General

The following discussion and analysis provides information, which we believe is relevant to an assessment and understanding of our financial condition and results of operations. The discussion should be read in conjunction with the Interim Condensed Financial Statements contained herein and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. Certain statements contained in this Quarterly Report on Form 10-Q, including, without limitation, statements containing the words "believes", "anticipates", "estimates", "expects", "intends", "projects", and words of similar import, are forward-looking as that term is defined by the Private Securities Litigation Reform Act of 1995 ("1995 Act"), and in releases issued by the United State Securities and Exchange Commission (the "Commission"). These statements are being made pursuant to the provisions of the 1995 Act and with the intention of obtaining the benefits of the "Safe Harbor" provisions of the 1995 Act. We caution that any forward-looking statements made herein are not guarantees of future performance and that actual results may differ materially from those in such forward-looking statements as a result of various factors, including, but not limited to, any risks detailed herein, in our "Risk Factors" section of our Form 10-K for the year ended December 31, 2021, in our most recent reports on Form 10-Q and Form 8-K and from time to time in our other filings with the Commission, and any amendments thereto. Any forward-looking statement speaks only as of the date on which such statement is made, and we are not undertaking any obligation to publicly update any forward-looking statements. Readers should not place undue reliance on these forward-looking statements.





Overview/Plan of Operations


Sales of drug tests continue to be negatively impacted as customer pricing continues to decrease as a result of our markets being saturated with products made outside of the United States; primarily products made in China. This has resulted in a commoditization of the onsite drug testing market at a time when costs associated with labor, utilities, materials, insurance, etc. keep rising. In attempts to retain current customers and/or attract new customers that require lower pricing, we are offering two drug test product lines that are manufactured in China.

In addition to the marketing of drug tests, we have continued to market various Covid-19 rapid tests. All of the Covid-19 tests we are offering are being marketed in accordance with the March 2020 Emergency Use Authorization ("EUA") policy set forth by the United States Food and Drug Administration (FDA) and in accordance with the individual EUAs issued for the products. We are currently offering a number of different rapid antigen tests and rapid antibody tests that can be used in various different settings, including home use; depending on their specific EUA issuance.

In addition to increased costs, the materials used in the manufacture of our drug test products are the same materials used in the manufacture of lateral flow Covid-19 tests and this has resulted in supply chain delays; some of which have negatively impacted our customer relationships.

Due to the Covid-19 pandemic, we are still not marketing our oral fluid drug test (OralStat®) in the employment and insurance markets in the United States (under a limited exemption set forth by the FDA). We remain hopeful that we can effectively market our OralStat in the United States markets given its superior sensitivity and accuracy. Initially we may re-introduce the product in markets outside the United States via distribution relationships.

In 2019 we expanded our contract manufacturing operations with two new customers. Unfortunately, the Covid-19 pandemic halted sales to these customers throughout 2020 and into 2021 but, in the year ended December 31, 2021, we started to ship orders to them again as their business started to return to normal. We are hopeful that sales to these customers will improve as we get further outside of the pandemic.

In our current fiscal year and beyond, we are focusing our efforts on further penetration of our markets with our current products that we manufacture and distribute and we are continually looking into other products to offer via distribution relationships.

Although the cost of manufacturing drug tests in the United States is proving to be nearly cost prohibitive, we do believe there are opportunities to capitalize on our US-based lateral flow manufacturing capabilities; specifically for small to mid-size diagnostic firms that require high quality manufacturing; especially given the current challenges with getting imports into the United States.

Gross margin has been declining due to the increased costs of manufacturing in the United States and the fact that overhead costs associated with our facility in Kinderhook, NY cannot be decreased. As sales continue to decline, and these costs cannot be adjusted downward, greater manufacturing inefficiencies occur. The manufacturing inefficiencies are increasing despite our efforts to mitigate them. We are also taking steps to obtain materials at the best available pricing. However, in many cases, we are purchasing at much lower volumes than the larger diagnostic companies and that results in higher per piece pricing. We are currently looking into possible production alternatives in attempts to address these fixed costs.

Operating expenses declined in the six months ended June 30, 2022 when compared to the six months ended June 30, 2021. We continuously make efforts to control operational expenses to ensure they are in line with sales including, but not limited to, consolidating job responsibilities in certain areas of the Company, securing more cost effective service providers and reduction of facility hours so they are more in line with production and administrative needs.

From August 2013 until June 2020 and from April 2022 through the date of this report, we maintained a salary deferral program for our sole executive officer, our Chief Executive Officer/Principal Financial Officer Melissa Waterhouse. The salary deferral program was initiated by Ms. Waterhouse voluntarily in both August 2013 and April 2022. Another member of senior management participated in the voluntary 2013 program until his retirement in November 2019. After the member of senior management retired, we agreed to make payments on the deferred compensation (i.e. deferred salary) owed to this individual. In the six months ended June 30, 2021, we made payments totaling $22,000 to this individual and his deferred compensation was paid in full in May 2021.






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Once the deferred compensation was paid in full to this individual in May 2021, we began to make payments at the same rate to Ms. Waterhouse given the length of time the amount had been owed and that Ms. Waterhouse had not received any payments on her deferred compensation since August 2017. We made payments totaling $10,000 to Ms. Waterhouse in the six months ended June 30, 2022 and $5,000 in payments in the six months ended June 30, 2021. We stopped making payments on Ms. Waterhouse's deferred compensation in April 2022 when Ms. Waterhouse again voluntarily deferred her salary by 20%. As of June 30, 2022, we had deferred compensation owed to Ms. Waterhouse in the amount of $71,000 and $6,000 in payroll taxes that are due as payments are made to Ms. Waterhouse; for a total of $77,000 in deferred compensation owed to Ms. Waterhouse. In addition, as of June 30, 2022, we owe Ms. Waterhouse $16,000 in current salary that was not paid.

Beginning in April 2022, another member of senior management participated in the salary deferral program. As of June 30, 2022, we had deferred compensation owed to this individual in the amount of $4,000 and $1,000 in payroll taxes that are due as payments are made to this individual; for a total of $5,000 in deferred compensation.

Our continued existence is dependent upon several factors, including our ability to: 1) raise revenue levels even though the drug testing market continues to be infiltrated by product manufactured outside of the United States as well as being impacted by supply chain issues 2) further penetrate the markets (in and outside of the United States) for the products we manufacture as well as products we offer via distribution, 3) secure new contract manufacturing customers, 4) control operational costs and manufacturing inefficiencies to generate positive cash flows, 5) maintain our current credit facilities or refinance our current credit facilities if necessary, and 6) if needed, obtain working capital by selling additional shares of our common stock. Should the Company not be able to achieve positive cash flows from operations or raise additional funding, it may be required to further reduce or terminate operations.

Results of operations for the six months ended June 30, 2022 compared to the six


                           months ended June 30, 2021

NET SALES:Net sales for six months ended June 30, 2022 decreased by $559,000, or 51.1%, when compared to net sales in the six months ended June 30, 2021; primarily as a result in a decline in sales of drugs of abuse ("DOA") tests that we manufacture. The decline in DOA sales stems almost entirely from decreased sales to our largest customer who has historically been a significant portion of our revenues. This customer has two segments of their business for which we supply products. They informed us in February 2022 that sales to one of those segments (which we supplied exclusively) would decrease as a result of their desire to have multiple vendors supplying the segment. They indicated this was to ensure uninterrupted supply as they had experienced periodic supply interruptions with us in 2021 (as a result of the supply chain issues we experienced in 2021 and continue to experience into 2022; particularly with plastics and other materials that are used to manufacture our drug tests; materials that are also used in the manufacture of lateral flow Covid-19 tests). They indicated that the other segment we supply would remain unchanged but, even in that particular segment; we saw a decline in sales when comparing the six months ended June 30, 2022 with the six months ended June 30, 2021. In addition to the decline in sales to this customer, international sales also declined; some of which is due to a backorder at June 30, 2022.

Partially offsetting these declines are increased contract manufacturing sales; primarily in sales of our private labeled RSV test and increased distribution sales; most of which is due to increased sales of the lower cost DOA tests we are selling. Sales of Rapid Antigen Covid-19 tests slightly increased when comparing the six months ended June 30, 2022 with the six months ended June 30, 2021; to $42,000 in the six months ended June 30, 2022 from $36,000 in the six months ended June 30, 2021. However, given the continued downward trend of pricing of these tests in the market and the fact that we are distributing these tests (which requires further markup); we believe that sales of Covid-19 tests will not have a significant impact on our sales going forward.

GROSS (LOSS) / PROFIT:For the first time in our operating history, we recorded a gross loss in the six months ended June 30, 2022 of $(45,000); this is compared to gross profit of $241,000 in the six months ended June 30, 2021. Gross profit began to dramatically decline in the first quarter of 2022 and further declined in the second quarter of 2022 due to even further reduced sales. This change to a gross (loss) from a gross profit is almost entirely due to decreased sales to our largest customer in one of their segments (previously discussed in net sales). The two segments we were supplying were comprised of one with low margin sales and one with higher margin sales. This allowed the Company to maintain an appropriate blended gross profit margin on the sales to the customer. The segment in which sales have decreased significantly is the segment in which products were sold at a higher profit margin and this has significantly reduced the blended gross profit margin on the account. At the same time, this decline in sales has resulted in greater inefficiencies in manufacturing. Manufacturing inefficiencies occur when production levels decrease but, not all costs can be reduced to be in line with production levels because they are fixed; these costs include but, are not limited to, depreciation, insurance, interest, taxes, utilities and other costs associated with running our two facilities.






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We have taken steps to reduce manufacturing costs, including but not limited to, costs associated with labor, to mitigate these inefficiencies; however, the previously discussed fixed costs cannot easily be decreased. Given the price sensitivity in our markets and the commoditized nature of drug testing products, customer pricing is challenging; however, we did implement a price increase to non-contractual customers in July 2021 however, the customer previously discussed has a contracted price in place that is not as easily increased.

Operating expenses decreased 36.3% in the six months ended June 30, 2022 compared to the six months ended June 30, 2021. Expenses in Selling and Marketing and General and Administrative expenses decreased and Research and Development expenses remained relatively unchanged. More specifically:

Research and development ("R&D")

R&D expense remained relatively unchanged (with a minimal decrease of 2.4%) when comparing the six months ended June 30, 2022 with the six months ended June 30, 2021. Salary expense was reduced slightly due to timing of pay periods. This slight decrease was partially offset by an increase in utility costs in our New Jersey facility. All other expenses remained relatively consistent when comparing the two six-month periods. In the six months ended June 30, 2022, our R&D department primarily focused their efforts on the enhancement of our current products and validations related to drug testing product components.





Selling and marketing


Selling and marketing expense in the six months ended June 30, 2022 decreased 46.5% when compared to the six months ended June 30, 2021. Reductions in sales salary expense and benefits (due to the termination of personnel for performance reasons as well as an employee departure), reductions in costs associated with shipping and promotional expense (due to the six months ended June 30, 2021 including fees paid to OTC Markets) were the primary reason for the decline in expenses. All other expenses remained relatively consistent when comparing the two six month periods.

In the six months ended June 30, 2022, we continued selling and marketing efforts related to the drug tests we manufacture and we promoted lower cost alternatives for onsite drug testing via distribution relationships. We also marketed and sold rapid Covid-19 tests via distribution relationships. These offerings did not result in increased selling and marketing expenses when comparing the six months ended June 30, 2022 with the six months ended June 30, 2021. Terminations of sales personnel have been due to poor performance. While we have taken efforts to increase the size of our sales team to further penetrate our markets; no new sales reps were hired in the six months ended June 30, 2022 due to lack of qualified candidates. We continue to look for contract manufacturing opportunities or situations in which we can leverage our U.S. based manufacturing operations.

General and administrative ("G&A")

G&A expense decreased 36.1% in the six months ended June 30, 2022 when compared to G&A expense in the six months ended June 30, 2021. The primary reason for the decline is that the six months ended June 30, 2022 did not include any fees associated with our loans with Cherokee while the six months ended June 30, 2022 included a total of $148,000 in fees incurred in connection with a penalty related to extension of the Cherokee loans in February 2021.

In addition, quality assurance salaries declined (due to retirement of an employee, departure of another employee as well as a reduced work week implemented early in April 2022), general and administrative salaries and benefits declined (due to fewer employees and the reduced work week implemented in April 2022), accounting fees declined (due to lower costs from our new accounting firm), and patent fees declined (due to less international patent maintenance fees paid), along with other smaller declines in other expenses. These declines were partially offset by increased consulting fees (due to the execution of the Financial Advisory Agreement with Landmark Pegasus, Inc. in the six months ended June 30, 2022), increased transfer agent expense and repairs and maintenance. There was no expense related to share based payments in either the six months ended June 30, 2022 or the six months ended June 30, 2021.






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OTHER INCOME AND EXPENSE: Other expense of $99,000 in the six months ended June 30, 2022 consisted of interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and shareholder loans) and interest income of $1,000 for interest received in connection with the ERC refund we received in June 2022. Other expense of $46,000 in the six months ended June 30, 2021 consisted of interest expense associated with our credit facilities (the same facilities indicated for the six months ended June 30, 2022) which was offset by other income of $50,000 related to certain non-refundable prepayments (customer deposits) that were forfeited when the customer did not remit the remaining amounts due on the order.

Results of operations for the three months ended June 30, 2022 compared to the


                        three months ended June 30, 2021

NET SALES:Net sales for the three months ended June 30, 2022 decreased 65%, when compared to net sales in the three months ended June 30, 2021 primarily as a result in a decline in sales of DOA tests that we manufacture.

The decline in DOA sales stems almost entirely from decreased sales to our largest customer who has historically been a significant portion of our revenues. This customer has two segments of their business for which we supply products. They informed us in February 2022 that sales to one of those segments (which we supplied exclusively) would decrease as a result of their desire to have multiple vendors supplying the segment. They indicated this was to ensure uninterrupted supply as they had experienced periodic supply interruptions with us in 2021 (as a result of the supply chain issues we experienced in 2021 and continue to experience into 2022; particularly with plastics and other materials that are used to manufacture our drug tests; materials that are also used in the manufacture of lateral flow Covid-19 tests). They indicated that the other segment we supply would remain unchanged but, even in that particular segment; we saw a decline in sales when comparing the three months ended June 30, 2022 with the three months ended June 30, 2021. In addition to the decline in sales to this customer, international sales also declined; some of which is due to a backorder at June 30, 2022.

Partially offsetting these declines are increased contract manufacturing sales; primarily in sales of our private labeled RSV test and increased distribution sales; most of which is due to increased sales of the lower cost DOA tests we are selling. In the three months ended June 30, 2022, we did not have sales of Covid-19 tests and in the three months ended June 30, 2021 we only had $1,000 in Covid-19 test sales. Market pricing of Covid-19 tests has continued to decline over the last several months. Going forward, this will make it difficult for the Company to sell these tests given we are only distributing them (which requires further mark up to customers), therefore, we believe that sales of Covid-19 tests will not have a significant impact on our sales going forward.





GROSS (LOSS) / PROFIT:


For the first time in our operating history, we recorded a gross loss in the three months ended June 30, 2022 of $(73,000); this is compared to gross profit of $136,000 in the three months ended June 30, 2021. Gross profit began to dramatically decline in the first quarter of 2022 and further declined in the second quarter of 2022 due to even further reduced sales. This change to a gross (loss) from a gross profit is almost entirely due to decreased sales to our largest customer in one of their segments (previously discussed in net sales). The two segments we were supplying were comprised of one with low margin sales and one with higher margin sales. This allowed the Company to maintain an appropriate blended gross profit margin on the sales to the customer. The segment in which sales have decreased significantly is the segment in which products were sold at a higher profit margin and this has significantly reduced the blended gross profit margin on the account. At the same time, this decline in sales has resulted in greater inefficiencies in manufacturing. Manufacturing inefficiencies occur when production levels decrease but, not all costs can be reduced to be in line with production levels because they are fixed; these costs include but, are not limited to, depreciation, insurance, interest, taxes, utilities and other costs associated with running our two facilities.

We have taken steps to reduce manufacturing costs, including but not limited to, costs associated with labor, to mitigate these inefficiencies; however, the previously discussed fixed costs are not able to be decreased. Given the price sensitivity in our markets and the commoditized nature of drug testing products increasing, customer pricing is challenging; however, we did implement a price increase to non-contractual customers in July 2021 however, the customer previously discussed has a contracted price in place that is not as easily increased.






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OPERATING EXPENSES: Operating expenses decreased 27.9% in the three months ended June 30, 2022 compared to the three months ended June 30, 2021. Expenses in all operating expense divisions decreased. More specifically:

Research and development ("R&D")

R&D expense in the three months ended June 30, 2022 decreased 14.3% when compared to the three months ended June 30, 2021. Salary expense decreased due to timing of pay periods. This decrease was nominally offset by an increase in utility costs in our New Jersey facility. All other expenses remained relatively consistent when comparing the two three-month periods.





Selling and marketing


Selling and marketing expense in the three months ended June 30, 2022 decreased 43.1% when compared to the three months ended June 30, 2021. Reductions in sales salary expense and benefits (due to the termination of personnel for performance reasons as well as an employee departure) along with a reduction in promotional expense (due to the six months ended June 30, 2021 including fees paid to OTC Markets) were the primary reasons for the decline in expenses. These reductions were partially offset by increased costs associated with shipping.

General and administrative ("G&A")

G&A expense decreased 25.1% in the three months ended June 30, 2022 when compared to G&A expense in the three months ended June 30, 2021. Decreased costs associated with general and administrative salaries and benefits (due to fewer employees and the reduced work week implemented in April 2022), quality assurance salaries (due to retirement of an employee, departure of another employee as well as a reduced work week implemented early in April 2022), and investor relations were partially offset by increased utility costs. There was no expense related to share based payments in either the three months ended June 30, 2022 or the three months ended June 30, 2021.





OTHER INCOME AND EXPENSE:


Other expense of $51,000 in the three months ended June 30, 2022 consisted of interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and shareholder loans) and interest income of $1,000 for interest received in connection with the ERC refund we received in June 2022. Other income of $1,000 in the three months ended June 30, 2021 consisted of other income of $50,000 related to certain non-refundable prepayments (customer deposits) that were forfeited when the customer did not remit the remaining amounts due on the order which was almost entirely offset by interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and a shareholder loan.





              Liquidity and Capital Resources as of June 30, 2022

Our cash requirements depend on numerous factors, including but not limited to manufacturing costs (such labor and overhead costs, raw materials, equipment, etc.), selling and marketing initiatives, product development activities, regulatory costs, legal costs, and effective management of inventory levels and production levels in response to sales history and forecasts. We are examining growth opportunities including strategic alliances and contract manufacturing. Given our current and historical cash position, such activities would need to be funded from the issuance of additional equity or additional credit borrowings, subject to market and other conditions.

The following transactions materially impacted our liquidity and cash flow in the six months ended June 30, 2022 and/or the six months ended June 30, 2021 or are expected to have an impact on our cash flow in the year ending December 31, 2022:

Employee Retention Credit ("ERC")

As discussed in Note F to our financial statements, we have been expecting to receive two ERC refunds totaling $400,000. On June 2, 2022, we received a refund for the second quarter of 2021 in the amount of $199,000. This amount represents the $198,000 claimed as a refund and $1,000 in interest.






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Lincoln Park Equity Line


On December 9, 2020, we entered into a Purchase Agreement and a Registration Rights Agreement with Lincoln Park under which Lincoln Park agreed to purchase from the Company, from time to time, up to $10,250,000 of shares of our common stock, par value $0.01 per share, subject to certain limitations set forth in the Purchase Agreement, over a two year period. On December 29, 2020 we filed a Form S-1 Registration Statement (the "Registration Statement"). We amended the Registration Statement on January 7, 2021 and the SEC declared the Registration Statement effective on January 11, 2021. In the six months ended June 30, 2022, we were not able to sell any shares of common stock to Lincoln Park due to the market price of our common shares (i.e. they are not closing at or above $0.05 per share and have not closed at that price since the latter part of the year ended December 31, 2021). In the six months ended June 30, 2022, the Company sold 4,900,000 shares of common stock to Lincoln Park (including 500,000 shares required as an initial purchase under the Purchase Agreement) as Regular Purchases and received proceeds of $564,000.





Going Concern


Our financial statements for the six months ended June 30, 2022 were prepared assuming we will continue as a going concern, which assumes the realization of assets and the satisfaction of liabilities in the normal course of business. Our current cash balances, together with cash generated from future operations, ERC refunds and amounts available under our credit facilities will not be sufficient to fund operations through August 2023. At June 30, 2022, we have Stockholders' Deficit of $(1,708,000). Should the Company not be able to increase sales to generate positive cash flows or obtain additional financing in the form of additional loans or sale of equity, it will be required to reduce or terminate operations.





Debt


Our loan and security agreement and 2019 Term Note with Cherokee for $1,000,000 and $240,000, respectively, expired on February 15, 2022. On June 14, 2022, Cherokee agreed that they would defer the principal amounts due under the Cherokee LSA until February 15, 2023 and that any applicable penalties would also be deferred as long as the Company remains current on the quarterly interest payments. Furthermore, any penalties will also be waived if the principal amounts are paid on or prior to February 15, 2023.

We do not expect cash from operations within the next 12 months to be sufficient to pay the amounts due under these credit facilities, which are due in full on February 15, 2023. Given this, we will be required to refinance the facilities either via a new debt facility or raising capital through some other means. There is no assurance that such financing will be available or that we will be able to complete financing on satisfactory terms, if at all or that we would be able to raise capital via other means.

Throughout the six months ended June 30, 2022, we had a line of credit with Crestmark Bank. The maximum availability on the line of credit is $1,000,000. However, because the amount available under the line of credit is based upon our accounts receivable, the amounts actually available under our line of credit (historically) have been significantly less than the maximum availability. When sales levels decline, we have reduced availability on our line of credit due to decreased accounts receivable balances. As of June 30, 2022, based on our availability calculation, there were no additional amounts available under the line of credit because we draw any balance available on a daily basis. The Crestmark line of credit automatically renewed on June 22, 2022 for another one year term, or until June 22, 2023.

If availability under our line of credit (from sales) and/or cash received as refunds under the ERC program are not sufficient to satisfy our working capital and capital expenditure requirements, we will be required to seek additional credit facilities or sell additional equity securities, or delay capital expenditures which could have a material adverse effect on our business. There is no assurance that such financing will be available or that we will be able to complete financing on satisfactory terms, if at all.

As of June 30, 2022, we had the following debt/credit facilities:





                                                          Balance as of
                                                            June 30,
               Facility                      Debtor           2022           Due Date
Loan and Security Agreement               Cherokee                           February
                                          Financial,                         15, 2023
                                          LLC            $     1,000,000
Revolving Line of Credit                  Crestmark                          June 22,
                                          Bank                    47,000         2023
Term Loan                                 Cherokee                           February
                                          Financial,                         15, 2023
                                          LLC                    240,000
Term Loan                                 Individual                         November
                                                                  50,000      4, 2022
Term Loan                                 Individual             175,000           NA (1)
Total Debt                                               $     1,512,000

(1) The loan agreement was amended on July 13, 2022; one of the revisions made was changing the maturity date from June 15, 2022 to no specific maturity date.





Working Capital Deficit


At June 30, 2022, we were operating at a working capital deficit of $2,220,000. This compares to a working capital deficit of $1,484,000 at December 31, 2021. The increase in the working capital deficit is primarily due to decline in cash balances and accounts receivable (due to decreased sales) along with increased debt facilities that are short-term facilities. We have historically satisfied working capital requirements through cash from operations, bank debt and equity financings.





Dividends


We have never paid any dividends on our common shares and anticipate that all future earnings, if any, will be retained for use in our business, and therefore, we do not anticipate paying any cash dividends.






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Cash Flow, Outlook/Risk


In the six months ended June 30, 2022, we had a net loss of $779,000 and net cash used in operating activities of $82,000.

Our cash position decreased to $2,000 at June 30, 2022 from $115,000 at December 31, 2021 and $30,000 at June 30, 2021. Cash at December 31, 2021 was positively impacted by an ERC refund in December 2021 (in the amount of $137,000). We did receive an ERC refund in the amount of $198,000 in early June 2022; however, the cash was used rather quickly to make debt payments, Cherokee interest payments and other outstanding amounts due. In the year ending December 31, 2022, we are expecting one more ERC refund in the amount of $202,000

In February 2022 we were informed by our largest customer that sales to one of their segments (which we supplied exclusively) would decrease as a result of their desire to have multiple vendors supplying the segment. This decrease in sales to the one segment of their business also negatively impacts gross profit as this segment is the more profitable segment from a margin perspective. This has resulted in less profit to the Company which is negatively impacting cash flows. While the Covid-19 pandemic is seemingly winding down, we continue to be impacted by it in the form of material delays and cost increases (in both manufacturing and other business costs).

The extent to which the pandemic and the commoditized nature of our markets will continue to impact our business, liquidity, results of operations and financial condition will depend on future developments, which are still uncertain and cannot be predicted. Current levels of sales declines are impacting our business, liquidity, results of operations and financial condition and our ability to access the capital markets may also be limited. Prior to the fourth quarter of the year ended December 31, 2021, we were able to utilize the Lincoln Park Equity Line; however, the downturn of our common stock starting in the third quarter of 2021 has prevented any further sales to be initiated.

Our ability to repay our current debt and other liabilities may also be affected by general economic, financial, competitive, regulatory, legal, business and other factors beyond our control, including those discussed herein. Given the current state of our business and the current stock price, it is unlikely we will be able to facilitate purchases under our Purchase Agreement with Lincoln Park in the near future. If we are unable to meet our credit facility obligations we will be required to raise money through new equity and/or debt financing(s) and, there is no assurance that we would be able to find new financing, or that any new financing would be at favorable terms.

We will continue to take steps to ensure that operating expenses remain in line with sales levels and make every effort to control manufacturing costs, although as previously discussed herein; certain overhead costs are fixed and cannot be reduced to be in line with sales levels. We have consolidated job responsibilities in multiple areas of the Company and this has enabled us to implement personnel reductions. We are also promoting new products and service offerings to diversify our revenue stream.

If we are forced to refinance our debt on less favorable terms, our results of operations and financial condition would be further adversely affected by increased costs and rates. There is also no assurance that we could obtain alternative debt facilities. We may also be forced to pursue one or more alternative strategies, such as restructuring, selling assets, reducing or delaying capital expenditures or seeking additional equity capital. There can be no assurances that any of these strategies could be implemented on satisfactory terms, if at all.

If events and circumstances occur such that 1) we do not meet our current operating plans to increase sales, 2) we are unable to raise sufficient additional equity or debt financing, 3) we are unable to effect sales under the Lincoln Park Equity Line, 4) we are unable to utilize equity as a form of payment in lieu of cash or 5) our credit facilities are insufficient or not available, we may be required to further reduce expenses or take other steps which could have a material adverse effect on our future performance including reducing or terminating operations.

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