second half of 2026 is clear: stabilize core revenues, control costs, and return to cash-flow positive results."

Segment Highlights

• Theranostics Products: Q2 revenue of $1.08 million (down 43% year-over-year) and six-month revenue of $2.48 million (down 33%). The primary driver was approximately $625,000 of lost capsule-related revenue in Q2 and approximately $850,000 for the first half. Inventory restoration and normalized ordering in July position the segment for recovery in the second half.
• Cobalt Products: Q2 revenue of $0.50 million. The segment returned to positive segment income in the quarter after the hot-cell rehabilitation, aided by lower waste expenses. Contracted for additional $1.2 million in second half sales.
• Calibration & Reference Products: Q2 revenue of $1.06 million, up 4% versus the same period last year, reflecting continued product development and sales growth despite ongoing global isotope supply constraints in certain lines.
• Medical Devices: Acquired Lara and Ellexa assets in late June; development of EasyFill and RadVent products continues with targeted commercial timelines in early 2027.

2026 Outlook and Focus Areas
Management's priorities for the remainder of 2026 center on:

• Realizing the full recovery of Theranostics volumes following the completion of recall-related remediation and inventory restoration.
• Converting the operational clean-up into more predictable manufacturing and lower ongoing compliance and waste costs.
• Advancing Medical Devices commercialization of EasyFill, Radvent, Lara & Ellexa products.
• Disciplined cost management and working-capital focus with the goal of returning to cash-flow positive results.
• Monetizing the DUF6/NRC-licensed assets by the end of FY2026

About Radnostix (formerly International Isotopes Inc.): Radnostix, Inc. (formerly International Isotopes Inc.) (INIS), established in 1995, with its headquarters in Idaho Falls, ID, USA, manufactures a wide range of radioisotope-focused products. Radnostix manufactures and supplies generic sodium iodide I-131 radio-pharmaceutical drug product for hyperthyroidism and thyroid cancer. Radnostix provides contract manufacturing of various drug products as well as radioisotope API supply for 3rd party theranostics clients. Radnostix manufactures and distributes a complete line of calibration and reference standards for nuclear pharmacies and SPECT/PET imaging systems as well as industrial calibration standards under its RadQual brand. Radnostix also manufacturers high activity sealed sources for industrial, medical, and defense applications. Radnostix is developing a portfolio of medical devices for use with diagnostic and therapeutic radiopharmaceutical applications. For more information, visit www.radnostix.com.

Non-GAAP Financial Measures

This report contains financial measures that do not comply with U.S. generally accepted accounting principles ("GAAP"), such as EBITDA and Adjusted EBITDA. EBITDA is defined as net income plus interest, income taxes, depreciation and amortization. Adjusted EBITDA is defined as EBITDA, adjusted to exclude items that are deemed to be unusual and non-recurring, and that we do not believe are indicative of the companies recurring operating performance, such as non-cash stock-based compensation, gain on disposal of assets, and costs associated with NRC enforcement matters and our medical devices buildout.

These non-GAAP financial measures are supplemental measures to our results of operations as reported under GAAP. Our management uses these measures to better analyze our financial results and business operations.  In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be considered alternatives to net income or any other performance measures derived in accordance with GAAP. The Company's measurement of EBITDA and Adjusted EBITDA may not be comparable to similar measures of other companies as they are not performance measures calculated in accordance with GAAP.

See the tables above for reconciliations of GAAP to non-GAAP measures.

Radnostix, Inc. (formerly International Isotopes Inc.) Safe Harbor Statement:
Certain statements in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to, statements regarding the Company's current expected financial impact from the termination of the APA, the estimated value of the DUF6 Plant and related assets, statements with respect to the Company's future growth expectations. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve a number of risks, uncertainties and other factors that could cause actual results, performance, or achievements of Radnostix, Inc. to be materially different from any future results, performance or achievements of the Company expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in the Company's filings with the Securities and Exchange Commission at www.sec.gov, including its Annual Report on Form 10-K for the year ended December 31, 2025. Investors, potential investors, and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements made herein are only made as of the date of this press release and Radnostix, Inc. and the Company undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Radnostix Contact: 
[email protected]
radnostix.com

SOURCE International Isotopes Inc.