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following table sets forth information from our statements of operations for the years ended December 31, 2024 and 2023:
−Removed: of goods sold
−Removed: (loss) profit
−Removed: Non-operating
−Removed: income (expense)
+Added: December 31, 2024
+Added: December 31, 2023
+Added: Cost of goods sold
+Added: Operating expense
+Added: Operating loss
+Added: Non-operating expense
$ (2,910,448 )
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was $27,995 and $19,500 for the years ended December 31, 2024 and 2023, respectively.
−Removed: All revenue recognized in the years ended December
−Removed: 31, 2023 and 2022 relate to the procedures performed with respect to the IsoPet ® therapies.
+Added: All revenue recognized in the year ended December
+Added: 31, 2023 relate to the procedures performed with respect to the IsoPet ® therapies.
+Added: All revenue except $4,995 in 2024 relate
+Added: to the procedures performed with respect to the IsoPet ® therapies.
+Added: The $4,995 relates to a new license fee charged by
+Added: the Company to clinics for certification to perform these therapies.
+Added: These revenues are recognized upon the certification being completed.
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.
−Removed: Operating expense for the years ended December 31, 2023 and 2022, respectively,
−Removed: consisted of the following:
−Removed: fees, including stock-based compensation
−Removed: and development expense
−Removed: and administrative expense
−Removed: operating expense
−Removed: Operating expense for the years ended December 31, 2023 and 2022 was
−Removed: $2,787,110 and $2,525,469, respectively.
−Removed: The increase in operating expense from 2022 to 2023 can be attributed to the decrease in professional
−Removed: fees ($1,606,923 for the year ended December 31, 2023 compared to $1,755,316 for the year ended December 31, 2022) as the Company utilized
−Removed: more services due to amending the offering statement on Form 1-A (File No.
−Removed: 024-11627) (the “ Offering Statement ”) for
−Removed: the Company’s offering being made pursuant to Regulation A+ (the “ Regulation A+ Offering ”), and the fees incurred
−Removed: for the consultants engaged in 2022, including:
+Added: expense for the years ended December 31, 2024 and 2023, respectively, consisted of the following:
+Added: December 31, 2024
+Added: December 31, 2023
+Added: Professional fees, including
stock-based compensation
−Removed: the increase in general and administrative expense ($165,773
−Removed: for the year ended December 31, 2023 compared to $151,111 for the year ended December 31, 2022);
−Removed: the increase in research and development
−Removed: expense ($732,698 for the year ended December 31, 2023 compared to $343.802 for the year ended December 31, 2022) as the Company ramped
−Removed: up the development of their products with the recent raising of capital;
−Removed: and, an increase in payroll expense ($281,716 for the year ended
−Removed: December 31, 2023 compared to $275,240 for the year ended December 31, 2022) related to our Chief Executive Officer’s employment
−Removed: contract taking effect.
+Added: Payroll expense
+Added: Research and development expense
+Added: General and administrative
+Added: Total operating expense
+Added: expense for the years ended December 31, 2024 and 2023 was $2,601,400 and $2,787,110, respectively.
+Added: The decrease in operating expense
+Added: from 2023 to 2024 can be attributed to the increase in professional fees ($1,606,923 for the year ended December 31, 2023 compared to
+Added: $1,682,350 for the year ended December 31, 2024) as the Company utilized more services due to amending the offering statement on Form
+Added: 1-A (the “ Offering Statement ”) for the Company’s offering being made pursuant to Regulation A+ (the “ Regulation
+Added: A+ Offering ”), and the fees incurred for the consultants engaged in 2024, including:
+Added: stock-based compensation;
+Added: in general and administrative expense ($165,773 for the year ended December 31, 2023 compared to $241,824 for the year ended December
+Added: the decrease in research and development expense ($732,698 for the year ended December 31, 2023 compared to $324,629 for the
+Added: year ended December 31, 2024) as the Company ramped up the development of their products with the recent raising of capital in 2023;
+Added: and, an increase in payroll expense ($281,716 for the year ended December 31, 2023 compared to $352,597 for the year ended December 31,
+Added: 2024) related to our Chief Executive Officer’s employment contract taking effect.
Non-Operating
Non-operating
−Removed: income for the years ended December 31, 2023 and 2022, respectively, consisted of the following:
+Added: expense for the years ended December 31, 2024 and 2023, respectively, consisted of the following:
December 31, 2024
December 31, 2023
−Removed: on issuance of shares
−Removed: Non-operating
+Added: Interest income
+Added: Loss on issuance of
+Added: shares and exchange of warrants
+Added: Non-operating expense
Non-operating
−Removed: income (expense) for the year ended December 31, 2023 varied from the year ended December 31, 2022 due to the forgiveness of debt on
−Removed: old payables as we satisfied agreements with vendors to pay a portion of the payable with the remaining amount forgiven in 2022.
−Removed: 2023, we recognized a loss on issuance of shares of $151,184 and interest earned on our bank accounts of $49,577.
+Added: income (expense) for the year ended December 31, 2023 varied from the year ended December 31, 2024.
+Added: In 2023, we recognized a loss on
+Added: issuance of shares of $151,184 and interest earned on our bank accounts of $49,577.
+Added: In 2024, we recognized a loss on the exchange of
+Added: warrants of $381,000, and incurred interest income of $74,936 related to our cash position in our bank accounts.
net loss for the years ended December 31, 2024 and 2023 was $(2,910,448) and $(2,894,753), respectively.
and Capital Resources
−Removed: At December 31, 2023, the Company had working capital of $1,365,120,
−Removed: compared to working capital of $1,661,044 at December 31, 2022.
−Removed: During the year ended December 31, 2023, the Company experienced negative
−Removed: cash flows from operations of $1,293,023 and realized $1,179,245 of cash flows from financing activities.
−Removed: As of December 31, 2023, the
−Removed: Company did not have any commitments for capital expenditures.
−Removed: used in operating activities increased from $1,120,958 for the year ended December 31, 2022, to $1,293,023 for the year ended December
−Removed: Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations,
−Removed: loss on conversion of debt and share based compensation offset by forgiveness of debt.
−Removed: Cash provided from financing activities decreased
+Added: December 31, 2024, the Company had working capital of $2,147,247, compared to working capital of $1,365,120 at December 31, 2023.
+Added: the year ended December 31, 2024, the Company experienced negative cash flows from operations of $1,684,039 and realized $2,304,300 of
+Added: cash flows from financing activities.
+Added: As of December 31, 2024, the Company did not have any commitments for capital expenditures.
+Added: the year ended December 31, 2023, the Company experienced negative cash flows from operations of $1,293,023 and realized $1,179,245 of
+Added: cash flows from financing activities.
+Added: As of December 31, 2023, the Company did not have any commitments for capital expenditures.
+Added: used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, loss on
+Added: exchange of warrants, loss on conversion of debt and share based compensation.
+Added: Cash provided from financing activities increased
from $1,179,245 for the year ended December 31, 2023 to $2,304,300 for the year ended December 31, 2024.
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$1,179,245 from sales of common stock.
−Removed: In 2022, the Company raise $1,220,000 from sales of common stock and warrants.
+Added: In 2024, the Company raised $2,284,950 from sales of common stock and warrants.
Company has generated material operating losses since inception.
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to curtail its business or cease all operations.
−Removed: The Company requires funding of at least $5 million per year to maintain
−Removed: current operating activities.
−Removed: Over the next 24 months, the Company believes it will cost approximately $9 million to:
−Removed: (1) fund the FDA
−Removed: approval process to conduct human clinical trials;
−Removed: (2) conduct Phase I, pilot, and clinical trials;
−Removed: (3) activate several regional clinics
−Removed: to administer IsoPet ® across the county;
−Removed: (4) create an independent production center within the current production site
−Removed: to create a template for future international manufacturing;
−Removed: and (5) initiate regulatory approval processes outside of the United States.
+Added: Company requires funding of at least $3.5 million per year to maintain current operating activities.
+Added: Over the next 36 months, the Company
+Added: believes it will cost approximately $10 million to:
+Added: (1) fund the FDA approval process to conduct human clinical trials;
+Added: (2) conduct Phase
+Added: I, pilot, and clinical trials;
+Added: (3) activate several regional clinics to administer IsoPet ® across the county;
+Added: an independent production center within the current production site to create a template for future international manufacturing;
+Added: (5) initiate regulatory approval processes outside of the United States.
principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the FDA’s
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additional capital raises.
−Removed: the Company is seeking to raise additional capital and has engaged in numerous discussions with investment bankers and investors, to
−Removed: date, the Company has not received firm commitments for the required funding.
−Removed: Based upon its discussions, the Company anticipates that
−Removed: if the Company is able to obtain the funding required to retire outstanding debt, pay past due payables and maintain its current operating
−Removed: activities, that the terms associated with such funding will result in material dilution to existing shareholders.
geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity in
−Removed: the capital markets, could impact the Company’s ability to obtain financing and its ability to execute its business plan.
+Added: the capital markets, could also impact the Company’s ability to obtain financing and its ability to execute its business plan.
Chief Executive Officer currently works from his home office in virtual communication with key personnel.
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financial condition, revenues, results of operations, liquidity, or capital expenditures.
+Added: Accounting Policies
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
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The updated guidance introduces a five-step model to achieve its
−Removed: core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects
+Added: core principle of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects
the consideration to which the entity expects to be entitled in exchange for those goods or services.
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guidance effective January 1, 2018 using the full retrospective method.
−Removed: Under the FASB’s Accounting Standards Codification (“ ASC ”)
−Removed: Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective
−Removed: obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods
−Removed: transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable.
+Added: the FASB’s Accounting Standards Codification (“ ASC ”) Topic 606, to recognize revenue, the Company is required
+Added: to identify an approved contract with commitments to preform respective obligations, identify rights of each party in the transaction
+Added: regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance
+Added: and verify that collection of substantially all consideration is probable.
Company recognized revenue as they (i) identified the contracts with each customer;
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to complete the procedures on the animals, the Company recognized revenue as that was considered the performance obligation.
+Added: Company in 2024 also implemented a license program for clinics that pay for certification to perform these therapies.
+Added: These revenues
+Added: are recognized upon the certification being completed.
+Added: During the year ended December 31, 2024, $4,995 of the revenue relates to this
+Added: certification.
Value of Financial Instruments
−Removed: Company adopted ASC Topic 820 (“Fair Value Measurements”) as of January 1, 2008 for financial instruments measured
−Removed: as fair value on a recurring basis.
−Removed: ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance
−Removed: with accounting principles generally accepted in the United States and expands disclosures about fair value measurements.
+Added: Company adopted ASC Topic 820 (“Fair Value Measurements”) as of January 1, 2008 for financial instruments measured as fair
+Added: value on a recurring basis.
+Added: ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting
+Added: principles generally accepted in the United States and expands disclosures about fair value measurements.
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
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such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
−Removed: The Company recognizes compensation costs under FASB ASC Topic 718,
−Removed: Compensation – Stock Compensation, and ASU No.
+Added: Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation, and ASU No.
Compensation – Stock Compensation (Topic 718):
−Removed: to Nonemployee Share-Based Payment Accounting.
−Removed: Companies are required to measure the compensation costs of share-based compensation arrangements
−Removed: based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required
−Removed: to provide services.
−Removed: Share based compensation arrangements include stock options, restricted share plans, performance-based awards, share
−Removed: appreciation rights and employee share purchase plans.
+Added: Improvements to Nonemployee Share-Based Payment Accounting.
+Added: Companies are required
+Added: to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs
+Added: in the financial statements over the period during which employees are required to provide services.
+Added: Share based compensation arrangements
+Added: include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase plans.
As such, compensation cost is measured on the date of grant at their fair value.
−Removed: Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
+Added: Such compensation amounts, if any, are amortized over
+Added: the respective vesting periods of the option grant.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
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on page F-1 and is hereby incorporated by reference.
−Removed: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
+Added: Changes in and Disagreements with Accountants on Accounting and Financial
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.