INIS 10-K & 10-Q changes, risk factors and insider trading
Radnostix Inc. · OTC · Industrial Instruments For Measurement, Display, And Control · CIK 1038277 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “We are subject to significant regulatory oversight of our import and export operations due to the nature of our product offerings.”
Largest changes
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 yearsee in full comparisonendingended December 31, 2024, there was a global shortage of cobalt-57, a key isotope for ourNuclearCalibrationMedicine&StandardsReference 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 wehaveadded additional suppliers in 2024.WeInare continuing to search for additional means to produce and procure certain critical isotopes, including through our Chinese Joint Venture, which2025, weentereddidintonotinexperienceJuneany2024.shortages of cobalt-57 raw materials.
We may be subject to NRCsee in full comparisonLicenselicenseEnforcementenforcementActions.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.”see in full comparison
“We are subject to significant regulatory oversight of our import and export operations due to the nature of our product offerings.”see in full comparison
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.see in full comparisonForOurinstance,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, aninterruptionequipmentin the supply of isotopes such as cobalt-57, cobalt-60,malfunction, oriodine-131a regulatory hold—could render an entire shipment partially or completely unusable. Such a failure would not only result inlostasalestotalinlossNuclearofMedicine Standards, Cobalt Product,product andTheranosticsrevenueProductsforsegments.thatWeproduct but would alsopurchasehavesomea direct, negative impact on patient care and could delay or halt customer’s clinical trials. The complexity ofourthismaterialsupply chain, including reliance on specialized facilities andproductshighlyfromregulatedoverseasglobalsupplierstransport, represents a fundamental andtheunavoidablepriceriskoftothoseourproductsbusinesscouldandbefutureadversely affected through changes in currency exchange rates.growth.
“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. …”see in full comparison
Full comparison: every changed paragraph (25)
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 andresults operatingof resultsoperations, or cash flow could be materially adversely affected.
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.
We are dependent upon key personnel. Our ongoing operations are currently dependent on Shahe Bagerdjian, President and Chief Executive Officer. The loss of Mr. Bagerdjian 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 JuneJuly 19,18, 2028.2030. However, there is no assurance that we will be able to retain Mr. Bagerdjian 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.
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. ForOur instance,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 interruptionequipment in the supply of isotopes such as cobalt-57, cobalt-60,malfunction, or iodine-131a regulatory hold—could render an entire shipment partially or completely unusable. Such a failure would not only result in losta salestotal inloss Nuclearof Medicine Standards, Cobalt Product,product and Theranosticsrevenue Productsfor segments.that Weproduct but would also purchasehave somea direct, negative impact on patient care and could delay or halt customer’s clinical trials. The complexity of ourthis materialsupply chain, including reliance on specialized facilities and productshighly fromregulated overseasglobal supplierstransport, represents a fundamental and theunavoidable pricerisk ofto thoseour productsbusiness couldand befuture adversely affected through changes in currency exchange rates.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 endingended December 31, 2024, there was a global shortage of cobalt-57, a key isotope for our NuclearCalibration Medicine& StandardsReference 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 have added additional suppliers in 2024. WeIn are continuing to search for additional means to produce and procure certain critical isotopes, including through our Chinese Joint Venture, which2025, we entereddid intonot inexperience Juneany 2024.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.
Radioactive Waste. All our manufacturing processes generate some radioactive waste.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 Policy 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. An unexpected or material increase in these costs could have a material adverse effect on our financial condition and results of operations. InWe 2024, we experiencerecorded material waste disposal costsexpenses totalingof $229,540.$150,000 Weand anticipate similar waste disposal expenses$230,000 in 2025.2025 and 2024 respectively.
HealthWe Compliance.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 Licenselicense Enforcementenforcement Actions.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.
Environmental Regulation. 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. These laws and regulations include, but are not limited to CERCLA,Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), the Resource Conservation and Recovery Act (“RCRA”) and state statutes such as the Idaho Hazardous Waste Management Act, the LLRW Policy Act, NRC regulations concerning various irradiated, radioactive, and depleted uranium materials, and U.S. DOT regulations concerning shipment of radioactive materials. Certain of these laws and regulations can impose substantial fines and criminal sanctions for violations and require installation of costly equipment or operational changes to limit emissions and/or decrease the likelihood of accidental hazardous substance releases. We have incurred, and expect to continue to incur, capital and operating costs to comply with these laws and regulations. In addition, changes in laws, regulations and enforcement of policies, or the imposition of new clean-up requirements or remedial techniques, could require us to incur costs in the future that would have a negative effect on our financial condition or results of operations.
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.
Import/Export Regulation. We are subject to significant regulatory oversight of our import and export operations due to the nature of our product offerings. Penalties for non-compliance can be significant, and violations can result in adverse publicity. Because of increasing security controls and regulations, it is likely that we may encounter additional regulations affecting the transportation, storage, sale, and import/export of radioactive materials.
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.
Taxes. We structure our operations to be tax efficient and to make use of tax credits and other incentives. Nevertheless, changes in tax laws, actual results of operations, final audit of tax returns by taxing authorities, and the timing and rate at which tax credits can be utilized can change the rate at which we are taxed, thereby affecting our 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. High-specific activity cobalt-60Cobalt-60 is supplied by other reactor facilities around the world. NuclearWe 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.
We are contractually obligated to issue shares in the future, which will dilute your interest in us. As of December 31, 2024,2025, there were approximately 17,982,50021,622,500 shares of common stock issuable upon the exercise of vested stock options, at a weighted-average exercise price of $.05 per share. An additional 32,529,29621,975,685 shares were reserved for issuance under our equity plansplan aswhen ofit Decemberterminated 31,on 2024.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.
Management's Discussion & Analysis (MD&A)
Largest changes
“Other income was $207,966 for 2024 as compared to other income of $160,173 for 2023. This increase of $47,793 was due to an increase in miscellaneous income partially offset by $63,000 of other expense for NRC fines. We have taken extensive internal actions to mitigate the risk of any similar violations and penalties occurring again. These matters have been finalized with the NRC.”see in full comparison
“On March 11, 2026, we executed a mutual termination of the DUF6 APA dated February 8, 2024 to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to AFR. AFR contacted the Company requesting a 1-year extension due to AFR being unable to make payment of the balance of the purchase price by the Outside Date of March 31, 2026 in order to meet the Condition to Seller’s Obligations as defined in the DUF6 APA. …”see in full comparison
“In December 2019 and February 2020, we borrowed an aggregate of $1,000,000 from our chief executive officer, Chairman, former Chairman, and one of our major shareholders pursuant to a promissory note (the “2019 Promissory Note”). The 2019 Promissory Note bears an interest rate of 4% annually and was originally due December 31, 2022. …”see in full comparison
see in full comparisonInterestOther incomein 2024was$122,385$310,838 for 2025 as compared to$78,890otherinincome2023.of $207,966 for 2024. This increase of$43,495$102,872 was due toincreasedaninterest rates and increased cash balances held at banks and other institutionsincrease ininterest-bearingmiscellaneousaccounts.income.
Insee in full comparisonDecemberApril2019,2018, weenteredborrowedinto$120,000 from our chief executive officer and the current chairman of our board of directors (“Chairman”) through an affiliated entity pursuant to a promissory noteagreement with our then Chief Executive Officer, Chairman of the Board, former Chairman of the Board, and one of our major shareholders(the2019“2018 Promissory Note”). The2019 Promissory Note authorizes us to borrow up to $1,000,000. As of December 31, 2019, we borrowed $675,000 under the 2019 Promissory Note; the remaining $325,000 was borrowed in February 2020. The 20192018 Promissory Note is secured andbearsaccrues interest at4%6% perannumannum,andwhichhasisapayable upon maturitydate of December 31, 2022. According to the termsof the20192018 PromissoryNote,Note.atAt any time,atheholderholders of the20192018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days.InTheconnection2018withPromissory Note was originally due August 1, 2018. Pursuit to six modifications within the2019 Promissory Note, we issued 30,000,000 Class O Warrants with a termperiod offiveJuneyears2018toandpurchaseDecembershares of our common stock at $0.045 per share (the Class O Warrants). All2023, theClass O Warrants were exercised in January 2021. In December 2022, the 20192018 Promissory Note was modified to extend the maturity date toDecemberJanuary 31,2024,2025, with all remaining terms unchanged. In February 2024, the20192018 Promissory Note wasfurthermodified to (i) extend the maturity date to March 31, 2026, (ii) remove the security provision to allow for the DUF6 Asset Sale, (iii) if reasonably possible, to reinstate a security provision against our sodium iodide ANDA and iodine-131 Processing Hot Cell, and (iv) to reinstate all security interests if the DUF6 Asset Sale does not close by March 31, 2026, with all remaining terms unchanged. To date, we have not yet removed the security interests against any of our assets related to this note. In August 2025, the 2018 Promissory Note was modified again to extend the maturity date to March 31,2026.2028, with all remaining terms unchanged. At December 31, 2025, accrued interest on the 2018 Promissory Note totaled $55,370.
“In December 2013, we entered into a promissory note agreement with our then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $500,000 (the 2013 Promissory Note). The 2013 Promissory Note is secured and bears interest at 6% per annum and was originally due June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of our common stock based on the average price of the shares over the previous 20 trading days. …”see in full comparison
Full comparison: every changed paragraph (37)
International IsotopesRadnostix Inc. (the “Company”, “we”, “us” and “our”) produces an FDA approved generic sodium iodide I-131 drug product, manufactures a wide range of nuclear medicine calibration and reference standards, produces a variety of cobalt-60 products, and is in development to manufacture and sell medical devices for the nuclear medicine industry. A more detailed description of each of these product lines and services along with a description of our business segments can be found in Item 1, “Business” within this Annual Report.
Total revenues in 20242025 were $13,899,760,$13,070,336, compared to $12,267,385$13,899,760 in 2023,2024, which represents an increasedecrease of $1,632,375,$829,424, or approximately 13%.6%. The performance of each segment is discussed in the following paragraphs.
Sales of Theranostics Products accounted for approximately 58%52% of our sales revenue in 20242025 as compared to 56%58% of our total sales revenue in 2023.2024. Sales in this segment increaseddecreased by $1,163,417,$1,165,221, or approximately 17%15% to $6,841,094 in 2025 as compared to $8,006,315 in 2024 as compared to $6,842,898 in 2023.2024. The increasedecrease is primarily the result of increasedperiodic supplier outages in 2025, totaling approximately $500,000 in lost revenue and decreased sales of our generic sodium iodide I-131 drug product.product to a major customer offset partially offset by expanded sales of our generic sodium iodide I-131 drug product to a new customer and increased API product sales to a returning international customer that was offline for the majority of 2024.
Sales of our FDA-approved generic sodium iodide drug product make up the bulk of sales in this segment. We expect continued growth in sales for this product in 20252026 and beyond. Within this segment, we also currently distribute sodium iodide (I-131) as a theranostics API product and a radiochemical product. The radiochemical product is used for a variety of applications including industrial use, and the theranostics API product is being used in investigational and clinical trials.trials as well as an API for international customers, used in their approved products in their local jurisdictions. We believe that market growth, new customers, and entry into new territories, in addition to any theranostics API that we plan to submit to the FDA,FDA and European Medicines Agency ("EMA"), should increase our future sales in this business segment.
Cobalt Products sales accounted for approximately 17%13% of our total revenue in 20242025 and approximately 8%17% in 2023.2024. Sales in this segment increaseddecreased by $1,328,499,$613,355, or approximately 128%,26%, in 20242025 to $2,365,572,$1,752,217, as compared to $1,037,073$2,365,572 in 2023.2024. The increasedecrease in revenue within this segment was the partially the result of increaseda cobalt-60shutdown salesof duemanufacturing operations in Q4 of 2025 in order to increasesrefurbish our Cobalt production hot cells. As a result of the shutdown, we delayed approximately $350,000 in supplyrevenues to 2026. These refurbishments were completed in Q1 of cobalt-602026 materialand fromwill extend the ATRlife of this important production equipment, and we also expect increased customerproduction activity.efficiency and a decrease in radiological waste expenses, estimated at $150,000 per year, as a result of the repairs. Revenue in the Cobalt Products segment is subject to the variability of cobalt-60 material supply and timing of our cobalt-60 customers' various contracts that utilize our products. Our sealed source manufacturing generates the majority of our revenue within this segment and sealed source sales depend on our ability to produce or procure cobalt-60 material.
We have entered into cobalt-60 supply agreements with several customers. The terms of these cobalt-60 contracts required some advance progress payments from each customer. The funding received under these contracts has been recorded as unearned revenue under short-term liabilities in our consolidated financial statements. We recognized some of this revenue in prior years including in 20242025 and 20232024 when we fulfilled contract performance objectives by supplying sealed sources manufactured with cobalt-60 from the ATR or alternate suppliers. In December 2025, we mutually terminated one of these supply agreements. As part of the termination, we refunded $23,000 and kept $74,000 in advance payments. We were also able to take 100% ownership of mobile hot cell assets which we shared with this customer. We plan to lease the hot cell out to various customers for field service work.
Sales in the Calibration & Reference Products Reference segment accounted for approximately 33% of our total revenue in 2025 as compared to 25% in 2024. Sales in this segment were $4,248,074 in 2025, as compared to $3,519,216 in 2024, this is an increase of $728,858, or approximately 21%. The increase in 2025 was due to continued growth of new products, including PET-focused calibration sources, and recovery from a global shortage of cobalt-57 isotope from January 2024 to the end of July 2024 that resulted in decreased sales for the year. In 2025, we had a full year of cobalt-57 isotope supply. This increase in sales was partially offset by reduced sales from an ongoing global outage of Gadolidium-153 radioisotope that began as a shortage in 2024 and become an outage in January 2025. We have been unable to manufacture any products that utilize this Gd-153 radioisotope. We are currently working with industry partners to restore supply of this isotope, however we are uncertain when we will see sales to return for products utilizing Gd-153. We had $0 of sales of the Gd-153 products in 2025 due to this outage as compared to $210,000 in sales in 2024.
Sales in the Nuclear Medicine Standards segment accounted for approximately 25% of our total revenue in 2024 as compared to 36% in 2023. Sales in this segment were $3,519,216 in 2024, as compared to $4,387,414 in 2023, this is a decrease of $868,198, or approximately 20%. The decrease in 2024 was due to a global shortage of cobalt-57 isotope from January 2024 to the end of July 2024. Due to the shortage of this raw material and our inability to deliver many of our products at that time, sales during this shortage period were approximately $1,000,000 below our projections for this segment. These potential lost sales were slightly offset by total sales of $1,419,503 for the three months ended December 31, 2024, which was the largest quarterly revenue for the Nuclear Medicine Standards segment in the Company's history. Our record 4th quarter 2024 sales for this segment are partly due to pent-up market demand because of the worldwide cobalt-57 shortage. We believe this segment will return to normal recurring revenue and profitability in 2025.
In 20242025 and 2023,2024, we had no revenues related to Fluorine Products. Work on our deconversion facility project that is the entirety of this business segment has been on hold since 2013 because of a slowdown in the nuclear industry that specifically impacted fuel cycle facilities. Since that time, we have limited our expenditures to essential items such as maintenance of the NRC license, land use agreements, communication with our prospective FEP product customers, and interface with the State of New Mexico and Lea County officials. In February 8, 2024, we entered into an asset purchase agreement to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources ("DUF6 Asset Sale"). We expect to close the agreement in the next 12 months subject to certain closing conditions, including approvals and agreements by the U.S. Nuclear Regulatory Commission and other third parties.
On March 11, 2026, we executed a mutual termination of the DUF6 APA dated February 8, 2024 to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to AFR. AFR contacted the Company requesting a 1-year extension due to AFR being unable to make payment of the balance of the purchase price by the Outside Date of March 31, 2026 in order to meet the Condition to Seller’s Obligations as defined in the DUF6 APA. The parties were in the final stages of the NRC consent process and were on the cusp of receiving NRC consent to transfer; however, the parties mutually agreed to withdraw the application and terminate the APA.
AFR already made a non-refundable $50,000 prepayment and twelve non-refundable NRC extension fee payments totaling $120,000 and was to pay an additional $12,450,000 at closing. We decided it was in the best interest of the shareholders to regain control of the assets as we believe they have appreciated in value since we had entered the DUF6 APA and we had low confidence that AFR would be able to secure funding to close the deal by the requested extension date. We will evaluate all possible options for the DUF6 Plant and related assets.
During 2024,2025, we received $50,000$100,000 of other income related to extension payment for the DUF6 Asset SaleAPA and incurred $109,187$114,573 of expenses related to maintaining licenses and permits for the proposed de-conversion project, as compared to $7,920$50,000 of other income related to the DUF6 APA and $113,019$109,187 of expenses in 2023.2024. The largest expense in this business segment is $104,379 for the amortization of our NRC license for this project; this amortization is approximately 96%91% and 92%96% of the total expenses for 20242025 and 20232024 respectively. We expect that our costs in the future will be limited to essential items such as continued interactions with our customers, the state of New Mexico, and Lea County, New Mexico. UponIf we were to sell all our assets related to the closureFluorine ofProducts the DUF6 Asset Sale,segment, we plan to pay down the related notes and dissolve our Fluorine Productsthe segment.
Given the recent boom in nuclear energy and fuel cycle industry and related global investments, the Company will evaluate all possible options for the DUF6 Plant and related assets, including keeping the assets and developing them into an operating entity focused on uranium deconversion. The company will also explore the potential to amend the current NRC approved license to include additional up-stream and down-stream uranium related activities.
Cost of revenues for 20242025 was $5,251,207$5,367,680 as compared to $4,888,409$5,251,207 in 2023,2024, an increase of $362,798,$116,473, or 7%.2%. Gross profit percentage increaseddecreased to 62%59% for 2024,2025, from 60%62% in 2023.2024. The following table presents revenues and cost of revenues information:
During 2024,2025, we continued to monitor and control direct costs. Raw materials used in our Theranostics Products and NuclearCalibration Medicine& StandardsReference Products represented the bulk of direct costs for 2024.2025. In each of these business segments, we have purchase agreements in place with suppliers to obtain optimum pricing. Periodically, the cost can increase for these raw materials or we may also use alternate supply sources for our material which might not carry pricing as favorable as our contracted suppliers.
The increasedecrease in gross profit percentage in 20242025 is a result of increaseda overallchange in our sales activity,mix. We had decreased sales activity in Theranostics Products and Cobalt Products segments and increased sales prices,activity andin betterour costCalibration controls.& Additionally,Reference weStandards havesegment. workedWe continue to work to find more effective cost controls and to increase our overall utilization of our raw materials.
Total operating costs and expenses for 20242025 were $8,641,652,$8,658,843, as compared to $8,155,275$8,641,652 in 2023.2024. This is an increase of $486,377,$17,191, orwhich approximatelyis 6%.less than 1%.
Salaries and contract labor expenses decreasedincreased by $10,259,$468,115, which was the result of aincreased decreaseemployee in non-cash equity compensation expense and executive salaries due to the conclusion of our CEO transition period. These decreases were partially offset by an increase to the number of our employeesheadcount and increases to labor rates due to merit raises and cost-of-living adjustments. Non-cash equity compensation expense recorded for the year ended December 31, 2024,2025, was $199,420$117,822 as compared to $464,041$199,420 for the same period in 2023.2024. This expense is for equity compensation recorded for outstanding stock options and restricted stock units granted to directors, officers, and employees.
General administrative and consulting expenses increaseddecreased 13%7% to $3,732,992 in 2025, as compared to $4,009,019 in 2024,2024. asThis compareddecrease was due to $3,545,766 in 2023.decreased Legal and professional expenses increased approximately $285,000 in 2024 as compared to 2023. We had one-time professional expenses of approximately $170,000 in 2024 related to legal consulting and rootdecreased causewaste audits for NRC enforcement and settlement for a violation that occurred in 2022. The remaining $115,000 increase in legal and professional expenses is due to increased activity in business development in all business segments and the building out of our Medical Devices segment.expenses. General and Administrative expenses also included waste disposal costs of $229,540$150,000 in 20242025 as compared to $181,804$229,540 in 2023.2024. Research and development expense was $610,737$435,840 for 2024,2025, compared to $577,354$610,737 for 2023.2024. This is ana increasedecrease of $33,383,$174,897, or approximately 6%.29%. This increasedecrease in research and development expenses was the result of increaseddecreased costs associated with product development in our Medical Device segment.
Other income was $207,966 for 2024 as compared to other income of $160,173 for 2023. This increase of $47,793 was due to an increase in miscellaneous income partially offset by $63,000 of other expense for NRC fines. We have taken extensive internal actions to mitigate the risk of any similar violations and penalties occurring again. These matters have been finalized with the NRC.
InterestOther income in 2024 was $122,385$310,838 for 2025 as compared to $78,890other inincome 2023.of $207,966 for 2024. This increase of $43,495$102,872 was due to increasedan interest rates and increased cash balances held at banks and other institutionsincrease in interest-bearingmiscellaneous accounts.income.
Interest income in 2025 was $76,628 as compared to $122,385 in 2024. This decrease of $45,757 was due to decreased interest rates and decreased cash balances held at banks and other institutions in interest-bearing accounts.
Interest expense decreasedincreased during 2024,2025, to $328,678,$339,281, from $331,780$328,678 in 2023.2024. This decreaseincrease of $3,102,$10,603, or approximately 1%,3%, was due to decreasedincreased interest for notes payable. Interest expense includes dividends accrued on our Series C Preferred Stock (as defined below) issued in 2017. In 20242025 and 20232024 we recorded interest expense of $243,030$243,780 and $244,530,$243,030, respectively, for dividends payable on our Series C Preferred Stock.
Our net incomeloss was $8,574$908,002 in 2024,2025, compared to a net lossincome of $869,016$8,574 in 2023.2024. This is ana increasedecrease in net income of $877,590.$916,576. This decrease is the result of increaseddecreased revenue and profit margin in 20242025 as compared to 2023.2024.
At December 31, 2024,2025, we had cash and cash equivalents of $1,945,523$1,695,158 compared to $2,688,141$1,945,523 at December 31, 2023.2024. Restricted cash, which is included in long-term assets increasedwas $1,492,227 at December 31, 2025 compared to $1,431,710 at December 31, 2024 compared to $880,752 at December 31, 2023.2024. This increase in Restricted Cash was due to requirementsinterest for increased reserved cash requirements as part of revisions to our Decommissioning Funding Plan.income. Net cash provided by operating activities was $638,783$620,163 in 2024,2025, compared to net cash provided by operating activities of $582,589$638,783 in 2023.2024. This represents ana increasedecrease in cash provided by operating activities of $56,194. This increase is due to improved operational performance, an increase in accounts payable and decreased inventory, partially offset by increased accounts receivable and decreased unearned revenues in the year over year comparison.$18,620.
We recognized net incomeloss of $8,574,$908,002, for the year ended December 31, 2024,2025, and have an accumulated deficit of $127,321,285$128,229,287 since inception. To date, our operations and plant and equipment expenditures have been funded principally from proceeds from public and private sales of debt and equity as well as through asset sales.
Net cash used in investing activities was $534,155 for 2025 and net cash used in investing activities was $685,215 for 20242024. During 2025, we used $534,155 to purchase equipment and netleasehold cashimprovements. used in investing activities was $149,058 for 2023. During 2024, weWe used $551,215 to purchase equipment and leasehold improvements and $170,000 towards our purchase of land. We used $149,058 to purchase equipmentland in 2023.2024. We had proceeds from sale of equipment of $36,000 in 2024, and we had no proceeds from sale of equipment in 2023.2025.
Financing activities used cash of $275,856 for the year ended December 31, 2025. We received proceeds from the sale of common stock in the amount of $20,259 and made principal payment on loans in the amount of $296,115 in 2025. For the year ended December 31, 2024, financing activities used cash of $145,228. We received proceeds from the sale of common stock in the amount of $11,969 and made principal payment on loans in the amount of $154,365 in 2024.
Financing activities used cash of $145,228 for the year ended December 31, 2024. We received proceeds from the sale of common stock in the amount of $11,969 and made principal payment on loans in the amount of $154,365 in 2024. For the year ended December 31, 2023, financing activities used cash of $80,504. We received proceeds from the sale of common stock in the amount of $8,398 and made principal payment on loans in the amount of $83,389 in 2023.
In December 2013, we entered into a promissory note agreement with the chairman of our board of directors at the time and one of our major shareholders, pursuant to which we borrowed $500,000 (the “2013 Promissory Note”). The 2013 Promissory Note is secured and bears interest at 6% per annum and was originally due June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of our common stock. Pursuant to four modifications in the time period between June 2014 and January 2022, the 2013 Promissory Note was modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In February 2024, the 2013 Promissory Note was modified again to (i) extend the maturity date to March 31, 2026, (ii) remove the security provision to allow for the sale of all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to American Fuel Resources, LLC (the “DUF6 Asset Sale”), (iii) if reasonably possible, to reinstate a security provision against our Sodium iodide abbreviated new drug application (“ANDA”) and Iodine-131 Processing Hot Cell, and (iv) to reinstate all security interests if the DUF6 Asset Sale does not close by March 31, 2026, with all remaining terms unchanged. To date, we have not yet removed the security interests against any of our assets related to this note. In August 2025, the 2013 Promissory Note was modified again to extend the maturity date to March 31, 2028, with all remaining terms unchanged. At December 31, 2025, accrued interest payable on the 2013 Promissory Note was $361,734.
In December 2013, we entered into a promissory note agreement with our then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $500,000 (the 2013 Promissory Note). The 2013 Promissory Note is secured and bears interest at 6% per annum and was originally due June 30, 2014. According to the terms of the 2013 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of our common stock based on the average price of the shares over the previous 20 trading days. In connection with the 2013 Promissory Note, each of the two lenders was issued 5,000,000 Class L warrants to purchase shares of our common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In June 2014, we renegotiated the terms of the 2013 Promissory Note. Pursuant to the modification, the maturity date was extended to December 31, 2017 and each lender was granted an additional 7,500,000 Class L warrants to purchase shares of our common stock at an exercise price of $0.06 per share. The warrants were immediately exercisable. In February 2017, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2020, with all remaining terms unchanged. On December 23, 2018, all 25,000,000 Class L warrants expired. In December 2019, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2021, with all remaining terms unchanged. In January 2022, the 2013 Promissory Note was further modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In February 2024, the 2013 Promissory Note was further modified to extend the maturity date to March 31, 2026.
In April 2018, we borrowed $120,000 from our then Chief Executive Officer and Chairman of the Board pursuant to a promissory note (the 2018 Promissory Note). The 2018 Promissory Note accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. The 2018 Promissory Note was originally unsecured and originally matured on August 1, 2018. At any time, the holder of the 2018 Promissory Note may elect to have any or all the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days. Pursuant to an amendment to the 2018 Promissory Note in June 2018, the maturity date was extended to March 31, 2019 with all other provisions remaining unchanged. Pursuant to a second amendment to the 2018 Promissory Note in February 2019, the maturity date was extended to July 31, 2019 with all other provisions remaining unchanged. Pursuant to a third amendment to the 2018 Promissory Note in July 2019, the maturity date was extended to January 31, 2020 with all other provisions remaining unchanged. Pursuant to a fourth amendment to the 2018 Promissory Note in December 2019, the maturity date was extended to December 31, 2021, and the note was modified to become secured by company assets, with all other provisions remaining unchanged. In December 2021, the 2018 Promissory Note was further modified to extend the maturity date to December 31, 2023, with all remaining terms unchanged. In December 2023, the 2018 Promissory Note was further modified to extend the maturity date to January 31, 2025. In February 2024, the 2018 Promissory Note was further modified to extend the maturity date to March 31, 2026.
In DecemberApril 2019,2018, we enteredborrowed into$120,000 from our chief executive officer and the current chairman of our board of directors (“Chairman”) through an affiliated entity pursuant to a promissory note agreement with our then Chief Executive Officer, Chairman of the Board, former Chairman of the Board, and one of our major shareholders (the 2019“2018 Promissory Note”). The 2019 Promissory Note authorizes us to borrow up to $1,000,000. As of December 31, 2019, we borrowed $675,000 under the 2019 Promissory Note; the remaining $325,000 was borrowed in February 2020. The 20192018 Promissory Note is secured and bearsaccrues interest at 4%6% per annumannum, andwhich hasis apayable upon maturity date of December 31, 2022. According to the terms of the 20192018 Promissory Note,Note. atAt any time, athe holderholders of the 20192018 Promissory Note may elect to have any or all of the principal and accrued interest settled with shares of our common stock based on the average price of the shares over the previous 20 trading days. InThe connection2018 withPromissory Note was originally due August 1, 2018. Pursuit to six modifications within the 2019 Promissory Note, we issued 30,000,000 Class O Warrants with a termperiod of fiveJune years2018 toand purchaseDecember shares of our common stock at $0.045 per share (the Class O Warrants). All2023, the Class O Warrants were exercised in January 2021. In December 2022, the 20192018 Promissory Note was modified to extend the maturity date to DecemberJanuary 31, 2024,2025, with all remaining terms unchanged. In February 2024, the 20192018 Promissory Note was furthermodified to (i) extend the maturity date to March 31, 2026, (ii) remove the security provision to allow for the DUF6 Asset Sale, (iii) if reasonably possible, to reinstate a security provision against our sodium iodide ANDA and iodine-131 Processing Hot Cell, and (iv) to reinstate all security interests if the DUF6 Asset Sale does not close by March 31, 2026, with all remaining terms unchanged. To date, we have not yet removed the security interests against any of our assets related to this note. In August 2025, the 2018 Promissory Note was modified again to extend the maturity date to March 31, 2026.2028, with all remaining terms unchanged. At December 31, 2025, accrued interest on the 2018 Promissory Note totaled $55,370.
In December 2019 and February 2020, we borrowed an aggregate of $1,000,000 from our chief executive officer, Chairman, former Chairman, and one of our major shareholders pursuant to a promissory note (the “2019 Promissory Note”). The 2019 Promissory Note bears an interest rate of 4% annually and was originally due December 31, 2022. According to the terms of the 2019 Promissory Note, at any time, the lenders may settle any or all of the principal and accrued interest with shares of the Company’s common stock based on the average closing price of the Company’s common stock for the 20 days preceding the payment. In December 2022, the 2019 Promissory Note was modified to extend the maturity date to December 31, 2024, with all remaining terms unchanged. In February 2024, the 2019 Promissory Note was modified to (i) extend the maturity date to March 31, 2026, (ii) remove the security provision to allow for the DUF6 Asset Sale, (iii) if reasonably possible, to reinstate a security provision against our sodium iodide ANDA and Iodine-131 Processing Hot Cell, and (iv) to reinstate all security interests if the DUF6 Asset Sale does not close by March 31, 2026, with all remaining terms unchanged. To date, we have not yet removed the security interests against any of our assets related to this note. In August 2025, the 2019 Promissory Note was modified again to extend the maturity date to March 31, 2028, with all remaining terms unchanged. At December 31, 2025, the accrued interest on the 2019 Promissory Note totaled $239,131.
We expect that cash from operations, cash obtained through securities offerings,operations and our current cash balance will be sufficient to fund operations for the next twelve months. Although we may need to seek additional debt financing forto fund operations or our projects and operations in the future, there is no assurance that we will be able to secure additional debt financing on acceptable terms to us, or at all.
Based upon the investments we have made in our facilities and investments we anticipate making, and based on projects, and products we developed in 2024,2025, we have the following goals for 20252026:
Asset retirement obligation – The asset retirement obligation is based on the expected future cash flows of the decommissioning funding plan. The decommissioning funding plan is based on the estimated number of hours of specific personnel, estimated wages and disposal costs. Once the decommissioning funding plan has been developed, we will use a discount rate to determine the estimated current value of the liability.
What changed in the latest 10-Q
Risk Factors
Removed heading “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.”
Removed heading “We may be subject to NRC license enforcement actions.”
Largest changes
“We are subject to ongoing NRC regulations, including complying with the NRC’s current Code of Federal Regulations (CFR) requirements, and are subject to regular inspections of our facilities. 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. …”see in full comparison
“We 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.”see in full comparison
“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.”see in full comparison
“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. …”see in full comparison
“To our knowledge and based upon review of FDA publications, we are the only domestic-based manufacturer of finished 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:”see in full comparison
Full comparison: every changed paragraph (14)
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 (for example: 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 our Calibration & Reference Products, Cobalt Product, and Theranostics Products segments.
We are in ongoing discussions regarding the long-term viability of some territorial or regional distributors and may need to procure new distributors. If we are unable to do so, we would have a loss of revenue.
We 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.
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 the end of 2026; however. if we are unable to do so, we would experience a loss of revenue in the Calibration & Reference Products segment.
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 loss of revenue for our Theranostics Products segment. In June of 2025, 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 finished 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 have in the past and may in the future, impede our ability to meet product demand for our customers, which would harm our sales and revenues.
In April 2025, an FDA inspection at our Idaho Falls facility resulted in an Official Action Indicated ("OAI"). RNX has developed and implemented corrective actions and submitted our 15-day, 90-day, and 180-day, 270-day, and subsequently submitted our 1-year updates. UponIn the completion of our corrective actions, we will submitresponse to the FDA Form 483 issued in April 2025, the Company completed all planned corrective and willpreventive actions. A request afor reinspectioninspection ofcloseout was submitted to the facilities.FDA on June 19, 2026. In addition, the Company continues to execute initiatives designed to strengthen its Quality Management System, with all actions scheduled for completion in July 2026 completed on time. There is a risk of additional action by the FDA up to and including a manufacturing and distribution hold or a warning letter. RNX continues to manufacture and distribute during the on-going corrective action implementation, and we believe we are on a pathway to implement and finalize our corrective actions within Q2 of 2026, and without any adverse effect on our business, results of operations and financial condition. While we believe that our corrective actions in response to the OAI will be deemed satisfactory, there can be no assurance that the FDA will not require additional corrective actions or take further actions as listed above.
In the three months ended March 31, 2026, we had two product recalls. Both recalls are being conducted with the knowledge of the FDA. The first was a voluntary recall of our Generic Sodium Iodide I-131 due to the discovery of septum in our finished product vials on January 26, 2026. We had recently been approved by the FDA to implement new septum for our finished products, with this change we discovered the septum did not perform equivalent to our previous testing and validation. The impact from this recall was limited to that first batch. The second recall was on February 19, 2026. We discovered during an internal review that specific lots of our Dibasic Sodium Phosphate Capsules that may be provided with our Generic Sodium Iodide I-131 kits manufactured between 2022 and 2025 were out of specification for final capsule weight. We initiated a voluntary recall of specific lots of our Dibasic Sodium Phosphate Capsules shipped between August 19, 2024 to February 17, 2026. We notified affected pharmacies, clinics, and veterinarians of the voluntary recall. We continue to provide Generic Sodium Iodide I-131, which was not impacted, to the majority of our customerscustomers. Both voluntary recalls have been fully executed and are currently awaiting formal closeout by the FDA.
We may be subject to NRC license enforcement actions.
We are subject to ongoing NRC regulations, including complying with the NRC’s current Code of Federal Regulations (CFR) requirements, and are subject to regular inspections of our facilities. 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 2025 we entered into a settlement agreement with the NRC related to our 2022 asset 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, starting on September 30th, 2025. We do not anticipate any material costs from the settlement, however our strict adherence to the confirmatory orders is required through the 36-month period and any violation way bring NRC action.
Management's Discussion & Analysis (MD&A)
Largest changes
“We had a net loss of $2,230,083 for the six months ended June 30, 2026 compared to net loss of $273,479 for the same period in 2025. This increase in net loss of $1,956,604 for the period ended was also the result of lost sales in our Theranostics Products due to the effects from two voluntary product recalls during January and February of 2026 as discussed in more detail below, decreased sales in our Cobalt Products segment due to the rehabilitation of our process hot cells during the period and timing of cobalt source projects, and decreased sales in our Calibration & Reference Products. …”see in full comparison
“Cost of product for Theranostics Products decreased to $450,522 for the three months ended June 30, 2026, as compared to $504,832 for the same period in 2025. This is a decrease of $54,310, or approximately 11%. Cost of product decreased to $1,008,786 for the six months ended June 30, 2026, as compared to $1,010,000 for the same period in 2025. This is a decrease of $1,214, or less than 1%. The decreases in Cost of Product during the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were the result of decreased sales. …”see in full comparison
“The decreases in sales during the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were largely due to two voluntary recalls: The first was a voluntary recall of our Generic Sodium Iodide I-131 due to the discovery of septum in our finished product vials on January 26, 2026. We had recently been approved by the FDA to implement new septum for our finished products, with this change we discovered the septum did not perform equivalent to our previous testing and validation. …”see in full comparison
“The decreases in sales during the three months ended March 31, 2026 was partially due to two voluntary recalls: The first was a voluntary recall of our Generic Sodium Iodide I-131 due to the discovery of septum in our finished product vials on January 26, 2026. We had recently been approved by the FDA to implement new septum for our finished products, with this change we discovered the septum did not perform equivalent to our previous testing and validation. The impact from this recall was limited to that first batch and resulted in $60,000 of lost revenue. …”see in full comparison
“Sale of product includes distribution of various third-party products. We plan to commercialize additional third-party medical devices and accessories related to the radiopharmaceutical and theranostics spaces and provide engineering, installation, and preventative maintenance and services related to those medical devices. We are also in development for our Swirler® and Tru-Fit™ Mouthpiece products which will be under the branding of RadVent. These products are based on assets and intellectual property rights we acquired previously from AMICI, Inc. …”see in full comparison
“Sale of product includes distribution of various third-party products. We plan to commercialize additional third-party medical devices and accessories related to the radiopharmaceutical and theranostics spaces and provide engineering, installation, and preventative maintenance and services related to those medical devices. We are also in development for our Swirler® and Tru-Fit™ Mouthpiece products which will be under the branding of RadVent. These products are based on assets and intellectual property rights we acquired previously from AMICI, Inc. …”see in full comparison
Full comparison: every changed paragraph (86)
Radnostix Inc. and its wholly-owned subsidiaries (including RadQual, LLC, TI Services, LLC, RadVent, LLC, International Isotopes Idaho Inc., International Isotopes Fluorine Products, Inc., and International Isotopes Transportation Services, Inc.) (collectively, the "Company", "we", "our", or "us") manufacture a full range of nuclear medicine calibration and reference standards, manufacture a range of cobalt products, and distribute sodium iodide I-131 as a generic drug. We own 100% of RadQual, LLC (RadQual), a global supplier of molecular imaging quality control and calibration devices. As TI Services, LLC is a 50/50 joint venture between the Company and RadQual, TI Services, LLC is also a wholly-owned subsidiary of the Company.
We have explored, and intend to continue to explore, opportunities to further develop cobalt-60 and other high-energy and high-activity products and sales on an ongoing basis.basis, including new suppliers of cobalt-60 and the applications of cobalt-60 in radioisotope thermoelectric generators (RTGs). The production, use, transport, and import/export of these products are all heavily regulated by the NRC and DOT, state and local agencies as well as similar regulatory authorities in territories outside of the United States (i.e., EU, China, Australia, Brazil and Argentina), but we have developed a highly experienced staff of technicians, shipping specialists, and supervisors in order to comply with the regulations and to deliver these products in a cost-effective, timely manner.
We believe that our domestically manufactured products and service offerings provide us with a competitive edge over other foreign cobalt-60 manufacturers.
In 2022 we entered a joint venture to develop the EasyFill Automated Capsule System, a robotic lab device to be paired with our Theranostics Products. The EasyFill is still in the developmental stage. We are targeting a Q3 2026 roll out and Q2 2027 commercial ramp up, including additional sales of I-131.
We are currently in development of the EasyFill Iodine Encapsulation System, a robotic lab device to be paired with our Theranostics Products. The EasyFill is still in the developmental stage. We are targeting a Q1 2027 roll out and Q3 2027 commercial ramp up, including additional sales of I-131. In 2023, we entered into an asset purchase agreement with AMICI, Inc. to purchase manufacturing molds, device registrations, trademarks, and all production rights to several AMICI, Inc. medical device and accessory products for lung ventilation; this included the Swirler Radioaerosol System and Tru-Fit mouthpiece products. In January 2025, as part of an amendment to the AMICI, Inc. asset purchase agreement, we received the manufacturing molds, device registrations, trademarks, and all production rights to the AMICI, Inc. line of Xenon System products. These acquired assets from AMICI, Inc. are currently under development and are expected to be released in Q3Q1 20262027 to be sold through our RadVent subsidiary. In 2024, our Medical Device segment entered into a distribution and servicing agreement with Scintomics ATT for their complete line of radiosynthesis modules; to date, all of our revenue in the Medical Devices segment comes from the sale of third party products. On June 25, 2026 the Company entered into an Asset Purchase Agreement with Lucerno Dynamics, LLC for certain assets related to the Lara System technology platform and the Ellexa Explorer Software, and all related accessories, parts, consumables, equipment, software, regulatory approval, intellectual property, and hardware associated with these systems. The Company has been working on asset transfers and registrations related to the sale. In addition to revenue from the existing Lara and Ellexa platform, the acquired IP carries additional applications in radiation detection, such as uptake, dosimetry, quantification, and integration into auto-infusion drug delivery systems, which the Company currently plans to explore the feasibility of developing and commercializing such IP.
On March 11, 2026, we executed a mutual termination of the DUF6 Asset Sale dated February 8, 2024 to sell all our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility to AFR. AFR contacted the Company requesting a 1-year extension due to AFR being unable to make payment of the balance of the purchase price by the Outside Date of March 31, 2026 in order to meet the Condition to Seller’s Obligations as defined in the DUF6 Asset Sale. The parties were in the final stages of the NRC consent process and were on the cusp of receiving NRC consent to transfer; however, the parties mutually agreed to withdraw the application and terminate the APA. AFR already made a non-refundable $50,000 prepayment and twelve non-refundable NRC extension fee payments totaling $120,000 and was to pay an additional $12,450,000 at closing. We decided it was in the best interest of the shareholders to regain control of the assets as we believe they have appreciated in value since we had entered the DUF6 Asset SaleSale, and we had low confidence that AFR would be able to secure funding to close the deal by the requested extension date. We willare evaluatereviewing all possible options for the DUF6 Plant and related assets. Given the recent boom in nuclear energy and fuel cycle industry and related global investments, the Company willactively evaluateworking alltowards possible options formonetizing the DUF6NRC Plantlicense and related assets, including keeping the assets and developing them into an operating entity focused on uranium deconversion. The company will also explore the potential to amend the current NRC approved license to include additional up-stream and down-stream uranium related activities.assets.
Three and Six Months Ended MarchJune 31,30, 2026, Compared to the Three and Six Months Ended MarchJune 31,30, 2025
Sale of Product for the three months ended March 31, 2026 was $2,378,924 as compared to $3,238,900 for the same period in 2025, an overall decrease of $859,976, or approximately 27%. This decrease in sales was the result of lost sales in our Theranostics Products segment due to voluntary recalls of our Generic Sodium Iodide I131 on January 26, 2026, and of our Dibasic Sodium Phosphate Capsules on February 19, 2026 as discussed in more detail below, decreased sales in our Cobalt Products segment due to operational shutdown for the rehabilitation of our process hot cells during the three months ended March 31, 2026, and decreased sales in our Calibration & Reference Products, as discussed in more detail below.
The following table presents a period-to-period comparison of total revenue by segment for the three months ended March 31, 2026:
Cost of product increased to $1,227,976 for the three months ended March 31, 2026 from $1,206,863 for the same period in 2025. This is an increase of $21,113, or approximately 2%. The increase in cost of product was partially due to adjustments for accounting for labor hours beginning in the three months ended March 31, 2026. We evaluated and updated our policies for classifying and recording direct labor hours. The adjustments resulted in an increased allocation of these labor costs to cost of product. We believe these updates will better reflect costs allocation for our current operations. Gross profit for the three months ended March 31, 2026 was $1,150,948, compared to $2,032,037 for the same period in 2025. This represents a decrease in gross profit of $881,089, or approximately 43%, compared to the same period in 2025. This decrease is due to decreased sale of product and increased cost of product.
The following table presents cost of product and gross profit data for each of our business segments for the three months ended March 31, 2026:
For the three months ended March 31, 2026, total operating costs and expenses in all segments increased approximately 17% to $2,460,980 from $2,097,053 for the same period in 2025. This increase of $363,927 in the three months ended March 31, 2026 was due to increased General, Administrative, and Consulting expenses due increases in professional expenses, increased Salaries and Contract Labor expenses due to increases in stock-based compensation expense which included an out-of-period adjustment of $102,441, and increased Research and Development expenses due to increased development activity in our Medical Device Products segment.
The following table presents a comparison of total operating expenses for the three months ended March 31, 2026 and 2025:
Other income was $32,475 for the three months ended March 31, 2026 as compared to other income $14,349 for the same period in 2025. This is an increase of $18,126, or approximately 126% that was due to extension payments as part of the Flourine Products Asset Sale.
InterestSale expenseof Product for the three months ended MarchJune 31,30, 2026 was $84,869,$2,671,785 as compared to $83,851$3,655,320 for the same period in 2025. This is2025, an increaseoverall decrease of $1,018,$983,535, or approximately 1%.27%.
Sale of Product for the six months ended June 30, 2026 was $5,050,709 as compared to $6,894,220 for the same period in 2025, an overall decrease of $1,843,511, or approximately 27%.
Interest expense includes dividends accrued on our Series C Preferred Stock. As discussed below, we issued Series C Preferred Stock in February 2017 and May 2017. For the three months ended March 31, 2026 and 2025, we accrued dividends payable of $60,945 and $60,945 respectively, which have been recorded as interest expense. See Note 6 “Debt” to our unaudited consolidated financial statements in this Quarterly Report for additional information about our indebtedness and the associated interest expense.
WeThis haddecrease ain net loss of $1,348,086sales for the three months and six months ended MarchJune 31,30, 2026 , as compared to net loss of $112,694 for the same periodperiods in 2025. This increase in net loss of $1,235,392 for the quarter2025 was the result of lost sales in our Theranostics Products segment due to the effects from two voluntary product recalls of our Generic Sodium Iodide I131 onduring January 26, 2026 and of our Dibasic Sodium Phosphate Capsules on February 19,of 2026 as discussed in more detail below,below and decreased sales in our Cobalt Products segment due to operational shutdown for the rehabilitation of our process hot cells during the three months ended March 31, 2026,2026 andalong decreasedwith timing of cobalt projects. For the three months ended June 30, 2026 there was an increase to sales in our Calibration & Reference Products,Products and decrease in sales for our Medical Device Products segment. For the six months ended June 30, 2026 we had a decrease in sales in our Calibration & Reference Products segment and an increase in sales in our Medical Device Products segment, as discussed in more detail below. Additionally, the increase in net loss was due to increased operating expenses due to increases in professional expenses, stock-based compensation expense which included an out-of-period adjustment of $102,441, and increased Research and Development expenses due to increased development activity in our Medical Device Products segment.
The following table presents a period-to-period comparison of total revenue by segment for the three and six months ended June 30, 2026 and June 30, 2025:
Cost of product decreased to $1,312,550 for the three months ended June 30, 2026 from $1,513,761 for the same period in 2025. This is a decrease of $201,211, or approximately 13%.
Cost of product decreased to $2,540,526 for the six months ended June 30, 2026 from $2,720,624 for the same period in 2025. This is a decrease of $180,098, or approximately 7%.
The decrease in cost of product for the three months and six months ended June 30, 2026, as compared to the same periods in 2025 was due to decreased sales overall which was partially offset by adjustments for accounting for labor hours beginning in 2026. We evaluated and updated our policies for classifying and recording direct labor hours. The adjustments result in an increased allocation of these labor costs to cost of product. We believe these updates will better reflect costs allocation for our current operations.
Gross profit for the three months ended June 30, 2026 was $1,359,235, compared to $2,141,559 for the same period in 2025. This represents a decrease in gross profit of $782,324, or approximately 37%, compared to the same period in 2025.
Gross profit for the six months ended June 30, 2026 was $2,510,183, compared to $4,173,596 for the same period in 2025. This represents a decrease in gross profit of $1,663,413, or approximately 40%, compared to the same period in 2025.
The decreases in cost of product for the three months and six months ended June 30, 2026, as compared to the same periods in 2025 is due to decreased sales of product and increases to cost of product.
The following table presents cost of product and gross profit data for each of our business segments for the three and six months ended June 30, 2026 and June 30, 2025:
For the three months ended June 30, 2026, total operating costs and expenses in all segments decreased approximately 4% to $2,193,484 from $2,276,400 for the same period in 2025. This decrease of $82,916 in the three months ended June 30, 2026 was due to decreased General, Administrative, and Consulting expenses due to decreases in waste expenses for our Cobalt Products segment, partially offset by increased Salaries and Contract Labor expenses due to increases in stock-based compensation expense and increased Research and Development expenses due to increased development activity in our Medical Device Products segment.
For the six months ended June 30, 2026, total operating costs and expenses in all segments increased approximately 6% to $4,654,464 from $4,373,453 for the same period in 2025. This increase of $281,011 in the six months ended June 30, 2026 was due to increased Salaries and Contract Labor expenses due to increases in stock-based compensation expense, which included an out-of-period adjustment of $102,441 in Q1 2026, and increased Research and Development expenses due to increased development activity in our Medical Device Products segment. These increases were partially offset by decreased General, Administrative, and Consulting expenses due to decreases in waste expenses for our Cobalt Products segment.
The following table presents a comparison of total operating expenses for the three and six months ended June 30, 2026 and 2025:
Other income was $21,821 for the three months ended June 30, 2026 as compared to other income $38,095 for the same period in 2025. This is a decrease of $16,274, or approximately 43%. Other income was $54,296 for the six months ended June 30, 2026 as compared to other income $52,444 for the same period in 2025. This is an increase of $1,852, or approximately 4%. The differences in both the three months and six months ended June 30, 2026 as compared to the same periods in 2025 were due to timing of extension payments from April 2025 through March 2026 as part of the Flourine Products Asset Sale.
Interest expense for the three months ended June 30, 2026 was $84,010, compared to $82,807 for the same period in 2025. This is an increase of $1,203, or approximately 1%. Interest expense for the six months ended June 30, 2026 was $168,879, compared to $166,658 for the same period in 2025. This is an increase of $2,221, or approximately 1%.
Interest expense includes dividends accrued on our Series C Preferred Stock. As discussed below, we issued Series C Preferred Stock in February 2017 and May 2017. For the three months ended June 30, 2026 and 2025, we accrued dividends payable of $60,945 for both periods, which have been recorded as interest expense. For the six months ended June 30, 2026 and 2025 we accrued dividends of $121,890 for both periods. See Note 6 “Debt” to our unaudited consolidated financial statements in this Quarterly Report for additional information about our indebtedness and the associated interest expense.
We had a net loss of $881,997 for the three months ended June 30, 2026 compared to net loss of $160,785 for the same period in 2025. This increase in net loss of $721,212 for the quarter was the result of lost sales in our Theranostics Products due to the effects from two voluntary product recalls during January and February of 2026 as discussed in more detail below, decreased sales in our Cobalt Products segment due to timing of projects. This was partially offset by increased sales in our Calibration & Reference Products. The increase in net loss was partially offset by decreased operating expenses.
We had a net loss of $2,230,083 for the six months ended June 30, 2026 compared to net loss of $273,479 for the same period in 2025. This increase in net loss of $1,956,604 for the period ended was also the result of lost sales in our Theranostics Products due to the effects from two voluntary product recalls during January and February of 2026 as discussed in more detail below, decreased sales in our Cobalt Products segment due to the rehabilitation of our process hot cells during the period and timing of cobalt source projects, and decreased sales in our Calibration & Reference Products. Additionally, the increase in net loss was due to increased operating expenses resulting from increased Salaries and Contract Labor expenses from increases in stock-based compensation expense, which included an out-of-period adjustment of $102,441, and increased Research and Development expenses due to increased development activity in our Medical Device Products segment. This was partially offset by decreased General, Administrative, and Consulting expenses due to decreases in waste expenses for our Cobalt Products segment.
Sales of Theranostics Products for the three months ended MarchJune 31,30, 2026 were $1,397,282,$1,078,127, compared to $1,787,054$1,905,402 for the same period in 2025. This is a decrease of $389,772,$827,275, or approximately 22%43% during the three months ended MarchJune 31,30, 2026.
The decreases in sales during the three months ended March 31, 2026 was partially due to two voluntary recalls: The first was a voluntary recall of our Generic Sodium Iodide I-131 due to the discovery of septum in our finished product vials on January 26, 2026. We had recently been approved by the FDA to implement new septum for our finished products, with this change we discovered the septum did not perform equivalent to our previous testing and validation. The impact from this recall was limited to that first batch and resulted in $60,000 of lost revenue. The second voluntary recall was due to the finished specifications of Dibasic Sodium Phosphate Capsules on February 19, 2026. On February 19, 2026, the Company, which is a manufacturer of its Generic Sodium Iodide I-131, discovered during an internal review that specific lots of our Dibasic Sodium Phosphate Capsules that may be provided with our Generic Sodium Iodide I-131 kits manufactured between 2022 and 2025 were out of specification for final capsule weight. We initiated a voluntary recall of specific lots of our Dibasic Sodium Phosphate Capsules shipped between August 19, 2024 to February 17, 2026 and a Field Alert Report for the expired lots from 2021 to 2024. We have notified affected pharmacies, clinics, and veterinarians of the voluntary recall. Both recalls have been conducted with the knowledge of the FDA. We issued customer credits of approximately $50,000 in the first quarter of 2026 related to refunds to certain customers. We wrote off our impaired capsule inventory of approximately $75,000 in 4Q 2025 and will restore our capsule inventory in Q2 2026. We continue to provide Generic Sodium Iodide I-131, which was not impacted. The majority of our customers have continued to order this material despite the lack of capsule inventory. But we are currently losing approximately $65,000 per week in sales for the customers that require capsules with their orders. We believe the impact from the recall will not extend beyond the 2nd quarter. Our business has not been impacted by the recall beyond the impacts addressed above.
Cost of product for Theranostics Products increased to $558,266 for the three months ended March 31, 2026, as compared to $505,168 for the same period in 2025. This is an increase of $53,098, or approximately 11%, and was the result of the cost associated with the two recalls. Gross profit of Theranostics Products for the three months ended March 31, 2026 was $839,016, compared to $1,281,886 for the same period in 2025, and gross profit percentage was approximately 60% and 72% for three months ended March 31, 2026 and 2025 respectively.
OperatingSales expensesof forTheranostics this segment increased to $432,118Products for the threesix months ended MarchJune 31,30, 2026,2026 were $2,475,409, compared to $404,892$3,692,456 for the same period in 2025. This inis ana increase in operating expensesdecrease of $27,226,$1,217,047, or approximately 7%33% dueduring tothe increasedsix salarymonths andended laborJune costs.30, 2026.
The decreases in sales during the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were largely due to two voluntary recalls: The first was a voluntary recall of our Generic Sodium Iodide I-131 due to the discovery of septum in our finished product vials on January 26, 2026. We had recently been approved by the FDA to implement new septum for our finished products, with this change we discovered the septum did not perform equivalent to our previous testing and validation. The impact from this recall was limited to that first batch and resulted in $60,000 of lost revenue. The second voluntary recall was due to the finished specifications of Dibasic Sodium Phosphate Capsules. On February 19, 2026, the Company, which is a manufacturer of its Generic Sodium Iodide I-131, discovered during an internal review that specific lots of our Dibasic Sodium Phosphate Capsules that may be provided with our Generic Sodium Iodide I-131 kits manufactured between 2022 and 2025 were out of specification for final capsule weight. We initiated a voluntary recall of specific lots of our Dibasic Sodium Phosphate Capsules shipped between August 19, 2024 to February 17, 2026 and a Field Alert Report for the expired lots from 2021 to 2024. We notified affected pharmacies, clinics, and veterinarians of the voluntary recall. We issued customer credits of approximately $50,000 in the first quarter of 2026 related to refunds to certain customers. We wrote off our impaired capsule inventory of approximately $75,000 in the fourth quarter of 2025. We continued to provide Generic Sodium Iodide I-131, which was not impacted. The majority of our customers continued to order this material during the time we had no capsules. For the customers that require capsules with their orders, we lost an estimated $850,000 in revenue during the six months ended June 30, 2026. This includes approximately $625,000 in lost revenue during the three months ended June 30, 2026. We were able to restore our capsule inventory at the end of June 2026. Customer volumes returned and sales were normalized in July 2026. Both recalls have been fully executed. All required documentation was submitted to the FDA in June 2026, and we are awaiting formal closeout of the recall. Our business has not been impacted by the recall beyond the impacts addressed above.
Cost of product for Theranostics Products decreased to $450,522 for the three months ended June 30, 2026, as compared to $504,832 for the same period in 2025. This is a decrease of $54,310, or approximately 11%. Cost of product decreased to $1,008,786 for the six months ended June 30, 2026, as compared to $1,010,000 for the same period in 2025. This is a decrease of $1,214, or less than 1%. The decreases in Cost of Product during the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were the result of decreased sales. This was partially offset by costs associated with the two recalls and by adjustments for accounting for labor hours to all segments that began in 2026 that increased the allocation to Cost of Product as discussed above.
Gross profit of Theranostics Products for the three months ended June 30, 2026 was $627,605, compared to $1,400,570 for the same period in 2025, and gross profit percentage was approximately 58% and 74% for three months ended June 30, 2026 and 2025 respectively. Gross profit for the six months ended June 30, 2026 was $1,466,623, compared to $2,682,456 for the same period in 2025, and gross profit percentage was approximately 59% and 73% for six months ended June 30, 2026 and 2025 respectively.
Operating expenses for this segment increased to $454,687 for the three months ended June 30, 2026, compared to $391,183 for the same period in 2025. Operating expenses for this segment increased to $886,808 for the six months ended June 30, 2026, compared to $796,075 for the same period in 2025. This in an increase in operating expenses of $90,733, or approximately 11%. Increases in operating expenses for the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were due to increased license and permit expense, increased research and development costs, and increased salary and labor costs.
For the three months ended June 30, 2026, this segment reported net income of $172,918 as compared to net income of $1,009,387 for the same period in 2025. This is a decrease in net income of $836,469. For the six months ended June 30, 2026, this segment reported net income of $579,815 as compared to net income of $1,886,381 for the same period in 2025. This is a decrease in net income of $1,306,566. Decreases in net income in the Theranostics Products segment for the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were the result of decreased sales due to the effects of the two voluntary recalls and increased operating expenses.
For the three months ended March 31, 2026,this segment reported net income of $406,898 as compared to net income of $876,994 for the same period in 2025. This is a decrease in net income of $470,096.
Decreases in net income for the three months ended March 31, 2026 were the result of decreased sales due to voluntary recalls.
Sales of product in the Cobalt Products segment for the three months ended MarchJune 31,30, 2026 was $9,739,$497,670, compared to $72,450$678,015 for the same period in 2025. This represents a decrease of $62,711,$180,345, or approximately 87%.27%. Sales of product in the Cobalt Products segment for the six months ended June 30, 2026 was $507,409, compared to $750,465 for the same period in 2025. This represents a decrease of $243,056, or approximately 32%.
The decreases in sales of product were primarily due shut down of Cobalt-60 manufacturing operations to prepare and repair the window gaskets of both our process hot cells. This is a significant and necessary rebuild to ensure the Cobalt-60 process hot cell can remain operational for the considerable future. In 2022 we noticed an issue with our hot cell window gasket. The issue was manageable, but it significantly hampered operational efficiency. While the issue affected only one of our process hot cell windows, we made a strategic decision to repair all the gaskets for the windows on all our process hot cells as the gaskets had reached their prescribed end-of-life. In the threefirst monthsquarter ended March 31,of 2026, we removed both sets of Cobalt hot cell windowswindows, and a 3rd party vendor rehabilitated the windows and gaskets on site. Work was completed in the threefirst monthsquarter endedof March 31, 2026,,2026, and we returned to regular manufacturing operations at the end of March. The cost for the rehabilitation was approximately $100,000. We believe the rehabilitation work to have extended the useful life of our Cobalt-60 process hot cell by 15 to 20 years and estimate we will save approximately $150,000 in annual radiological waste costs (management, storage and disposal) by resolving the gasket issues.
Cost of product for the three months ended
MarchJune 31,30, 2026, was
$76,154,$205,236, as compared to
$38,872,$432,727, for the same period in
2025.2025 for a
decrease of
53%. Gross profit for cobalt products for the three months ended
MarchJune 31,30, 2026 was (
$66,415)$292,434 compared to
$33,578$245,288 for the same period in
2025. Gross profit percentages were
59% and
36% respectively. This is aan
decreaseincrease of
$99,993,$47,146, or approximately
298%.19%. The
increasedecrease in cost of product was partially due to improved margins in the sale of product partially offset by adjustments for accounting for labor hours beginning in the three months ended
March 31, 2026. We evaluated and updated our policies for classifyingall andsegments recording direct labor hours. The adjustments resulted in anthat increased allocation of these labor costs to costCost of product.Product Webeginning believein these2026 updatesas willdiscussed better reflect costs allocation for our current operations.above.
Cost of product for the six months ended June 30, 2026, was $281,391, as compared to $471,599, for the same period in 2025. for a decrease of 40%. Gross profit for cobalt products for the six months ended June 30, 2026 was $226,018 compared to $278,866 for the same period in 2025. This is a decrease of $52,848, or approximately 19%. Gross profit percentages were 45% and 37% respectively. The decrease in cost of product was due to decreased sales in the six months ended June 30, 2026.
Operating costs and expenses in this segment were
$180,388$229,161 for the three months ended
MarchJune 31,30, 2026, compared to
$181,804$342,328 for the same period in
2025. This
decrease in operating costs and expenses is due to waste expense of $129,000 in the three months ended
June March 31,30, 2025 compared to no such expense in 2026. We had a net lossincome for Cobalt Products of
$246,803$63,273 for the three months ended
MarchJune 31,30, 2026, as compared to net loss of
$148,226$97,040 for the same period in
2025. The increase in net lossincome of
$98,577,$160,313, or approximately
67%,165%, was attributable to decreased salesoperating andcosts increasedfrom costreduced ofwaste product.expense.
Operating costs and expenses in this segment were $409,548 for the six months ended June 30, 2026, compared to $524,132 for the same period in 2025. This decrease in operating costs and expenses is also due to waste expense of $129,000 in the six months ended June 30, 2025 compared to no such expense in 2026. We had a net loss for Cobalt Products of $183,530 for the six months ended June 30, 2026, as compared to net loss of $245,266 for the same period in 2025. The decrease in net loss of $61,736, or approximately 25%, was attributable to decreased operating costs from reduced waste expense.
Sales of product in the Calibration & Reference Products segment for the three months ended MarchJune 31,30, 2026, were $882,790,$1,055,031, compared to $1,326,766$1,013,814 for the same period in 2025. This represents an decreaseincrease in sales of $443,976,$41,217, or approximately 33%.4%. This increase in sales for the three months ended June 30, 2026 was due sales growth as we continue to develop additional products.
Sales of product in the Calibration & Reference Products segment for the six months ended June 30, 2026, were $1,937,821, compared to $2,340,580 for the same period in 2025. This represents a decrease in sales of $402,759, or approximately 17%. We had a decrease in sales in the threesix months ended MarchJune 31,30, 2026 because of catch-up revenue that occurred in the three months ended March 31, 2025 due to pent up demand from a global shortage of Cobalt-57 radioisotope during 2024.2024 that resulted in increased sales in the first quarter of 2025.
Cost of product for our Calibration & Reference Products segment for the three months ended MarchJune 31,30, 2026, was $546,794,$621,073, as compared to $615,470$529,354 for the same period in 2025. The decreaseincrease in cost of product in the period-to-period comparison of $68,676,$91,719, or 11%,17%, was partially due to decreasedadjustments totalfor salesaccounting for labor hours to increase allocation to Cost of Product all segments beginning in 2026 as discussed in more detail above and chargespartially due to increased sales during the three-month period ended MarchJune 31,30, 2026 compared to the same period in 2025. Gross profit for our Calibration & Reference Products segment for the three months ended MarchJune 31,30, 2026 was $335,996$433,958 compared to $711,296$484,460 for the same period in 2025. This is a decrease in gross profit of $375,300,$50,502, or approximately 53%.10% due to the increase to cost of product.
OperatingCost costsof and expensesproduct for thisour Calibration & Reference Products segment for the threesix months ended MarchJune 31,30, 20262026, increasedwas $1,167,868, as compared to $453,648, from $443,733$1,144,824 for the same period in 2025. This is anThe increase in cost of $9,915,product in the period-to-period comparison of $23,044, or approximately 2%, and was thepartially resultdue to adjustments for accounting for labor hours to increase allocation to Cost of increasedProduct licensefor costsall duringsegments thebeginning three months ended March 31,in 2026. NetGross lossprofit for thisour Calibration & Reference Products segment for the threesix months ended MarchJune 31,30, 2026 was $117,652,$769,953 compared to net income of $267,563$1,195,756 for the same period in 2025. This is a decrease ofin netgross lossprofit of $385,215$425,803, andor wasapproximately largely36% thedue result ofto decreased sales.
Operating costs and expenses for this segment for the three months ended June 30, 2026 increased to $532,757, from $522,847 for the same period in 2025. This is an increase of $9,910, or approximately 2%. Operating costs and expenses for this segment for the six months ended June 30, 2026 increased to $986,404, from $966,580 for the same period in 2025. This is an increase of $19,824, or approximately 2%, The increases to operating costs and expenses during the three months and six months ended June 30, 2026, as compared to the same periods in 2025, were the result of increased professional fees.
Net loss for this segment for the three months ended June 30, 2026 was $98,799, compared to net loss of $38,387 for the same period in 2025. This is an increase of net loss of $60,412 and was largely the result of decreased gross profit.
Net loss for this segment for the six months ended June 30, 2026 was $216,451, compared to net income of $229,176 for the same period in 2025. This is a decrease of net income of $445,627 and was largely the result of decreased sales.
For the three months ended MarchJune 31,30, 2026 we had sale of product in the Medical Device Products segment of $89,113$40,957 compared to $52,630$58,089 for the same period ending MarchJune 31,30, 2025. This represents ana increasedecrease in sales of $36,483,$17,132, or approximately 69%.29%.
Cost of product for our Medical Device Products segment for the three months ended March 31, 2026, was $46,762, as compared to $47,353 for the same period in 2025. The decrease in cost of product in the period-to-period comparison of $591, or 1%, was due to sales of higher margin products during the three-month period ended March 31, 2026 compared to the same period in 2025. Gross profit for our Medical Device Products segment for the three months ended March 31, 2026 was $42,351 compared to $5,277 for the same period in 2025. This is an increase in gross profit of $37,074, or approximately 703%.
INIS insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2025-02-17 | Grosso Christopher G |
Other | 269,999 | — | — |
| 2025-02-17 | Grosso Christopher G |
Other | 230,769 | — | — |
| 2025-02-17 | Grosso Christopher G |
Other | 40,384 | — | — |
Well-known investors holding INIS (13F)
None of the 59 investors we track reported a position in their latest 13F.