UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 10-Q

Commission File Number:0-28666

518-758-8158

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days x☒ Yes¨ ☐ No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files)x ☒ Yes¨ ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act¨ ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)¨ ☐ Yesx ☒ No

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

29,297,33348,098,476 Common Shares as of November 14, 2017

May 16, 2022

American Bio Medica Corporation

Index to Quarterly Report on Form 10-Q

For the quarter ended September 30, 2017March 31, 2022

PART I –- FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

American Bio Medica Corporation

Condensed Balance Sheets

The accompanying notes are an integral part of the condensed financial statements

American Bio Medica Corporation

Condensed Statements of Operations

(Unaudited)

The accompanying notes are an integral part of the condensed financial statements

American Bio Medica Corporation

Condensed Statements of Operations

(Unaudited)

The accompanying notes are an integral part of the condensed financial statements

American Bio Medica Corporation

Condensed Statements of Cash Flows

(Unaudited)

The accompanying notes are an integral part of the condensed financial statements

Notes to condensed financial statements (unaudited)

September 30, 2017March 31, 2022

Note A –- Basis of Reporting

The accompanying unaudited interim condensed financial statements of American Bio Medica Corporation (the “Company”) have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Regulation S-X. Accordingly, these unaudited interim condensed financial statements do not include all information and footnotes required by U.S. GAAP for complete financial statement presentation. These unaudited interim condensed financial statements should be read in conjunction with audited financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.2021. In the opinion of management, the interim condensed financial statements include all normal, recurring adjustments which are considered necessary for a fair presentation of the financial position of the Company at September 30, 2017,March 31, 2022, and the results of operations for the three and nine month periods ended September 30, 2017 and September 30, 2016 and cash flows for the ninethree month periods ended September 30, 2017March 31, 2022 (the “First Quarter 2022”) and September 30, 2016.March 31, 2021 (the “First Quarter 2021”).

Operating results for the three and nine months ended September 30, 2017First Quarter 2022 are not necessarily indicative of results that may be expected for the year ending December 31, 2017.2022. Amounts at December 31, 20162021 are derived from audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.2021.

During the nine months ended September 30, 2017,First Quarter 2022, there were no significant changes to the Company’s critical accounting policies, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.2021.

The preparation of these interim condensed financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates estimates, including those related to product returns, bad debts, inventories, income taxes, warranty obligations, contingencies and litigation. 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 the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

These unaudited interim condensed financial statements have been prepared assuming that the Company will continue as a going concern and, accordingly, do not include any adjustments that might result from the outcome of this uncertainty. The independent registered public accounting firm’s report on the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016,2021, contained an explanatory paragraph regarding the Company’s ability to continue as a going concern. As of the date of this report, ourthe Company’s current cash balances, together with cash generated from future operations and amounts available under ourthe Company’s credit facilities may not be sufficient to fund operations through November 2018. On May 1, 2017, we extended our line2023.

Through the First Quarter of credit. The new expiration date of our2022, the Company had a line of credit is June 29, 2020.with Crestmark Bank. The maximum availability on ourthe Company’s line of credit remains to be $1,500,000.was $1,000,000. However, because the amount available under ourthe line of credit is based upon ourthe Company’s accounts receivable, and inventory.the amounts actually available under the line of credit (historically) have been significantly less than the maximum availability. As of September 30, 2017,March 31, 2022, based on ourthe Company’s availability calculation, there were no additional amounts available under ourthe Company’s line of credit because we drawthe Company draws any balance available on a daily basis.

The Company’s credit facilities with Cherokee Financial, LLC (“Cherokee”) matured/expired on February 15, 2022 with a final balloon payment of $1,240,000 which has not been paid and is now past due. The Company is currently in discussions with Cherokee related to the maturity and loan payoff, including, but not limited to, methods to pay off the two credit facilities, restructuring of the credit facilities and/or further extension of the facilities. Considering these discussions, as of the date of this report, Cherokee has not called a default under either facility nor have they imposed default interest under either facility. The Company is hoping to conclude these discussions with Cherokee shortly and expects to file a Current Report on Form 8-K when required.

The Company’s total debt at March 31, 2022 with Cherokee Financial, LLC is $1,240,000. The Company does not expect cash from operations within the next 12 months to be sufficient to pay the amounts due under these credit facilities so, the Company is currently looking at alternatives to pay off or refinance these facilities.

As discussed in more detail in “Cash Flow, Outlook/Risk”, if sales levels decline further, wethe Company will have further reduced availability on ourits line of credit due to decreased accounts receivable balances. In addition, we would expect our inventory levels to decrease if sales levels decline further, and this also will result in reduced availability on our line of credit. If availability under ourthe Company’s line of credit is not sufficient to satisfy our working capital and capital expenditure requirements, wethe Company will be required to obtain additional credit facilities or sell additional equity securities, or delay capital expenditures.expenditures, which could have a material adverse effect on the business. There is no assurance that such financing will be available or that wethe Company will be able to complete financing on satisfactory terms, if at all.

Recently Adopted Accounting Standards

We have disclosedASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40), issued in May 2021, addresses an issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment is effective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU 2021-04 on January 1, 2022 and the adoption did not have an impact on the Company’s financial condition or results of previously releasedoperations.

ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities About Government Assistance, issued in November 2021 requires entities to provide disclosures on material government assistance transactions for annual reporting periods. The disclosures include information around the nature of the assistance, the related accounting standards in earlier quarterly reports filed withpolicies used to account for government assistance, the U.S. Securitieseffect of government assistance on the entity’s financial statements, and Exchange Commission (the “Commission”); these adoptionsany significant terms and conditions of the agreements, including commitments and contingencies. The Company adopted ASU 2021-10 on January 1, 2022 and the adoption did not have an impact on our financial statementcondition or results of operations. In the three months ended September 30, 2017, we determined that ASU 2017-07, “Compensation - Retirement Benefits” and ASU 2017-04 “Intangibles - Goodwill and Other (Topic 350)” (both previously disclosed in our Form 10-Q for the period ended June 30, 2017) did not apply to the Company. We did not adopt any new accounting standards in the three months ended September 30, 2017.operations as ASU-2021-10 only impacts annual financial statement footnote disclosures.

Accounting Standards Issued; Not Yet Adopted

ASU 2017-11, “Earnings Per Share, Distinguishing Liabilities from Equity, Derivatives and Hedging”. ASU 2017-11 was issued in July 2017. The amendments in ASU 2017-11 change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature will no longer preclude equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) would not be accounted for as a derivative liability at fair value as a result of the existence of a down round feature. For freestanding equity classified financial instruments, the amendments require entities that present earnings per share (EPS) in accordance with Topic 260 to recognize the effect of the down round feature when it is triggered. That effect is treated as a dividend and as a reduction of income available to common shareholders in basic EPS. Convertible instruments with embedded conversion options that have down round features are now subject to the specialized guidance for contingent beneficial conversion features (in Subtopic 470-20, Debt—Debt with Conversion and Other Options), including related EPS guidance (in Topic 260). ASU 2017-11 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption is permitted. The Company is evaluating the impact of ASU 2017-11.

ASU 2017-09, “Compensation – Stock Compensation (Topic 718)”. ASU 2017-09 was issued in May 2017. The amendments in ASU 2017-09 provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. More specifically, that an entity should account for the effects of modification unless all the following are met: 1) the fair value, calculated or intrinsic value of the modified award is the same fair value, calculated or intrinsic value of the original award immediately before the original award is modified, 2) the vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified and 3) the classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original grant is modified. The current disclosure requirements in Topic 718 apply regardless of whether accounting modification is applied. ASU 2017-09 is effective for annual periods and interim periods within those annual periods, beginning after December 15, 2017. Early adoption is permitted. The Company is evaluating the impact of ASU 2017-09.

ASU 2017-01, “Business Combinations (Topic 805)”. ASU 2017-01 was issued in January 2017. The amendments in ASU 2017-01 clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions or disposals of assets or businesses. The definition of a business affects many areas of accounting including acquisitions, disposals, goodwill, and consolidation. The guidance is effective for interim and annual periods beginning after December 15, 2017 and should be applied prospectively on or after the effective date. The Company is in the process of evaluating the impact of ASU 2017-01.

ASU 2016-02, “Leases”. ASU 2016-02 was issued in February 2016 and it requires a lessee to recognize a lease liability and a right-of-use asset on its balance sheet for all leases, including operating leases, with a term greater than 12 months. Lease classification will determine whether a lease is reported as a financing transaction in the income statement and statement of cash flows. ASU 2016-02 does not substantially change lessor accounting, but it does make certain changes related to leases for which collectability of the lease payments is uncertain or there are significant variable payments. Additionally, ASU 2016-02 makes several other targeted amendments including a) revising the definition of lease payments to include fixed payments by the lessee to cover lessor costs related to ownership of the underlying asset such as for property taxes or insurance; b) narrowing the definition of initial direct costs which an entity is permitted to capitalize to include only those incremental costs of a lease that would not have been incurred if the lease had not been obtained; c) requiring seller-lessees in a sale-leaseback transaction to recognize the entire gain from the sale of the underlying asset at the time of sale rather than over the leaseback term; and d) expanding disclosures to provide quantitative and qualitative information about lease transactions. ASU 2016-02 is effective for all annual and interim periods beginning January 1, 2019, and is required to be applied retrospectively to the earliest period presented at the date of initial application, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2016-02.

ASU 2014-09, “Revenue from Contracts with Customers”. ASU 2014-09 was issued in May 2014 and it provides guidance for revenue recognition. The core principle of ASU 2014-09 is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under current guidance. Examples of the use of judgments and estimates may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. The update also requires more detailed disclosures to enable users of financial statements to understand the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. ASU 2014-09 provides for two transition methods to the new guidance: a retrospective approach and a modified retrospective approach. In August 2015, ASU 2015-14, “Revenue from Contracts with Customers: Deferral of the Effective Date” was issued as a revision to ASU 2014-09. ASU 2015-14 revised the effective date to fiscal years, and interim periods within those years, beginning after December 15, 2017. Early adoption is permitted but not prior to periods beginning after December 15, 2016 (i.e. the original adoption date per ASU No. 2014-09). The Company is currently evaluating the transition methods and the impact of adopting this ASU.

There are nonot any new accounting standards issued but, not yet adopted in the First Quarter 2022.

Any other new accounting pronouncements issues duringrecently issued, but not yet effective, have been reviewed and determined to be not applicable or were related to technical amendments or codification. As a result, the nine months ended September 30, 2017 that areadoption of such new accounting pronouncements, when effective, is not expected to have or that could have a significant impactmaterial effect on ourthe Company’s financial position or results of operations.

Reclassifications

Certain items have been reclassified from the prior year to conform to the current year presentation.

Note B – Inventory

Inventory is comprised of the following:

NoteN ote C – Net Loss Per Common Share

Basic net loss per common share is calculated by dividing the net loss by the weighted average number of outstanding common shares during the period. Diluted net lossincome per common share includes the weighted average dilutive effect of stock options and warrants. When the Company has a loss, option and warrants are not included as they would be anti-dilutive. Potential common shares outstanding as of September 30, 2017March 31, 2022 and 2016:2021:

The number of securities not included in the diluted net loss per share for the three and nine months ended September 30, 2017 was 4,207,000, as their effect would have been anti-dilutive due to the net loss in each period.

The number of securities not included in the diluted net loss per share for the three and nine months ended September 30, 2016 was 4,242,000, as their effect would have been anti-dilutive due to the net loss in each period.

Note D – Litigation/Legal Matters

In February 2017, the Company filed a complaint in the Supreme Court of the State of New York in Columbia County against Premier Biotech Inc., Premier Biotech Labs, LLC and its principals, including its President Todd Bailey, and Peckham Vocational Industries, Inc. (together the “Defendants”). Mr. Bailey formerly served as the Company’s Vice President of Sales and Marketing and as a sales consultant until December 23, 2016. The complaint seeks preliminary and permanent injunctions and a temporary restraining order against Todd Bailey (for his benefit or the benefit of another party or entity) related to the solicitation of Company customers as well as damages related to any profits and revenues that would result from actions taken by the Defendants related to Company customers. In March 2017, the complaint was moved to the federal court in the Northern District of New York. In April 2017, the Defendants filed a motion to dismiss, to which the Company responded on April 21, 2017. On July 10, 2017, the Company was notified that it was not awarded a contract with a state agency for which it has held a contract in excess of 10 years. The contract in question is included in the February 2017 complaint. The Company believes that the Defendants actions related to this customer and a RFP that was issued by the state agency resulted in the loss of the contract award to the Company and the award of the contract to Peckham and Premier Biotech. This contract historically accounted for 10-15% of the Company’s annual revenue. The Company continued to hold a contract with the agency through September 30, 2017. The Company did protest the award of the contract to Peckham and Premier Biotech, and the state agency advised the Company on July 26, 2017 that they denied the Company’s protest of the award. The Company amended its complaint against the Defendants to show actual damages caused by the Defendants and to show proprietary and confidential information (belonging to the Company) used by the Defendants in their response to the RFP. This confidential information belonging to the Company enabled the Defendants to comply with specifications of the RFP. The Defendants filed a response to the court opposing our supplemental motion and we filed our reply papers to the Defendants response on November 2, 2017. As of the date of this report, the Company is awaiting the court’s rulings on the parties’ motions.

In addition, from                From time to time, the Company may be named in immaterial legal proceedings in connection with matters that arise during the normal course of business. While the ultimate outcome of any such litigation cannot be predicted, if we arethe Company is unsuccessful in defending any such immaterial litigation, the resulting financial losses couldare not expected to have ana material adverse effect on the financial position, results of operations and cash flows of the Company. We are aware of no significant litigation loss contingencies for which management believes it is both probable that a liability has been incurred and that the amount of the loss can be reasonably estimated.

Note E – Line of Credit and Debt

                The Company’s Line of Credit and Debt consisted of the following as of March 31, 2022 and December 31, 2021:

LOAN AND SECURITY AGREEMENT ("LSA")WITH CHEROKEE FINANCIAL, LLC (“CHEROKEE”)

On March 26, 2015, the Company entered into a LSA with Cherokee Financial, LLC (the “Cherokee LSA”). The purpose of thedebt with Cherokee LSA was to refinance, at a better interest rate, the Company’s Series A Debentures and Cantone Asset Management Bridge Loan (both of which matured on February 1, 2015), as well as the Company’s Mortgage Consolidation Loan with First Niagara Bank (“First Niagara”). The loan is collateralized by a first security interest in real estate and machinery and equipment. Under the Cherokee LSA, the Company was provided the sum of $1,200,000 in the form of a 5-year Note at ana fixed annual interest rate of 8%. The Company is making interest only payments; paid quarterly on the Cherokee Note, with the first interest payment paid on May 15, 2015. The Company is also required to make an annual principal reduction payment of $75,000 on each anniversary of the date of the closing; with the first principal reduction payment being made on February 15, 2016 and the most recent principal reduction payment being made on February 16, 2017. A final balloon payment is due on March 26, 2020.in arrears. In addition to the 8% interest, the Company paysis required to pay Cherokee Financial, LLC (“Cherokee”) a 1% annual fee for oversight and administration of the loan. This oversight fee is paid in cash and is paid contemporaneously with the quarterly interest payments. The Company can pay off the Cherokee Note at anytime with no penalty; except that a 1% administration fee would be required to be paid to Cherokee to close out all participations.

The Company issued 1.8 million restricted shares of the Company’s common stock to Cherokee for payment of fees. In addition, because the loan was not repaid in full as of March 19, 2016, the Company issued another 600,000 restricted shares of common stock to Cherokee in March 2016.

As placement agent for the transaction, Cantone Research, Inc. (“CRI”) received a 5% cash fee on the $1.2 million, or $60,000, and 200,000 restricted shares of the Company’s common stock. In addition, because the loan was not repaid in full as of March 19, 2016, the Company issued another 196,000 restricted shares of common stock to CRI in March 2016.

The Company received net proceeds of $80,000 after $1,015,000 of debt payments, $60,000and $105,000 in placement agentother expenses and fees $19,000 in legal fees, $19,000 in expenses, $3,000 in state filing fees and $4,000 in interest expense (for 8% interest on $511,000 in new participations received from February 24, 2015 through March 25, 2015). With the adoption of ASU No. 2015-03 in the First Quarter 2016, these transaction costs (with the exception of the interest expense) are now beingwhich, were deducted from the balance on the Cherokee LSA and are being amortized over the initial term of the debt.debt (in accordance with ASU No. 2015-03). The Company was required to make annual principal reduction payments of $75,000 on each anniversary of the date of the closing; with the first principal reduction payment being made on February 15, 2016 and the last principal reduction payment being made on February 15, 2019; partially with proceeds received from a term loan with Cherokee (See 2019 Term Loan with Cherokee within this Note E).

From these net proceeds,In February 2020, the Company extended the due date of the Cherokee LSA (with a balance of $900,000) to February 15, 2021. No terms of the facility were changed in April 2015,February 2020. In connection with this extension, the Company was required to issue 2% of the $900,000 principal, or $18,000, in 257,143 restricted shares of the Company’s common stock to Cherokee.

On February 24, 2021, the Company completed a transaction related to another one-year Extension Agreement dated February 14, 2021 (the “Second Extension”) with Cherokee under which Cherokee extended the due date of the Cherokee LSA to February 15, 2022.

Under the terms of the Second Extension, the Cherokee LSA was increased to $1,000,000 to include a $100,000 penalty that was due as a result of the Company being unable to pay back the principal balance to Cherokee on February 15, 2021. Under the Second Extension, the annual interest rate on the Cherokee LSA was increased to a fixed rate of 10% (the prior fixed rate was 8%) plus a 1% annual oversight fee (that remained unchanged). Interest and the oversight fee are due quarterly.

In the event of default, this includes, but is not limited to; the Company’s inability to make any payments due under the Cherokee LSA (as amended) Cherokee has the right to increase the interest rate on the financing to 18%. A final balloon payment was due on February 15, 2022. Under the terms of the Second Extension Agreement, if the Company doesn’t pay off the principal on or before February 15, 2022, Cherokee may impose an 8% delinquent fee. This delinquent fee applies to the principal balance due on February 15, 2022. Although the facility was not paid off on February 15, 2022, Cherokee has not imposed this delinquent fee or increased the interest rate.

Cantone Research, Inc. earned a 3% fee on the extended principal of $900,000 (or $27,000) for their services related to securing the Second Extension with Cherokee investors. The Company also paid $15,000Cherokee’s legal fees in the amount of $1,000.

On August 18, 2021, we issued 625,000 restricted shares of common stock to Cherokee in lieu of paying the $25,000 August 2021 interest expense related to 15% interestpayment in cash. The closing price of the Company’s common shares on $689,000the date of the payment in Series A Debentures and CAM Bridge Loan for the periodlieu of February 1, 2015 through March 25, 2015.cash was $0.04.

The Company recognized $128,000$25,000 in interest expense related to the Cherokee LSA in the nine months ended September 30, 2017 (of which $70,000 is debt issuance cost amortization recorded as interest expense as a result of the adoption of new accounting standards in the first quarter of 2016,First Quarter 2022 and $137,000 in interest expense in the nine months ended September 30, 2016 (of which $64,000 was debt issuance cost amortization recorded as interest expense as a result of the adoption of new accounting standards in the first quarter of 2016). The Company recognized $45,000$23,000 in interest expense related to the Cherokee LSA in the three months ended September 30, 2017 (of which $23,000 is debt issuance cost amortization recorded as interest expense as a result of the adoption of new accounting standards in the first quarter of 2016) and $47,000 in interest expense in the three months ended September 30, 2016 (of which $23,000 was debt issuance cost amortization recorded as interest expense as a result of the adoption of new accounting standards in the first quarter of 2016).First Quarter 2021.

The Company had $11,000$8,000 in accrued interest expense at September 30, 2017, and $18,000 at DecemberMarch 31, 2016.2022 related to the Cherokee LSA.

As of September 30, 2017, the balance on the Cherokee LSA is $1,050,000; however the discounted balance is $823,000. As ofMarch 31, 2022 and December 31, 2016,2021, the balance on the Cherokee LSA was $1,125,000; however$1,000,000. See Note I – Subsequent Events for more information on the discounted balance, netstatus of debt discount and debt issuance costs was $828,000.the Cherokee LSA.

LINE OF CREDIT WITH CRESTMARK BANK (“CRESTMARK”)

On June 29, 2015 (the “Closing Date”), the Company entered into a three-year Loan and Security Agreement (“LSA”) with Crestmark related to a new Senior Lender, to refinance the Company’s Linerevolving line of Credit with Imperium Commercial Finance, LLC (“Imperium”credit (the “Crestmark LOC”). The Crestmark Line of CreditLOC is used for working capital and general corporate purposes. On May 1, 2017,Upon completion of the initial 5 year term, the Crestmark LOC automatically renews for additional one (1) year terms unless notice of termination from the Company entered into term loan withis received by Crestmark in the amount of $38,000 relatednot less than sixty (60) days prior to the purchase of manufacturing equipment (See “Equipment Loan with Crestmark”), and in connection with this equipment loan, the Company executed an amendment to its LSA and Promissory Note with Crestmark. The amendments addressed the inclusionend of the equipment loan into the Crestmark LSA and an extension of the Company’s line of credit with Crestmark. Apart from the extension of the LSA, no terms of the line of credit were changed in the amendment.renewal term. The terminationcurrent maturity date of the Crestmark LOC is June 22, 2023.

Although secured by inventory and other assets, the Crestmark LOC is a receivables-based only line of credit was changed from June 22, 2018 to June 22, 2020 underand the amendments.

Under the LSA, Crestmark is providing the Company with a Line of Credit of up to $1,500,000maximum availability (“Maximum Amount”) withunder the Crestmark LOC is $1,000,000. The Crestmark LOC has a minimum loan balance requirement of $500,000. At March 31, 2022, the Company did not meet the minimum loan balance requirement as our balance was $93,000. Under the LSA, Crestmark has the right to calculate interest on the minimum balance requirement rather than the actual balance on the Crestmark LOC (and they are exercising that right). The Line of CreditCrestmark LOC is secured by a first security interest in the Company’s inventory, and receivables and security interest in all other assets of the Company (in accordance with permitted prior encumbrances).

The Maximum Amount is subject to an Advance Formula comprised of: 1) 90% of Eligible Accounts Receivables (excluding, receivables remaining unpaid for more than 90 days from the date of invoice and sales made to entities outside of the United States), and 2) up to 40% of eligible inventory plus up to 10% of Eligible Generic Packaging Components not to exceed the lesser of $350,000 (“Inventory Sub-Cap Limit”), or 100% of the Eligible Accounts Receivable.

So long as any obligations are due to Crestmark, the Company must comply with a minimum Tangible Net Worth (“TNW”) Covenant. Under the LSA, as amended, the Company must maintain a TNW of at least $650,000. Additionally, if a quarterly net income is reported, the TNW covenant will increase by 50% of the reported net income. If a quarterly net loss is reported, the TNW covenant will remain the same as the prior quarter’s covenant amount. TNW is defined as: Total Assets less Total Liabilities less the sum of (i) the aggregate amount of non-trade accounts receivables, including accounts receivables from affiliated or related persons, (ii) prepaid expenses, (iii) deposits, (iv) net lease hold improvements, (v) goodwill and (vi) any other asset that would be treated as an intangible asset under GAAP; plus Subordinated Debt. Subordinated Debt means any and all indebtedness presently or in the future incurred by the Company to any creditor of the Company entering into a written subordination agreement with Crestmark. The Company is in compliance with this covenant at September 30, 2017.

If the Company terminates the LSA prior to June 22, 2020, an early exit fee of 2% of the Maximum Amount (plus any additional amounts owed to Crestmark at the time of termination) would be due.

In the event of a default of the LSA, which includes but is not limited to, failure of the Company to make any payment when due, and non-compliance with the TNW covenant, Crestmark is permitted to charge an Extra Rate. The Extra Rate is the Company’s then current interest rate plus 12.75% per annum.

Under the LSA, interestInterest on the Crestmark Line of CreditLOC is at a variable rate based on the Wall Street Journal Prime Rate plus 2%3% with a floor of 5.25%. As of March 31, 2022 and as of the date of this report, the interest only rate on the Crestmark LineLOC is 6.50%. As of Credit is 6.25%. In addition to the date of this report, with all fees considered (the interest rate on the Closing Date and on each one-year anniversary date thereafter, the Company will pay Crestmark a+ an Annual Loan Fee of 0.50%, or $7,500 and+ a Monthly Maintenance Feemonthly maintenance fee of 0.30% of the actual average monthly loan balance from the prior month will be paid to Crestmark. As of the date of this report,month), the interest rate in effect is 10.93% (with all fees; including the weighted annual fee, which is charged on the closing date anniversary andCrestmark LOC is $7,500 regardless of our balance on the line of credit)12.58%.

In addition to the Loan Fee paid to Crestmark on the Closing Date, the Company had to pay a success fee (i.e. early termination fee) to Imperium in the amount of $50,000 on the Closing Date, and a Broker’s Fee of 5%, or $75,000, to Landmark Pegasus Inc. Prior to the Closing, the Company paid $12,000 in due diligence fees to Crestmark. The Company also incurred $3,000 of its own legal costs related to the Crestmark Line of Credit. With the exception of the early term fee ($50,000) paid to Imperium (which was fully expensed in the year ended December 31, 2015), these expenses are all being amortized over the initial term of the Crestmark Line of Credit, or three years. The Company recognized $24,000 of this expense in the nine months ended September 30, 2017 and in the nine months ended September 30, 2016. The Company recognized $8,000 of this expense in the three months ended September 30, 2017 and in the three months ended September 30, 2016.

The Company recognized $76,000 of interest expense related to the Crestmark Line of Credit in the nine months ended September 30, 2017 (of which $24,000 is debt issuance cost amortization recorded as interest expense as a result of the adoption of new accounting standards) and $73,000incurred $10,000 in interest expense in the nine months ended September 30, 2016 (of which $26,000 is debt issuance cost amortization recorded as interest expense). The Company recognized $25,000 of interest expense in the three months ended September 30, 2017 (of which $8,000 is debt issuance cost amortization recorded as interest expense)First Quarter 2022 and $24,000$12,000 in interest expense in the three months ended September 30, 2016 (of which $8,000 is debt issuance cost amortization recorded as interest expense).

First Quarter 2021 related to the Crestmark LOC. Given the nature of the administration of the Crestmark Line of Credit,LOC, at September 30, 2017,March 31, 2022, the Company had $0 in accrued interest expense related to the Crestmark Line of Credit,LOC, and there is $0 in additional availability under the Crestmark Line of Credit.LOC.

As of September 30, 2017, the balance on the Crestmark Line of Credit was $580,000, and as of December 31, 2016, the balance on the Crestmark Line of Credit was $639,000.

EQUIPMENT2019 TERM LOAN WITH CRESTMARKCHEROKEE

On May 1, 2017,February 25, 2019, the Company entered into terman agreement dated (and effective) February 13, 2019 with Cherokee under which Cherokee provided the Company with a loan with Crestmark in the amount of $38,000$200,000. The annual interest rate under the 2019 Cherokee Term Loan is 18% (fixed) paid quarterly in arrears.

On February 24, 2020, the Company completed a transaction related to a one-year Extension Agreement dated February 14, 2020 (the “Extension Agreement”) with Cherokee under which Cherokee extended the purchase of manufacturing equipment. The equipment loan is collateralized by a first security interest in a specific piece of manufacturing equipment. The Company executed an amendment to its LSA and Promissory Note with Crestmark. The amendments addressed the inclusiondue date of the term loan into the LSA and an extension of the Company’s line of credit with Crestmark.2019 Cherokee Term Loan to February 15, 2021. No terms of the line of creditfacility were changed under the Extension Agreement. The final balloon payment was due on February 15, 2021; however the Company further extended the 2019 Cherokee Term Loan on February 24, 2021 to February 15, 2022. Under the terms of this additional extension, the 2019 Cherokee Term Loan was increased to $240,000 to include a $20,000 penalty that was due as a result of the Company being unable to pay back the principal balance to Cherokee on February 15, 2021. The annual interest rate under the 2019 Cherokee Term Loan remains fixed at 18% paid quarterly in arrears.

In the amendment. Theevent of default, this includes, but is not limited to, the Company’s inability to make any payments due under the Agreement; Cherokee has the right to increase the interest rate on the financing to 20%. A final balloon payment was due on February 15, 2022. If the Company didn’t pay off the principal on or before February 15, 2022, Cherokee could impose an 8% delinquent fee. This delinquent fee applies to the principal balance due on February 15, 2022. Although the facility was not paid off on February 15, 2022, Cherokee has not imposed this delinquent fee or increased the interest rate.

The Company recognized $11,000 in interest expense in the First Quarter 2022 and $10,000 in interest expense in the First Quarter 2021 related to the 2019 Cherokee Term Loan. The Company had $4,000 in interest expense accrued at March 31, 2022. The balance on the 2019 Cherokee Term Loan is $240,000 at March 31, 2022 and December 31, 2021. See Note I – Subsequent Events for more information on the status of the 2019 Cherokee Term Loan.

NOVEMBER 2020 TERM LOAN

On November 4, 2020, the Company entered into a loan agreement with an unaffiliated, individual shareholder in the amount of $50,000. There were no expenses related to the term loan and the interest rate is 7% (Prime + 3.75%). The first interest only payment was paid on February 4, 2021 and the WSJ Prime Rate plus 3%;final interest payment and 50,000 principal was due on May 4, 2021. On May 4, 2021, the Company extended this loan for another 6 months, or 7.25%until November 4, 2021. The interest rate and all other terms of the note remained unchanged under the Extension.

On November 4, 2021, the Company entered into a twelve-month Extension Agreement (the “Extension”) with the shareholder. Under the Extension, the principal is now due on November 4, 2022. The interest rate and all other terms of the note remain unchanged under the Extension. All interest payments due to the shareholder have been paid as required with the next interest payment being due on May 4, 2022.

The Company recognized $1,000 in interest expense related to the November 2020 term loan in the First Quarter 2022 and the First Quarter 2021. The Company had less than $1,000 of interest expense accrued related to the November 2020 Term Loan in the First Quarter 2022. The balance on the November 2020 Term Loan was $50,000 at March 31, 2022 and at December 31, 2021.

DECEMBER 2021 SHAREHOLDER LOANS

On December 14, 2021, the Company entered into Loan Agreements with two non-affiliated investors resulting in gross (and net) proceeds of $75,000 as there were no costs associated with the loans. The loans bear interest of 7% per annum until principal and interest are both due in full, or until June 15, 2022. The first interest payments were due on March 15, 2022 and payment of final interest and principal are due June 15, 2022, or earlier as we receive further ERC refunds.

The Company incurred $1,000 in interest expense related to these loans in the First Quarter 2022 and $0 in interest expense in the First Quarter 2021 (as the facilities were not in place until December 2021). The Company had less than $1,000 in accrued interest expense at March 31, 2022. The balance on these loans was $75,000 at March 31, 2022 and at December 31, 2021.

OTHER DEBT INFORMATION

In addition to the debt indicated previously, previous debt facilities (paid in full via refinance or conversion into equity) had financial impact on the First Quarter 2021. More specifically:

SBA PAYCHECK PROTECTION LOAN (PPP LOAN)

On April 22, 2020, the Company entered into a Promissory Note (“PPP Note”) for $332,000 with Crestmark Bank, pursuant to the U.S. Small Business Administration Paycheck Protection Program under Title I of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act passed by Congress and signed into law on March 27, 2020. The PPP Note was unsecured, with an interest rate of 1.00% per annum, with principal and interest payments deferred for the first six months, and would mature in two years. On June 15, 2021, the Company applied for forgiveness of the PPP loan in the amount of $332,000 under PPP guidelines. Our forgiveness application was reviewed by the SBA and on August 3, 2021, the Small Business Administration remitted payment to Crestmark Bank for the balance of the PPP Loan principal and all interest due on the PPP Loan.

The Company recognized $1,000 in interest expense related to the PPP Loan in the First Quarter 2021. The Company had $3,000 in accrued interest expense at March 31, 2021.

NOTE F – Employee Retention Credit

The employee retention credit (“ERC”), as originally enacted on March 27, 2020 by the CARES Act, is a refundable tax credit against certain employment taxes equal to 50% of the qualified wages an eligible employer pays to employees. On March 1, 2021, the IRS released Notice 2021-20 to provide guidance on the original ERC, as modified by the Relief Act. The Relief Act extended and enhanced the ERC for qualified wages paid after December 31, 2020 through June 30, 2021. Under the Relief Act, eligible employers may claim a refundable tax credit against certain employment taxes equal to 70% of the qualified wages an eligible employer pays to employees after December 31, 2020 through June 30, 2021. Under the American Rescue Plan Act and previously under the Consolidated Appropriations Act, 2021, the ERC was extended and expanded allowing claims through December 31, 2021 by eligible employers who retained employees during the Covid-19 pandemic. However, on November 5, 2021, the House of Representatives passed the Infrastructure Investment and Jobs Act (“Infrastructure Bill”) under which the ERC would terminate as of September 20, 2021 instead of December 31, 2021 and, President Biden signed the bill on November 15, 2021.

The maximum qualified wages for each employee under the current ERC is $10,000 per quarter. Also, because we have 100 or fewer full-time employees, health plan expenses borne by the Company can also be included as qualified wages in addition to salary. To qualify for the ERC in 2021, an employer must have experienced at least a 20% reduction in gross receipts when compared to the same quarter in either 2020 or 2019. During the first quarter of 2021, the second quarter of 2021 and the third quarter of 2021, the Company qualified for the ERC when comparing its 2021 quarters with both 2020 and 2019 quarters. In August 2021, the Company’s payroll service provider processed and mailed a Form 941-X to claim a refund in the amount of $202,000 on qualified wages paid in the first quarter of 2021. Due to a change in the Form 941-X, the Company’s payroll service provider did not process and mail its Form 941-X to claim a refund in the amount of $198,000 on qualified wages paid in the second quarter of 2021 until October 28, 2021. In the middle of the third quarter of 2021, the Company began taking the ERC in our current payroll; which reduced payroll by approximately $44,000 in the third quarter of 2021. Given this, the Company did not have to amend its Form 941 for the third quarter of 2021; however the Form 941 claiming a refund in the amount of $137,000 was filed electronically with the IRS on November 1, 2021 by the Company’s payroll service provider. Upon passing of the Infrastructure Bill, the Company ceased taking the ERC in its current payroll.

On December 28, 2021, the Company received its refund for the third quarter of Fiscal 2021 in the amount of $137,000. Shortly before receiving the first refund, the Company spoke with the Internal Revenue Service (“IRS”) to obtain statuses of our filings. The Company was informed that the IRS did not have record of receiving the Company’s Form 941-X for the first quarter of Fiscal 2021 (which was mailed by the Company’s service provider in August 2021). The Company re-sent the Form 941-X for the first quarter of Fiscal 2021 via overnight service on December 31, 2021 and the IRS received it on January 5, 2022. This lack of receipt will result in a delay in receiving the expected refund in the amount of $202,000. Based on our discussion with the IRS, we were expecting the refund for the second quarter of Fiscal 2020 sometime in February 2022; however, as of the date of this report.report, we have not received any further refund payments. The termination dateCompany’s expected refunds; totaling $400,000, are included on the Condensed Balance Sheets under current assets, as well as on the Company’s Condensed Statements of Operations under other income.

Laws and regulations concerning government programs, including the Crestmark line of credit was changed from June 22, 2018Employee Retention Credit are complex and subject to June 22, 2020varying interpretations. Claims made under the amendments. The balanceCARES Act may also be subject to retroactive audit and review. There can be no assurance that regulatory authorities will not challenge the Company’s claim to the ERC, and it is not possible to determine the impact (if any) this would have upon the Company. Although the Company has recorded $400,000 under other long term liabilities on our Condensed Balance Sheets at March 31, 2022, even if the equipment loanCompany’s refund claim was $34,000challenged and ultimately denied, the Company would not actually have to remit $400,000 to the IRS as of September 30, 2017.that amount has already been remitted to the IRS.

NOTE FG – Stock Options and Warrants

The Company currently has two non-statutory stock option plans, the Fiscal 2001 Non-statutory Stock Option Plan (the “2001 Plan”) and the 2013 Equity Compensation Plan (the “2013 Plan”). Both plans have been adopted by our Board of Directors and approved by our shareholders. Both the 2001 Plan and the 2013 Plan have options available for future issuance. Any common shares issued as a result of the exercise of stock options would be new common shares issued from our authorized issued shares.

During the three months ended September 30, 2017First Quarter 2022 and September 30, 2016,the First Quarter 2021, the Company issued 0 stock options.options to purchase shares of common stock.

Stock option activity for the nine months ended September 30, 2017First Quarter 2022 and September 30, 2016the First Quarter 2021 is summarized as follows (the figures contained within the tables below have been rounded to the nearest thousand):

The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2017 and September 30, 2016:

The Company recognized $33,000$0 in share based payment expense in the nine months ended September 30, 2017First Quarter 2022 and $49,000 inthe First Quarter 2021. At March 31, 2022, there was $0 of unrecognized share based payment expense in the nine months ended September 30, 2016. The Company recognized $10,000 in share based payment expense in the three months ended September 30, 2017 and $13,000 in share based payment expense in the three months ended September 30, 2016. As of September 30, 2017, there was approximately $16,000 of total unrecognized compensation cost related to non-vested stock options, which vest over time. The cost is expected to be recognized over a period ranging from 3-8 months.

Warrantsoptions.

WarrantWarrants

There was no warrant activity in the First Quarter 2022 or the First Quarter 2021.

NOTE H – Changes in Stockholders’ Deficit         

The following table summarizes the changes in stockholders’ deficit for the nine months ended September 30, 2017three month periods ending March 31, 2022 and September 30, 2016 is summarized as follows:March 31, 2021:

LANDMARK CONSULTING AGREEMENT

On March 7, 2022, the Company entered into a Financial Advisory Agreement (the “Agreement”) with Landmark Pegasus, Inc. (‘Landmark”). The Agreement provides that Landmark will provide certain financial advisory services for a minimum period of 3 months (which period commenced on February 28, 2022), and as consideration for these services, the Company will pay Landmark (a) a retainer fee consisting of 500,000 restricted shares of common stock and a warrant to purchase 2.75 million shares of the Company’s common stock at a strike price equal to the average closing price of the Company’s common shares for the 30 days preceding the Agreement, or $0.035 per share, resulting in gross proceeds to the Company in the amount of $96,250. The warrant would vest upon the closing of a transaction involving Landmark or upon the invocation of a “Breakup Fee”.

In a subsequent amendment, the terms of the warrant were changed to reflect that the warrant would be issued immediately preceding the closing of a transaction involving Landmark or immediately upon the invocation of the Breakup Fee. In each case, the warrant would vest immediately (i.e. the warrant would be 100% immediately exercisable).

The Breakup Fee will be invoked upon the generation of a specific transaction to ABMC which meets certain criteria agreed upon by both the Company and Landmark; which transaction is then rejected by the Company. The Company will also pay to Landmark a “Success Fee” for the consummation of a transaction closing during the term of the Agreement and for 12 months thereafter, between the Company and any party first introduced to the Company by Landmark, or with any party the Company has specifically requested Landmark’s assistance with the transaction.

Upon invocation of the Breakup Fee or payment of the Success Fee, the Company will also issue an additional 250,000 restricted shares of the Company’s common stock.

In the nine months ended September 30, 2017 and September 30, 2016,event that the Company recognized $0 in debt issuance and deferred finance costs relatedconsummates a transaction involving the provision of services to any party introduced to the issuance of the above warrants outstanding. In the three months ended September 30, 2017 and September 30, 2016,Company by Landmark or with any party the Company recognized $0has specifically requested Landmark’s assistance with, the Company will pay Landmark 10% of any revenues received from the transaction, unless this percentage is modified by both the Company and Landmark in debt issuancewriting. There is no material relationship between the Company and deferred finance costs relatedLandmark, other than with respect to the issuance of the above warrants. As of September 30, 2017, there was $0 of total unrecognized expense.Agreement.

NOTE GLINCOLN PARK EQUITY LINE OF CREDIT – SUBSEQUENT EVENTDECEMBER 2020

On October 20, 2017,December 9, 2020, the Company entered into a Purchase Agreement and a Registration Rights Agreement with Lincoln Park (together the “Agreements”) under which Lincoln Park agreed to purchase from the Company, from time to time, up to $10,250,000 of its shares of common stock, par value $0.01 per share, subject to certain limitations set forth in the Purchase Agreement, during the term of the Purchase Agreement (two years).

Pursuant to the terms of the Registration Rights Agreement, on December 29, 2020, the Company filed a registration statement on Form S-1 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) to register for resale under the Securities Act of 1933, as amended (the “Securities Act”), the shares of common stock issued and sold as well as the shares of common stock that the Company may elect in the future to issue and sell to Lincoln Park. The SEC declared the Form S-1, as amended, effective on January 11, 2021. On January 11, 2021, the Company sold the remaining 500,000 shares of common stock to Lincoln Park required as an initial purchase under the Purchase Agreement for a purchase price of $125,000.

Under the Purchase Agreement, on any business day selected by the Company on which the closing sale price of its common stock exceeds $0.05, the Company may direct Lincoln Park to purchase up to 200,000 common shares on the applicable purchase date (a “Regular Purchase”), which maximum number of shares may be increased to certain higher amounts up to a maximum of 250,000 or 500,000 common shares, if the market price of the Company’s common stock at the time of the Regular Purchase equals or exceeds amounts outlined in the Purchase Agreement. However, Lincoln Park’s purchase obligation under any single Regular Purchase may not exceed $500,000. The purchase price of the shares of common stock the Company may elect to sell to Lincoln Park under the Purchase Agreement in a Regular Purchase, if any, will be based on 95% of the lower of: (i) the lowest sale price on the purchase date for such Regular Purchase and (ii) the arithmetic average of the three lowest closing sale prices for the Company’s common shares during the 15 consecutive business days ending on the business day immediately preceding the purchase date for a Regular Purchase (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction.)

Lincoln Park cannot require the Company to sell them any common stock, but is obligated to make purchases as the Company directs, subject to certain conditions outlined under the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for the Company’s common shares that the Company may elect to sell to them pursuant to the Purchase Agreement. In all instances, the Company may not sell common shares to Lincoln Park under the Purchase Agreement to the extent that the sale of shares would result in Lincoln Park beneficially owning more than 9.99% of our common shares. There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, other than the Company’s agreement not to enter into any “variable rate” transactions (as defined in the Purchase Agreement) with any third party, subject to certain exceptions set forth in the Purchase Agreement, for the period set forth in the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any direct or indirect short selling or hedging of the Company’s common stock.

Actual sales of common stock to Lincoln Park, and the timing of the same, under the Purchase Agreement depend on a variety of factors to be determined by the Company from time to time. Proceeds the Company received notice that Todd Bailey (“Bailey”), its former Vice Presidentfrom sales of Sales & Marketingcommon stock to Lincoln Park under the Purchase Agreement are used at the sole discretion of Company management and sales consultant filed a complaint againstare used for general corporate purposes, capital expenditures and working capital.

The Company did not sell any shares of common stock to Lincoln Park in the First Quarter 2022 as the closing price of the Company’s shares of common stock did not exceed $0.05. In fact, the last sale to Lincoln Park was in October 2021. In the First Quarter 2021, the Company insold a total of 2,100,000 shares of common stock to Lincoln Park (including the Statebalance of Minnesota seeking deferred commissionsthe required initial purchase) as Regular Purchases and received proceeds of $164,000 that Bailey alleges is owed$381,000.

NOTE I – SUBSEQUENT EVENTS

Amendment to him by the Company. Bailey isDecember 2021 Shareholder Loan

On April 6, 2022, we amended a loan with one of the defendantsnon-affiliated shareholders. This amendment (No.1; hereinafter referred to in this paragraph as Amendment No. 1) increasing the principal due to the shareholder by $25,000; bringing their total principal to $75,000. No other terms of the loan were changed under Amendment No. 1.

On April 14, 2022, the loan was amended again (under Amendment No. 2; hereinafter referred to in this paragraph as Amendment No. 2) increasing the principal again by $50,000; bringing their total principal to $125,000. No other terms of the loan were changed under Amendment No. 2.

On May 11, 2022, the loan was amended again (under Amendment No. 3; hereinafter referred to in this paragraph as Amendment No. 3) increasing the principal again by $75,000; bringing their total principal to $200,000. The loan was further amended to include a specific payment schedule based on receipt of anticipated ERC refunds. More specifically, $75,000 will be repaid to the shareholder upon receipt of the next ERC refund (anticipated to be $198,000), $100,000 will be repaid to the shareholder upon receipt of the final ERC refund (anticipated to be $202,000) and the final $25,000 and any accrued interest due under the loan will be paid prior to December 31, 2022.

Cherokee LSA and 2019 Term Loan

As of the date of this report, we are still in discussions with Cherokee about our inability to pay off these credit facilities. These discussions involve possible payoff of the loans (via a refinance or other means), modification of the terms of the facilities and/or further extension of the due date of the credit facilities.

NOTE J- INCOME TAXES

                The Company follows ASC 740 “Income Taxes” (“ASC 740”) which prescribes the asset and liability method whereby deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted laws and tax rates that will be in effect when the differences are expected to reverse.  The measurement of net, deferred tax assets is reduced, if necessary, by a valuation allowance for any tax benefits that are not expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the litigation discussed previously in Note D. On November 2, 2017, we filed a Noticeperiod that such tax rate changes are enacted.   Under ASC 740, tax benefits are recorded only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of Removal in this actionbenefit that is greater than 50 percent likely to move the matter from state to federal court. On November 9, 2017, we filed a motion to dismiss or,be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in the alternative to transfer venueCompany’s tax returns that do not meet these recognition and consolidate, the Bailey complaint with our litigation filed previously against Bailey and others (see Note D).measurement standards.

                On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. With regards to the use of net losses incurred for 2018 and later, such net operating losses have no expiration date, while net operating loss carryforwards can only be used to offset up to 80% of taxable income. Net operating losses incurred prior to 2018 may be fully utilized to offset taxable income, but expire in 20 years.

A reconciliation of the U.S. Federal statutory income tax rate to the effective income tax rate is as follows:

Item2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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, 2016,2020, 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

Our abilitySales of drug tests continue to maintain and/or increase salesbe negatively impacted as customer pricing continues to be impacted bydecrease as a very cost-competitive market currently dominated byresult of our markets being saturated with products made outside of the United States. EvidencedStates; 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 factUnited 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 tests 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 tests (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 looking into other products to offer via distribution relationships.

Although the cost of manufacturing drug tests in the nine months ended September 30, 2017 decreased againUnited States is proving to be nearly cost prohibitive, we do believe there are opportunities to capitalize on our US-based lateral flow manufacturing capabilities; especially 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 profit margin has been declining due to the increased costs of manufacturing in the United States (many of which were previously mentioned). We continually take actions to adjust our production schedules to try to mitigate manufacturing inefficiencies, and take 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 also have certain overhead costs associated with manufacturing that are fixed and as sales decline, these costs cannot be adjusted downward and this results in greater manufacturing inefficiencies. We are currently looking into possible production alternatives in attempts to address these fixed costs.

Operating expenses declined in the First Quarter 2022 when compared to the same period last year. In addition, ourFirst Quarter 2021. We continuously make efforts to control operational expenses to ensure they are in line with sales have been impacted by actions taken by a former Vice President Sales & Marketing/Sales Consultant. We have initiated litigation against this former employee/consultant relatedincluding, but not limited to, these actions (see Note D – Litigation/Legal Matters).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.

During the nine months ended September 30, 2017,From August 2013 until June 2020, we recorded an operating loss of $83,000. This compares to an operating loss of $118,000 in the same period last year. Decreased operating expenses were the primary cause of the improvement in operating loss (relative to sales). Net loss in the nine months ended September 30, 2017 was $252,000, compared to a net loss of $130,000 in the same period last year. This is primarily due to other income of $200,000 (of which $150,000 was related to a tech transfer with a contract manufacturing customer) in the nine months ended September 30, 2016 that did not reoccur in the nine months ended September 30, 2017.

We had cash provided by operating activities of $158,000 in the nine months ended September 30, 2017. This compares to cash provided by operating activities of $185,000 in the nine months ended September 30, 2016.

We continuously examine all expenses in efforts to achieve profitability (when/if sales levels improve) or to minimize losses going forward (if sales continue to decline). Over the course of the last two fiscal years (Fiscal 2016 and Fiscal 2015), we refinanced substantially all of our existing debt at lower interest rates, manufactured our products in a partially consolidated operating environment, and maintained a salary and commission deferral program; all as part ofprogram for our efforts to decrease expenses and improve cash flow.

sole executive officer, our Chief Executive Officer/Principal Financial Officer Melissa Waterhouse. The salary and commission deferral program previously referenced continued throughoutwas initiated by Ms. Waterhouse voluntarily. Another member of senior management participated in the nine months ended September 30, 2017. The deferral program currently consists of a 20% salary deferral for our executive officer and our non-executive VP Operations (and previously included the former Vice President Sales & Marketing/Sales Consultant referred to earlier in this report;voluntarily until his terminationretirement in December 2016). AsNovember 2019. After the member of September 30, 2017,senior management retired, we had totalagreed to make payments on the deferred compensation owed of $253,000. Overto this individual. In the course of the program,First Quarter 2021, we repaid portions ofmade payments totaling $13,000 to this individual and his deferred compensation was paid in full in May 2021. Once the deferred compensation (with $29,000was 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. In the First Quarter 2022, we made payments totaling $10,000 to Ms. Waterhouse. We did not make any payments on deferred compensation to Ms. Waterhouse in the nine months ended September 30, 2017 and $70,000 in paymentsFirst Quarter 2021. As of March 31, 2022, we had deferred compensation owed to Ms. Waterhouse in the nine months ended September 30, 2016.). As cash flow from operations allows, we intendamount of $64,000 and $5,000 in payroll taxes that are due as payments are made to continueMs. Waterhouse; for a total of $69,000 in deferred compensation owed to make paybacks, however the deferral program is continuing and we expect it will continue for up to another 12 months.Ms. Waterhouse.

We continue to believe that new products and our ability to sell those products in new markets will be a future growth driver. In August 2017, the U.S. Food and Drug Administration granted over-the-counter marketing clearance for our Rapid TOX Cup II (an all-inclusive, urine based drug testing cup). We are hopeful that this marketing clearance will enable us to further penetrate clinical markets as to increase our business with our laboratory alliance.

Although our primary markets continue to be extremely price-competitive, this marketing clearance should enable us to garner new sales in clinical markets (such as pain management and drug treatment) because although price is always a factor, quality and accuracy are equally important in these clinical markets.

New assays and product platform developments are also in our future research and development plans. We remain focused on selling our point of collection drugs of abuse tests, and growing our business through direct sales and select distributors.

Over the course of the last 12 months, we have reorganized and restructured our sales and marketing department. In addition, we brought on new products and service offerings to diversify our revenue stream through third party relationships. These new products and services include products for the detection of alcohol, alternative sample options for drug testing (such as lab based oral fluid testing and hair testing) as well as toxicology management services. In addition, we are now offering customers lower-cost alternatives for onsite drug testing. And finally, we are reviewing our contract manufacturing operations in efforts to capitalize on offerings in that area. We have not derived any significant revenue from these new additions; however, the majority of the relationships were only finalized in March/April 2017.

In September 2016, our contract manufacturing sales began to decrease on an annual basis due to a manufacturing shift with one of our contract customers. More specifically, as a result of a tech transfer with the customer, they are now their own primary supplier with the Company moving into a position of back up or secondary supplier. Although contract manufacturing is not considered a material portion of our net sales, given this expected change, we are making efforts to identify and secure new contract work and possible diversification alternatives. In connection with the tech transfer, we received a $300,000 tech transfer fee from this customer. We recognized $150,000 related to this tech transfer fee as other income in the nine months ended September 30, 2016.

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 have suffered the loss of a materialmanufacture as well as products we offer via distribution, 3) secure new contract that will impact sales starting October 1, 2017, 2)manufacturing customers, 4) control operational costs to generate positive cash flows, 3)5) maintain our current credit facilities or refinance our current credit facilities if necessary, and 4)6) if needed, our ability to obtain working capital by selling additional shares of our common stock.

Results of operations for the nine months ended September 30, 2017

First Quarter 2022 compared to the nine months ended September 30, 2016First Quarter 2021

NET SALES:Net sales for the nine months ended September 30, 2017First Quarter 2022 decreased 9.5%38.0% when compared to net sales in the nine months ended September 30, 2016. The decreaseFirst Quarter 2021 primarily as a result in a decline in sales isof drugs of abuse (“DOA") test 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 anticipated decreasesupply chain issues we experienced in contract manufacturing sales2021 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 nine months ended September 30, 2017manufacture of lateral flow Covid-19 tests. and other companies as well). They indicated that the other segment we supply would remain unchanged and in that particular segment, we actually saw a slight increase in sales when compared tocomparing the nine months ended September 30, 2016. More specifically, contract manufacturing sales declined by approximately $222,000 (of which $197,000 was to the customer involvedFirst Quarter 2022 with the tech transfer). The remaining $195,000First Quarter 2021. Nominally offsetting this decline was an increase in decreasedinternational sales resulted primarily fromas a decreasefew of our distributors start to see a rebound in government sales (mostbusiness since the pandemic.

Also partially offsetting the decline was an increase in distribution sales; most of which is due to the loss of an account in the fourth quarterincreased sales of the year ended December 31, 2016). These declines were partially offset by anlower cost DOA tests we are selling along with a small increase in national accounts and international sales of rapid Covid-19 tests we are distributing. Contract manufacturing sales also increased when comparing First Quarter 2022 to Latin and South America.the First Quarter 2021. This was primarily a result of increased sales of our private labeled RSV test due to increased testing since the Covid-19 pandemic.

GROSS PROFIT:Gross profit in the nine months ended September 30, 2017 decreased to 42.7% of net sales compared to 44.2%8% of net sales in the nine months ended September 30, 2016. While we are still maintaining manufacturing efficiencies, there were certain periods withinFirst Quarter 2022 from 18.6% of net sales in the nine months ended September 30, 2017 that we produced less testing stripsFirst Quarter 2021. This decline in 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 productCompany to maintain an appropriate blended gross profit margin on the sales mix.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.

We have taken steps to reduce manufacturing costs, including but not limited to, costs associated with labor and facility costs, to mitigate these inefficiencies. 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.

OPERATING EXPENSES: Operating expenses decreased 14.0% in the nine months ended September 30, 2017First Quarter 2022 compared to the nine months ended September 30, 2016. Expenses in researchFirst Quarter 2021. Selling and developmentMarketing and sellingGeneral and marketingAdministrative expenses decreased while generalResearch and administrative expense increased.Development expenses increased slightly. More specifically:

Research and development (“R&D”)

R&D expense decreased 30.9%10.0%, when comparing the nine months ended September 30, 2017First Quarter 2022 with the same period last year. DecreasedFirst Quarter 2021. Although the increase was 10.0%, the actual change in R&D expenses was only $2,000. Employment taxes increased slightly along with FDA compliance costs associated withand certain facility costs. However, overall, expenses were relatively unchanged. In the timing of actions taken related toFirst Quarter 2022, our FDA marketing clearance for Rapid TOX Cup II were partially offset by an increase in supplies and materials. Our R&D department continues to focusprimarily focused their efforts on the enhancement of our current products the development of newand validations related to drug testing assays, new product platforms and the evaluation of contract manufacturing opportunities.components.

Selling and marketing

Selling and marketing expense in the nine months ended September 30, 2017First Quarter 2022 decreased 35.7%49.4% when compared to the same period last year. OneFirst Quarter 2021. Reductions in sales salary expense and benefits (due to the termination of personnel for performance reasons) and reductions in costs associated with shipping were the primary reasonsreason for the decline in expenses. All other expenses is decreased commission expense. were relatively unchanged when comparing the quarters.

In the latter part of December 2016,First Quarter 2022, we terminated our relationship with a sales consultant due to competitive issues that arose during our relationship; we subsequently filed a complaint against this consultant in the early part of 2017 (See Note D – Litigation/Legal Matters). In additioncontinued selling and marketing efforts related to the decline in commissions, sales salariesdrug tests we manufacture and benefits, customer relations expense, postage and marketing consulting expenses decreased. These declines were minimally offset by an increase in costs associated with trade show attendance. Our direct sales force continues to focus their efforts in our target markets, which include, but are not limited to, Workplace, Government, and Clinical (i.e. pain management and drug treatment) and in the forensic and international markets for our oral fluid product. Our sales force has also started to promote new products and service offerings to diversify our revenue stream. These new products and services (through relationships with third parties) include products for the detection of alcohol, alternative sample options for drug testing (such as lab based oral fluid testing and hair testing) as well as toxicology management services, and lower-costwe promoted lower cost alternatives for onsite drug testing. And finally,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 First Quarter 2022 with the FDA marketing clearance granted in August 2017,First Quarter 2021. Terminations of sales personnel have been due to poor performance. We are taking steps to increase the size of our sales force is also promoting theteam to further penetrate our markets; however, no new market application of the productsales reps were hired in the clinical market.First Quarter 2022. 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 increased 4.3%decreased 42.3% in the nine months ended September 30, 2017 whenFirst Quarter 2022 compared to the same period last year. IncreasesFirst Quarter 2021. The primary reason for the decrease was First Quarter 2022 did not include any fees associated with our loans with Cherokee while the First Quarter 2021 includes a total of $148,000 in legal 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 the initiationretirement of litigation in the early part of 2017; see Note D – Litigation/Legal Matters)an employee), general and administrative salaries and benefits declined due to fewer employees, accounting fees were partially offset by reduced expenses relateddeclined due to investor relationslower costs from our new accounting firm, and patent fees declined (due to decreased travel), telephone and non-cash compensation (I.e. share based payment expense; due to less options outstanding subject to amortization). Share based paymenttiming of patent maintenance fees) along with other smaller declines in other expense was $33,000 in the nine months ended September 30, 2017 compared to $49,000 in the nine months ended September 30, 2016.

Results of operations for the three months ended September 30, 2017

compared to the three months ended September 30, 2016

NET SALES:Net sales for the three months ended September 30, 2017 declined 4.4% when compared to the three months ended September 30, 2016. The decrease in sales results from a decrease in government sales (most of which is due to the loss of an account in the fourth quarter of 2016), and a decline in contract manufacturing sales.areas. These declines were partially offset by increased salescosts associated with SEC filing fees and annual meeting expense (due to Latin America and South America and to national accounts.

GROSS PROFIT:Gross profit decreased to 41.8%timing of net sales in the three months ended September 30, 2017 compared to gross profit of 43.1% of net sales in the three months ended September 30, 2016. While we are still maintaining manufacturing efficiencies, there were certain periods within the three months ended September 30, 2017 that we produced less testing strips due to the product sales mix.

OPERATING EXPENSES: Operating expenses decreased 16.4% in the three months ended September 30, 2017, compared to the three months ended September 30, 2016. Expenses in research and development and selling and marketing decreased while general and administrative expense increased. More specifically:

Research and development (“R&D”)

R&D expense decreased 7.1% when comparing the three months ended September 30, 2017 with the three months ended September 30, 2016. Decreased supplies and materials costs were partially offset byfees), increased employee benefit costs. Our R&D department continues to focus their efforts on the enhancement of current products, the development of new testing assays, new product platforms and the evaluation of contract manufacturing opportunities.

Selling and marketing

Selling and marketing expense in the three months ended September 30, 2017 decreased 42.2% when compared to the three months ended September 30, 2016. One of the primary reasons for the decline in expenses is related to decreased commission expense. In the latter part of December 2016, we terminated our relationship with a sales consultant due to competitive issues that arose during our relationship; we subsequently filed a complaint against this consultant in the early part of 2017 (See Note D – Litigation/Legal Matters). In addition to the decline in commissions, sales salaries and benefits, customer relations expense, and marketing consulting expenses decreased. These declines were minimally offset by an increase sales travel expense. Our direct sales force continues to focus their efforts in our target markets, which include, but are not limited to, Workplace, Government, and Clinical (i.e. pain management and drug treatment) and in the forensic and international markets for our oral fluid product. Our sales force has also started to promote new products and service offerings to diversify our revenue stream. These new products and services (through relationships with third parties) include products for the detection of alcohol, alternative sample options for drug testing (such as lab based oral fluid testing and hair testing) as well as toxicology management services, and lower-cost alternatives for onsite drug testing. And finally, with the FDA marketing clearance granted in August 2017, our sales force is also promoting the new market application of the product in the clinical market.

General and administrative (“G&A”)

G&A expense increased 2.2% in the three months ended September 30, 2017 when compared to G&A expense in the three months ended September 30, 2016. Increased legal fees (due to the initiationexecution of litigationthe Financial Advisory Agreement with Landmark Pegasus, Inc. in the early part of 2017; see Note D – Litigation/Legal Matters) were partially offset by reduced expensesFirst Quarter 2022) and increased utility and repair costs. There was no expense related to telephone, consulting fees, brokers fees and non-cash compensation (i.e. share based payment expense; due to less options outstanding subject to amortization). Share based paymentpayments in either the First Quarter 2022 or the First Quarter 2021.

Other income / (expense):

Other expense was $10,000 in the three months ended September 30, 2017 compared to $13,000 inFirst Quarter 2022 and the three months ended September 30, 2016.First Quarter 2021 consisted of interest expense associated with our credit facilities (our line of credit with Crestmark Bank, our loans with Cherokee Financial, LLC and our loans with two shareholders).

Liquidity and Capital Resources as of September 30, 2017March 31, 2022

Our cash requirements depend on numerous factors, including but not limited to manufacturing costs (such as raw materials, labor, equipment, etc.), selling and marketing initiatives, product development activities, regulatory costs, legal costs, associated with current litigation, and effective management of inventory levels and production levels in response to sales history and forecasts. We expect to devote capital resources related to continue selling and marketing initiatives and product development/research and development activities.initiatives. We are examining other growth opportunities including strategic alliances.alliances and contract manufacturing. Given our current and historical cash position, we expect 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 First Quarter 2022 and/or the First Quarter 2021 or are expected to have an impact on our cash flow in the year ending December 31, 2022:

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 First Quarter 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 First Quarter 2021, the Company sold 2,100,000 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 $381,000.

Employee Retention Credit ("ERC")

As discussed in Note F to our financial statements for the First Quarter 2022, we are expecting to receive two ERC refunds totaling $400,000. The receipt of these two refunds will have a positive impact on our cash flow.

Going Concern

Our financial statements for the year ended December 31, 2016First Quarter 2022 were prepared assuming we will continue as a going concern.

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 may not be sufficient to fund operations through November 2018. May 2023. At March 31, 2022, we have Stockholders’ Deficit of $(1,308,000).

Debt

Our currentloan and security agreement and 2019 Term Note with Cherokee for $900,000 and $220,000, respectively, expired on February 15, 2021; however, on February 24, 2021, the we completed a transaction related to another one-year Extension of both facilities dated February 14, 2021 (the “Second Extension”) with Cherokee under which Cherokee extended the due date of the Cherokee LSA and the 2019 Term Note to February 15, 2022.

Under the terms of the Second Extension, the Cherokee LSA was increased to $1,000,000 to include a $100,000 penalty that was due as a result of the Company being unable to pay back the principal balance to Cherokee on February 15, 2021 and the 2019 Term Note was increased to $240,000 to include a $20,000 penalty. Under this Second Extension, the annual interest rate on the Cherokee LSA was increased to a fixed rate of 10% (the prior fixed rate was 8%) plus a 1% annual oversight fee (that remained unchanged). The interest rate on the 2019 Tern More remained at 18%. Interest on both facilities and the oversight fee on the Cherokee LSA are due quarterly. If the Company didn’t pay off the principal on the Cherokee LSA and the 2019 Term Note before February 15, 2022, Cherokee could impose an 8% delinquent fee. This delinquent fee applies to the principal balance due on each facility on February 15, 2022. Although the facilities were not paid off on February 15, 2022, Cherokee has not imposed the delinquent fees or increased the interest rates.

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 were due in full on February 15, 2022. We were not able to these pay off the credit facilities when they were due and we are currently in discussions with Cherokee related to possible payoff of the loans (via a refinance or other means) or to extend the due date of the loans. See Note I – Subsequent Events for information related to the status of the Cherokee loans.

Throughout the First Quarter 2022, we had a line of credit expires on June 22, 2020 and has awith Crestmark Bank. The maximum availability on the line of $1,500,000.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 is based upon(historically) have been significantly less than the balance of our accounts receivable and inventory. As of September 30, 2017, based on our availability calculation, there were no additional amounts available under our line of credit because we draw any balance available on a daily basis. Ifmaximum availability. When sales levels decline, further, we will have reduced availability on our line of credit due to decreased accounts receivable balances. In addition, we would expect our inventory levels to decrease if sales levels decline further, which would result in further reduced availabilityAs of March 31, 2022, based on our availability calculation, there were no additional amounts available under the line of credit. credit because we draw any balance available on a daily basis. Upon completion of the initial 5 year term, the Crestmark line of credit automatically renews for additional one (1) year terms unless notice of termination from the Company is received by Crestmark not less than sixty (60) days prior to the end of the renewal term. We did not provide Crestmark with a notice of non-renewal and therefore, the Crestmark line of credit will automatically renew on June 22, 2022 for another one year term, or until June 22, 2023.

If availability under our line of credit is(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 obtainseek additional credit facilities or sell additional equity securities, or delay capital expenditures.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 September 30, 2017,March 31, 2022, we had the following debt/credit facilities:

(1) Facility was not repaid on February 15, 2022 and we are currently in discussions with Cherokee related to possible payoff of the facility (via a refinanceor other means) or to extend the due date of the facility.

Working Capital Deficit

OurAt the end of the First Quarter 2022, we were operating at a working capital was $664,000 at September 30, 2017; this isdeficit of $1,833,000. This compares to a decrease of $129,000 when compared to working capital deficit of $793,000$1,484,000 at December 31, 2016. This decrease2021. The increase in the working capital deficit between the First Quarter 2022 and the year ended December 31, 2021 is primarily the result ofdue to decline in cash balances and accounts receivable (due to decreased sales.sales). We have historically satisfied working capital requirements through cash from operations, bank debt and debt.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.

Cash Flow, Outlook/Risk

We do not expect significant increasesIn the First Quarter 2022, we had a net loss of $379,000 and net cash used in expenses during the year endingoperating activities of $13,000.

Our cash position decreased to $17,000 at March 31, 2022 from $115,000 at December 31, 20172021 and $63,000 at March 31, 2021. Cash at December 31, 2021 was positively impacted by an ERC refund in December 2021 (in the amount of $137,000) and cash at March 31, 2021 was positively impacted by $381,000 received from sales of shares of our common stock to Lincoln Park. There were no similar cash infusions in the First Quarter 2022 and sales continued to decline.

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); as evidenced by the one customer’s decision to decrease sales to the Company in one of their market segments.

The extent to which the pandemic and the commoditized nature of our operating expenses for the year ended December 31, 2016 (“Fiscal 2016”), we have taken steps (andmarkets will continue to take steps)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 already impacting our business, liquidity, results of operations and financial condition and our ability to ensure that operating expenses and manufacturing costs remain in line with sales levels. In 2017, we will continue to focus our efforts on improving sales. Such steps include, but are not limited to, further penetratingaccess the Clinicalcapital markets such as pain management and drug treatment now that our Rapid TOX Cup II received OTC marketing clearance from FDA in August 2017 and entering into strategic relationships with third parties to offer additional products and services to our customers. This includes products for the detection of alcohol, alternative sample options for drug testing (such as lab based oral fluid testing and hair testing) as well as toxicology management services, and lower-cost alternatives for onsite drug testing. We are hopeful that these additional product and service offerings will have a positive impact on sales in the future. In the nine months ended September 30, 2017, we utilized cash resources to complete our FDA marketing application process (which resulted in a marketing clearance in August 2017) and to take other steps that could result in increased sales. In addition, cash resources have been utilized to initiate litigation against Premier Biotech Inc., and its President, Todd Bailey (a former Vice President and sales consultant of the Company), and Peckham Vocational Industries, Inc., among others. While we expect additional cash resources tomay also be used relatedlimited. Prior to the ligation, we do not expect additional expenditures related to marketing clearances in the year ending December 31, 2017.

None of these efforts related to sales, or any other efforts being taken related to other operational activities, resulted in a substantial increase in cash requirements in the nine months ended September 30, 2017. In the secondfourth quarter of the year ended December 31, 2016,2021, we receivedwere able to utilize the Lincoln Park Equity Line; however, the downturn of our final paymentcommon stock starting in the third quarter of $150,000 related2021 has prevented any further sales to a tech transfer withbe initiated.

In December 2021, we received one of our contract-manufacturing customers. The lossERC refunds (in the amount of a state agency contract starting October 1, 2017 is expected to have a material impact on our sales. If we are unable to recoup this loss (which has historically been 10-15% of our annual sales), it is possible that our current line of credit (and advance rates) would not be adequate for our cash requirements in$137,000) from the IRS. In the year ending December 31, 2017, especially if expense levels do not decline in line with the sales decline and especially considering the costs related to litigation. In addition, extraordinary events could occur that would result in unexpected, increased expenditures.2022, we are expecting two more refunds; totaling $400,000.

Our ability to repay our current debt will depend primarily upon our future operating performance, whichand other liabilities may also be affected by the loss of a material contract in October 2017, general economic, financial, competitive, regulatory, legal, business and other factors beyond our control, including those discussed herein. In addition,If we cannot assure you that future borrowings or equity financingare unable to meet our credit facility obligations and we continue to be unable to facilitate purchases under our Purchase Agreement with Lincoln Park, we will be available for the payment ofrequired 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 indebtedness we may have.new financing would be at favorable terms.

Our failureWe will continue to complytake steps to ensure that operating expenses remain in line with the covenant under our revolving credit facility could resultsales levels and make every effort to control manufacturing costs. We have consolidated job responsibilities in an eventcertain areas of default, which, if not cured or waived, could result in the Company being requiredand this has enabled us to pay higher costs associated with the indebtedness. implement personnel reductions. We are also promoting new products and service offerings to diversify our revenue stream, including new Covid-19 tests.

If we are forced to refinance our debt on less favorable terms, our results of operations and financial condition could be 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.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

As a smaller reporting company, we are not required to provide the information required by this item.

Item 4. Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

Our Chief Executive Officer (Principal Executive Officer)/Chief Financial Officer (Principal Financial Officer), together with other members of management, has reviewed and evaluated the effectiveness of our “disclosure controls and procedures” (as defined in the Securities Exchange Act of 1934 Rule 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on this review and evaluation, our Principal Executive Officer/Principal Financial Officer concluded that our disclosure controls and procedures are effective to ensure that material information relating to the Company is recorded, processed, summarized, and reported in a timely manner.

(b) Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting during the last quarterly period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.