Radnostix (INIS) Q1 2026 revenue falls 27% as recalls and shutdown widen loss
Radnostix Inc. reported weaker results for the quarter ended March 31, 2026. Sale of product fell to $2,378,924 from $3,238,900, a 27% drop, driven by lower Theranostics, Cobalt, and Calibration & Reference segment revenue.
Net loss widened sharply to $1,348,086 from $112,694 as gross margin compressed to 48% from 63% and operating expenses rose 17% to $2,460,980. Results were hurt by two voluntary recalls in Theranostics, a cobalt production shutdown for hot-cell rehabilitation, and continued isotope supply constraints.
Cash and cash equivalents were $1,347,394 and total cash, cash equivalents, and restricted cash were $2,852,931. Management expects existing cash, operations, and potential financing to fund the next 12 months but notes dependence on key customers, suppliers, and ongoing access to capital.
Positive
- None.
Negative
- Revenue and profitability deterioration: Sale of product declined 27% to $2.38M while net loss increased more than tenfold to $1.35M, with gross margin compressing from 63% to 48% and operating expenses up 17%.
Insights
Q1 2026 shows revenue contraction, margin pressure, and recall-driven disruption.
Radnostix saw sale of product decline 27% to $2.38M while net loss ballooned to $1.35M. Gross margin fell from 63% to 48% as volumes dropped and cost of product edged higher, particularly in Theranostics and Cobalt.
Theranostics revenue fell 22% and Cobalt 87%, reflecting two voluntary recalls in Generic Sodium Iodide I‑131 and Dibasic Sodium Phosphate Capsules plus a planned cobalt hot‑cell shutdown. Calibration & Reference sales also declined 33% amid isotope shortages, while Medical Devices grew from a small base.
Operating expenses rose 17% to $2.46M, partly from higher stock‑based compensation including a $102,441 out‑of‑period correction for CEO RSUs and increased R&D for new medical devices. Cash decreased to $1.35M and net cash used in operations was modest at $72,442, so subsequent quarters will be important to see if recalled products, cobalt operations, and isotope supplies normalize as management anticipates.
Key Figures
Key Terms
Theranostics Products financial
right-of-use asset financial
Restricted Stock Units financial
mandatorily redeemable convertible preferred stock financial
DUF6 Asset Sale financial
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period from _____________ to _______________
Commission file number:
RADNOSTIX INC.
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ |
| | Smaller reporting company |
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
As of May 11, 2026, the number of shares of common stock, $0.01 par value, outstanding was
RADNOSTIX INC.
FORM 10-Q
For The Quarter Ended March 31, 2026
TABLE OF CONTENTS
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| PART I – FINANCIAL INFORMATION |
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| Item 1. |
Financial Statements |
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| Unaudited Condensed Consolidated Balance Sheets at March 31, 2026 and December 31, 2025 |
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| Unaudited Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2026 and 2025 |
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| Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2026 and 2025 |
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| Unaudited Condensed Consolidated Statement of Stockholder’s (Deficit) Equity for the Three Months Ended March 31, 2026 and 2025 |
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| Notes to Unaudited Condensed Consolidated Financial Statements |
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| Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
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| Item 4. |
Controls and Procedures |
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| PART II – OTHER INFORMATION |
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| Item 1. |
Legal Proceedings |
29 |
| Item 1A. |
Risk Factors |
30 |
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
31 |
| Item 5. | Other Information | 31 |
| Item 6. |
Exhibits |
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| Signatures |
33 |
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PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
RADNOSTIX INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(unaudited)
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| Common stock, $0.01 par value; 750,000,000 shares authorized; 528,968,316 and 528,209,538 shares issued and outstanding, respectively | ||||||||
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See accompanying notes to unaudited condensed consolidated financial statements.
RADNOSTIX INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Operations
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| Weighted average common shares outstanding - basic |
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See accompanying notes to unaudited condensed consolidated financial statements.
RADNOSTIX INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Cash Flows
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| Net (decrease) increase in cash, cash equivalents, and restricted cash |
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| Cash, cash equivalents, and restricted cash at end of period |
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| Decrease in current installments of notes payable for issuance of stock |
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| Increase in operating lease right-of-use asset and right-of-use liability for new lease |
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| Decrease in accrued interest and increase in equity for conversion of dividends to stock |
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Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:
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2025 |
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| Total cash, cash equivalents, and restricted cash shown in statement of cash flows |
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See accompanying notes to unaudited condensed consolidated financial statements.
RADNOSTIX INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders' (Deficit) Equity
Three Months Ended March 31, 2026
(Unaudited)
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| Balance, January 1, 2026 |
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| Net loss |
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| Balance, March 31, 2026 |
$ | $ | $ | ( |
) | $ | ||||||||||||||
RADNOSTIX INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders' (Deficit) Equity
Three Months Ended March 31, 2025
(Unaudited)
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| Balance, January 1, 2025 |
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| Net loss |
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| Balance, March 31, 2025 |
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See accompanying notes to the unaudited condensed consolidated financial statements
RADNOSTIX INC. AND SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
March 31, 2026
(1) The Company and Basis of Presentation
Radnostix Inc. (RNX) was incorporated in Texas in November 1995. The accompanying unaudited condensed consolidated financial statements are presented in conformity with accounting principles generally accepted in the United States of America (GAAP) and include all operations and balances of RNX and its wholly-owned subsidiaries, including RadQual, LLC, an Idaho limited liability company (RadQual); TI Services, LLC, an Ohio limited liability company (TI Services); RadVent, LLC, an Idaho limited liability company; International Isotopes Idaho Inc., a Texas corporation; International Isotopes Fluorine Products, Inc., an Idaho corporation; and International Isotopes Transportation Services, Inc., an Idaho corporation. RNX, and its wholly-owned subsidiaries are collectively referred to herein as the “Company,” “we,” “our” or “us.”
Nature of Operations – The Company manufactures a wide range of radioisotope-focused products used in variety of medical and industrial applications. The Company's products include a full range of nuclear medicine calibration and reference standards, a wide range of products, including cobalt teletherapy sources, and an FDA-approved radiopharmaceutical drug product. The Company also holds several patents for a fluorine extraction process that would be used in conjunction with a proposed commercial depleted uranium de-conversion facility which would be located in Lea County, New Mexico (the “De-Conversion Facility”). For 2026, the Company’s business consists of five major business segments: Theranostics Products, Cobalt Products, Calibration & Reference Products (previously called Nuclear Medicine Standards), Medical Devices, and Fluorine Products. The Company’s headquarters and all operations, with the exception of TI Services, are located in Idaho Falls, Idaho.
With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products could be considered two to three years. Accordingly, preliminary payments received on cobalt contracts, where shipment will not take place for greater than one year, have been recorded as unearned revenue and, depending upon estimated ship dates, classified under either current or long-term liabilities on the Company’s condensed consolidated balance sheets. These unearned revenues are being recognized as revenue in the periods during which the cobalt shipments take place. All assets expected to be realized in cash or sold during the normal operating cycle of business are classified as current assets.
Principles of Consolidation – The accompanying unaudited condensed consolidated financial statements are presented in conformity with GAAP and include all operations and balances of RNX and its wholly-owned subsidiaries including RadQual and TI Services. See Note 4 “Investment and Business Consolidation” for additional information. All significant intercompany accounts and transactions have been eliminated in consolidation.
Interim Financial Information – The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, all adjustments and reclassifications considered necessary in order to make the financial statements not misleading and for a fair and comparable presentation have been included and are of a normal recurring nature. Operating results for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026 or any future periods. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 31, 2026.
Recent Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024‑03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220‑40). This ASU requires entities to disaggregate certain costs and expenses within relevant income statement captions, including disclosures related to employee compensation, depreciation, amortization, and other expense categories. The ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact that adoption of this ASU will have on its consolidated financial statements and related disclosures.
(2) Current Developments and Liquidity
Business Condition – Since inception, the Company has incurred substantial losses. During the three months ended March 31, 2026, the Company reported a net loss of $
During the three months ended March 31, 2026, the Company continued its focus on its strongest long-standing core business segments which consist of its Theranostics Products (previously called Radiochemical Products), Cobalt Products, and Calibration & Reference Products (previously called Nuclear Medicine Standards), and in particular, the pursuit of new business opportunities within those segments. Additionally, the Company has begun to focus on the start-up of its Medical Device segment which includes assets purchased from AMICI, Inc. (AMICI) in 2023 and investing in the development of an EasyFill Automated Iodine Capsule System.
The Company holds a Nuclear Regulatory Commission (NRC) construction and operating license for the depleted uranium facility in, as well as the property agreement with, Lea County, New Mexico, where the plant is intended to be constructed. The NRC license for the de-conversion facility is a forty (
The Company expects that cash from operations, the availability of equity or debt financing, and its current cash balance will be sufficient to fund operations for the next twelve months. Future liquidity and capital funding requirements will depend on numerous factors, including commercial relationships, technological developments, market factors, available credit, and management of redeemable convertible preferred stock. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.
(3) Net Income (Loss) Per Common Share - Basic and Diluted
For the three months ended March 31, 2026, the Company had
For the three months ended March 31, 2025, the Company had
The table below shows the calculation of diluted shares:
| Three Months Ended | ||||||||
| March 31, | March 31, | |||||||
| 2026 | 2025 | |||||||
| Weighted average common shares outstanding - basic | ||||||||
| Effects of dilutive shares | ||||||||
| Stock Options | ||||||||
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| Weighted average common shares outstanding - diluted | ||||||||
The table below summarizes common stock equivalents outstanding at March 31, 2026 and March 31, 2025:
| March 31, | ||||||||
| 2026 | 2025 | |||||||
| Stock options | ||||||||
| Restricted Stock Units | ||||||||
| Shares of Series C Preferred Stock | ||||||||
(4) Investment and Business Consolidation
In June 2023, the Company acquired several medical devices with related assets and intellectual property rights from AMICI and has been working on FDA 510k transfers, and start-up of manufacturing. In January 2025, the parties amended the Asset Purchase Agreement whereby the Company received additional product rights and related assets to make up for a shortfall by AMICI in deliverable assets originally contemplated in the Asset Purchase Agreement.
On June 3, 2024, the Company entered into a Strategic Development and Distribution Agreement with Alpha Nuclide Inc for the rights to manufacture and distribute the Company’s Theranostics Products and Nuclear Medicine Products in mainland China as part of a 50/50 joint Venture between the Company and Alpha Nuclides. The parties will begin with the distribution of the Company’s Calibration & Reference Products as part of phase I of the strategic alliance, with further planned milestones for the establishment of a joint venture to register the Company’s Theranostics and Calibration & Reference Products with the CFDA for local manufacturing and distribution. The parties envision commercializing RNX's radiopharmaceutical Iodine-131, radiochemical API, and theranostics API I-131 for 3rd party therapeutic applications in China. The parties intend to manufacture and distribute the products from Alpha Nuclide's Jiaxing facility, which Alpha Nuclides is responsible for establishing. The parties also intend to enter into a supply agreement for raw material isotopes to be supplied from Alpha Nuclide to the Company to be used in the Company’s manufacturing process at the Company’s Idaho Falls, Idaho facility.
On August 6, 2024, the Company entered into a joint venture agreement with Phantech LLC to form PhanQual. PhanQual will leverage RNX’s and Phantech’s technologies, facilities, experience, and global network to design, manufacture, and distribute sealed sources, including adapting Phantech's patented and cutting-edge fillable calibration source technology, into sealed source calibration devices to better serve the R&D and theranostics community. Additionally, RadQual will globally distribute Phantech’s entire portfolio of fillable sources through RadQual’s global network of distributors. PhanQual’s revenues and operations will operate through RadQual and will be included in our Calibration & Reference Products segment.
(5) Stockholders’ Equity, Options, and Warrants
Employee Stock Purchase Plan
The Company has an employee stock purchase plan pursuant to which employees of the Company may participate to purchase shares of common stock at a discount. During the three months ended March 31, 2026 and 2025, the Company issued
Stock-Based Compensation Plans
2015 Incentive Plan - In April 2015, the Company’s Board of Directors approved the International Isotopes Inc. 2015 Incentive Plan (as amended, the “2015 Plan”) which was subsequently approved by the Company’s shareholders in July 2015. The 2015 Plan was amended and restated in July 2018 to increase the number of shares authorized for issuance under the 2015 plan by an additional
Employee/Director Grants - The Company accounts for issuances of stock-based compensation to employees by recognizing, as compensation expense, the cost of employee services received in exchange for equity awards. The compensation expense is based on the grant date fair value of the award. Stock compensation expense is recognized over the period during which an employee is required to provide service in exchange for the award (the vesting period).
Non-Employee Grants - The Company accounts for its issuances of stock-based compensation to non-employees by recognizing compensation expense based on the grant date fair value of the award. Stock compensation expense is recognized over the vesting period for the award.
Option awards outstanding as of March 31, 2026, and changes during the three months ended March 31, 2026, were as follows:
| Weighted | ||||||||||||||||
| Weighted | Average | |||||||||||||||
| Average | Remaining | Aggregate | ||||||||||||||
| Fixed Options | Shares | Exercise Price | Contractual Life | Intrinsic Value | ||||||||||||
| Outstanding at December 31, 2025 | $ | |||||||||||||||
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| Outstanding at March 31, 2026 | $ | 675,175 | ||||||||||||||
| Exercisable at March 31, 2026 | $ | $ | ||||||||||||||
The intrinsic value of outstanding and exercisable shares is based on the closing price of the Company’s common stock on the OTCQB of $
As of March 31, 2026, there was $
Total stock-based compensation expense for the three months ended March 31, 2026 and 2025 was $
During the three months ended March 31, 2026, the Company did not grant any additional stock options.
Restricted Stock Units outstanding as of March 31, 2026, and changes during the three months ended March 31, 2026, were as follows:
| Non-Vested Restricted Stock Units | Number of restricted stock units | Weighted average grant-date fair value | ||||||
| Outstanding at December 31, 2025 | $ | |||||||
| Granted | 37,500,000 | $ | 0.03 | |||||
| Vested and Exercised | — | |||||||
| Forfeited / Cancelled | — | |||||||
| Outstanding at March 31, 2026 | $ | |||||||
As of March 31, 2026, there was $
On October 10, 2025, the Company granted its CEO
Additionally, during the three months ended March 31, 2026, the Company identified an error related to the accounting for these RSUs. Specifically, compensation expense associated with these awards was not recognized in the Company’s consolidated financial statements for the year ended December 31, 2025. In accordance with ASC 250, Accounting Changes and Error Corrections, the Company evaluated the materiality of the error, both quantitatively and qualitatively, and determined that the impact was not material to the previously issued financial statements for the year ended December 31, 2025, and that correction of the error in the current period is appropriate. As a result, the Company recorded an out-of-period adjustment of approximately $
Preferred Stock
At March 31, 2026, there were
During the three months ended March 31, 2026 and 2025, dividends due to holders of the Series C Preferred Stock totaled $243,780. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. For the three months ended March 31, 2026 and 2025, the Company issued an aggregate of
(6) Debt
In December 2013, the Company entered into a promissory note agreement with its then Chairman of the Board and one of our major shareholders, pursuant to which we borrowed $
In April 2018, the Company borrowed $
In December 2019 and February 2020, the Company borrowed an aggregate of $
In June 2023, the Company executed an asset purchase agreement with AMICI, Inc. for the purchase of medical devices and related assets and intellectual property rights. In connection with the asset purchase agreement, the Company entered a promissory note to AMICI, Inc. with a principal amount of $
(7) Commitments and Contingencies
Dependence on Third Parties
Sales to the Company’s top three customers for the three months ended March 31, 2026 and March 31, 2025 were approximately
The production of Cobalt-60 is dependent upon the U.S. Department of Energy (DOE), and its prime operating contractor, which controls the Advanced Test Reactor (ATR) and laboratory operations at the ATR located outside of Idaho Falls, Idaho. From 2014 to 2024, the Company had a ten-year contract with the DOE for the irradiation of cobalt targets for the production of cobalt-60. The Company was able to purchase cobalt targets as available for a fixed price per target and with an annual
Sales of our most predominant Theranostics Products are dependent upon a few key suppliers. An interruption in production by any of these individual suppliers could have an immediate negative impact upon Theranostics Products sales until material could be purchased from alternate suppliers including obtaining regulatory approval to use material from alternative suppliers if necessary. During multiple weeks in 2025, the Company experienced low quantities or complete outages for our key raw material supplier which resulted in an estimated $
The Calibration & Reference Products sold by the Company are dependent upon certain radioisotopes that are supplied to the Company through agreements with several suppliers. A loss of any of these suppliers could adversely affect operating results by causing a delay in production or a possible loss of sales. Starting in January 2024, there has been a continuing global outage of gadolinium-153, a key isotope for the Company's Calibration & Reference Products segment. The outage has resulted in lost sales. The Company is working on establishing new suppliers and believes that it will be able to have supply restored by the end of 2026.
Contingencies
Because all the Company’s business segments involve the handling or use of radioactive material, the Company is required to have an operating license from the NRC and specially trained staff to handle these materials. The Company has amended this operating license numerous times to increase the amount of material permitted within the Company’s facility. Although this license does not currently restrict the volume of business operations performed or projected to be performed in the upcoming year, additional processing capabilities and license amendments could be implemented that would permit the processing of other reactor-produced radioisotopes by the Company. The financial assurance required by the NRC to support this license has been provided for with a surety bond held with Swiss Re Corporate Solutions Premier Insurance Corporation which is supported by a restricted money market account held with Merrill Lynch. At March 31, 2026, the balance of this account was $
(8) Revenue Recognition
Revenue from Product Sales
The Company’s revenue consists primarily of distribution of theranostics including sodium iodide I-131 drug product, calibration and reference standards manufactured for use in the nuclear medicine industry, and cobalt source manufacturing. With the exception of certain unique products, the Company’s normal operating cycle is considered to be one year. Due to the time required to produce some cobalt products, the Company’s operating cycle for those products is considered to be two to three years. Accordingly, preliminary payments received on cobalt contracts where shipment has not taken place have been recorded as unearned revenue on the Company’s condensed consolidated balance sheets and classified under current or long-term liabilities, depending upon estimated ship dates. For the three months ended March 31, 2026, the Company reported current unearned revenue of $
Contract Balances
The Company records a receivable when it has an unconditional right to receive consideration after the performance obligations are satisfied. As of March 31, 2026, and December 31, 2025, accounts receivable totaled $
(9) Leases
The Company leases office and warehouse space under operating leases. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments under the lease. Operating lease, right-of-use assets, and liabilities are recognized at the lease commencement date based on the present value of lease payments over the reasonably certain lease term. The implicit rates with the Company’s operating leases are generally not determinable and the Company uses its incremental borrowing rate at the lease commencement date to determine the present value of its lease payments. The determination of the Company’s incremental borrowing rate requires judgement. The company determines its incremental borrowing rate for each lease using its then-current borrowing rate. Certain of the Company’s leases include options to extend or terminate the lease. The Company establishes the number of renewal options periods used in determining the operating lease term based upon its assessment at the inception of the operating lease. The option to renew the lease may be automatic, at the option of the Company, or mutually agreed to between the landlord and the Company. Once the facility lease term has begun, the present value of the aggregate future minimum lease payments is recorded as a right-of-use asset. Lease expense is recognized on a straight-line basis over the term of the lease.
In January 2025, the Company entered into a new operating lease agreement for a second facility across the street from its main headquarters. The initial term of the lease is five years, ending December 2029 and includes the option to extend the lease for two additional terms of five years each. The monthly lease rate increases annually by
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| Operating lease costs | $ | $ | ||||||
| Short-term operating lease costs | ||||||||
| Financing lease expense: | ||||||||
| Amortization of right-of-use assets | ||||||||
| Interest on lease liabilities | ||||||||
| Total financing lease expense | ||||||||
| Total lease expense | $ | $ | ||||||
| Right-of-use assets obtained in exchange for new operating lease liabilities | $ | $ | ||||||
| Right-of-use assets obtained in exchange for new financing lease liabilities | $ | $ | ||||||
| Weighted-average remaining lease term (years) - operating leases | ||||||||
| Weighted-average remaining lease term (years) - financing leases | — | — | ||||||
| Weighted-average discount rate - operating leases | % | % | ||||||
| Weighted-average discount rate - financing leases | % | |||||||
The future minimum payments under these operating lease agreements are as follows:
| Operating Leases | Financing Leases | |||||||
| 2026 (excluding the three-months ended March 31, 2026) | $ | |||||||
| 2027 | ||||||||
| 2028 | ||||||||
| 2029 | ||||||||
| 2030 | ||||||||
| Thereafter | ||||||||
| Total minimum lease obligations | ||||||||
| Less-amounts representing interest | ( | ) | ||||||
| Present value of minimum lease obligations | ||||||||
| Current maturities | ( | ) | ||||||
| Lease obligations, net of current maturities | $ | $ | ||||||
(10) Segment Information
The Company’s reportable segments are reported in a manner consistent with the way management evaluates the businesses. The results of operations are regularly reviewed by the Company's chief operating decision maker ("CODM"), the Chief Executive Officer. The Company identifies its reportable business segments based on differences in products and services. The accounting policies of the business segments are the same as those described in the summary of significant accounting policies. In order to evaluate each reportable segment's performance, the CODM uses income from operations as a measure of profit and loss. The CODM compares operational performance against management expectations when making decisions regarding allocation of operating and capital resources to each segment.
In 2026, the Company has five reportable segments which include: Theranostics Products, Cobalt Products, Calibration & Reference Products, Medical Device Products, and Fluorine Products. Information regarding the operations and assets of these reportable business segments is contained in the following table:
| Three months ended March 31, | ||||||||
| Sale of Product | 2026 | 2025 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Calibration & Reference Products | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate revenue | ||||||||
| Total Consolidated | $ | $ | ||||||
| Three months ended March 31, | ||||||||
| Depreciation and Amortization | 2026 | 2025 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Calibration & Reference Products | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate depreciation and amortization | ||||||||
| Total Consolidated | $ | $ | ||||||
| Three months ended March 31, | ||||||||
| Segment Income (Loss) | 2026 | 2025 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ( | ) | ( | ) | ||||
| Calibration & Reference Products | ( | ) | ||||||
| Medical Device Products | ( | ) | ( | ) | ||||
| Fluorine Products | ( | ) | ( | ) | ||||
| Total Segments | ( | ) | ||||||
| Corporate loss | ( | ) | ( | ) | ||||
| Net Loss | $ | ( | ) | $ | ( | ) | ||
| Three months ended March 31, | ||||||||
| Expenditures for Segment Assets | 2026 | 2025 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Calibration & Reference Products | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate purchases | ||||||||
| Total Consolidated | $ | $ | ||||||
| March 31, | December 31, | |||||||
| Segment Assets | 2026 | 2025 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Calibration & Reference Products | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate assets | ||||||||
| Total Consolidated | $ | $ | ||||||
(11) Subsequent Events
On May 14, 2026, the Company received approval of a modification to the term of its Series C Convertible Redeemable Preferred Stock from a majority of the outstanding shares of the Series C Preferred Stock. The modification extends the maturity date of the Series C Preferred for approximately one year to February 28, 2028. All other terms in the Series C Preferred Stock remain unchanged.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding industry prospects and future results of operations or financial position, made in this Quarterly Report are forward-looking statements. Words such as “anticipates,” “believes,” “should,” “expects,” “future,” “intends” and similar expressions identify forward-looking statements. Forward-looking statements reflect management’s current expectations, plans or projections, and are inherently uncertain. Actual results could differ materially from management's expectations, plans or projections. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report. Certain risks and uncertainties that could cause our actual results to differ significantly from management’s expectations are described in the risk factors set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 31, 2026 and in the other reports we file with the SEC. These factors describe some but not all of the factors that could cause actual results to differ significantly from management’s expectations. We undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are urged, however, to review the risks and other factors set forth in the reports that we file from time to time with the SEC.
BUSINESS OVERVIEW
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.
Our core business consists of five reportable segments which include: Theranostics Products, Cobalt Products, Calibration & Reference Products, Medical Devices, and Fluorine Products.
| - |
In our Theranostics Products segment, which is our largest segment by revenue, we produce: |
| • |
an FDA approved generic sodium iodide I-131 drug product for the treatment of hyperthyroidism and thyroid cancer; |
| • |
radiochemicals for multiple uses in clinical research and life sciences (including Tb-161 and variations of I-131); and |
| • |
cGMP Active Pharmaceutical Ingredient (“API”) supply for third party theranostics clients. “cGMP” refers to current Good Manufacturing Practice regulations that are enforced by the FDA for quality and safety control; |
| - |
In our Cobalt Products segment, we produce a variety of cobalt-60 products for medical, research and industrial applications. Cobalt-60 is a synthetic radioactive isotope of cobalt that is produced by irradiating the stable isotope cobalt-59; |
| - |
In our Calibration & Reference Products segment (formerly referred to as Nuclear Medicine), we produce a wide range of sealed source calibration and reference standards (which are sealed to prevent the release of radioactive materials), that are used in: (i) nuclear pharmacies that specialize in preparing and dispensing radioactive pharmaceuticals for diagnostic imaging and medical treatments, (ii) nuclear medicine imaging clinics and hospitals which administer radioactive pharmaceuticals, (iii) certain laboratories and equipment that require radiation detection, and (iv) industrial settings that use radioactive sources for calibration, testing, and measurement. We also sell bulk isotopes through this segment; |
| - |
In our Medical Devices segment, we are currently sell various 3rd party products and we are developing our own products for commercial use, including an I-131 encapsulation system and Radvent devices. |
| - |
In our Fluorine Products segment, we are currently evaluating the possibility of fund raising, joint venturing, or divesting these assets, as discussed in more detail below. |
We believe that we are well positioned to serve the growing radioisotope and radiopharmaceutical market segments.
Theranostics Products. This segment includes the production and distribution of various isotopically pure radiopharmaceuticals, APIs, and radiochemicals for medical, industrial, and research applications. These products are produced by us from radioisotopes supplied by our vendors. We produce and distribute various products in customized volumes, concentrations, chemical formulations, packages, and specifications tailored to meet our FDA specifications or customer and market demands. To our knowledge, our FDA approved generic sodium iodide I-131 drug product is the only generic product of this type manufactured in the U.S. and offers customers an attractive domestic alternative to the single existing foreign commercial drug manufacturer. Additionally, this segment distributes APIs, and radiochemicals from third party suppliers for pre-clinical, industrial, and research applications. According to BCC Research, the theranostics market was valued at $4.3 billion in 2024 and is expected to grow to $12.7 billion by 2029, reflecting a 24% compound annual growth rate.
The markets for most radiochemicals is highly competitive. The target markets for these products are customers who (1) incorporate them into finished industrial or medical devices; (2) use radioisotope products in clinical trials for various medical applications with the aim to further process and include the radioisotope products into pharmaceutical products approved by the U.S. FDA for labeled use in therapy or imaging, or (3) include our radioisotope products into their pharmaceutical products approved outside the U.S. for encapsulated and/or labeled use in therapy or imaging. We can ship to all 50 states and internationally. We are deploying a unique product strategy which we believe will make us the go-to API supplier for third party radiopharmaceutical products.
We believe that we are well positioned to hold a competitive advantage in the growing theranostics space because of our unique combination of high energy and high activity NRC licensing status that permits handling of high energy and high activity radioisotopes, our compliance with GMP, our FDA licensed operating facility, and experienced and skilled personnel.
Cobalt Products. Our Cobalt Products segment includes the production of various cobalt-60 products and services, including the fabrication of cobalt-60 sealed sources for radiation therapy, various industrial and medical applications, and recycling of expended cobalt-60 sources.
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. 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 cobalt-60 manufacturers.
Calibration & Reference Products. (formerly known as Nuclear Medicine Standards) The Calibration & Reference Products segment consists of various sealed source calibration and reference products, including our own manufactured products, jointly manufactured products, and third-party products. These products are sold through our RadQual subsidiary for use with SPECT and PET imaging equipment, patient positioning, radiopharmacy and radiopharmaceutical Contract Development and Manufacturing Organization (“CDMO”) lab equipment, pre-clinical imaging equipment, clinical trial or custom geometry applications, and calibration or operational testing of measuring and/or testing equipment. Our Calibration & Reference Products include flood sources, dose calibrator sources, cylinder phantoms, annulus phantoms, rod sources, line sources, flexible and rigid rulers, spot markers, pen point markers, and a host of specialty design items. Our pre-clinical products include distribution of fillable sources from Phantech and pre-clinical sealed sources via our PhanQual joint venture with Phantech. Our Calibration and Reference sources include RadQual products for lab equipment; we also distribute non-medical sealed source calibration and reference standards manufactured by ORANO LEA, with whom we have a bilateral relationship. Our Calibration & Reference Products segment also commercializes bulk isotope sales and shielding and accessories related to our sealed source products.
According to the International Atomic Energy Agency’s Medical imAGIng and Nuclear mEdicine global resources database (IMAGINE), as of September 2025, at least 131 countries have SPECT and/or PET imaging cameras, with more than 29,000 installed units in total. These installed cameras use calibration and reference sources on a regular repeat basis, with many of them requiring calibration as part of on-going certification. Most Calibration and Reference Product sales are to U.S. customers. However, in recent years, because of stronger marketing efforts, we have seen an increase in foreign sales. All these products contain radioactive isotopes that decay at a predictable rate. Therefore, customers are required to periodically replace most of these products when they reach the end of their useful lives. The useful life of these products varies depending on the isotope used in manufacture, but in most cases averages eighteen months to two years. The various isotopes used in manufacturing these Calibration & Reference Products are from several sources world-wide, and we are continually working to develop multiple sources of each isotope. In addition to the products themselves, we have developed a line of specialty packaging for the safe transportation and handling of these products.
To our knowledge there are a few small regional suppliers internationally and only one major producer of a similar catalog of products in the world that competes directly with us for this broad portfolio of products. Most of the products manufactured by our major competitor are similar in design to our products as these products must meet Original Equipment Manufacturer (“OEM”) dimensional and performance standards. We attempt to differentiate our products through strategic alignment with OEMs, high levels of service, competitive pricing, patent protections, and exclusive arrangements with OEMs.
We continue working to expand the number and types of products that are manufactured in this segment and expand our qualified suppliers for the raw material used for our products. We plan to eventually manufacture some of our medical products in China through our joint-venture, Radnostix China.
Medical Devices. We started the Medical Devices segment in 2024 and many of our products in this segment remain under development. Our Medical Device segment will consist of our own medical devices and the distribution and servicing of third-party products.
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.
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 Q3 2026 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.
Fluorine Products. We established the fluorine products business segment in 2004 to support production and sale of various fluoride gases produced using our Fluorine Extraction Process (“FEP”). FEP was intended to be completed in conjunction with the operation of a proposed depleted uranium, or DUF6, de-conversion facility in Lea County, New Mexico. DUF6 is the waste by-product of uranium enrichment, and any uranium enrichment facility will create very large quantities of DUF6. In October 2012, we received a construction and operating license from the NRC for the planned facility. Changes in the nuclear industry near the end of 2013, however, significantly reduced commercial demand for this type of facility. Therefore, we suspended all further development work on the project, but we have maintained all licenses and permits for the project.
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 Sale 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. 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.
RESULTS OF OPERATIONS
Three Months Ended March 31, 2026, Compared to Three Months Ended March 31, 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:
| For the Three |
For the Three |
|||||||||||||||
| Months Ended |
Months Ended |
|||||||||||||||
| March 31, |
March 31, |
|||||||||||||||
| Sale of Product |
2026 |
2025 |
$ Change |
% Change |
||||||||||||
| Theranostics Products |
$ | 1,397,282 | $ | 1,787,054 | $ | (389,772 | ) | -22 | % | |||||||
| Cobalt Products |
9,739 | 72,450 | (62,711 | ) | -87 | % | ||||||||||
| Calibration & Reference Products |
882,790 | 1,326,766 | (443,976 | ) | -33 | % | ||||||||||
| Medical Device Products |
89,113 | 52,630 | 36,483 | 69 | % | |||||||||||
| Fluorine Products |
— | — | — | — | % | |||||||||||
| Total Consolidated Sale of Product |
$ | 2,378,924 | $ | 3,238,900 | $ | (859,976 | ) | -27 | % | |||||||
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 |
For the Three |
|||||||||||||||
| Months Ended |
% of |
Months Ended |
% of |
|||||||||||||
| March 31, |
Total Sales |
March 31, |
Total Sales |
|||||||||||||
| 2026 |
2026 |
2025 |
2025 |
|||||||||||||
| Total Sale of Product |
$ | 2,378,924 | $ | 3,238,900 | ||||||||||||
| Cost of Product |
||||||||||||||||
| Theranostics Products |
$ | 558,266 | 23 | % | $ | 505,168 | 16 | % | ||||||||
| Cobalt Products |
76,154 | 3 | % | 38,872 | 1 | % | ||||||||||
| Calibration & Reference Products |
546,794 | 23 | % | 615,470 | 19 | % | ||||||||||
| Medical Device Products |
46,762 | 2 | % | 47,353 | 1 | % | ||||||||||
| Fluorine Products |
— | — | % | — | — | % | ||||||||||
| Total Cost of Product |
$ | 1,227,976 | 52 | % | $ | 1,206,863 | 37 | % | ||||||||
| Gross Profit |
$ | 1,150,948 | $ | 2,032,037 | ||||||||||||
| Gross Profit % |
48 | % | 63 | % | ||||||||||||
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:
| For the three |
For the three |
|||||||||||||||
| months ended |
months ended |
|||||||||||||||
| March 31, |
March 31, |
|||||||||||||||
| Operating Costs and Expenses: |
2026 |
2025 |
% change |
$ change |
||||||||||||
| Salaries and Contract Labor |
$ | 1,297,617 | $ | 1,119,326 | 16 | % | $ | 178,291 | ||||||||
| General, Administrative and Consulting |
1,014,235 | 871,024 | 16 | % | 143,211 | |||||||||||
| Research and Development |
149,128 | 106,703 | 40 | % | 42,425 | |||||||||||
| Total operating expenses |
$ | 2,460,980 | $ | 2,097,053 | 17 | % | $ | 363,927 | ||||||||
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.
Interest expense for the three months ended March 31, 2026 was $84,869, compared to $83,851 for the same period in 2025. This is an increase of $1,018, 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 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.
We had a net loss of $1,348,086 for the three months ended March 31, 2026 compared to net loss of $112,694 for the same period in 2025. This increase in net loss of $1,235,392 for the quarter was the result of lost sales in our Theranostics Products due to two 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 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. 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.
Theranostics Products.
Sales of Theranostics Products for the three months ended March 31, 2026 were $1,397,282, compared to $1,787,054 for the same period in 2025. This is a decrease of $389,772, or approximately 22% during the three months ended March 31, 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.
Operating expenses for this segment increased to $432,118 for the three months ended March 31, 2026, compared to $404,892 for the same period in 2025. This in an increase in operating expenses of $27,226, or approximately 7% due to increased salary and labor costs.
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.
Cobalt Products.
Sales of product in the Cobalt Products segment for the three months ended March 31, 2026 was $9,739, compared to $72,450 for the same period in 2025. This represents a decrease of $62,711, or approximately 87%.
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 three months ended March 31, 2026, we removed both sets of Cobalt hot cell windows and a 3rd party vendor rehabilitated the windows and gaskets on site. Work was completed in the three months ended March 31, 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.
Calibration & Reference Products (formerly Nuclear Medicine Standards)
Sales of product in the Calibration & Reference Products segment for the three months ended March 31, 2026, were $882,790, compared to $1,326,766 for the same period in 2025. This represents an decrease in sales of $443,976, or approximately 33%.
We had a decrease in sales in the three months ended March 31, 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.
Due to an ongoing global shortage of Gadolidium-153 radioisotope beginning in January 2025, we have been unable to manufacture any products that utilize this radioisotope. We expect these sales to return with a period of catch-up once we have been able to source this radioisotope.
Cost of product for our Calibration & Reference Products segment for the three months ended March 31, 2026, was $546,794, as compared to $615,470 for the same period in 2025. The decrease in cost of product in the period-to-period comparison of $68,676, or 11%, was due to decreased total sales and charges during the three-month period ended March 31, 2026 compared to the same period in 2025. Gross profit for our Calibration & Reference Products segment for the three months ended March 31, 2026 was $335,996 compared to $711,296 for the same period in 2025. This is a decrease in gross profit of $375,300, or approximately 53%.
Operating costs and expenses for this segment for the three months ended March 31, 2026 increased to $453,648, from $443,733 for the same period in 2025. This is an increase of $9,915, or approximately 2%, and was the result of increased license costs during the three months ended March 31, 2026. Net loss for this segment for the three months ended March 31, 2026 was $117,652, compared to net income of $267,563 for the same period in 2025. This is a decrease of net loss of $385,215 and was largely the result of decreased sales.
Medical Device Products.
For the three months ended March 31, 2026 we had sale of product in the Medical Device Products segment of $89,113 compared to $52,630 for the same period ending March 31, 2025. This represents an increase in sales of $36,483, or approximately 69%.
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%.
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. Due to the impact of tariff issues, we expect these RadVent products to release in Q3 2026. We are also continuing the development of our EasyFill Iodine Encapsulation System.
Operating costs and expenses for this segment for the three months ended March 31, 2026 were $205,945 compared to $181,669 in the same period in 2025.
This increase in operating expenses of $24,276 for the three months ended March 31, 2026 was due to increased research and development related to the startup of this new business segment.
Net loss for this segment for the three months ended March 31, 2026 was $163,594, compared to net loss of $181,669 for the same period in 2025. This is an increase in net loss of $18,075 due to the increased development activity in the segment.
Fluorine Products.
For the three months ended March 31, 2026 and the three months ended March 31, 2025, we had no sales and cost of product in our Fluorine Products segment.
During the three months ended March 31, 2026, we incurred $31,384 of expenses related to maintenance of plans, designs, and other assets for a proposed de-conversion facility, as compared to $26,159 for the same periods in 2025.
During the three months ended March 31, 2026 and 2025 we received $30,000 in extension payments related to the DUF6 Asset Sale, which was terminated in February as described in more detail above. These payments were included in Other Income on our Statement of Operations.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2026, we had cash and cash equivalents of $1,347,394 as compared to $1,695,158 at December 31, 2025. This is a decrease of $347,764 or approximately 21% was largely due to increased net loss and purchases of property, plant, and equipment. For the three months ended March 31, 2026, net cash used in operating activities was $72,442 and for the three months ended March 31, 2025, net cash used in operating activities was $5,119. The increase in cash used in operating activities was a result of an increase in net loss in the three months ended March 31, 2026.
Inventories at March 31, 2026 totaled $831,943, and inventories at December 31, 2025 totaled $875,449. Our inventory consists of work in process material for our Theranostics Products, Cobalt Products, Calibration & Reference Products, and Medical Device Products segments.
Cash used in investing activities was $205,175 for the three months ended March 31, 2026, and cash used in investing activities was $128,881 for the same period in 2025. The cash used in both periods was for the purchase of equipment.
Cash used in financing activities was $56,837 during the three months ended March 31, 2026, and cash used in financing activities for the same period in 2025 was $150,591. During the three months ended March 31, 2026, cash paid for interest was $43,800 as compared to cash paid for interest of $39,954 for the same three-month period in 2025. Additionally, during the three months ended March 31, 2026, we received $9,446 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $3,894 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan in the three months ended March 31, 2025. During the three months ended March 31, 2026, principal payments on notes payable were $66,283, as compared to $200,000 for the same period in 2025.
In February 2026, we declared our annual dividend on the Series C Preferred Stock. Dividends payable totaled $243,780 at that time. Some holders of the Series C Preferred Stock elected to settle their dividend payments with shares of the Company’s common stock in lieu of cash. The Company issued 573,570 shares of common stock in lieu of a dividend payment of 48,180. $39,300 of dividend payable was settled with cash. $156,300 in dividends will be settled in the second quarter of 2026.
Total decrease in cash for the three months ended March 31, 2026, was $334,454 compared to a cash decrease of $284,591 for the same period in 2025.
We expect that cash from operations, cash raised via equity financing, and our current cash balance will be sufficient to fund operations for the next twelve months. Our future liquidity and capital funding requirements will depend on numerous factors, including commercial relationships, technological developments, market factors, available credit, and preferred stock shareholders. There is no assurance that additional capital and financing will be available on acceptable terms to the Company or at all.
Debt
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 (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 March 31, 2026, accrued interest payable on the 2013 Promissory Note was $369,234.
In April 2018, we borrowed $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 (the “2018 Promissory Note”). The 2018 Promissory Note is secured and accrues interest at 6% per annum, which is payable upon maturity of the 2018 Promissory Note. At any time, the holders of the 2018 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. The 2018 Promissory Note was originally due August 1, 2018. Pursuit to six modifications within the period of June 2018 and December 2023, the 2018 Promissory Note was modified to extend the maturity date to January 31, 2025, with all remaining terms unchanged. In February 2024, the 2018 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 2018 Promissory Note was modified again to extend the maturity date to March 31, 2028, with all remaining terms unchanged. At March 31, 2026, accrued interest on the 2018 Promissory Note totaled $57,170.
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 March 31, 2026, the accrued interest on the 2019 Promissory Note totaled $249,131.
In June 2023, we executed an asset purchase agreement with AMICI, Inc. for the purchase of medical devices and related assets and intellectual property rights. In connection with the asset purchase agreement, we entered a promissory note to AMICI, Inc. with a principal amount of $558,593. According to the terms of the note, we made an initial cash payment of $100,000 into escrow, issued the seller $25,000 in shares of the Company’s common stock, and paid the seller $6,493 in a closing cash reimbursement payment. For the remaining principal balance of the promissory note of $427,100, we are required to pay the seller a minimum of $10,000 per month for a period of 45 months. The amount due was not subject to interest until the 25th month after the anniversary of the closing of the transaction. At March 31, 2026, the balance of this promissory note was $97,100.
CRITICAL ACCOUNTING POLICIES
From time-to-time, management reviews and evaluates certain accounting policies that are considered to be significant in determining our results of operations and financial position.
A description of the Company’s critical accounting policies that affect the preparation of the Company’s financial statements is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 31, 2026.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), that are designed to ensure that material information relating to us is made known to the officers who certify our financial reports and to other members of senior management and the Board of Directors. These disclosure controls and procedures are designed to ensure that information required to be disclosed in our reports that are filed or submitted under the Exchange Act are recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
Management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness, as of March 31, 2026, of our disclosure controls and procedures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of March 31, 2026.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
A discussion of legal matters is found in Note 7, “Commitments and Contingencies”, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I - Item 1. Financial Statements of this Quarterly Report.
ITEM 1A. RISK FACTORS
There have been no material changes or updates to the risk factors previously disclosed in Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025, except as set forth below:
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:
| - |
access to cobalt-59 pellets, which is the necessary feed stock for irradiation; |
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reliance on research reactors for medical isotopes and our reliance in particular on the Advanced Test Reactor (“ATR”) at INL that will have planned maintenance in 2027 which could disrupt our access to isotopes; |
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ATR’s main goal is to service the U.S. Navy’s nuclear fleet and there is a risk that the ATR would need to solely focus on Naval operations and thus not be able to supply us with cobalt-60; and |
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our reliance on ATR means that we are subject to availability and ongoing access to products from the ATR and any transition to another reactor would be time-consuming and complicated. |
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.
If the FDA concludes that we have failed to comply with applicable regulations, it could take various actions including: issuing warning letters, imposing civil or criminal penalties, suspending regulatory approvals, requiring product recalls, seizing products, or enjoining future violations. Such enforcement actions could have a material adverse effect on our business, results of operations and financial condition.
We are subject to ongoing FDA regulations, including complying with the FDA’s current Good Manufacturing Practice (cGMP) requirements, and are subject to regular inspections of our facilities. If the FDA concludes that we have failed to comply with applicable regulations, it could take various actions including: issuing warning letters, imposing civil or criminal penalties, suspending or withdrawing regulatory product approvals, requiring product recalls, seizing products, enjoining future violations, or suspending or withdrawing some or all FDA facility approvals and licenses. Such enforcement actions could have a material adverse effect on our business, results of operations and financial condition.
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. Upon the completion of our corrective actions, we will submit to the FDA and will request a reinspection of the facilities. 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 customers
We may be subject to NRC license enforcement actions.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 5. OTHER INFORMATION
During the quarter ended March 31, 2026, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
ITEM 6. EXHIBITS
| Exhibit No. |
Description |
| 31.1* |
Certification by the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2* |
Certification by the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1** |
Certification by the Chief Executive Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 32.2** |
Certification by the Chief Financial Officer furnished pursuant to 18 U.S.C. Section 1350 adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 101.INS* |
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
| 101.SCH* |
Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL* |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF* |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB* |
Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE* |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document and contained in Exhibit 101). |
* Filed herewith.
** Furnished herewith.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Date: May 20, 2026 |
Radnostix Inc. |
|
| By: |
/s/ Shahe Bagerdjian |
|
| Shahe Bagerdjian |
||
| Chief Executive Officer |
||
| By: |
/s/ W. Matthew Cox |
|
| W. Matthew Cox |
||
| Chief Financial Officer |
||