Risk Factors Dashboard

Readers should carefully consider the following factors that may affect our business, future operating results, and financial condition, as well as other information included in this Annual Report. The risks and uncertainties described below are not the only ones the Company faces. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations. If any of the following risks occur, our business, financial condition results of operations, or cash flow could be materially adversely affected.

Risks Related To Our Company

We have incurred, and may continue to incur, losses. We have incurred net losses for most fiscal periods since our inception. From inception through December 31, 2025, we have an accumulated deficit (including preferred stock dividends and returns) in the amount of $128,229,287. The negative cash flow we have sustained has materially reduced our working capital, which in turn could materially and negatively impact our ability to fund future operations and continue to operate as a going concern. Management has taken, and continues to take, actions to improve our financial condition and results of operations. The availability of necessary working capital, however, is subject to many factors beyond our control, including, among other things, our ability to obtain financing on favorable terms, or at all, economic cycles, market acceptance of our products, competitors' responses to our products, the intensity of competition in our markets, and the level of demand for our products.

We may need additional financing to continue operations. Because we may continue to experience negative cash flow, we may need to obtain additional financing to continue operations. Additionally, we may need financing in connection with our development activities. Management will continue to plan and take actions to improve our financial results which could enhance our ability to obtain financing. However, obtaining additional financing is subject to many factors beyond our control and may not be available to us on acceptable terms or at all. If we are unable to raise additional funds when needed, we could be required to delay the development and construction of projects, reduce the scope of, abandon or sell some or all our growth projects or default on our contractual commitments in the future, any of which would have a material adverse effect on our business, financial condition and operating results. If we are unable to raise additional funds when needed, we could be required to delay development and construction of projects, reduce the scope of, abandon or sell some or all our growth projects or default on our contractual commitments in the future, any of which would have a material adverse effect on our business, financial condition and operating results.

Our operations expose us to the risk of material environmental liabilities. We are subject to potential material liabilities related to the remediation of environmental hazards and to personal injuries or property damage that may be caused by hazardous substance releases and exposures. The materials used in our operations expose us to risks of environmental contamination that could subject us to liability, including remediation obligations that could be very costly. In addition, the discovery of previously unknown contamination could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations. We have a surety bond in place supported by funds in a restricted cash account to provide the financial assurance required by the NRC for our Idaho facility license for decommissioning and a similar mechanism will be required to fund the decommissioning of the proposed new depleted uranium facility. We have a Surety Bond in place supported by funds in a restricted cash account to provide the financial assurance required by the NRC for our Idaho facility license for decommissioning and a similar mechanism will be required to fund the decommissioning of the proposed new depleted uranium facility. However, if a contamination event occurred within, or outside of, our facility, we may be financially responsible to remediate such contamination and could have to borrow money or fund the remediation liability from our future revenue. We may not be able to borrow the funds, or have available revenue, sufficient to meet this potential liability, which could have a significant negative impact on our financial condition and results of operations.

We are dependent upon key personnel. Our ongoing operations are currently dependent on Shahe Bagerdjian, President and Chief Executive Officer. Our ongoing operations are currently dependent on Steve T. The loss of Mr. Bagerdjian could have a material adverse effect on our business. Laflin could have a material adverse effect on our business. We maintain a $4.1 million key man life insurance policy on Mr. Bagerdjian and an employment agreement that extends through July 18, 2030. However, there is no assurance that we will be able to retain Mr. Bagerdjian or our existing personnel or attract additional qualified employees. Laflin or our existing personnel or attract additional qualified employees. The loss of any of our key personnel or an inability to attract additional qualified employees could result in a significant decline in revenue.

General economic conditions in markets in which we do business can impact the demand for our goods and services. Decreased demand for our products and services can have a negative impact on our financial performance and cash flow. Demand for our products and services, in part, depends on the general economic conditions affecting the countries and industries in which we do business. A downturn in economic conditions in the U.S. or industry that we serve may negatively impact demand for our products and services, in turn negatively impacting our operations and financial results. Further, changes in demand for our products and services can magnify the impact of economic cycles on our businesses.

Volatility in raw material and energy costs, interruption in ordinary sources of supply and an inability to recover unanticipated increases in energy and raw material costs from customers could result in lost sales or significantly increase the cost of doing business. Market and economic conditions affecting the costs of raw materials, utilities, energy costs, and infrastructure required for the delivery of our goods and services are beyond our control and any disruption or halt in supplies, or rapid escalations in costs could affect our ability to manufacture products or to competitively price our products in the marketplace. Our reliance on a just-in-time supply chain for radioisotopes could cause significant and irreversible harm to our business, including delays in manufacturing and commercial operations. Unlike traditional pharmaceuticals that can be stockpiled, our business is uniquely dependent on a just-in-time supply chain for our radioisotopes and finished products. The radioisotopes we use have a medium-to-long half-lives. This physical constraint means we have limited ability to maintain inventory as a buffer against disruption. Any delay at a single point in our supply chain—from a production outage at a nuclear reactor or cyclotron to a logistics failure, an equipment malfunction, or a regulatory hold—could render an entire shipment partially or completely unusable. Such a failure would not only result in a total loss of product and revenue for that product but would also have a direct, negative impact on patient care and could delay or halt customer’s clinical trials. The complexity of this supply chain, including reliance on specialized facilities and highly regulated global transport, represents a fundamental and unavoidable risk to our business and future growth.

For instance, an interruption in the supply of isotopes such as cobalt-57, cobalt-60, or iodine-131 could result in lost sales in Calibration & Reference Products, Cobalt Product, and Theranostics Products segments.

We also are in ongoing discussions regarding the long-term viability of some territorial or regional distributors and may need to procure new distributors and if we are unable to do so, we would have a loss of revenue.

We also purchase a significant portion of our raw material radioisotopes from overseas suppliers, some of which are government agencies or work with government agencies for the manufacture of radioisotopes. The price and availability of those products could be adversely affected through changes in currency exchange rates, tariffs, sanctions, geopolitics, national security classifications, embargos, regional conflicts, or other restrictions. During the year ended December 31, 2024, there was a global shortage of cobalt-57, a key isotope for our Calibration & Reference Products segment. This shortage occurred from January 2024 until the end of July 2024 and resulted in significant lost sales for this business segment. Our supply of cobalt-57 was restored in July 2024, and we added additional suppliers in 2024. In 2025, we did not experience any shortages of cobalt-57 raw materials.

Starting in January 2024, there has been a continuing global outage of gadolinium-153, a key isotope for our Calibration & Reference Products segment. We are working on establishing new suppliers and believe that we will be able to have supply restored by 2026; however. if we are unable to do so, we would have a loss of revenue.

We are continuing to search for additional means to produce and procure certain critical isotopes, including through our joint venture with Alpha Nuclide Inc., which we entered into in June 2024 for our I-131 and Radqual products.

During multiple weeks in March, July, and August of 2025, we had low quantities or complete outages for our Theranostics Products segments’ raw material radioisotopes. These constraints in supply resulted in lost revenue for this segment. In July of 2024, the FDA approved an additional raw material radioisotope supplier. Our I-131 products are highly reliant on research reactors for this supply; research reactors have a higher frequency of down time compared to traditional power reactors.

To our knowledge and based upon review of FDA publications, we are the only domestic-based manufacturer of finishing cobalt-60 sources and are sole-sourcing cobalt-60 from the Idaho National Lab (“INL”), located less than 60 miles from our facility. We work through the U.S. Department of Energy’s (“DOE”) National Isotope Development Center and the Office of Science and INL to coordinate manufacturing and delivery schedules. There are known risks related to the DOE supply chain including:

Disruptions to our supply chain would likely impede our ability to meet product demand for our customers, which could harm our sales and revenues.

We are subject to extensive government regulation in jurisdictions around the globe in which we do business. Regulations address, among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, can significantly increase the cost of doing business, which in turn can negatively impact our operations, financial results and cash flow. Regulations address, among other things, environmental compliance, import/export restrictions, healthcare services, taxes and financial reporting, and can significantly increase the cost of doing business, which in turn can negatively impact our operations, financial results and cash flow. We are subject to government regulation and intervention both in the United States and in all foreign jurisdictions in which we conduct business. Compliance with applicable laws and regulations results in higher capital expenditures and operating costs and changes to current regulations with which we must comply can necessitate further capital expenditures and increases in operating costs to enable continued compliance. Additionally, from time to time, we may be involved in legal or administrative proceedings under certain of these laws and regulations. Significant areas of regulation and intervention include the following:

All our manufacturing processes generate some radioactive waste that is expensive to dispose of safely. For waste that cannot be decayed in storage we must handle this waste pursuant to the LLRW Act, which requires the safe disposal of mildly radioactive materials. The estimated costs for storage and disposal of these materials have been included in the manufacturing and sales price of our products. However, actual disposal costs are subject to change at the discretion of the disposal site. However, actual disposal costs are subject to change at the discretion of the disposal site and are ultimately applied at the time of disposal. An unexpected or material increase in these costs could have a material adverse effect on our financial condition and results of operations. We recorded material waste disposal expenses of $150,000 and $230,000 in 2025 and 2024 respectively.

We are subject to extensive health and safety regulations. Health regulations dictated by the United States Occupational Safety and Health Administration and NRC are extensive in our business. There is no assurance that our activities will comply with all applicable health regulations at times and, as a result, may expose us to liability under applicable health regulations. Costs and expenses resulting from such liability may materially negatively impact our operations and financial condition. Overall, health laws and regulations will continue to affect our business worldwide.

We may be subject to NRC license enforcement actions. The NRC may take enforcement action in the event that we are found to be in violation of NRC regulations or in violation of any of our license requirements. Consequences of violations depend upon the severity of the violations as well as the adequacy and timeliness of corrective actions implemented by the licensee to investigate and correct the cause of the violation and to prevent reoccurrence. The NRC has discretionary authority in the action they choose to take against license violations, but these actions can include civil penalties and restrictions upon licensee operations or license suspension. The imposition of any such penalties and/or restrictions upon our operations or suspension of our license could have a material adverse effect on our financial condition and results of operations. In 2024 we incurred significant expenses related to two violations in 2021 and 2022. These violations resulted in NRC fines of $63,000, additional legal expenses of $47,636, and professional expenses for corrective actions of $123,216. In 2025 we entered into a settlement agreement with the NRC related to our 2022 sale and sublease to Pharmalogic, and such settlement carried no fines, penalties or violations. However, we will have to commit to various non-material administrative tasks as a license condition for a 36-month period. We do not anticipate any material costs from the settlement.

We are subject to various federal, state, local and foreign government requirements regulating the discharge of materials into the environment or otherwise relating to the protection of the environment.

There are upcoming new rules under consideration with respect to cobalt-60, in particular. While we believe the current regulatory outlook for cobalt-60 is stable and favorable, there are long-term proposed rules regarding Financial Assurance Requirements for Category 1 and 2 Byproduct Material Sealed Sources, which would essentially decommission funding of cobalt-60 finished sources, which may substantially increase costs for parties with cobalt-60 finished sources in inventory, such as the Company, as we have significant inventory of finished sources. The current timeline is as such: Regulatory Basis Publication – 6/30/2026, Proposed Rule for Signature – 5/14/2027, Proposed Rule Publication – 11/15/2027, Final Rule for Signature – 6/14/2028, Final Rule Publication – 12/14/2028.

We are subject to significant regulatory oversight of our import and export operations due to the nature of our product offerings.

We are subject to regulations governing the certification of specialty shielded transportation casks for transporting cobalt-60. We are subject to regulations governing the approval and certification of Type B packages authorized for the transport of our high activity (Type B quantities) cobalt-60 products and bulk materials. Foreign approved Type B packages may only be utilized for imports and exports of these products and bulk materials if the Type B package certificate has been revalidated by the DOT, which may take several months, but is currently provided at no cost. Domestic shipments of Type B quantities of radioactive materials require approval and certification through the NRC, which can cost millions of dollars and take years to complete. Given the cost difference to obtain a DOT revalidation of a foreign-approved Type B package, the availability of NRC certified Type B packages authorized for the domestic transport of cobalt-60 products and bulk materials is very limited. We are currently working with private and government parties to address the limited availability of Type B packages authorized for domestic use by the Company.

We may incur material losses and costs as a result of product liability claims that may be brought against us. We face an inherent business risk of exposure to product liability claims in the event that products supplied by us fail to perform as expected or such failures result, or are alleged to result, in bodily injury. Although we have purchased insurance with coverage and in amounts that we believe to be adequate and reasonable in light of our current and planned operations, if a successful product liability claim were brought against us in excess of our available insurance coverage, it would have a material adverse effect on our business and financial results. Although we have purchased insurance with coverage and in amounts that we believe to be adequate and reasonable in light of our current and planned operations, including our planned uranium de-conversion and fluoride gas production business, if a successful product liability claim were brought against us in excess of our available insurance coverage, it would have a material adverse effect on our business and financial results.

Catastrophic events such as natural disasters, pandemics, war and acts of terrorism could disrupt our business or the business of our suppliers or customers, and any such disruptions could have a negative impact on our operations, financial results and cash flow. Our operations are at all times subject to the occurrence of catastrophic events outside our control, ranging from severe weather conditions such as hurricanes, floods, earthquakes and storms, to health epidemics and pandemics, to acts of war and terrorism. Our operations are at all times subject to the occurrence of catastrophic events outside our control, ranging from severe weather conditions such as hurricanes, floods, earthquakes and storms, to health epidemics and pandemics, to acts of war and terrorism. Any such event could cause a serious business disruption that could affect our ability to produce and distribute our products and possibly expose us to third-party liability claims. Additionally, such events could impact our suppliers, thereby causing energy and raw materials to become unavailable to us, and our customers, who may be unable to purchase or accept our products and services. Any such occurrence could have a negative impact on our operations and financial condition.

Our future growth is largely dependent upon our ability to develop new products that achieve market acceptance with acceptable margins. Our businesses operate in global markets that are characterized by rapidly changing technologies and evolving industry standards. Our businesses operate in global markets that are characterized by rapidly changing technologies and evolving industry standards. Accordingly, our future growth rate depends upon several factors, including, but not limited to, our ability to (i) identify emerging technological trends in our target end-markets, (ii) develop and maintain competitive products, (iii) enhance our products by adding innovative features that differentiate our products from those of our competitors, and (iv) develop, manufacture, and bring products to market quickly and cost-effectively. Our ability to develop new products based on technological innovation or U.S. FDA approval can affect our competitive position and requires the investment of significant resources. These development efforts divert resources from other potential investments in our businesses, and they may not lead to the development of new products on a timely basis or that meet the needs of our customers as fully as competitive offerings. In addition, the markets for our products may not develop or grow as we currently anticipate. The failure of our technologies or products to gain market acceptance due to more attractive offerings by our competitors could significantly reduce our revenues and adversely affect our competitive standing and prospects.

We are dependent on various third parties in connection with our business operations. The production of high-specific activity cobalt-60 is dependent upon the U.S. Department of Energy (DOE), and its prime-operating contractor, which controls the Idaho reactor. Current activity at the Idaho ATR may continue to affect the supply of cobalt-60 material needed for the manufacture of cobalt-60 sources for our Cobalt Products business segment. Current activity at the Idaho ATR may continue to affect the supply of cobalt material needed for the manufacture of cobalt sources. Loss of this cobalt-60 supply would have a significantly impact on this business segment because there is not currently another reactor available in the U.S. that is capable of providing this type of service for us. We are continuing to search for additional means to produce and procure cobalt-60 material. Our radiochemical iodine is supplied to us through two supply sources. Unanticipated contract terminations by these suppliers or suppliers of the key raw materials of our other products or other third parties would have a material adverse impact on our operations, financial results, and cash flow. Unanticipated contract terminations by these suppliers or suppliers the key raw materials of our other products or other third parties would have a material adverse impact on our operations, financial results, and cash flow.

We are dependent on a limited number of customers in connection with some of our current business operations. Combined sales to our three top customers accounted for 31% and 32% of our total gross revenue during 2025 and 2024, respectively. Although we are making efforts to reduce our dependency on a small number of customers, the loss of any one of these customers could have a significant impact on our future results of operations and financial condition. Unanticipated contract terminations by any of these current customers could have a material adverse impact on operations, financial results, and cash flow.

We believe that we have a good product to offer and have a strong relationship with our customers due to the customer’s need for supply security and the only alternative is a vertically integrated direct competitor to our customers. We believe our EasyFill capsule system has the potential to help maintain existing customers and attract new customers. We are targeting a roll out in the third quarter of 2026 and a commercial ramp up in the second quarter of 2027, including additional sales of I-131.

We are subject to competition from other companies. Each of our existing business areas has direct competition from other businesses. Each of our existing business areas has direct competition from other businesses. Cobalt-60 is supplied by other reactor facilities around the world. We are aware that nuclear medicine calibration and reference standards are being produced by at least one other major manufacturer in the U.S. We believe we have at least one major competitor in the U.S. for our generic sodium iodide I-131 drug product. Most of our competitors have significantly greater financial resources that could give them a competitive advantage over us.

Risks Related To Our Common Stock

Trading in our common stock is limited, and the price of our common stock may be subject to substantial volatility. Our common stock is quoted on the OTCQB Marketplace under the U.S. trading symbol “INIS”. The market for our securities is limited, the price of our stock is volatile, and the risk to investors in our common stock is greater than the risk associated with stock trading on other markets. These factors may reduce the potential market for our common stock by reducing the number of potential investors. This may make it more difficult for investors in our common stock to sell shares to third parties or to otherwise dispose of their shares. This could cause our stock price to decline.

We currently do not intend to pay dividends on our common stock. We do not plan to pay dividends on shares of our common stock in the near future. Consequently, an investor in our common stock can only achieve a return on its investment in us if the market price of our common stock appreciates.

We are contractually obligated to issue shares in the future, which will dilute your interest in us. As of December 31, 2025, there were approximately 21,622,500 shares of common stock issuable upon the exercise of vested stock options, at a weighted-average exercise price of $.05 per share. An additional 21,975,685 shares were reserved for issuance under our equity plan when it terminated on July 14, 2025. In 2026, we plan to submit for approval by the Company's shareholders to reinstate and extend by amendment the 2015 plan or adopt a new incentive plan. Our outstanding preferred stock and certain of our outstanding debt is also convertible into shares of our common stock at the holders’ option. In addition, we expect to issue additional options to purchase shares of our common stock to compensate employees, consultants and directors, and we may issue additional shares to raise capital to expand our manufacturing capability, develop additional products, or business segments. Any such issuance will have the effect of further diluting the interest of the holders of our securities.

Item 1B. UNRESOLVED STAFF COMMENTS

We are a smaller reporting company, and therefore, are not required to provide the information required by this item.

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