Overview

We have developed and intend to commercialize our patented miniform pads and PAD based over-the-counter products for the treatment of hemorrhoids, minor vaginal infection, urinary incontinence, general catamenial uses and other medical needs. We are also developing genomic diagnostics for the laboratory market, based on our lateral flow patents. Our platforms include: inSync®, UniqueTM, and OEM branded over-the-counter and laboratory testing products based on our core intellectual property related to our PAD technology.

The continuation of our operations remains contingent upon the receipt of additional financing required to execute our business and operating plan, which is currently focused on the commercialization of our PAD technology either directly or through a joint venture or other relationship intended to increase shareholder value. In the interim, we have nominal operations, focused principally on maintaining our intellectual property portfolio and maintaining compliance with the public company reporting requirements. In order to continue as a going concern, we will need to raise capital, which may include through the issuance of debt and/or equity securities. No assurances can be given that we will be able to obtain financing on terms favorable to us, if at all, or otherwise successfully develop a business and operating plan or enter into an alternative relationship to commercialize our PAD technology.

Our principal business line consists of our OTC Business, which includes commercialization of our InSync feminine hygienic interlabial pad, the Unique® Miniform for hemorrhoid application, and other treated miniforms, as well as maintaining established and continuing licensing relationships related to the OTC Business. We also own certain diagnostic testing technology that is based on our lateral flow patents. Management believes this corporate structure permits us to more efficiently explore options to maximize the value of the Businesses, with the objective of maximizing the value of the Businesses for the benefit of the Company and our shareholders.

Our current focus is to obtain additional working capital necessary to continue as a going concern, and develop a longer term financing and operating plan to: (i) commercialize our over-the-counter products either directly or through joint ventures, mergers or similar transactions intended to capitalize on potential commercial opportunities; (ii) contract manufacturing of our over-the-counter products to third parties while maintaining control over the manufacturing process; (iii) maintain our intellectual property portfolio with respect to patents and licenses pertaining to both the OTC Business and the Diagnostics Business; and (iv) maximize the value of our investments in non-core assets. As a result of our current financial condition, however, our efforts in the short-term will be focused on obtaining financing necessary to maintain the Company as a going concern.

Our Results of Operations

We did not generate any revenue during the years ended December 31, 2020 or 2019. The absence of revenue is due to no royalty revenue attributable to our PAD technology received during the 2020 and 2019 periods. Management does not anticipate that we will generate any revenue until such time as we develop a plan to commercialize our over-the-counter products, which is contingent on the receipt of financing.

Total costs and operating expense for the years ended December 31, 2020 and 2019 were $60,624 and $201,739, respectively. Highlights of the major components of our results of operations are detailed and discussed below:




                                  Year Ended    Year Ended
                                  December 31,  December 31,
                                  2020          2019

Sales, general and administrative $12,726 $59,904 Professional fees

$37,398       $57,835

Professional fees, related party $10,500 $84,000







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Sales, general and administrative expense includes, but is not limited to, consulting expense, office and insurance expense, accounting and other costs to maintain compliance with our reporting requirements to the Securities and Exchange Commission (the "SEC"). The decrease in sales, general and administrative expense in the year ended December 31, 2020 compared to the year ended December 31, 2019 is principally attributable to lower costs incurred during the 2020 period for intellectual property and Directors and Officers Liability Insurance.

Professional fees include the costs of legal, consulting and auditing services provided to us, each of which were lower in the 2020 period, as compared to the 2019 period. The period over period decrease is due to lower costs of legal fees during the 2020 period due to the lower legal and audit fees compared to the 2019 period.

Professional fees, related party include the costs of consulting fees paid to Dr. Hirschman and Mr. Abrams for their services provided to the Company. During the year ended December 31, 2020, professional fees, related party were lower compared to the 2019 period due to a Dr. Hirschman and Mr. Abrams waiving certain of the service fees during the 2020 period.

We did not incur any research and development costs during the years ended December 31, 2020 or 2019 and did not engage in any research and development efforts in the 2020 or 2019 periods. The Company does not expect to engage in any research and development activity until funding is secured and we develop a plan to commercialize our products.

Other income and expense for the years ended December 31, 2020 and 2019 includes expense of $192,110 and expense of $420,181, respectively. Highlights of the major components of other income and expense related to our results of operations are detailed and discussed below:




                                       Year Ended    Year Ended
                                       December 31,  December 31,
                                       2020          2019




Interest expense                        $(216,720)    $(198,181)
Loss on impairment                      $-            $(222,000)

Gain on settlement of accounts payable $24,610 $-

During the year ended December 31, 2020, interest expense increased to $216,720 from $198,181 for the 2019 period. The increase in interest expense in the 2020 period compared to the 2019 period is primarily due to higher interest rate calculations on certain notes payable during the 2020 periods.

During the year ended December 31, 2019, we recorded non-cash expense of $222,000 due to impairment of certain assets during the period.

During the year ended December 31, 2020, we recorded a net gain on the settlement of accounts payable of $24,610.

Net loss for the 2020 period was $252,734, compared to a net loss of $621,920 reported for the 2019 period. The decrease in net loss in the 2020 period is directly attributable to lower expenses, described above.

Although we anticipate that we will likely incur net loss in future periods, we expect such net loss to decrease in future periods due to the current suspension of our active operations and our lack of revenue. We do not expect to re-commence active operations until we are able to secure financing necessary to execute our business and operating plan, including the development and launch of our products, or to otherwise capitalize on our PAD technology.





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Liquidity and Capital Resources

At December 31, 2020, we had cash and cash equivalents of $55,428, as compared to $130,351 at December 31, 2019. At December 31, 2020, we had negative working capital of $2,381,055 and an accumulated deficit of $52,114,986.

During the years ended December 31, 2020 and 2019, we made aggregate cash payments of $3,500 and $78,000, respectively, to certain officers of the Company and to a consultant for services provided to the Company. During the year ended December 31, 2019, we had prepaid $7,000 of compensation to an officer which was applied to 2020 consulting fees.

During the year ended December 31, 2020, cash used for operating activities was $74,923, compared to $191,673 during the year ended December 31, 2019. The net overall decrease in cash used for operating activities during the year ended December 31, 2020, is attributable to losses incurred in the period.

Cash provided by investing activities during the year ended December 31, 2020 and 2019 was $0 and $0, respectively.

Cash used by financing activities during the year ended December 31, 2020 was $0 and $0, respectively.

We have not generated sufficient revenue from operations to meet our operating expenses. We require additional funding to complete the development and launch of our products, or to otherwise capitalize on our PAD technology. We have historically financed our operations primarily through issuances of equity securities and the proceeds of debt instruments. In the past, we have also provided for our cash needs by issuing Common Stock, options and warrants for certain operating costs, including consulting and professional fees. In addition, in the fiscal year ended December 31, 2017, we received a large cash payment from Preprogen as consideration for the sale and transfer of the Purchased Assets.

Management believes that given the current economic environment and the continuing need to strengthen our cash position, there is substantial doubt about our ability to continue as a going concern. We are pursuing various funding options, including licensing opportunities and the sale of investment holdings, as well other financing transactions, to obtain additional funding to continue the development of our products and bring them to commercial markets. There can be no assurance that we will be successful in our efforts. Should we be unable to raise adequate financing or generate sufficient revenue in the future, our business, results of operations, liquidity and financial condition would be materially and adversely harmed.

We believe that our ability to re-commence operations, and therefore continue as a going concern, is dependent upon our ability to do any or all of the following:



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obtain adequate sources of funding to pay operating expenses and fund long-term business operations;



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enter into a licensing or other relationship that allows us to commercialize our products;



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manage or control working capital requirements by reducing operating expenses; and



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develop new and enhance existing relationships with product distributors and other points of distribution for our products.

There can be no assurance that we will be successful in achieving our short- or long-term plans as set forth above, or that such plans, if consummated, will enable us to obtain profitable operations or continue in the long-term as a going concern.

Off-Balance Sheet Arrangements

We have not entered into any transactions with unconsolidated entities in which we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support.





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Critical Accounting Estimates and Policies

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("U.S. GAAP") requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities of the date of the financial statements and the reported amounts of revenue and expense during the reporting period. Note 3 to the Financial Statements describes the significant accounting policies and methods used in the preparation of the Financial Statements. Estimates are used for, but not limited to, contingencies and taxes. Actual results could differ materially from those estimates. The following critical accounting policies are impacted significantly by judgments, assumptions, and estimates used in the preparation of the Financial Statements.

Impairment of Assets

We assess the impairment of long-lived assets, including our other intangible assets, at least annually, or whenever events or changes in circumstances indicate that their carrying value may not be recoverable. The determination of related estimated useful lives and whether or not these assets are impaired involves significant judgments, related primarily to the future profitability and/or future value of the assets. Changes in our strategic plan and/or market conditions could significantly impact these judgments and could require adjustments to recorded asset balances. We hold investments in companies having operations or technologies in areas which are within or adjacent to our strategic focus when acquired, all of which are privately held and whose values are difficult to determine. We record an investment impairment charge if we believe an investment has experienced a decline in value that is other than temporary. Future changes in our strategic direction, adverse changes in market conditions or poor operating results of underlying investments could result in losses or an inability to recover the carrying value of the investments that may not be reflected in an investment's current carrying value, thereby possibly requiring an impairment charge in the future.

In determining fair value of assets, the Company bases estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about carrying values of assets that are not readily apparent from other sources. Actual fair value may differ from management estimates resulting in potential impairments causing material changes to certain assets and results of operations.

Transactions with Related Parties

During the year ended December 31, 2020, we paid Dr. Hirschman $3,500 of consulting fees for services as Chief Executive Officer. Dr. Hirschman waived ongoing fees during the 2020 calendar year. During the year ended December 31, 2019, the Company paid Dr. Hirschman $43,000 of consulting fees for services as Chief Executive Officer and a prepaid advance of $7,000 that was applied to services performed in 2020.

As of December 31, 2020 and 2019, we owed Mr. Abrams, a director of the Company, an aggregate total of $166,251 and $150,968, respectively, for outstanding principal and accrued and unpaid interest due pursuant to certain Bridge Notes. As of December 31, 2019, we owed Mr. Abrams $14,085 of accrued consulting fees that were paid in 2020.

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