What changed in this filing

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Item 7. Management’s Discussion and Analysis

2024-03-18 compared with 2023-03-01 · 68 added, 121 removed, 115 unchanged (62% of the section changed)

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following table sets forth information from our statements of operations for the years ended December 31, 2023 and 2022:

December 31, 2022

December 31, 2021

Cost of goods sold

Operating expenses

Operating loss

Non-operating income (expense)

of goods sold

(loss) profit

Non-operating

income (expense)

$ (2,894,753 )

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and Cost of Goods Sold

was $36,499 and $14,887 for the year ended December 31, 2022 and 2021, respectively.

was $19,500 and $36,499 for the years ended December 31, 2023 and 2022, respectively.

All revenue recognized in the years ended December

31, 2022 and 2021 relate to consulting income with respect to the IsoPet ® therapies.

31, 2023 and 2022 relate to the procedures performed with respect to the IsoPet ® therapies.

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.

expenses for the years ended December 31, 2022 and 2021, respectively consists of the following:

December 31, 2022

December 31, 2021

Professional fees, including stock-based compensation

Payroll expenses

Research and development

General and administrative expenses

Total operating expenses

expenses for the years ended December 31, 2022 and 2021 was $2,525,469 and $2,504,685, respectively.

The increase in operating expenses

from 2021 to 2022 can be attributed to the decrease in professional fees ($1,755,316 for the year ended December 31, 2022 versus $1,838,323

for the year ended December 31, 2021) as the Company utilized more services due to amending their Regulation A+ and the fees incurred

for the consultants engaged in 2021 including stock-based compensation;

Operating expense for the years ended December 31, 2023 and 2022, respectively,

consisted of the following:

fees, including stock-based compensation

and development expense

and administrative expense

operating expense

Operating expense for the years ended December 31, 2023 and 2022 was

$2,787,110 and $2,525,469, respectively.

The increase in operating expense from 2022 to 2023 can be attributed to the decrease in professional

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

more services due to amending the offering statement on Form 1-A (File No.

024-11627) (the “ Offering Statement ”) for

the Company’s offering being made pursuant to Regulation A+ (the “ Regulation A+ Offering ”), and the fees incurred

for the consultants engaged in 2022, including:

stock-based compensation;

the increase in general and administrative expense ($165,773

for the year ended December 31, 2022 versus $112,037 for the year ended December 31, 2021);

for the year ended December 31, 2023 compared to $151,111 for the year ended December 31, 2022);

the increase in research and development

($343,802 for the year ended December 31, 2022 versus $286,848 for the year ended December 31, 2021) as the Company ramped up the development

of their products with the recent raising of capital, and an increase in payroll expenses ($275,240 for the year ended December 31, 2022

versus $267,477 for the year ended December 31, 2021) related to the CEOs employment contract taking effect.

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

up the development of their products with the recent raising of capital;

and, an increase in payroll expense ($281,716 for the year ended

December 31, 2023 compared to $275,240 for the year ended December 31, 2022) related to our Chief Executive Officer’s employment

contract taking effect.

Non-Operating

Income (Expense)

Non-operating

income (expense) for the years ended December 31, 2022 and 2021, respectively consists of the following:

income for the years ended December 31, 2023 and 2022, respectively, consisted of the following:

December 31, 2023

December 31, 2022

Interest expense

Forgiveness of debt

Loss on debt extinguishment

Non-operating income (expense)

on issuance of shares

Non-operating

income (expense) for the year ended December 31, 2022 varied from the year ended December 31, 2021 primarily due to a decrease in interest

expense from $25,375 for the year ended December 31, 2021 to $0 for the year ended December 31, 2022 as a result of conversions and repayments

of notes payable.

In addition, the Company converted a note in January 2021 which resulted in a loss on conversion and recognized a gain

on forgiveness of debt on old payables as they satisfied agreements with vendors to pay a portion of the payable with the remaining amount

forgiven in both 2021 and 2022.

Non-operating

income (expense) for the year ended December 31, 2023 varied from the year ended December 31, 2022 due to the forgiveness of debt on

old payables as we satisfied agreements with vendors to pay a portion of the payable with the remaining amount forgiven in 2022.

2023, we recognized a loss on issuance of shares of $151,184 and interest earned on our bank accounts of $49,577.

net loss for the years ended December 31, 2023 and 2022 was $(2,894,753) and $(2,470,161), respectively.

and Capital Resources

December 31, 2022, the Company had working capital of $1,661,044, as compared to working capital of $1,467,383 at December 31, 2021.

During the year ended December 31, 2022, the Company experienced negative cash flow from operations of $1,120,058 and realized $1,220,000

of cash flows from financing activities.

As of December 31, 2022, the Company did not have any commitments for capital expenditures.

At December 31, 2023, the Company had working capital of $1,365,120,

compared to working capital of $1,661,044 at December 31, 2022.

During the year ended December 31, 2023, the Company experienced negative

cash flows from operations of $1,293,023 and realized $1,179,245 of cash flows from financing activities.

As of December 31, 2023, the

Company did not have any commitments for capital expenditures.

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

Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations, loss

on conversion of debt and share based compensation offset by forgiveness of debt.

Cash provided from financing activities decreased from

$1,666,238 for the year ended December 31, 2021 to $1,220,000 for the year ended December 31, 2022.

Cash used in operating activities was primarily a result of the Company’s non-cash items, such as loss from operations,

loss on conversion of debt and share based compensation offset by forgiveness of debt.

Cash provided from financing activities decreased

from $1,220,000 for the year ended December 31, 2022 to $1,179,245 for the year ended December 31, 2023.

In 2023, the Company raised

from sales of common stock and warrants offset by repayments of convertible notes of $50,000 and related party notes of $100,000.

2022, the Company raise $1,220,000 from sales of common stock and warrants.

$1,179,245 from sales of common stock.

In 2022, the Company raise $1,220,000 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.

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 fund:

(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 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.

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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differ from those estimates.

assets are carried at the lower of cost or net realizable value.

Production equipment with a cost of $2,500 or greater and other fixed

assets with a cost of $1,500 or greater are capitalized.

Major betterments that extend the useful lives of assets are also capitalized.

Normal maintenance and repairs are charged to expense as incurred.

When assets are sold or otherwise disposed of, the cost and accumulated

depreciation are removed from the accounts and any resulting gain or loss is recognized in operations.

is computed using the straight-line method over the following estimated useful lives:

and fixtures:

improvements and capital lease assets are amortized over the shorter of the life of the lease or the estimated life of the asset.

of the Company reviews the net carrying value of all of its equipment on an asset by asset basis whenever events or changes in circumstances

indicate that its carrying amount may not be recoverable.

These reviews consider the net realizable value of each asset, as measured

in accordance with the preceding paragraph, to determine whether impairment in value has occurred, and the need for any asset impairment

fees are stated at cost, less accumulated amortization.

Amortization of license fees is computed using the straight-line method over

the estimated economic useful life of the asset.

and Intellectual Property

patents are being developed or pending, they are not being amortized.

Management has determined that the economic life of the patents

to be ten years and amortization, over such ten-year period and on a straight-line basis will begin once the patents have been issued

and the Company begins utilization of the patents through production and sales, resulting in revenues.

Company evaluates the recoverability of intangible assets, including patents and intellectual property on a continual basis.

factors are used to evaluate intangibles, including, but not limited to, management’s plans for future operations, recent operating

results and projected and expected undiscounted future cash flows.

May 2014, the Financial Accounting Standards Board (“ FASB ”) issued Accounting Standard Update (“ ASU ”)

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guidance effective January 1, 2018 using the full retrospective method.

ASC 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective

Under the FASB’s Accounting Standards Codification (“ ASC ”)

Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to preform respective

obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods

transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable.

The adoption of ASC 606 did not have an impact on the Company’s operations or cash flows.

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.

Loss Per Share

Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted earnings

Basic loss per share is computed by dividing loss available to common stockholders (the numerator) by the weighted-average

number of common shares outstanding (the denominator) for the period and does not include the impact of any potentially dilutive common

stock equivalents.

The computation of diluted earnings per share is similar to basic earnings per share, except that the denominator

is increased to include the number of additional common shares that would have been outstanding if potentially dilutive common shares

had been issued.

When the Company incurs a loss, the denominator is not increased by the potentially dilutive common shares as the effect

would be anti-dilutive.

and Development Costs

and developments costs, including salaries, research materials, administrative expenses and contractor fees, are charged to operations

The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed

assets and not treated as an expense in the period acquired.

Depreciation of capitalized equipment used to perform research and development

is classified as research and development expense in the year computed.

Company accounts for income taxes under FASB ASC Topic 740-10-25 (“ ASC 740-10-25 ”).

Under ASC 740-10-25, deferred

tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement

carrying amounts of existing assets and liabilities and their respective tax bases.

Deferred tax assets and liabilities are measured

using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered

ASC 740-10-25, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that

includes the enactment date.

Company files income tax returns in the U.S.

federal jurisdiction.

costs and penalties related to income taxes, if any, will be classified as interest expense and general and administrative costs, respectively,

in the Company’s financial statements.

For the years ended December 31, 2022 and 2021, the Company did not recognize any interest

or penalty expense related to income taxes.

The Company believes that it is not reasonably possible for the amounts of unrecognized tax

benefits to significantly increase or decrease within the next 12 months.

Value of Financial Instruments

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such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

Company recognizes compensation costs under FASB ASC Topic 718, Compensation – Stock Compensation and ASU 2018-07.

Companies are

required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize

the costs in the financial statements over the period during which employees are required to provide services.

Share based compensation

arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase

The Company recognizes compensation costs under FASB ASC Topic 718,

Compensation – Stock Compensation, and ASU No.

2018-07 – Compensation – Stock Compensation (Topic 718):

to Nonemployee Share-Based Payment Accounting.

Companies are required to measure the compensation costs of share-based compensation arrangements

based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required

to provide services.

Share based compensation arrangements 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.

Such compensation amounts, if any, are amortized

over the respective vesting periods of the option grant.

Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

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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.

What changed 10-K

Item 7. Management’s Discussion and Analysis