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VIVOS INC

For the period ended Mar 31, 2025. Filed May 9, 2025.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 9, 2025

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What changed in Management’s Discussion and Analysis?

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Previous report: 10-Q

Period ended 2024-09-30; filed 2024-11-13.

0001493152-24-045032

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-03-31; filed 2025-05-09.

0001641172-25-009496

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 64 previous paragraphs and 57 current paragraphs.

27 unchanged; 19 reworded; 6 added; 12 removed; 6 previous and 5 current paragraphs rearranged.

Tables are not compared: 8 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (6)

Current report

In 2013, the United States Food and Drug Administration (“FDA”) issued the determination that RadioGel™ is a device for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval.

Current report

The Company’s headquarters are in Northeast Washington, however, our focus on the animal therapy market has been the Northwestern sector of the U.S. The Company continues its marketing efforts on the animal therapy market and our attempts to increase the exposure to our product, and generate revenue accordingly.

Current report

Commencing in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of goods sold over time.

Current report

Non-operating income for the three months ended March 31, 2025 and 2024 were as follows:
Removed paragraphs (12)

Previous report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Previous report

Revenue was $23,000 and $19,500 for the nine months ended September 30, 2024 and 2023, respectively. All revenue recognized in the nine months ended September 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.

Previous report

Operating expense for the nine months ended September 30, 2024 and 2023 was $1,944,885 and $1,853,319, respectively. The increase in operating expense from 2023 to 2024 can be attributed to an increase in professional fees from $1,205,819 for the nine months ended September 30, 2023 to $1,310,604 for the nine months ended September 30, 2024, partially attributable to the stock based compensation expense related to the restricted stock units; an increase in general and administrative expense from $132,831 for the nine months ended September 30, 2023 to $143,468 for the nine months ended September 30, 2024; a decrease in research and development expense from $300,586 for the nine months ended September 30, 2023 to $223,660 for the nine months ended September 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEO’s employment contract and bonus, to $267,153 for the nine months ended September 30, 2024 from $214,083 for the nine months ended September 30, 2023.

Previous report

Non-operating income (expense) for the nine months ended September 30, 2024 and 2023 consists of the following:

Previous report

Our net loss for the nine months ended September 30, 2024 and 2023 was $(1,887,260) and $(1,818,534), respectively.

Previous report

Non-operating income (expense) for the three months ended September 30, 2024 and 2023 consists of the following:

Previous report

Although the Company is seeking to raise additional capital and has engaged in numerous discussions with investment bankers and investors, to date the Company has not received firm commitments for the required funding. Based upon its discussions, the Company anticipates that if the Company is able to obtain the funding required to retire outstanding debt, pay past due payables and maintain its current operating activities, that the terms and conditions associated with such future funding will result in material dilution to existing shareholders.
Reworded paragraphs (19)

Previous wording

The Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device, RadioGel™, for the treatment of non-resectable tumors. A prominent team of radiochemists, scientists and engineers, collaborating with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.

Current wording

The Company is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM. A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer.

Previous wording

In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel™should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the Food and Drug Administration (“FDA”) Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.

Current wording

In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TMshould be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet®for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.

Previous wording

Based on the FDA’s recommendation, RadioGel™ will be marketed as “IsoPet®” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®” name. IsoPet®and RadioGel™ are used synonymously throughout this document. The only distinction between IsoPet®and RadioGel™ is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage, and reserve “RadioGel™” for human therapy. Based on these developments, the Company has shifted its primary focus to the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet®Solutions division.

Current wording

Based on the FDA’s recommendation, RadioGel TM is being marketed as “IsoPet®” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet®” name. IsoPet®and RadioGel TM are used synonymously throughout this document. The only distinction between IsoPet®and RadioGel TM is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage, and reserve “RadioGel TM”for human therapy. Historically, the Company’s primary focus was on the development and marketing of Isopet® for animal therapy, through the Company’s IsoPet® Solutions division. Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device Exemption and to obtain approval for clinical trials in India.

Previous wording

In November 2019, the Securities and Exchange Commission (the “SEC”) qualified the Company’s offering of its Common Stock under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”)(“Regulation A”), which offering was and amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (together with the 2019 Regulation A+ Offering, the “Prior Regulation A+ Offerings”). During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock and the private placement of 18,797,000 warrants. During the period January 1, 2024 through May 10, 2024, the Company raised $834,000 through the issuance of 13,000,000 shares of Common Stock and the private placement of 2,000,000 warrants. During the nine months ended September 30, 2024, the Company raised $839,000 through the issuance of 13,000,000 shares of Common Stock and 7,000,000 warrants. The Company’s Prior Regulation A Offerings undertaken pursuant to Regulation A+ have raised approximately $6,000,000 from the sale of shares of Common Stock.

Current wording

In November 2019, the SEC qualified the Company’s offering of its Common Stock, under Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”) (“Regulation A”), which offering was and amended from time to time thereafter (the “2019 Regulation A+ Offering”). In September 2021, the SEC qualified the Company’s offering of Common Stock under Regulation A, which offering was amended from time to time thereafter (the “2021 Regulation A Offering”). On July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock (the “July 2024 Regulation A+ Offering” and, together with the 2019 Regulation A+ Offering and the 2021 Regulation A Offering, the “Regulation A+ Offerings”.).

Previous wording

Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $2.5 million annually to maintain operating activities. Over the next 36 months, the Company believes it will cost approximately $8.0 to $9.0 million to: (1) fund the FDA approval process to conduct human clinical trials; (2) conduct Phase I, pilot, clinical trials; (3) activate several regional clinics to administer IsoPet® across the county; (4) create an independent production center within the current production site to create a template for future international manufacturing; and (5) initiate regulatory approval processes outside of the United States. The proceeds raised from the Prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will used to continue such development efforts.

Current wording

Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Prior Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet®across the U.S.; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States. The proceeds raised from the prior Regulation A+ Offerings were used to fund this development and proceeds from the July 2024 Regulation A+ Offering will be used to continue such development efforts.

Previous wording

The continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution, and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds raised from the Prior Regulation A+ Offering and from the July 2024 Regulation A+ Offering.

Current wording

The continued deployment of the precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds raised from the Regulation A+ Offerings.

Previous wording

The Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors. It is anticipated that the medical community may begin to use RadioGel off-label, we will support but will not encourage that practice.

Current wording

The Company intends to expand the indications for use in phases: first, for lymph nodes associated with thyroid cancer, secondly, cancerous lung nodules, and finally, all non-sectable solid tumors.

Previous wording

The Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern sector of the U.S. The Company has initiated marketing efforts to the animal therapy market in other regions of the U.S., attempting to increase the exposure to our product and increase revenue opportunities.

Current wording

The Company’s headquarters are in the State of Washington., The initial focus of the animal therapy market has been the Northwestern sector of the United States. The Company has initiated marketing efforts to the animal therapy market in other regions of the United States, attempting to increase the exposure to our product and increase revenue opportunities.

Previous wording

As of September 30, 2024, the Company had $1,218,160 cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that enhance our objectives.

Current wording

There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will not be enough to cover the fixed and variable obligations of the Company. The Company has focused on operating on minimum overhead, including using a virtual office for the last several years and retaining experienced industry consultants available on an as needed basis. This has helped focus the capital received from the Company’s Regulation A+ Offerings on activities that enhance our objectives.

Previous wording

No assurances can be given that the Company will be able to raise additional funds or to do so on terms advantageous to the Company or its stockholders.

Current wording

There is no guarantee that the Company will be able to raise additional funds or to do so on terms advantageous to the Company’s stockholders.

Previous wording

The financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financings and to improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There is no assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Current wording

The financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain profitability. The Company plans to seek additional funding to maintain its operations through debt and equity financing and to improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements to the cost structure. There can be no assurance that the Company will be successful in its efforts to raise additional working capital or achieve profitable operations. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous wording

Revenue was $5,000 and $7,000 for the three months ended September 30, 2024 and 2023, respectively. All revenue recognized in the three months ended September 30, 2024 and 2023 relate to consulting income with respect to the IsoPet® therapies.

Current wording

Revenue was $26,748 and $4,500 for the three months ended March 31, 2025 and 2024, respectively. All revenue recognized in the three months ended March 31, 2025 and 2024 except for $19,988 in the three months ended March 31, 2025 relate to the procedures performed with respect to the IsoPet® therapies.

Previous wording

Operating expense for the three months ended September 30, 2024 and 2023 was $844,226 and $694,633, respectively. The increase in operating expense from 2023 to 2024 can be attributed to an increase in professional fees from $512,856 for the three months ended September 30, 2023 to $627,152 for the three months ended September 30, 2024, attributable to the stock based compensation expense related to the restricted stock units; an increase in general and administrative expense from $31,357 for the three months ended September 30, 2023 to $65,123 for the three months ended September 30, 2024 related to attendance at various conferences and a marketing campaign commenced in this quarter; a decrease in research and development expense from $80,858 for the three months ended September 30, 2023 to $66,551 for the three months ended September 30, 2024 as the Company ramped up the development of their products in 2023 to include studies that are required to continue to have their products accepted by the FDA, and completed some of those studies for the 2024 period; and an increase in payroll expense related to the CEO’s employment contract and bonus to $85,400 for the three months ended September 30, 2024 from $69,562 for the three months ended September 30, 2023.

Current wording

Operating expense for the three months ended March 31, 2025 and 2024 was $854,449 and $575,629, respectively. The increase in operating expense from 2024 to 2025 can be attributed to the increase in professional fees ($403,637 for the three months ended March 31, 2024 versus $588,268 for the three months ended March 31, 2025) related to the fees incurred for the consultants engaged in 2025 versus 2024; the increase in general and administrative expense ($23,420 for the three months ended March 31, 2024 versus $52,203 for the three months ended March 31, 2025); the increase in research and development ($57,447 for the three months ended March 31, 2024 versus $119,281 for the three months ended March 31, 2025) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($91,125 for the three months ended March 31, 2024 versus $94,697 for the three months ended March 31, 2025) related to the CEOs employment contract and bonus.

Previous wording

Non-operating income (expense) for the three months ended September 30, 2024 and 2023 related to interest earned on the Company’s cash accounts.

Current wording

Non-operating income for the three months ended March 31, 2025 and 2024 related to interest earned on the Company’s cash accounts.

Previous wording

Our net loss for the three months ended September 30, 2024 and 2023 was $(825,263) and $(667,690), respectively.

Current wording

Our net loss for the three months ended March 31, 2025 and 2024 was $(834,696) and $(558,539), respectively.

Previous wording

At September 30, 2024, the Company had working capital of $1,195,505, as compared to working capital of $1,365,120 at December 31, 2023. During the nine months ended September 30, 2024 and 2023, the Company experienced negative cash flow from operations of $1,213,127 and $829,886 and had no cash from investing activities. In both 2024 and 2023, there were no investing activities, and in 2024 and 2023, the Company raised $839,000 and $650,665 from the sales of Common Stock and warrants as part of our Regulation A+ Offerings. We also received $10,000 in September 2023 from advances from our CEO that was repaid in October 2023.As of September 30, 2024, the Company did not have any commitments for capital expenditures.

Current wording

At March 31, 2025, the Company had working capital of $3,186,489, as compared to working capital of $2,147,247 at December 31, 2024. As of March 31, 2025, the Company did not have any commitments for capital expenditures.

Previous wording

Cash used in operating activities increased from $829,886 for the nine months ended September 30, 2023 to $1,213,127 for the nine months ended September 30, 2024. Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, stock-based compensation, as well as the changes in accounts receivable, prepaid expense and accounts payable in 2024 compared to only having net changes from current assets and liabilities and stock-based compensation in 2023.

Current wording

Net cash used in operating activities for the three months ended March 31, 2025 and 2024, was $455,198 and $351,458, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the three months ended March 31, 2025 and 2024, there was no cash used in investing activities. Net cash provided by financing activities for the three months ended March 31, 2025 and 2024 was $1,507,750 and $130,000, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings.

Previous wording

The Company has generated material operating losses since inception. The Company had a net loss of $1,887,260 and $1,818,534 for the nine months ended September 30, 2024 and 2023, respectively. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although no assurances can be given that such additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.

Current wording

The Company has generated material operating losses since inception. The Company had a net loss of $834,696 for the three months ended March 31, 2025 as compared to a net loss of $558,539 for the three months ended March 31, 2024. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.

Previous wording

The Company requires funding of at least $5 million per year to maintain current operating activities. Over the next 24 months, the Company believes it will cost approximately $9 million to: (1) fund the FDA approval process to conduct human clinical trials; (2) conduct Phase I, pilot, and clinical trials; (3) activate several regional clinics to administer IsoPet®across the county; (4) create an independent production center within the current production site to create a template for future international manufacturing; and (5) initiate regulatory approval processes outside of the United States.

Current wording

The Company requires funding of at least $3.0 million per year to maintain current operating activities. Over the next 36 months, the Company believes it will require approximately $9,0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, and clinical trials; (iii) activate several regional clinics to administer IsoPet®across the county; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

During the year ended December 31, 2023, $1,179,245 was raised through the sale of 16,132,000 shares of Common Stock through the Regulation A+ Offerings and concurrent private placements of 18,797,000 warrants. During the year ended December 31, 2024, $2,266,000 was raised through the issuance of 24,950,000 shares of Common Stock through the Regulation A+ Offerings. During the three months ended March 31, 2025, $1,500,000 was raised through the issuance of 12,500,000 shares of Common Stock through the Regulation A+ Offerings and $6,250 through a concurrent private placement of 6,250,000 warrants.

Current report — wording carried from elsewhere

Following receipt of required regulatory approvals and necessary financing to fund our working capital requirements, the Company intends to outsource material aspects of manufacturing, distribution, sales, and marketing for operations within the U.S. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy.

Current report — wording carried from elsewhere

Long-term, the Company intends to consider resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment of cancer and other illnesses. These long-term goals are subject to the Company: (i) receiving adequate funding; (ii) receiving regulatory approval for RadioGel™ and other brachytherapy products; and (iii) being able to successfully commercialize its brachytherapy products.

Current report — wording carried from elsewhere

As of March 31, 2025, the Company had $3,265,100 in cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash will be insufficient to cover the fixed and variable obligations of the Company.

Current report — wording carried from elsewhere

Based on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations.
Rearranged previous paragraphs (6)

Previous report — wording carried elsewhere

On July 17, 2024, the SEC qualified the Company’s offering under Regulation A to offer up to $60,000,000 shares of its Common Stock (the “July 2024 Regulation A+ Offering”).

Previous report — wording carried elsewhere

The following table sets forth information from our statements of operations for the nine months ended September 30, 2024 and 2023:

Previous report — wording carried elsewhere

Operating expense for the nine months ended September 30, 2024 and 2023, respectively consists of the following:

Previous report — wording carried elsewhere

Non-operating income (expense) for the nine months ended September 30, 2024 and 2023 related to interest earned on the Company’s cash accounts.

Previous report — wording carried elsewhere

Revenues and Cost of Goods Sold

Previous report — wording carried elsewhere

Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel™ and/or any of our other brachytherapy technologies.