INIS 10-Q
Radnostix Inc (INIS)
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:
INTERNATIONAL ISOTOPES INC.
(Exact name of registrant as specified in its charter)
| | | |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
(Address of principal executive offices, including zip code)
(
(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 9, 2025, the number of shares of common stock, $0.01 par value, outstanding was
FORM 10-Q
For The Quarter Ended March 31, 2025
TABLE OF CONTENTS
| Page No. |
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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, 2025 and December 31, 2024 |
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| Unaudited Condensed Consolidated Statement of Stockholder’s (Deficit) Equity for the Three Ended March 31, 2025 and 2024 |
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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. |
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| PART II – OTHER INFORMATION |
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| Item 1. |
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| Item 1A. |
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| Item 2. |
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| Item 5. | Other Information | 24 |
| Item 6. |
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PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(unaudited)
| March 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventories | ||||||||
| Prepaids and other current assets | ||||||||
| Total current assets | ||||||||
| Long-term assets | ||||||||
| Restricted cash | ||||||||
| Property, plant and equipment, net | ||||||||
| Capitalized lease disposal costs, net | ||||||||
| Financing lease right-of-use asset | ||||||||
| Operating lease right-of-use asset | ||||||||
| Goodwill | ||||||||
| Patents and other intangibles, net | ||||||||
| Total long-term assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Unearned revenue | ||||||||
| Current portion of operating lease right-of-use liability | ||||||||
| Current portion of related party notes payable | ||||||||
| Current installments of notes payable | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities | ||||||||
| Accrued long-term liabilities | ||||||||
| Related party notes payable, net of current portion | ||||||||
| Notes payable, net of current portion | ||||||||
| Asset retirement obligation | ||||||||
| Operating lease right-of-use liability, net of current portion | ||||||||
| Mandatorily redeemable convertible preferred stock | ||||||||
| Total long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Stockholders' equity | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding respectively | ||||||||
| Additional paid in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total equity | ||||||||
| Total liabilities and stockholders' equity | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Operations
| Three months ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Sale of product | $ | $ | ||||||
| Cost of product | ||||||||
| Gross profit | ||||||||
| Operating costs and expenses: | ||||||||
| Salaries and contract labor | ||||||||
| General, administrative, and consulting | ||||||||
| Research and development | ||||||||
| Total operating expenses | ||||||||
| Net operating loss | ( | ) | ( | ) | ||||
| Other income (expense): | ||||||||
| Other income | ||||||||
| Interest income | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Total other (expense) income | ( | ) | ||||||
| Net Loss | $ | ( | ) | $ | ( | ) | ||
| Net loss per common share - basic: | $ | $ | ||||||
| Net loss per common share - diluted: | $ | $ | ||||||
| Weighted average common shares outstanding - basic | ||||||||
| Weighted average common shares outstanding - diluted | ||||||||
See accompanying notes to condensed consolidated financial statements.
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Cash Flows
| Three months ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities | ||||||||
| Depreciation and amortization | ||||||||
| Accretion of obligation for lease disposal costs | ||||||||
| Equity based compensation | ||||||||
| Right-of-use asset changes, net | ( | ) | ( | ) | ||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ||||||
| Inventories | ( | ) | ||||||
| Prepaids and other current assets | ||||||||
| Accounts payable and accrued liabilities | ( | ) | ||||||
| Unearned revenues | ||||||||
| Net cash (used in) provided by operating activities | ( | ) | ||||||
| Cash flows from investing activities: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of stock and exercise of options and warrants | ||||||||
| Payments on financing lease | ( | ) | ||||||
| Proceeds from the issuance of notes payable | ||||||||
| Principal payments on notes payable | ( | ) | ( | ) | ||||
| Net cash used in financing activities | ( | ) | ( | ) | ||||
| Net (decrease) increase in cash, cash equivalents, and restricted cash | ( | ) | ||||||
| Cash, cash equivalents, and restricted cash at beginning of period | ||||||||
| Cash, cash equivalents, and restricted cash at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow activities: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental disclosure of noncash financing and investing transactions | ||||||||
| Decrease in current installments of notes payable for issuance of stock | $ | $ | ||||||
| Increase in operating lease right-of-use asset and right-of-use liability for new lease | $ | $ | ||||||
| Decrease in accrued interest and increase in equity for conversion of dividends to stock | $ | $ | ||||||
Reconciliation of cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows is presented in the table below:
| March 31, | March 31, | |||||||
| 2025 | 2024 | |||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash included in long-term assets | ||||||||
| Total cash, cash equivalents, and restricted cash shown in statement of cash flows | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders' (Deficit) Equity
Three Months Ended March 31, 2025
(Unaudited)
| Common stock | ||||||||||||||||||||
| Additional | ||||||||||||||||||||
| Shares | Common | Paid-in | Accumulated | Total | ||||||||||||||||
| Outstanding | Stock | Capital | Deficit | (Deficit) Equity | ||||||||||||||||
| Balance, January 1, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Shares issued under employee stock purchase plan | ||||||||||||||||||||
| Stock in lieu of dividends on convertible preferred C | ||||||||||||||||||||
| Stock for Amici | ||||||||||||||||||||
| Shares issued for issuance of RSUs | ( | ) | ||||||||||||||||||
| Stock based compensation | ||||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Stockholders' (Deficit) Equity
Three Months Ended March 31, 2024
(Unaudited)
| Common stock | ||||||||||||||||||||
| Additional | ||||||||||||||||||||
| Shares | Common | Paid-in | Accumulated | Total | ||||||||||||||||
| Outstanding | Stock | Capital | Deficit | (Deficit) Equity | ||||||||||||||||
| Balance, January 1, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Shares issued under employee stock purchase plan | ||||||||||||||||||||
| Stock in lieu of dividends on convertible preferred C | ||||||||||||||||||||
| Shares issued for issuance of RSUs | ( | ) | ||||||||||||||||||
| Stock based compensation | ||||||||||||||||||||
| Net loss | — | — | — | ( | ) | ( | ) | |||||||||||||
| Balance, March 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to the condensed consolidated financial statements
INTERNATIONAL ISOTOPES INC. AND SUBSIDIARIES
Notes to Unaudited Condensed Consolidated Financial Statements
March 31, 2025
(1) The Company and Basis of Presentation
International Isotopes Inc. (INIS) 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 INIS and its wholly-owned subsidiaries, including International Isotopes Idaho Inc., a Texas corporation; International Isotopes Fluorine Products, Inc., an Idaho corporation; International Isotopes Transportation Services, Inc., an Idaho corporation; RadQual, LLC, a limited liability company (RadQual); RadVent, LLC, a limited liability company; Radnostix, LLC, a limited liability company; and TI Services, LLC, a limited liability company (TI Services). RadQual is a global supplier of molecular imaging quality control and calibration devices, and is based at INIS headquarters in Idaho Falls, Idaho. TI Services is headquartered in Boardman, Ohio and distributes products for nuclear medicine, nuclear cardiology, and Positron Emission Tomography (PET) imaging. INIS, and its wholly-owned subsidiaries are collectively referred to herein as the “Company,” “we,” “our” or “us.”
Nature of Operations – The Company manufacture 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”). The Company’s business consists of five major business segments: Theranostics Products, Cobalt Products, 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. For 2025, the Company’s business consists of business segments: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, Medical Device Products, and Fluorine Products. The Company’s headquarters and all manufacturing operations 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 is considered to be 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 INIS 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, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 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, 2024 filed with the SEC on March 3, 2025.
Recent Accounting Pronouncements – In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures, which enhances the disclosures required for income taxes in the Company’s annual consolidated financial statements. Notably, this ASU requires entities to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements.
(2) Current Developments and Liquidity
Business Condition – Since inception, the Company has incurred substantial losses. During the three months ended March 31, 2025, the Company reported a net loss of $
During the three months ended March 31, 2025, 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 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 into 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, 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, 2025, the Company had
For the three months ended March 31, 2024, the Company had
The table below shows the calculation of diluted shares:
| 3 Months Ended | ||||||||
| March 31, | March 31, | |||||||
| 2025 | 2024 | |||||||
| Weighted average common shares outstanding - basic | ||||||||
| Effects of dilutive shares | ||||||||
| Stock Options | ||||||||
| Series C Preferred Stock | ||||||||
| Weighted average common shares outstanding - diluted | ||||||||
The table below summarizes common stock equivalents outstanding at March 31, 2025 and March 31, 2024:
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| 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 Nuclear Medicine 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 & Nuclear Medicine Products with the CFDA for local manufacturing and distribution. The parties envision commercializing INIS'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 INIS’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 Nuclear Medicine Standards 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, 2025 and 2024, 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 option 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 option compensation expense is recognized over the vesting period for the award.
Option awards outstanding as of March 31, 2025, and changes during the three months ended March 31, 2025, were as follows:
| Weighted | ||||||||||||||||
| Weighted | Average | |||||||||||||||
| Average | Remaining | Aggregate | ||||||||||||||
| Fixed Options | Shares | Exercise Price | Contractual Life | Intrinsic Value | ||||||||||||
| Outstanding at December 31, 2024 | $ | |||||||||||||||
| Granted | ||||||||||||||||
| Exercised | ||||||||||||||||
| Expired | ||||||||||||||||
| Forfeited | ||||||||||||||||
| Outstanding at March 31, 2025 | $ | |||||||||||||||
| Exercisable at March 31, 2025 | $ | $ | ||||||||||||||
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, 2025, there was $
Total stock-based compensation expense for the three months ended March 31, 2025 and 2024 was $
During the three months ended March 31, 2025, the Company granted an aggregate of
Restricted Stock Units outstanding as of March 31, 2025, and changes during the three months ended March 31, 2025, were as follows:
| Non-Vested Restricted Stock Units | Number of restricted stock units | Weighted average grant-date fair value | ||||||
| Outstanding at December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested and Exercised | ) | |||||||
| Forfeited / Cancelled | ||||||||
| Outstanding at March 31, 2025 | $ | |||||||
As of March 31, 2025, there was $
Preferred Stock
At March 31, 2025, there were
During the three months ended March 31, 2025 and 2024, dividends paid to holders of the Series C Preferred Stock totaled $
(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 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 agreement for $
(7) Commitments and Contingencies
Dependence on Third Parties
Sales to the Company’s top
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 -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. In the three-months ended March 31, 2025, we experienced a short supply interruption from our key raw material supplier. The Company has identified additional suppliers, with anticipated regulatory approvals for those suppliers later this year and continue to search for additional means to produce and procure certain critical isotopes.
The Nuclear Medicine Reference and Calibration Standard 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. Beginning in the three months ended March 31, 2024, there was a global shortage of Cobalt-57 isotopes, a key isotope for this business segment that resulted in significant lost sales. In the third quarter of 2024 our main supply of Cobalt-57 was restored, and our global isotope supply chain has normalized. In three months ended March 31, 2025, a global outage of Gadolinium-153 isotopes, a key isotope for this business segment, resulted in significant lost sales. While the Company continues to work with industry to restart supply of this key isotope, we are uncertain of the timeframe to restore supply.
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 North American Specialty Insurance Company which is supported by a restricted money market account held with Merrill Lynch. At March 31, 2025, the balance of this account was $
On February 8, 2024, the Company entered into a definitive agreement to sell all of its assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility, including the Lea County land, for an aggregate purchase price of approximately $
(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, 2025, 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, 2025, and December 31, 2024, 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.
Beginning and January 2025, the Company entered into a new operating lease agreement for a second facility across the street for our main headquarters. The initial term of the lease is years, ending December 2029 and includes the option to extend the lease for two additional terms of years each. The monthly lease rate increases annually by
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| 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 | |||||||
| 2025 (excluding the three-months ended March 31, 2025) | $ | |||||||
| 2026 | ||||||||
| 2027 | ||||||||
| 2028 | ||||||||
| 2029 | ||||||||
| 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 2025, the Company has reportable segments which include: Theranostics Products, Cobalt Products, Nuclear Medicine Standards, 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 | 2025 | 2024 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Nuclear Medicine Standards | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate revenue | ||||||||
| Total Consolidated | $ | $ | ||||||
| Three months ended March 31, | ||||||||
| Depreciation and Amortization | 2025 | 2024 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Nuclear Medicine Standards | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate depreciation and amortization | ||||||||
| Total Consolidated | $ | $ | ||||||
| Three months ended March 31, | ||||||||
| Segment Income (Loss) | 2025 | 2024 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ( | ) | ( | ) | ||||
| Nuclear Medicine Standards | ||||||||
| Medical Device Products | ( | ) | ( | ) | ||||
| Fluorine Products | ( | ) | ||||||
| Total Segments | ||||||||
| Corporate loss | ( | ) | ( | ) | ||||
| Net Income | $ | ( | ) | $ | ( | ) | ||
| Three months ended March 31, | ||||||||
| Expenditures for Segment Assets | 2025 | 2024 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Nuclear Medicine Standards | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate purchases | ||||||||
| Total Consolidated | $ | $ | ||||||
| March 31, | December 31, | |||||||
| Segment Assets | 2025 | 2024 | ||||||
| Theranostics Products | $ | $ | ||||||
| Cobalt Products | ||||||||
| Nuclear Medicine Standards | ||||||||
| Medical Device Products | ||||||||
| Fluorine Products | ||||||||
| Total Segments | ||||||||
| Corporate assets | ||||||||
| Total Consolidated | $ | $ | ||||||
ITEM 2. MANAGEMENT’S 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, 2024 filed with the Securities and Exchange Commission (SEC) on March 3, 2025 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
International Isotopes Inc., its wholly-owned subsidiaries (including RadQual, LLC, TI Services, LLC, RadVent, LLC, and Radnostix, LLC) (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 business consists of the following five business segments:
Theranostics Products. Our Theranostics Products segment (formerly called Radiochemical Products) includes production and distribution of various isotopically pure radiopharmaceuticals, APIs, and radiochemicals for medical, industrial, and research applications. The Company produces these products from radioisotopes supplied by its vendors. The Company produces and distributes various products in customized volumes, concentrations, chemical formulations, packages, and specifications tailored to meet FDA specifications or customer and market demands. The Company's 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 includes the Theranostics Products segment of our Radnostix China Joint Venture.
Cobalt Products. Our Cobalt Products segment includes the production of bulk cobalt (cobalt-60), fabrication of cobalt capsules for radiation therapy and various industrial applications, and recycling of expended cobalt sources. We are the only company in the U.S. that can provide all these unique services.
Nuclear Medicine Standards. Our Nuclear Medicine Standards 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 Single Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) imaging equipment, patient positioning, radiopharmacy and radiopharmaceutical CDMO lab equipment, pre-clinical imaging equipment, clinical trial or custom geometry applications, and calibration or operational testing of measuring and/or testing equipment industry. Nuclear Medicine Standards products include flood sources, dose calibrators, cylinder phantoms, rod sources, line sources, flexible and rigid rulers, spot markers, pen point markers, and a host of specialty design items. Pre-clinical products include distribution of fillable sources from Phantech and pre-clinical sealed sources via our PhanQual joint venture with Phantech. Calibration & Reference sources include RadQual products for nuclear pharmacies and related lab equipment; the Company also distributes non-medical sources manufactured by its partner, ORANO LEA. The Nuclear Medicine Standards segment also commercializes bulk isotope sales, medical devices, shielding, and accessories related to the Company's sealed source products.
Medical Devices Our Medical Devices segment was started in 2024 from assets previously reported as part of the Nuclear Medicine Standards segment. The products for the Medical Devices segment are currently under development. In 2022 the Company entered a joint venture to develop the EasyFill Automated Capsule System, a robotic lab device to be paired with its Theranostics Products. The EasyFill is still in the developmental stage. In 2023, the Company entered an asset purchase agreement with AMICI, Inc. (AMICI) to purchase manufacturing molds, device registrations, trademarks, and all production rights to several AMICI diagnostic and therapeutic 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 asset purchase agreement, the Company received the manufacturing molds, device registrations, trademarks, and all production rights to the AMICI line of Xenon System products. The products that will use these acquired assets from AMICI are currently under development and are expected to be released in the second half of 2025 to be sold through its RadVent subsidiary. In 2024, the Company's Medical Devices segment entered into a distribution and servicing agreement with Scintomics for its complete line of radiosynthesis modules
Fluorine Products. We established the Fluorine Products segment in 2004 in conjunction with the development and operation of the proposed depleted uranium de-conversion facility in Lea County, New Mexico. Near the end of 2013, due to changes in the nuclear industry, we placed further engineering work for this project on hold. On February 8, 2024, we entered into a definitive agreement to sell all of our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility, for an aggregate purchase price of approximately $12.5 million, subject to conditions. We expect to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties.
RESULTS OF OPERATIONS
Three Months Ended March 31, 2025, Compared to Three Months Ended March 31, 2024
Sale of Product for the three months ended March 31, 2025 was $3,238,900 as compared to $2,904,458 for the same period in 2024, an overall increase of $334,442, or approximately 12%. This increase in sales was the result of increased revenue in our Nuclear Medicine Standards segment partially offset by decreased sales in our Theranostics Products and Cobalt 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, 2025 and 2024:
| For the three |
For the three |
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| months ended |
months ended |
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| March 31, |
March 31, |
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| Sale of Product |
2025 |
2024 |
$ change |
% change |
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| Theranostics Products |
$ | 1,787,054 | $ | 1,905,082 | $ | (118,028 | ) | -6 | % | |||||||
| Cobalt Products |
72,450 | 233,968 | (161,518 | ) | -69 | % | ||||||||||
| Nuclear Medicine Standards |
1,326,766 | 765,408 | 561,358 | 73 | % | |||||||||||
| Medical Device Products |
52,630 | — | 52,630 | — | % | |||||||||||
| Fluorine Products |
— | — | — | — | % | |||||||||||
| Total Consolidated |
$ | 3,238,900 | $ | 2,904,458 | $ | 334,442 | 12 | % | ||||||||
Cost of product increased to $1,206,863 for the three months ended March 31, 2025 from $1,038,347 for the same period in 2024. This is an increase of $168,516, or approximately 16%. The increase in cost of product in the three-month comparison was primarily due to the increased sales in the same period. Gross profit for the three months ended March 31, 2025 was $2,032,037, compared to $1,866,111 for the same period in 2024. This represents an increase in gross profit of $165,926, or approximately 9%.
The following table presents cost of product and gross profit data for each of our business segments for the three months ended March 31, 2025 and March 31, 2024:
| For the three |
For the three |
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| months ended |
% of |
months ended |
% of |
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| March 31, |
Total Sales |
March 31, |
Total Sales |
|||||||||||||
| 2025 |
2025 |
2024 |
2024 |
|||||||||||||
| Total Sales |
$ | 3,238,900 | $ | 2,904,458 | ||||||||||||
| Cost of Sales |
||||||||||||||||
| Theranostics Products |
$ | 505,168 | 16 | % | $ | 576,411 | 20 | % | ||||||||
| Cobalt Products |
38,872 | 1 | % | 109,036 | 4 | % | ||||||||||
| Nuclear Medicine Standards |
615,470 | 19 | % | 352,900 | 12 | % | ||||||||||
| Medical Device Products |
47,353 | 1 | % | |||||||||||||
| Fluorine Products |
— | — | % | — | — | % | ||||||||||
| Total Segments |
$ | 1,206,863 | 37 | % | $ | 1,038,347 | 36 | % | ||||||||
| Gross Profit |
$ | 2,032,037 | $ | 1,866,111 | ||||||||||||
| Gross Profit % |
63 | % | 64 | % | ||||||||||||
Total operating expenses decreased approximately 2% to $2,097,053 for the three months ended March 31, 2025, from $2,132,307 for the same period in 2024. This decrease of $35,254 is due to decreased General, Administrative, and Consulting expenses due to reduced professional fees and decreased Research and Development expenses due to reduced legal expenses in three months ended March 31, 2025, partially offset by an increase in Salaries and Contract Labor expenses due to increased headcount and increased payrates.
The following table presents a comparison of total operating expenses for the three months ended March 31, 2025 and 2024:
| For the three |
For the three |
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| months ended |
months ended |
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| March 31, |
March 31, |
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| Operating Costs and Expenses: |
2025 |
2024 |
% change |
$ change |
||||||||||||
| Salaries and Contract Labor |
$ | 1,119,326 | $ | 940,503 | 19 | % | $ | 178,823 | ||||||||
| General, Administrative and Consulting |
871,024 | 1,003,557 | (13 | %) | (132,533 | ) | ||||||||||
| Research and Development |
106,703 | 188,247 | (43 | )% | (81,544 | ) | ||||||||||
| Total operating expenses |
$ | 2,097,053 | $ | 2,132,307 | -2 | % | $ | (35,254 | ) | |||||||
Other income was $14,349 for the three months ended March 31, 2025 as compared to other income $160,720 for the same period in 2024. This is a decrease of $146,371, or approximately 91% that was due to a decrease in miscellaneous income.
Interest expense for the three months ended March 31, 2025 was $83,851, compared to $81,303 for the same period in 2024. This is an increase of $2,548, or approximately 3%. 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, 2025 and 2024, we accrued dividends payable of $60,945 in each period, which have been recorded as interest expense. See Note 7 “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 $112,694 for the three months ended March 31, 2025 compared to net loss of $154,051 for the same period in 2024. This increase in net income of $41,357 is largely the result of increased sales in our Nuclear Medicine Standards Products segment and increased gross profit percentages partially offset by the decrease in sales in our Theranostics Products and Cobalt Products segments for the three months ended March 31, 2025, as compared to the same period in 2024.
Theranostics Products. Sales of Theranostics Products for the three months ended March 31, 2025 was $1,787,054, compared to $1,905,082 for the same period in 2024. This is a decrease of $118,028, or approximately 6% during the three months ended March 31, 2025. The decrease is the result of a two-week temporary supplier outage during the three months ended March 31, 2025. We expect continued sales growth for our Theranostics Products going forward, primarily from the sale of our generic sodium iodide I-131 drug product and new sales of theranostic API product
Gross profit of Theranostics Troducts for the three months ended March 31, 2025 was $1,281,886, compared to $1,328,671 for the same period in 2024, and gross profit percentage was approximately 72% for both periods. Cost of product for Theranostics Products decreased to $505,168 for the three months ended March 31, 2025, as compared to $576,411 for the same period in 2024. This is a decrease of $71,243, or approximately 12%, and was the result of the decreased sales. Operating expenses for this segment increased to $404,892 for the three months ended March 31, 2025, compared to $315,207 for the same period in 2024. This in an increase in operating expenses of $89,685, or approximately 28%. This segment reported net income of $876,994 for the three months ended March 31, 2025, as compared to net income of $1,013,464 for the same period in 2024. The decrease in net income of $136,470 is the result of decreases in sales due to a temporary supplier outage and increased operating expenses.
Cobalt Products. Sales of cobalt products for the three months ended March 31, 2025 was $72,450, compared to $233,968 for the same period in 2024. This represents a decrease of $161,518, or approximately 69%. The decrease was primarily due to the timing of cobalt sealed source manufacturing sales. Large value sales of high activity cobalt sources occur at various times throughout the year. Frequently the timing of these sales can have a significant impact on period comparisons.
Nuclear Medicine Standards. Sales from nuclear medicine products for the three months ended March 31, 2025, was $1,326,766, compared to $765,408 for the same period in 2024. This represents an increase in sales of $561,358, or approximately 73%. The increase was due to a global shortage of Cobalt-57 isotope during the three months ended March 31, 2024 with no such shortage in the three months ended March 31, 2025. The Cobalt-57 shortage began in January of 2024 and was restored in the third quarter of 2024. We added additional suppliers of Cobalt-57 in 2024.
Cost of product for our nuclear medicine standards segment for the three months ended March 31, 2025, was $615,470, as compared to $352,900 for the same period in 2024. The increase in cost of sales in the period-to-period comparison of $262,570, or 74%, was due to increased sales during the three-month period ended March 31, 2025, as compared to the same period in 2024. Gross profit for our nuclear medicine standards segment for the three months ended March 31, 2025 was $711,296 compared to $412,508 for the same period in 2024. This is an increase in gross profit of $298,788, or approximately 72%.
Operating expenses for this segment for the three months ended March 31, 2025 increased to $443,733, from $403,011 for the same period in 2024. This is an increase of $40,722, or approximately 10%, and is the result of the increased sales activity in the segment. Net income for this segment for the three months ended March 31, 2025 was $267,563, compared to net income of $9,497 for the same period in 2024. This is an increase in net income of $258,066 and is the result of increased sales.
Medical Device Products. For the three months ended March 31, 2025 we had sale of product of $52,630 with no sales in the same period ending March 31, 2024. Sale of product in the first quarter of 2025, included 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. We expect these RadVent products to release later in 2025. We also are under development through a joint venture of our EasyFill Automated Iodine Capsule System.
Operating expenses for this segment for the three months ended March 31, 2025 were $181,669 as compared to $28,511 in the same period in 2024. This increase in operating expenses of $153,158 is due to increased activity including labor, professional services, and research and development related to the startup of this new business segment. Net loss for this segment for the three months ended March 31, 2025 was $181,669, compared to net loss of $28,511 for the same period in 2024. This is an increase in net loss of $153,158 due to the increased development activity in the segment.
Fluorine Products. For the three months ended March 31, 2025 and March 31, 2024, we had no revenue for our fluorine products segment.
During the three months ended March 31, 2025, we incurred $26,159 of expenses related to maintenance of plans, designs, and other assets for a proposed de-conversion facility, as compared to $28,751 for the same three-month period in 2024.
On February 8, 2024, we entered into a definitive agreement to sell all of our assets related to the Fluorine Products segment and the Planned Uranium De-Conversion Facility. We expect to close the agreement within 24 months of signing. Closing is contingent on various conditions being met, including approvals and agreements by the NRC and other third parties. Upon closing of this agreement, the costs of maintenance for the assets in this segment would not continue. With no assets nor operating activities, this business segment would be phased out.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2025, we had cash and cash equivalents of $1,645,663 as compared to $1,945,523 at December 31, 2024. This is a decrease of $299,860 or approximately 15% was largely due to a decrease in accounts payable and principal payments on notes payable. For the three months ended March 31, 2025, net cash used in operating activities was $5,119 and for the three months ended March 31, 2024, net cash provided in operating activities was $412,444. The decrease in cash provided by operating activities was a result of a decrease of $540,028 in accounts payable in the three months ended March 31, 2025.
Inventories at March 31, 2025 totaled $723,524, and inventories at December 31, 2024 totaled $820,893. Our inventory consists of work in process material for our Theranostics Products, Cobalt Products, Nuclear Medicine Products, and Medical Device Products segments.
Cash used in investing activities was $128,881 for the three months ended March 31, 2025, and cash used in investing activities was $170,921 for the same period in 2024. The cash used in both periods was for the purchase of equipment.
Cash used in financing activities was $150,591 during the three months ended March 31, 2025, and cash used in financing activities for the same period in 2024 was $63,641. During the three months ended March 31, 2025, cash paid for interest was $39,954 as compared to cash paid for interest of $155,168. the for the same three-month period in 2024. Additionally, during the three months ended March 31, 2025, we received $3,894 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan, as compared to $1,479 in proceeds from the sale of our common stock through our Employee Stock Purchase Plan in the three months ended March 31, 2024. During the three months ended March 31, 2025, principal payments on notes payable were $200,000, as compared to $64,365 for the same period in 2024.
In February 2025, 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 118,846 shares of common stock in lieu of a dividend payment of $6,180. $37,800 of dividend payable was settled with cash. The remaining balance of $199,800 was outstanding as of March 31, 2025 pending receipt of information from shareholders and will be settled in the second quarter of 2025.
Total decrease in cash for the three months ended March 31, 2025, was $284,591 compared to a cash increase of $177,882 for the same period in 2024.
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 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. Pursuit 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 extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest payable on the 2013 Promissory Note was $339,234.
In April 2018, we borrowed $120,000 from our Chief Executive Officer and Chairman of the Board 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 extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, accrued interest on the 2018 Promissory Note totaled $49,970.
In December 2019 and February 2020, we borrowed an aggregate of $1,000,000 from our Chief Executive Officer, Chairman of the Board, former Chairman of the Board, 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 extend the maturity date to March 31, 2026, with all remaining terms unchanged. At March 31, 2025, the accrued interest on the 2019 Promissory Note totaled $209,131.
In June 2023, we executed an asset purchase agreement with AMICI 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 for $427,100 to AMICI. According to the terms of the note, we are required to pay the seller a minimum of $10,000 per month for a period of 45 months. The amount due is not subject to interest until the 25th month after the anniversary of the closing of the agreement. At March 31, 2025, the balance of this promissory note was $217,100.
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, 2024, filed with the SEC on March 3, 2025.
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, 2025, 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, 2025.
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, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
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.
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, 2024.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
During the quarter ended March 31, 2025, 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.
| Exhibit No. |
Description |
| 3.1 |
| 3.2 |
| 3.3 |
| 3.4 |
|
| 3.5 |
|
| 3.6 |
| 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** |
| 32.2** |
| 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.
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 15, 2025 |
International Isotopes Inc. |
|
| By: |
/s/ Shahe Bagerdjian |
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| Shahe Bagerdjian |
||
| Chief Executive Officer |
||
| By: |
/s/ W. Matthew Cox |
|
| W. Matthew Cox |
||
| Chief Financial Officer |
||