Radnostix, Inc. (INIS): America’s Only Domestic I-131 Manufacturer
Radnostix, Inc. (OTCQB: INIS), formerly International Isotopes, is an Idaho Falls-based specialty manufacturer of radioactive products for healthcare applications. The company changed its name on December 31, 2025, signaling a renewed focus on its core theranostics business.
What makes Radnostix notable: the company manufactures the only US-produced FDA-approved generic Iodine-131 drug product—a critical treatment for thyroid cancer and hyperthyroidism.
| Metric | Value |
|---|---|
| Market Cap | ~$32M |
| 2024 Revenue | $13.9M |
| Gross Margin | 62% |
| Shares Outstanding | 528M |
| Stock Price | ~$0.06 |
| Exchange | OTCQB |
Business Overview
Radnostix operates four active business segments:
Theranostics Products (58% of revenue, ~$8M)
The company’s primary business. Radnostix’s FDA-approved I-131 sodium iodide capsules treat thyroid cancer and hyperthyroidism. Approved in February 2020, this product addresses a theranostics market projected to grow at 24% CAGR, reaching $12.7 billion by 2029 according to BCC Research. As the only domestic US manufacturer, Radnostix provides healthcare systems with an alternative to foreign-sourced supply.
Calibration & Reference Standards (25% of revenue, ~$3.5M)
Through subsidiary RadQual, the company produces calibration and reference standards for nuclear pharmacies, imaging clinics, and hospitals. This segment showed strong growth in 2025, up 57% year-to-date.
Cobalt Products (17% of revenue, ~$2.4M)
Cobalt-60 sealed sources used in radiation therapy equipment calibration and cancer treatment, sourced from Idaho National Laboratory’s Advanced Test Reactor.
Medical Devices (<2% of revenue)
An early-stage segment including EasyFill (automated radiopharmaceutical capsule system, targeting Q3 2026 launch), RadVent pulmonary ventilation products, and distribution of Scintomics synthesis equipment.
The DUF6 Sale: A Pivotal Catalyst
The company is divesting its Fluorine Products segment—assets related to a proposed uranium deconversion facility in New Mexico. The company received an NRC construction and operating license in October 2012, but suspended development in late 2013 when market conditions changed.
In February 2024, Radnostix entered a definitive agreement to sell these assets to American Fuel Resources for $12.5 million, with closing expected by March 2026.
Transaction economics:
| Item | Amount |
|---|---|
| Gross proceeds | $12.5M |
| Repay insider notes | ($1.62M) |
| Accrued interest | (~$618K) |
| Net cash to company | ~$10.2M |
This transaction would transform the company’s balance sheet. Current available cash stands at approximately $1.65 million. The proceeds would also remove liens on core assets (the I-131 ANDA and Hot Cell facility) that were pledged as security on the insider notes.
The company notes in its most recent 10-Q that it is “currently evaluating any effects the current government shutdown will have on this NRC review process.”
Potential Impact of the DUF6 Asset Sale
The DUF6 transaction represents the most significant near-term catalyst for Radnostix. Understanding its potential impact on the company’s financial position and strategic options is essential.
Balance Sheet Transformation
| Metric | Pre-DUF6 Close | Post-DUF6 Close |
|---|---|---|
| Available cash | $1.65M | ~$11.85M |
| Related-party debt | $1.62M + $618K interest | $0 |
| Liens on core assets | Yes (ANDA, Hot Cell) | Removed |
| Series C preferred | $4.06M (due Feb 2027) | $4.06M (payable from cash) |
| Net cash after preferred | Negative | ~$7.8M |
The transaction would increase the company’s available cash by approximately 7x, fundamentally changing its financial flexibility.
Strategic Options Unlocked
With a strengthened balance sheet, management would have several options:
Operational resilience: Maintain a cash reserve to absorb supply chain disruptions without returning to losses. The 2025 experience—where approximately $750K in lost sales pushed the company back into the red—illustrates the value of this cushion.
Debt elimination: Repaying the $4.06M Series C preferred stock (due February 2027) would remove a near-term obligation and simplify the capital structure.
Growth investment: The Medical Devices segment requires capital to commercialize EasyFill and other products. Proceeds could accelerate these initiatives.
Supply chain investment: Resources to pursue backup supplier relationships or joint venture arrangements to reduce single-source dependencies.
Scenario Analysis
If the transaction closes as expected:
- Company cleans up balance sheet and has meaningful cash reserves built up throughout 2026
- Management can focus entirely on operating the core business
- Removes a distraction and historical drag on cash flow and balance sheet
If the transaction is delayed or fails:
- Company continues with ~$1.65M cash and roughly breakeven operations
- Liens remain on core assets, limiting future financing flexibility
- Series C preferred becomes a more pressing concern as February 2027 approaches
- Any significant supply disruption could require additional equity financing
Capital Allocation Priorities
Post-transaction, the company has not provided specific guidance on capital allocation. However, a prudent approach might include:
| Priority | Estimated Allocation | Rationale |
|---|---|---|
| Operating reserve | $2-3M | Buffer for supply disruptions |
| Preferred stock repayment | $4.06M | Eliminate 2027 maturity obligation |
| Growth investment | $1-2M | Medical Devices commercialization |
This would leave minimal excess cash but position the company with a clean balance sheet and funded growth initiatives.
Financial Position
Nine months ending September 30, 2025:
- Revenue: $10.17M (+2% YoY)
- Net loss: $(477K)
- Cash from operations: +$210K
The company reported positive operating cash flow, though supply disruptions impacted results. Management estimates approximately $750,000 in lost sales during the first nine months of 2025 due to temporary supplier outages affecting the Theranostics segment.
Balance sheet (September 30, 2025):
- Available cash: $1.65M
- Restricted cash: $1.48M (NRC surety bond)
- Series C preferred stock: $4.06M (due February 2027)
- Accumulated deficit: $127.8M
Series C Preferred Stock
The Series C preferred stock warrants additional explanation. This $4.06M obligation is held by insiders—specifically John McCormack’s family trusts and Chairman Christopher Grosso. While technically equity, it functions as debt because it is “mandatorily redeemable” at maturity.
Key terms:
- Maturity: February 2027
- Convertible: Holders may convert to 12.04M common shares at their option
- Early redemption: Company may redeem early only if stock trades above $0.25 for 90 consecutive days
- Track record: Holders have extended maturity three times (from 2022 to 2027), demonstrating flexibility
At current prices (~$0.06), the conversion option is deeply out of the money. Holders would receive only ~$722K in stock versus $4.06M in cash, so they will almost certainly elect cash redemption. The DUF6 proceeds would provide sufficient funds to retire this obligation.
Supply Chain Considerations
The nature of radioisotope manufacturing creates inherent supply chain challenges. Radioactive materials decay continuously—Iodine-131 has an 8-day half-life—making inventory stockpiling impossible. This necessitates just-in-time supply chain operations.
I-131 supply: The company sources I-131 from external suppliers. In the first nine months of 2025, temporary supplier outages in March, July, and August impacted Theranostics revenue. In June 2025, FDA approved an additional I-131 supplier, and as of September 2025, the company began regularly sourcing from two suppliers.
Cobalt-60 supply: The company sources Cobalt-60 from Idaho National Laboratory’s Advanced Test Reactor. The company has disclosed there is “no other reactor currently available in the U.S.” for this material, though they are exploring foreign suppliers.
The company continues working to diversify its supplier base across all product lines and established a joint venture (Alpha Nuclide) in June 2024 that may provide additional manufacturing flexibility.
Regulatory Status
In April 2025, an FDA inspection at the Idaho Falls facility resulted in an Official Action Indicated (OAI) classification. The company has submitted required 15-day, 90-day, and 180-day updates and continues manufacturing operations while implementing corrective actions. Upon completion, the FDA will reinspect the facility. The company states it believes it is “on a pathway to implement and finalize our corrective actions without any adverse effect on our business.”
Ownership Structure
| Owner | Shares | Ownership |
|---|---|---|
| Kennerman Associates (Kershner/Grosso) | 234.9M | 42.2% |
| John McCormack family trusts | 109.7M | 20.6% |
| All directors & officers | 98.5M | 18.1% |
| Public float | ~83M | ~16% |
Insider alignment is notable: in August 2025, holders of the company’s related-party notes extended maturity dates to March 2028.
Leadership:
- CEO: Shahe Bagerdjian (since September 2023)
- CFO: W. Matthew Cox
Valuation Considerations
At $0.06 per share and approximately $32 million market cap, the company trades at roughly 2.3x trailing revenue.
Key variables affecting valuation:
- DUF6 closing: Successful completion would add approximately $10.2 million in net cash and remove asset liens
- Operational execution: Consistent supply chain performance would support revenue growth
- FDA OAI resolution: Successful reinspection would remove regulatory overhang
- Medical Devices commercialization: EasyFill launch in 2026-2027 could provide additional revenue streams
Considerations for potential investors:
The investment presents a risk/reward profile typical of micro-cap situations:
- Limited liquidity (some trading days see minimal volume)
- Concentration in specialized nuclear medicine manufacturing
- Dependence on external isotope suppliers
- Potential strategic value as sole domestic I-131 manufacturer
Looking Ahead
Near-term milestones to monitor:
- DUF6 transaction closing (target: March 2026)
- FDA reinspection and OAI resolution
- Q4 2025 and Q1 2026 operational results
- EasyFill product launch timeline (targeting Q3 2026)
The company states it expects “cash from operations, cash raised via equity financing, and our current cash balance will be sufficient to fund operations for the next twelve months.”
Disclosure: This analysis is for informational purposes only and does not constitute investment advice. Always conduct your own due diligence before making investment decisions.