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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

~~[X]~~ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2020~~ 2021

~~[ ]~~ ☐ TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period ______ ~~--------------~~ to ~~-------------------~~ ______

Commission File Number: 0-28666

American Bio Medica Corporation (Exact name of registrant as specified in its charter)

(Exact name of registrant as specified in its charter)

New York		14-1702188
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

122 Smith Road Kinderhook, New York		12106
(Address of principal executive offices)		(Zip Code)

New York (State or other jurisdiction of incorporation or organization)	14-1702188 (I.R.S. Employer Identification No.)
122 Smith Road Kinderhook, New York (Address of principal executive offices)	12106 (Zip Code)

Registrant’s telephone number (including area code): (518) 758-8158

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	ABMC	OTCQB® Venture Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No

~~Yes~~ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ☐ No Yes ☒ No

Indicate by check mark ifwhether the registrant is(1) ~~not~~has filed all reports required to ~~file~~be ~~reports pursuant~~filed toby Section 13 or ~~Section~~ 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for 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. ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). ☒ Yes ☐ No ☒

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 for 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.

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, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated Filer ☐ Smaller reporting company ☒ ~~Non-accelerated filer ☐~~ Emerging growth company ☐

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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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

~~Yes ☐ No ☒~~The aggregate market value of 47,451,640 voting Common Shares held by non-affiliates of the registrant was approximately $2,847,000 based on the last sale price of the registrant’s Common Shares, $.01 par value, as reported on the OTCQB Venture Market on June 30, 2021.

~~The aggregate~~As ~~market value~~ of 28April 14,~~795,572~~ ~~voting~~2022 ~~Common Shares held by non-affiliates of~~ the registrant ~~was~~had ~~approximately $30~~48,~~235~~098,~~000 based~~476 onoutstanding ~~the last sale price of the registrant’s~~ Common Shares, $.01 par value~~, as reported on the OTC Pink Open Marketplace on June 30, 2020~~.

As of April 15, 2021 the registrant had 40,003,476 outstanding Common Shares, $.01 par value.

Documents Incorporated by Reference:

(1)

	(1)	Portions of the Registrant’s Proxy Statement for the year ended December 31, 2021 in Part III of this Form 10-K
	(2)	Other documents incorporated by reference on this report are listed under Part IV, Item 15(B); Exhibits

Portions of the Registrant’s Proxy Statement for the year ended December 31, 2020 in Part III of this Form 10-K

(2)

Other documents incorporated by reference on this report are listed under Part IV, Item 15(B); Exhibits

American Bio Medica Corporation

Index to Annual Report on Form 10-K

For the year ended December 31, ~~2020~~2021

PART I	~~PAGE~~		PAGE
Item 1.	Business	3	4
Item 1A.	Risk Factors	8	9
Item 1B.	Unresolved Staff Comments	15	16
Item 2.	Properties	15	16
Item 3.	Legal Proceedings	15	16
Item 4.	Mine Safety Disclosures	15	16
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	16	17
Item 6.	~~Selected Financial Data~~Reserved	17	18
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17	18
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	24	26
Item 8.	Financial Statements and Supplementary Data	24	26
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	24	26
Item 9A	Controls and Procedures	24	26
Item 9B.	Other Information	25	27
PART III
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections		27
Item 10.	Directors, Executive Officers, and Corporate Governance	26
PART III
Item 11.	Executive Compensation	26
Item 10.	Directors, Executive Officers, and Corporate Governance		28
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	26
Item 11.	Executive Compensation		28
Item 13.	Certain Relationships and Related Transactions, and Director Independence	26
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters		28
Item 14.	Principal Accounting Fees and Services	26
Item 13.	Certain Relationships and Related Transactions, and Director Independence		28
PART IV
Item 14.	Principal Accountant Fees and Services		28
Item 15.	Exhibits, Financial Statement Schedules	27
PART IV
Item 16.	Form 10-K Summary	27
Item 15.	Exhibits and Financial Statement Schedules		29
SIGNATURES		29
Item 16.	Form 10-K Summary		29
SIGNATURES			S-1

Table of Contents

This Form 10-K may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this Form 10-K that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may”, “could”, “should”, “will”, “expect”, “believe”, “anticipate”, “estimate” or “continue” or comparable terminology is intended to identify forward-looking statements. It is important to note that actual results could differ materially from those anticipated from the forward-looking statements depending on various important factors. These important factors include our history of losses, our ability to continue as a going concern, adverse changes in regulatory requirements related to the marketing and use of our products, the uncertainty of acceptance of current and new products in our markets, competition in our markets and other factors discussed in our “Risk Factors” found in Part I, Item 1A. Unless the context indicates otherwise, all references in this Form 10-K to the “Company”, “we”, “us” and “our” refer to American Bio Medica Corporation.

Table of Contents

PART I

ITEM 1. BUSINESS

Form and Year of Organization

American Bio Medica Corporation (the “Company”) was incorporated on April 2, 1986 under the laws of the State of New York under the name American Micro Media, Inc. On September 9, 1992, we filed an amendment to our Articles of Incorporation and changed our name to American Bio Medica Corporation.

Our Business

We manufacture and sell lateral flow immunoassay tests, primarily for the immediate detection of drugs in urine and oral fluid. Our products are self-contained, cost-effective and user-friendly products that are capable of accurately identifying the presence or absence of drugs in a sample within minutes. The products we manufacture are made 100% in in the United States while our competitors manufacture their products outside the United States, primarily in China. One of our drug testing lines is private labeled for another diagnostic company.

We also provide strip manufacturing, product assembly and packaging services to an unaffiliated third party related to a diagnostic test that they sell outside the United States and, we manufacture a diagnostic product that is sold under a private label by an unaffiliated third party. We sell (via distribution) a number of other products related to the immediate detection of drugs in urine and oral fluid, as well as offering other point of care diagnostic products via distribution.

Beginning in March 2020, weand ~~began~~throughout ~~marketing,~~the ~~via~~year aended ~~non-exclusive~~December ~~distribution partnership~~31, ~~a rapid test to detect Covid-19 antibodies in whole blood~~2021, ~~serum or plasma. In October 2020,~~ we ~~announced that we~~ also ~~signed~~ acontinued ~~distribution~~to ~~agreement with Co-Diagnostics~~distribute, ~~Inc. granting us the right to market and sell its EUA issued Logix Smart Covid-19 tests in the United States~~ on a non-exclusive basis~~. On December 14~~, ~~2020,~~various ~~we announced we were distributing a Rapid~~ Covid-19 ~~Antigen~~ ~~test,~~rapid an immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of Covid-19 by their healthcare providertests.

Our Products

Products for the Detection of Drugs in Urine. We manufacture a number of products that detect the presence or absence of drugs in urine. We offer a number of standard configurations, custom configurations on special order, and different cut-off levels for certain drugs. Cut-off levels are concentrations of drugs or metabolites that must be present in urine (or oral fluid) specimens before a positive result will be obtained. Our urine drugs tests are either 510(k) cleared, CLIA Waived and/or OTC cleared (see “Government Regulations” for information on the regulations related to the sale of our drug tests). We currently manufacture the following urine drug testing product lines:

Rapid Drug Screen® The Rapid Drug Screen, or RDS®, is a patented rapid drug test that detects the presence or absence of 2 to 10 drugs simultaneously in a single urine specimen. The RDS is available as a card only, or as part of a kit that includes a collection cup.

RDS InCup® The patented RDS InCup is a drug-testing cup that detects the presence or absence of 1 to 12 drugs in a urine specimen. The RDS InCup incorporates collection and testing of a urine sample in a single step. Each RDS InCup contains multiple channels, and each channel contains a drug-testing strip that contains the chemistry to detect a single drug.

~~Rapid~~4 ~~TOX® Rapid~~Table ~~TOX is a cost-effective drug test in a cassette platform that simultaneously detects the presence or absence~~ of ~~1 to 10 drugs in a urine specimen. Each Rapid TOX contains one or two channels, and each channel contains a drug-testing strip that contains the chemistry to detect 1-5 drugs.~~Contents

3Rapid TOX® Rapid TOX is a cost-effective drug test in a cassette platform that simultaneously detects the presence or absence of 1 to 10 drugs in a urine specimen. Each Rapid TOX contains one or two channels, and each channel contains a drug-testing strip that contains the chemistry to detect 1-5 drugs.

Rapid TOX Cup® II. The patented Rapid TOX Cup II is another drug testing cup that detects the presence or absence of 1 to 16 drugs in a urine specimen. The Rapid TOX Cup II also incorporates collection and testing of the urine sample in a single step. Each Rapid TOX Cup II contains multiple channels and each channel contains a single drug-testing strip that contains the chemistry to detect more than one drug. This product is available in two (2) formats; one of which has a smaller cup and testing strips to be more cost competitive.

Private Label Products. We provide a private labeled version of Rapid TOX to an unaffiliated third party for sale globally. In the year ended December 31, ~~2020~~2021 (“Fiscal ~~2020~~2021”), sales of these products were not material.

Products for the Detection of Drugs in Oral Fluid. We manufacture drug tests that detect the presence or absence of drugs in oral fluids. These products are easy to use and provide test results within minutes with enhanced sensitivity and detection. As of the date of this report, our oral fluid drug tests are marketed “for forensic use only” or for “employment use only” as well as in markets outside the United States; (see “Government Regulations” for information on the regulations related to the sale of our drug tests). We currently offer the following oral fluid drug tests:

OralStat® OralStat is a patented and patent pending, innovative drug test for the detection of drugs in oral fluids. Each OralStat simultaneously tests for 6 or 10 drugs in an oral fluid specimen.

Private Label Products. We do provide a private labeled version of our OralStat product to an unaffiliated third party for sale outside of the United States. ~~Sales~~There were no sales of this product ~~were not material~~ in Fiscal ~~2020~~2021.

Other Products. Throughout Fiscal ~~2020~~2021, we distributed a number of other products related to the detection of substances of abuse as well as products to detect certain infectious disease. We do not manufacture these products. WeWith ~~did~~the ~~not~~exception ~~derive~~of Covid-19 test sales in the year ended December 31, 2020 (“Fiscal 2020”) outlined below, sales of these products are not a ~~significant~~material portion of our ~~revenues from~~total ~~the~~net ~~sale~~sales (i.e. they do not total more than 10% of ~~these~~our ~~products~~net sales in ~~Fiscal~~the ~~2020~~fiscal year).

In ~~March~~ ~~2020~~Fiscal 2021, we ~~began~~continued ~~marketing,~~to ~~via~~market avarious ~~non~~Covid-~~exclusive~~19 ~~distribution partnership, a~~ rapid ~~test~~tests tovia ~~detect Covid~~non-19exclusive ~~antibodies~~distribution inrelationships. ~~whole blood,~~Currently ~~serum~~we orare ~~plasma~~offering ~~(the~~a “Covid-19 IgG/IgM Rapid Test ~~Cassette”).~~ ~~The~~to ~~test~~detect isCovid-19 ~~not~~antibodies ~~available for consumer use and is being marketed~~ in ~~full~~whole ~~compliance~~blood, ~~with~~serum anor ~~Emergency~~plasma ~~Use Authorization~~ (~~“EUA”)~~via ~~issued~~a bydistribution ~~the~~agreement USwith ~~Food~~Healgen ~~and~~Scientific, ~~Drug Administration (“FDA”~~LLC) ~~on May 29~~, ~~2020.~~the ~~In October 2020, we announced that we also signed a distribution agreement with~~ Co-Diagnostics, ~~Inc. granting us the right to market and sell their EUA issued~~ Logix Smart Covid-19 ~~tests~~test, ~~(“Logix~~various ~~Smart~~ Covid-19 ~~Test”)~~rapid inantigen ~~the~~tests, ~~United States on~~ a ~~non-exclusive basis. The Logix Smart~~ Covid-19 ~~Test operates using a single step RT~~-~~PCR~~Influenza ~~process~~A/B incombination ~~lower respiratory tract fluid samples such as bronchoalveolar lavage~~test, ~~sputum, tracheal aspirate,~~ and ~~upper respiratory~~in ~~tract~~late ~~fluid~~Fiscal ~~samples~~2021, ~~such~~we asstarted ~~nasopharyngeal~~to ~~and oropharyngeal~~offer ~~swabs.~~an ~~And~~“at ~~finally,~~home” ~~on December 14, 2020, we announced we were distributing a~~ Covid-19 Ag rapid antigen test ~~(“Rapid~~. All of the Covid-19 ~~Antigen~~tests ~~Test~~we ~~Cassette”),~~are ~~an immunochromatographic~~offering ~~assay~~are ~~for~~being ~~the~~marketed ~~qualitative~~in ~~detection~~full ~~of nucleocapsid~~compliance ~~protein~~with ~~antigen~~an ~~from~~Emergency ~~SARS-CoV-2~~Use inAuthorization ~~direct nasopharyngeal~~ (NP“EUA”) ~~swab~~issued ~~from~~by ~~individuals~~the ~~who~~US ~~are~~Food ~~suspected~~and ~~of Covid-19~~Drug byAdministration ~~their~~(“FDA”) ~~healthcare~~and ~~provider.~~in Itcompliance iswith ~~intended~~each tospecific ~~aid~~product’s inEUA ~~the rapid~~issued ~~diagnosis~~by ~~of SARS-CoV-2 infections~~FDA. ~~The~~In ~~test~~Fiscal is2021, ~~CE-marked~~we ~~and can~~sold be$54,000 ~~sold~~in toCovid-19 ~~locations~~testing ~~outside~~products; ~~the~~which ~~United~~was ~~States~~2.4% ~~The~~of ~~Rapid Antigen~~our ~~test~~net issales ~~not~~in ~~for~~Fiscal ~~home use or at-home specimen collection~~2021. ~~The~~ ~~test~~In ~~provides~~the ~~results~~year inended 15December ~~minutes.~~31, In2020 (“Fiscal 2020”), we sold $1,~~567~~572,000 in Covid-19 testing products; which was 37.89% of our net sales in Fiscal 2020.

Our Markets and Distribution Methods

Rehabilitation/Drug Treatment

The Rehabilitation/Drug Treatment market includes people in both inpatient and outpatient treatment for substance abuse. Drug testing is a positive aspect of treatment as it aids in relapse prevention and encourages honesty both within the patient and with outside interactions. In addition, being able to accurately gauge the current drug use by patients enrolled in a substance abuse program is essential so, urine drug testing is an integral part of treatment programs, including physician office-based programs. There is typically a high frequency of testing in this market. We sell our urine drug tests in this market primarily through our direct sales force and also through a number of distributors.

~~Pain~~5 ~~Management~~Table of Contents

~~Drug testing~~Pain in pain management is one of the major tools of adherence monitoring in the assessment of a patient’s predisposition to, and patterns of, misuse/abuse; a vital first step towards establishing and maintaining the safe and effective use of drugs in the treatment of chronic pain. There are many benefits of using an ABMC drug test; these include reducing the risk for toxicity in patients vulnerable to adverse drug effects, detecting patient non-compliance, reducing the risk of therapeutic failure, and avoiding or detecting drug-drug interaction. Additionally, drug testing enhances the physician’s ability to use drugs effectively and minimize costs. We currently sell our urine drug tests in this market primarily through our direct sales force and also through a number of distributors.Management

4Drug testing in pain management is one of the major tools of adherence monitoring in the assessment of a patient’s predisposition to, and patterns of, misuse/abuse; a vital first step towards establishing and maintaining the safe and effective use of drugs in the treatment of chronic pain. There are many benefits of using an ABMC drug test; these include reducing the risk for toxicity in patients vulnerable to adverse drug effects, detecting patient non-compliance, reducing the risk of therapeutic failure, and avoiding or detecting drug-drug interaction. Additionally, drug testing enhances the physician’s ability to use drugs effectively and minimize costs. We currently sell our urine drug tests in this market primarily through our direct sales force and also through a number of distributors.

Other Clinical

Other Clinical markets include emergency rooms/hospitals, family physician offices and laboratories. There are a number of medical emergencies associated with adverse reactions, accidental drug ingestions, and misuse or abuse of prescription drugs and over-the-counter medications. To address this issue, drug testing is performed so healthcare professionals are able to ascertain the drug status of a patient before they administer pharmaceuticals or other treatment. We currently sell our urine drug tests in this market primarily through our direct sales force and also through a number of distributors. We also have a long-term relationship with one of the world’s largest clinical laboratories.

Government (including law enforcement and criminal justice)

The Government market includes federal, state, county and local agencies, including police departments, adult and juvenile correctional facilities, pretrial agencies, probation, drug courts and parole departments at the federal and state levels. A significant number of individuals on parole or probation, or within federal, state, county and local correctional facilities and jails, have one or more conditions to their sentence, including but not limited to, periodic drug-testing and substance abuse treatment. We sell our products in this market through our direct sales force.

Employment/Workplace

The Workplace market consists of pre-employment testing of job applicants, as well as random, cause and post-accident testing of employees. Many employers recognize the financial and safety benefits of implementing drug-free workplace programs, of which drug testing is an integral part. In some states, there are workers’ compensation and unemployment insurance premium reductions, tax deductions and other incentives for adopting these programs. We sell our products in this market through our direct sales force and through a select network of distributors.

International

The International market consists of various markets outside of the United States. Although workplace testing is not as prevalent outside of the United States as within, the international Government and Clinical markets are somewhat in concert with their United States counterparts. One market that is significantly more prevalent outside of the United States is roadside drug testing. We sell in this market through a select network of distributors.

Contract Manufacturing

We provide strip manufacturing and assembly and packaging services to non-affiliated diagnostic companies. In Fiscal ~~2020~~2021, we manufactured a test for the detection of RSV (Respiratory Syncytial Virus; the most common cause of lower respiratory tract infections in children worldwide), a test for Malaria (a disease transmitted to humans through bites from infected mosquitoes) and we manufactured a special custom panel of our Rapid TOX as a private label. Fiscal ~~2020~~2021 contract manufacturing sales ~~did~~were ~~not~~9.44% ~~represent~~of ~~a significant~~our ~~portion~~net ofsales ~~our~~in ~~revenue~~Fiscal 2021.

5Competition

~~Competition~~We compete on the following factors:

Pricing: The pricing structure in our markets is highly competitive. We ~~compete~~ onoffer the ~~following~~only ~~factors:~~drug testing products that contain testing strips that are 100% manufactured in the US and that is 100% assembled in the United States. Price pressure is the greatest when comparing our pricing with pricing of products manufactured outside of the United States.

~~Pricing:~~6 ~~The~~Table pricing structure in our markets is highly competitive. We offer the only drug testing products that contain testing strips that are 100% manufactured in the US and that is 100% assembled in the United States. Price pressure is the greatest when comparing our pricing with pricing of ~~products~~ ~~manufactured outside of the United States.~~Contents

Quality: We manufacture, assemble and package our testing strips and products completely in the United States in accordance with quality system regulations set forth by FDA. Many companies in our industry claim their products are manufactured in the United States when in fact; their products are only assembled or packaged in the Unites States. The testing strips and in most cases the assembly of the product is done outside of the Unites States; usually in China. Products manufactured outside of the United States are generally manufactured outside of the requirements of quality system regulations set forth by FDA. In our opinion, this results in inferior, sub-par products being offered in the market. Most of our markets require accurate detection near the cut-off level of the test. Our products are manufactured to detect drug use closer to the cut-off level of the test. The majority of the drug tests on the market today are less “aggressive”; meaning they are not as sensitive and they will miss positive results. Missing positive results can be extremely troublesome to customers from both an economic and liability perspective; and in the clinical market, missing positives can be a threat to the health of the individuals being tested. We do offer products manufactured outside of the United States via distribution relationships to those customers that do not require accuracy near or at the cutoff level in their drug testing programs.

Customer and technical support: Our customers often need guidance and assistance with certain issues, including but not limited to, test administration, drug cross reactivity and drug metabolism. We provide our customers with continuous customer and technical support on a 24/7/365 basis; staffed by our employees. We believe that this support gives us a competitive advantage since our competitors do not offer this “employee staffed” extended service to their customers.

Raw Materials and Suppliers

The primary raw materials required for the manufacture of our test strips and our drug tests consist of antibodies, antigens and other reagents, plastic molded pieces, membranes and packaging materials. We maintain an inventory of raw materials. Currently, most raw materials are available from several sources. We own the molds and tooling for our plastic components that are custom and proprietary. The ownership of these molds affords us flexibility and control in managing the supply chain for these components. We do not own the molds and tooling for plastic components that are “stock” items.

Major Customers

One of our customers accounted for 3557.25% ~~and 44.8%~~ of net sales in Fiscal ~~2020~~ 2021 and in35.2% ~~the~~of ~~year~~net ~~ended~~sales ~~December~~in ~~31, 2019 (“~~Fiscal ~~2019”)~~, respectively.

Patents and Trademarks/Licenses

As of December 31, ~~2020~~2021, we have 2326 patents issued related to our testing products affording protection in 15 different countries outside the United States and we hold 1110 patents in the United States. As of December 31, ~~2020~~2021, we have 21 foreign patent ~~applications~~application pending. We are incurring fees related to these patent applications that ~~will~~ beare being capitalized over the term of the patents.

As of December 31, ~~2020~~2021, we have 15 trademarks registered in the United States and 10 trademarks registered in countries/regions such as Canada, Mexico, and the United Kingdom.

6Government Regulations

~~Government~~DOA ~~Regulations~~Products

~~DOA~~In ~~Products~~certain markets, the development, testing, manufacture and sale of our drug tests, and possible additional testing products for other substances or conditions, are subject to regulation by the United States and foreign regulatory agencies. Pursuant to the Federal Food, Drug, and Cosmetic Act, and associated regulations, the FDA regulates the pre-clinical and clinical testing, manufacture, labeling, distribution and promotion of medical devices. When a product is a medical device, a 510(k) marketing application must be submitted to the FDA. A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective. Applicants must compare their 510(k) device to one or more similar devices currently being marketed in the United States. Most of our urine-based products are marketed and sold in the Clinical market (in addition to other markets) and therefore, we have obtained 510(k) marketing clearance, CLIA waiver (see below) and/or Over-The-Counter (OTC) marketing clearance on our urine based products. Our oral fluid products are not 510(k) cleared; so we can only market and sell these products to the forensic market, the employment market (under a limited exemption issued by FDA in July 2017) and for export outside the United States.

~~In certain~~7 ~~markets,~~Table ~~the development, testing, manufacture and sale~~ of ~~our~~ drug tests, and possible additional testing products for other substances or conditions, are subject to regulation by the United States and foreign regulatory agencies. Pursuant to the Federal Food, Drug, and Cosmetic Act, and associated regulations, the FDA regulates the pre-clinical and clinical testing, manufacture, labeling, distribution and promotion of medical devices. When a product is a medical device, a 510(k) marketing application must be submitted to the FDA. A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is safe and effective. Applicants must compare their 510(k) device to one or more similar devices currently being marketed in the United States. Most of our urine-based products are marketed and sold in the Clinical market (in addition to other markets) and therefore, we have obtained 510(k) marketing clearance, CLIA waiver (see below) and/or Over-The-Counter (OTC) marketing clearance on our urine based products. Our oral fluid products are not 510(k) cleared; so we can only market and sell these products to the forensic market, the employment market (under a limited exemption issued by FDA in July 2017) and for export outside the United States.Contents

In order to sell our products in Canada, we must comply with ISO 13485:2003, the International Standards Organization’s Directive for Quality Systems for Medical Devices (MDD or Medical Device Directive), and in order to sell our products in the European Union, we must obtain CE marking for our products (in the European Union, a “CE” mark is affixed to the product for easy identification of quality products). Collectively, these standards are similar to FDA regulations, and are a reasonable assurance to the customer that our products are manufactured in a consistent manner to help ensure that quality defect-free goods are produced. As of the date of this report, we have received approval and the right to bear the CE mark on our Rapid Drug Screen, Rapid ONE, Rapid TOX, RDS InCup, Rapid TOX Cup II, Rapid Reader and OralStat. We are currently certified to I.S. EN ISO 13485:2016 with an expiration date of July 31, ~~2021~~2022. ~~We do currently have our products registered to allow sale in Canada.~~ In Fiscal 2020, we decided not to renew our product licenses in Canada due to significant increased costs of licensing compared to the negligible sales we had in Canada.

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 established quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. As a result, those using CLIA waived tests are not subject to the more stringent and expensive requirements of moderate or high complexity laboratories. We have received CLIA waiver from the FDA related to our Rapid TOX product line and OTC clearance on our Rapid TOX Cup II product line (the OTC clearance of the Rapid TOX Cup II product line means they are CLIA waived products).

Due to the nature of the manufacturing of our drug tests, the products we offer through contract manufacturing and the raw materials used for both, we do not incur any material costs associated with compliance with environmental laws, nor do we experience any material effects of compliance with environmental laws.

Covid-19 Testing Products

Covid-19 related testing products are (as of the date of this report), being marketed and sold in the United States under the March 2020 Emergency Use Authorization (“EUA”) policy set forth by the FDA. An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including testing devices, during public health emergencies, such as the current COVID-19 pandemic. In order for a product to be marketed under the EUA policy, a number of requirements must be met. ~~Under~~All ~~the policy, commercial manufacturers can develop and distribute Covid-19 test kits after validation~~ of the test and before EUA submission. The anticipated timeframe for commercial manufacturers to prepare and submit an EUA is fifteen (15) business days after notification of completion of validation. FDA expects validation data to be provided for review informally by email at the time of notification. FDA also expects the manufacturer to make the instructions for use and the performance characteristics available on the manufacturer’s website while it awaits EUA determination from FDA. Any clinical testing completed during the review period should include a statement that the test is validated but that the FDA’s review is pending. The Covid-19 ~~IgG/IgM~~tests ~~Rapid Test Cassette~~ we ~~began~~ ~~distributing~~are inoffering ~~March~~are ~~2020 detects Covid-19 antibodies in whole blood, serum or plasma. The test is not available for consumer use and is~~ being marketed in full compliance with ~~FDA~~the EUA~~. The~~ ~~Logix~~issued ~~Smart~~by ~~Covid-19~~the ~~Test~~FDA weand ~~began distributing~~ in ~~October 2020 is also being marketed in full~~ compliance with ~~FDA~~each ~~EUA.~~specific ~~The~~product’s ~~Rapid Covid-19~~EUA ~~Antigen~~issued ~~Test~~by ~~Cassette we began distributing in December 2020 is currently being marketed to only locations outside the United States~~FDA. In order to sell Covid-19 tests to locations within Europe, the products must be CE marked. All ~~three~~ of the Covid-19 testing products referenced herein bear CE marking.

7Manufacturing and Employees

~~Manufacturing~~Our facility in Kinderhook, New York houses assembly and ~~Employees~~packaging of the products we manufacture (including the products we supply on a contract manufacturing basis and the products we supply to a third party who markets the products under their own private label). Our warehouse, shipping department and administrative offices are also within our New York facility.

~~Our facility~~In inour ~~Kinderhook~~Logan Township, New ~~York~~Jersey ~~houses~~facility, ~~assembly and packaging of the products~~ we manufacture ~~(including~~our ~~the~~drug ~~products~~test westrips ~~supply on a contract manufacturing basis~~ and ~~the~~test ~~products~~strips wefor ~~supply~~unaffiliated ~~to a~~ third ~~party~~ ~~who markets the products under their own private label)~~parties. ~~Our warehouse,~~We ~~shipping~~also ~~department~~perform research and ~~administrative~~development ~~offices~~in ~~are also within~~ our New ~~York~~Jersey facility.

InUnaffiliated ~~our Logan~~third ~~Township,~~parties ~~New~~manufacture ~~Jersey~~the ~~facility~~adulteration, wealcohol ~~manufacture~~and ~~our~~certain forensic drug ~~test strips~~testing ~~and~~products ~~test~~we ~~strips~~offer ~~for~~as ~~unaffiliated~~well ~~third~~as ~~parties~~the Covid-19 testing products we distribute. We ~~also perform~~continue ~~research~~to ~~and~~primarily ~~development~~outsource the printing of the plastic components used in our ~~New~~products, ~~Jersey facility~~and we outsource the manufacture of the plastic components used in our products.

~~Unaffiliated~~As ~~third parties~~of ~~manufacture~~December ~~the~~31, ~~adulteration~~2021, ~~alcohol~~we ~~and~~had ~~certain~~37 ~~forensic drug~~employees, ~~testing~~of ~~products~~which we32 ~~offer~~were asfull-time ~~well~~and as5 ~~the~~were ~~Covid~~part-~~19 testing products we distribute~~time. WeNone ~~continue to primarily outsource the printing~~ of ~~the plastic components used in~~ our ~~products,~~employees ~~and~~are ~~we outsource~~covered ~~the~~by ~~manufacture~~collective ofbargaining ~~the plastic components used in our products~~agreements.

As8 ~~of December~~Table ~~31, 2020, we had 42 employees,~~ of ~~which 39 were full-time and 3 were part-time. None of our employees are covered by collective bargaining agreements.~~Contents

ITEM 1A. RISK FACTORS

Before you make a decision to invest in our securities, you should consider carefully the risks described below, together with other information within this Annual Report on Form 10-K and other periodic reports filed with the US Securities and Exchange Commission (“SEC”). If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. The risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also significantly impair our business operations and could result in a complete loss of your investment.

Risks Related to our Financial Condition

We have a history of incurring net losses. As of December 31, ~~2020~~2021, we have a ~~negative~~ stockholders’ ~~equity~~deficit.

Since our inception and throughout most of our history, we have incurred net losses, including but not limited to, a net loss of $~~796~~463,000 incurred in Fiscal ~~2020~~2021. As of December 31, ~~2020~~2021, we also reported negative stockholders’ equity of $1944,~~256,~~000. We incur substantial expenditures for sales and marketing, general and administrative and research and development purposes. Our ability to achieve profitability in the future will primarily depend on our ability to increase sales of our products. Stockholders’ equity improvement will also be dependent on our ability to increase sales which will increase the value of our assets and decrease our liabilities. Future profitability is also dependent on our ability to reduce manufacturing costs and successfully introduce new products or new versions of our existing products into the marketplace. There can be no assurance that we will be able to increase our revenues at a rate that equals or exceeds expenditures. Our failure to increase sales while controlling sales and marketing, general and administrative, and research and development costs (relative to sales) would result in additional losses.

Our inability to comply with our debt obligations could result in our creditors declaring all amounts owed to them due and payable with immediate effect, or result in the collection of collateral by the creditor, both of which would have an adverse material impact on our business and our ability to continue operations.

We have a credit facility with Crestmark Bank consisting of a revolving line of credit (the “Crestmark LOC”). The Crestmark LOC is secured by a first security interest in all of our receivables and inventory and security interest in all other assets of the Company (in accordance with permitted prior encumbrances), (together the “Collateral”). On June 22, 2020, we extended the Crestmark LOC and as a result of this extension, a Tangible Net Worth (“TNW”) covenant was removed effective with the quarter ending June 30, 2020. With the exception of the quarter ended June 30, 2019; we had not been in compliance with prior TNW covenants since December 31, 2017.

In addition to the Crestmark LOC, we have a loan and security agreement with Cherokee Financial, LLC. (“Cherokee”) which is secured by a first security interest in our real estate and machinery and equipment. InWe ~~addition~~also tohave ~~general~~an ~~economic, financial,~~unsecured ~~competitive,~~term ~~regulatory,~~loan ~~business~~with ~~and other factors beyond our control, our ability to make payments to~~ Cherokee ~~Financial,~~. ~~LLC~~We ~~will~~also ~~depend~~have ~~primarily~~a ~~upon~~number ~~our future operating performance; which has been negatively impacted by the loss~~ of ~~material~~ ~~contracts~~smaller ~~and~~loans ~~the increased price competition in our core markets for drug testing. In February 2021, we extended our loan facilities~~ with ~~Cherokee~~individuals.

8In addition to general economic, financial, competitive, regulatory, business and other factors beyond our control, our ability to make payments to our creditors will depend primarily upon our future operating performance; which has been negatively impacted by the loss of material contracts, the increased price competition in our core markets for drug testing and the continued negative impact of the Covid-19 pandemic on our drug testing markets.

A failure to repay any of our debt obligations could result in an event of default, which, if not cured or waived, could result in the Company being required to pay much higher costs associated with the indebtedness and/or enable our creditors to declare all amounts owed to them due and payable with immediate effect. IfIn wefact, ~~are forced~~in toFebruary ~~refinance~~2021, ~~our~~with ~~debt~~the onextension ~~less favorable terms, our results~~ of ~~operations~~the ~~and~~loans ~~financial~~until ~~condition~~February ~~could~~2022, beCherokee ~~adversely~~imposed ~~affected by~~penalties ~~increased~~in ~~costs~~the ~~and~~amount ~~rates.~~of We$120,000 ~~may~~in ~~also~~response beto ~~forced~~our inability to ~~pursue~~pay ~~one or~~back ~~more~~our ~~alternative~~facilities ~~strategies,~~along ~~such~~with asincreasing ~~restructuring,~~the ~~selling assets,~~interest ~~reducing~~rate oron ~~delaying~~our ~~capital~~larger ~~expenditures~~facility orfrom ~~seeking additional~~8% ~~equity~~to ~~capital~~10%. ~~There~~In ~~can~~February be2022, nowe ~~assurances~~did ~~that~~not ~~any~~repay ~~of these~~the ~~strategies~~Cherokee ~~could~~loans. beAs ~~implemented~~of onthe ~~satisfactory~~date ~~terms,~~of ifthis ~~at all~~report, orwe ~~that~~are ~~future~~currently ~~borrowings~~in ordiscussions ~~equity~~with ~~financing~~Cherokee ~~would~~related ~~be available~~to ~~for~~this ~~the~~ non-payment ofwhich ~~any~~include, ~~indebtedness~~but weare ~~may~~not ~~have.~~limited ~~In addition~~to, inpossible anpayoff ~~event~~ of ~~default, our creditors could begin proceedings to collect~~ the ~~collateral~~loans ~~securing~~(via ~~the debt. This would have~~ a ~~material~~refinance) ~~adverse~~or ~~effect~~further onextension ~~our~~of ~~ability~~the ~~to continue operations~~loans.

If we are forced to refinance our debt on less favorable terms, our results of operations and financial condition would be further adversely affected by increased costs and rates. We may ~~need~~also be forced to pursue one or more alternative strategies, such as restructuring, selling assets, reducing or delaying capital expenditures or seeking additional ~~funding~~equity capital. There can be no assurances that any of these strategies could be implemented on satisfactory terms, if at all, or that future borrowings or equity financing would be available for the payment of any indebtedness we may have. In addition, in an event of default, our ~~existing~~creditors ~~and~~could ~~future~~ begin proceedings to collect the collateral securing the debt. This would have a material adverse effect on our ability to continue operations.

~~Our financial~~9 ~~statements~~Table for Fiscal 2020 were prepared assuming we will continue as a going concern. If sales do not improve, our current cash balances and cash generated from future operations may not be sufficient to fund operations through April 2022. Future events, including the expenses and difficulties which may be encountered in maintaining a market for our products could make cash on hand and cash available under our line of credit facility insufficient to fund operations. If this happens, we may be required to sell equity or debt securities or obtain additional credit facilities. There can be no assurance that any of these financings will be available or that we will be able to complete such financing on satisfactory terms.Contents

~~It is~~We ~~still~~may ~~uncertain~~need ~~what~~additional ~~the~~funding ~~impact~~for ~~of the Covid-19 pandemic could have on~~ our ~~company~~existing and ~~the~~future ~~degree to which the pandemic will adversely affect our business, revenues, financial condition and results of~~ operations ~~if it continues for a significant period of time~~.

~~In December~~Our ~~2019,~~financial anstatements ~~outbreak~~for ofFiscal a2021 ~~novel~~were ~~strain~~prepared ofassuming ~~coronavirus (Covid-19)~~we ~~spread~~will ~~globally~~continue as a going concern. InIf ~~March~~sales ~~2020,~~continue ~~the~~to ~~World~~decline, ~~Health Organization~~our ~~declared~~current ~~Covid-19~~cash tobalances beand acash ~~pandemic.~~generated Tofrom ~~date,~~future ~~this global~~operations ~~pandemic~~may ~~has~~not ~~severely~~be ~~impacted~~sufficient ~~levels~~to offund ~~economic~~operations ~~activity around~~through ~~the~~April ~~world~~2023. In ~~response~~addition, toin ~~this~~February ~~pandemic~~2022, ~~governments~~we ~~and public~~were ~~health~~not ~~officials~~able ofto ~~many~~repay ~~countries,~~certain ~~states,~~loans ~~cities~~when ~~and~~they ~~other geographic~~were ~~regions~~due ~~have~~and ~~taken~~we ~~preventative~~are orcurrently ~~protective~~in ~~actions~~discussions ~~to mitigate~~with the ~~spread~~lender ~~and~~related ~~severity~~to ofpossible ~~Covid-19,~~payoff ~~such~~(via asa ~~imposing restrictions~~refinance) onof ~~travel~~the ~~and~~loans ~~business~~or ~~operations~~to ~~and~~extend ~~advising~~the ~~or requiring~~due ~~individuals~~date toof ~~limit~~the orloans. ~~forego~~Future ~~their~~events, ~~time~~including ~~outside~~the ~~of their~~expenses ~~homes~~and bydifficulties ~~imposing~~which ~~shelter-~~may be encountered in~~-place~~ ~~orders.~~maintaining ~~The~~a ~~primary markets~~market for our ~~DOA~~ products ~~were~~could ~~all~~make ~~negatively~~cash ~~impacted~~on byhand ~~the Covid-19~~and ~~pandemic~~cash inavailable ~~Fiscal~~under ~~2020~~our ~~and~~line of credit facility insufficient to fund operations. If this ~~negative~~happens, ~~impact~~we ~~continues in~~may ~~the~~be ~~early~~required ~~part~~to ofsell ~~the~~equity ~~year~~or ~~ending~~debt ~~December~~securities ~~31,~~or ~~2021~~obtain ~~although~~additional ~~the negative~~credit ~~impact~~facilities. ~~does~~There ~~appear~~can tobe ~~have~~no ~~diminished~~assurance asthat ~~areas~~any of ~~the economy~~these ~~open~~financings ~~up.~~will ~~This~~be ~~decline~~available inor ~~DOA~~that ~~sales~~we ~~was~~will ~~offset~~be byable ~~sales~~to ~~of Covid-19~~complete ~~tests~~such infinancing ~~Fiscal~~on ~~2020~~satisfactory terms.

~~We cannot~~The ~~presently~~Covid-19 ~~predict the final scope and ultimate severity or duration of the coronavirus~~ pandemic ~~and~~has ~~any~~had ~~possible~~a ~~related disruptions~~negative toimpact ~~our~~on ~~business, but the coronavirus pandemic and the resulting economic and commercial shutdowns to date have negatively impacted~~ our ~~ability~~drug totesting ~~conduct~~markets ~~business in accordance with our plans. Disruptions to our business include restrictions on the ability of our sales~~ and ~~marketing personnel to travel, some disruptions of~~ our ~~global~~company ~~supply chain, and reduced demand and/or suspension of~~ operations; ~~by our customers. We cannot predict~~ the degree to, ~~or the time period over,~~ which ~~our business will be affected by~~ the ~~Covid-19~~ pandemic. ~~There are still numerous uncertainties associated with this outbreak, including the number of individuals who~~ will ~~become~~continue ~~infected,~~to ~~whether~~adversely ~~the~~affect ~~vaccines recently~~our ~~introduced will significantly mitigate the effect of the virus~~business, ~~the extent of the protective and preventative measures that have been put in place by both governmental entities and other businesses and those that may be put in place in the future~~revenues, ~~whether~~ ~~the~~financial ~~coronavirus’~~condition ~~impact will be seasonal~~ and ~~the further~~results ~~impact on the U.S. and world economy, and various other uncertainties. Further, even after containment~~ of ~~the~~operations ~~virus~~is ~~any significant~~still ~~reduction in employee willingness to return to work would result in a reduction of manufacturing capacity~~uncertain.

~~We expect~~In ~~Covid-19~~March ~~will~~2020, ~~continue~~the toWorld ~~negatively~~Health ~~affect~~Organization ~~customer~~declared ~~demand of~~Covid-19 ~~our~~to ~~DOA~~be ~~products~~a inpandemic ~~Fiscal~~(“the ~~2021~~Pandemic”). orTo atdate, ~~least~~the ~~part~~Pandemic ofhas ~~Fiscal~~severely ~~2021, and~~impacted ~~the~~levels ~~duration~~ of ~~this~~economic ~~negative~~activity ~~impact~~around isthe ~~uncertain~~world. WeIn doresponse ~~not yet~~to ~~know~~this ~~the~~Pandemic, ~~full~~governments ~~extent~~and ofpublic ~~the~~health ~~negative~~officials ~~impact~~ of ~~Covid-19~~many oncountries, ~~our DOA business~~states, ~~financial~~cities ~~condition~~ and ~~results~~other ofgeographic ~~operations.~~regions ~~The extent~~have taken preventative or protective actions to ~~which~~mitigate the spread and severity of Covid-19. ~~pandemic~~The ~~may~~primary ~~impact~~markets for our ~~business, operating~~DOA ~~results,~~products ~~financial~~were ~~condition,~~all ornegatively ~~liquidity~~impacted inby the ~~future will~~Pandemic ~~depend~~in onFiscal ~~future~~2021 ~~developments~~and ~~which~~this ~~are~~negative ~~evolving~~impact ~~and~~continues ~~highly uncertain~~in ~~including~~ the ~~duration~~early part of the ~~outbreak,~~year ~~travel restrictions,~~ending ~~business~~December ~~and workforce disruptions~~31, ~~the~~2022. ~~timing~~Declines ~~of reopening~~in ~~the~~DOA ~~economic~~sales ~~regions~~were inonly ~~which~~nominally weoffset ~~and~~by our ~~customers~~distribution ~~do business~~sales ~~and the effectiveness~~ of ~~actions~~Covid-19 ~~taken~~tests toin ~~contain~~Fiscal ~~and treat~~2021 ~~the~~(unlike ~~disease.~~Fiscal In2020 ~~addition,~~when ~~resurgence in the number of cases of~~ Covid-19 ~~could~~test ~~further~~sales ~~negatively~~significantly ~~impact~~contributed to our ~~business~~ revenues).

~~While we~~In ~~expect the marketing of Covid-19 test products to positively impact our revenues in~~ Fiscal 2021, we doexperienced ~~not~~supply ~~yet~~chain ~~know~~issues ~~the~~as ~~full extent~~a result of the ~~positive~~Pandemic; ~~impact~~particularly ofwith ~~Covid-19~~plastics ~~test~~and ~~sales~~other onmaterials ~~our business,~~that ~~our~~are ~~financial~~used ~~condition~~to ~~and~~manufacture ~~results~~our ofdug ~~operations.~~tests ~~The extent~~that toare ~~which~~also ~~sales~~used ofin the manufacture of lateral flow Covid-19 ~~test~~tests. ~~may~~The ~~impact~~lead ~~our~~times ~~business, operating~~for ~~results,~~materials ~~financial~~increased ~~condition,~~significantly orand ~~liquidity~~ in ~~the~~most ~~future will~~cases ~~depend~~without onnotice. ~~future~~This ~~developments~~impairs ~~which~~our ~~are~~ability ~~evolving~~to ~~and~~deliver ~~highly uncertain~~product ~~including~~to ~~the~~our ~~duration~~customers ofwithin the ~~outbreak~~time ~~and~~frame ~~the~~required ~~need~~and ~~for antibody~~can ~~testing~~result in ~~the~~loss ~~future~~of business.

9We cannot presently predict the final scope and ultimate severity or duration of the Pandemic and any possible continued disruptions to our business, but the Pandemic and the resulting economic and commercial shutdowns to date have negatively impacted our ability to conduct business in accordance with our plans. Disruptions to our business include, but are not limited to, disruptions in our supply chain and reduced demand and/or suspension of operations by our customers. We cannot predict the degree to, or the time period over, which our business will continue to be negatively impacted by the Pandemic as the impact will depend on future developments which are evolving and highly uncertain. The extent to which distribution sales of Covid-19 tests may impact our business, operating results, financial condition, or liquidity in the future will depend on future developments which are also evolving and highly uncertain.

~~Our inability~~One toof ~~meet~~ our ~~operating~~customers ~~plans~~accounted ~~could~~for ~~have~~more athan ~~material~~50% ~~adverse effect~~of on our ~~future~~total ~~performance~~net sales in Fiscal 2021.

~~If events~~One ~~and~~of ~~circumstances~~our ~~occur~~customers ~~such~~accounted ~~that~~for we57.5% doand ~~not~~35.2% ~~meet~~of our ~~current operating~~net ~~plans,~~sales ifin weFiscal ~~are~~2021 ~~unable~~and toFiscal ~~raise~~2020, ~~sufficient~~respectively. ~~additional equity~~We orcurrently ~~debt~~have ~~financing~~a orcontract ~~our~~in ~~credit~~place ~~facilities~~with ~~are~~this ~~insufficient or~~long-standing customer that does not ~~available~~expire in the near future. However, wethere ~~may~~can be ~~required~~no toassurance ~~further~~that ~~reduce~~this ~~expenses~~customer, or ~~take~~ ~~other~~any ~~steps~~of ~~which~~our ~~could~~current ~~have~~customers awill ~~material~~continue ~~adverse~~to ~~effect~~place onorders, ~~our future~~or ~~performance~~that orders by existing customers will continue at current or historical levels.

~~One of our customers accounted for more than~~ 10% Table of ~~our total net sales in Fiscal 2020.~~Contents

~~One~~Our ~~of our~~ability ~~customers~~to ~~accounted~~request ~~for~~purchases ~~35.2%~~of ~~and~~shares ~~44.8%~~ of our ~~net~~common ~~sales~~stock ~~in Fiscal~~under ~~2020~~our ~~and~~equity ~~Fiscal~~line ~~2019,~~of ~~respectively.~~credit Wewith ~~currently~~Lincoln ~~have~~Park ~~a contract~~Capital inFund, ~~place~~LLC ~~with~~(“Lincoln ~~this~~Park”) ~~long-standing~~is ~~customer~~dependent ~~that~~on ~~does not expire in~~ the ~~near~~market ~~future.~~value ~~However,~~of ~~there~~our ~~can~~securities; beand nomanagement ~~assurance~~has ~~that this~~broad ~~customer,~~discretion orover ~~any~~the use of ~~our~~the ~~current~~net ~~customers~~proceeds ~~will~~from ~~continue~~sales ~~to place~~of ~~orders,~~shares orof ~~that~~common ~~orders~~stock byto ~~existing~~Lincoln ~~customers will continue at current or historical levels~~Park.

~~Our management~~On ~~will~~December ~~have~~9, ~~broad~~2020, ~~discretion~~we ~~over~~entered ~~the~~into ~~use~~a Purchase Agreement and a Registration Rights Agreement with Lincoln Park under which Lincoln Park agreed to purchase up to $10,250,000 of shares of our common stock subject to certain limitations set forth in the ~~net proceeds~~Purchase ~~from~~Agreement, ~~our~~over ~~sale~~a two year period. In Fiscal 2021, we sold 500,000 shares of common stock that represented the balance of the Initial Purchase and 6,000,000 shares of common stock to Lincoln Park as Regular Purchases; raising $639, ~~and~~000 ~~shareholders~~in ~~may~~Fiscal ~~not~~2021. ~~agree~~However, ~~with~~one ~~how~~of wethe ~~use~~limitations under the ~~proceeds~~Lincoln ~~and~~Park equity line of credit is that we cannot request a purchase of shares of common stock if the ~~proceeds~~ ~~may~~closing sale price of our common shares does not exceed $0.05. Our last purchase under the Lincoln Park equity line of credit was on October 1, 2021 as our ability to request purchases has been limited by the value of our securities. There can be ~~invested~~no ~~successfully~~assurance that we will be able to request any further purchases from Lincoln Park for this reason along with the fact that a new registration statement would need to be filed to register additional shares of common stock.

~~Our management~~Management ~~will~~has ~~have~~ broad discretion as to the use of the net proceeds from our sale of shares of common stock to Lincoln Park (see Risk Factor “The sale or issuance of our common stock to Lincoln Park may cause dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause the price of our common stock to fall” for more detail on Lincoln Park). Accordingly, shareholders are relying on the judgment of ~~ABMC~~ management with regard to the use of those net proceeds, and shareholders will not have the opportunity to assess whether the proceeds are being used appropriately. ~~It is possible that, pending their use, the Company may invest net proceeds in a way that does not yield a favorable, or any, return for ABMC.~~ The failure of ~~ABMC~~ management to use ~~such~~ funds effectively could have a material adverse effect on our business, financial condition, operating results and cash flows.

Risks Related to our Operations

We depend on one individual to manage our business effectively.

We are dependent on the expertise and experience of one individual ~~for~~to manage all aspects of our ~~future~~ ~~success~~business, the loss of whom could negatively impact our business and results of operations. Melissa A. Waterhouse serves as our sole executive officer. She serves as our Chief Executive Officer, President and ~~principal~~Principal ~~financial~~Financial ~~officer~~Officer. We have an employment agreement in place with Ms. Waterhouse, but there can be no assurance that Ms. Waterhouse will continue her employment. The loss of Ms. Waterhouse could disrupt the business and have a negative impact on business results. We also have a limited number of ~~other~~ individuals in senior management positions. There can be no assurance that they too will continue their employment. We do not currently maintain key man insurance on Ms. Waterhouse.

We rely on third parties for raw materials used in our drug test products and in our bulk test strip contract manufacturing processes as well as for supply of products we sell via distribution arrangements.

We currently have approximately 3744 suppliers that provide us with the materials necessary to manufacture our drug-testing strips, our drug test kits and the products we supply third parties on a contract manufacturing basis as well as the products we sell to our customers via distribution arrangements. For most of our raw materials, we have multiple suppliers, but there are a few raw materials for which we only have one supplier. The loss of one or more of these suppliers, the non-performance of one or more of their materials or the lack of availability of raw materials could suspend our manufacturing process for one or more product lines. This interruption of the manufacturing process could impair our ability to fill customers’ orders as they are placed, putting us at a competitive disadvantage. The inability to secure supplies of products that we sell via distribution would also prohibit us from supplying our customers and put us at a competitive disadvantage.

10We have a significant amount of raw material and “work in process” inventory on hand that may not be used in the year ending December 31, 2022 if the expected configuration of sales orders is not received at projected levels.

We ~~have~~ ahad ~~significant~~approximately ~~amount~~$461,000 in raw material components for the manufacture of our products at December 31, 2021. The non-chemical raw material components may be retained and used in production indefinitely and the chemical raw materials components have lives in excess of 20 years. In addition to the raw material inventory, we had approximately $109,000 in “work in process” (manufactured testing strips) inventory onat ~~hand~~December ~~that~~31, ~~may~~2021. The components for much of this “work in process” inventory have lives of 12-36 months. If sales orders received are not for products that would utilize the raw material components, or if product developments make the raw materials obsolete, we may be ~~used~~required to dispose of these unused raw materials. In addition, since the components for much of the “work in process” inventory have lives of 12-36 months, if sales orders within the ~~year ended~~next 12-36 months are not for products that contain the components of the “work in process” inventory, we may need to discard this expired “work in process” inventory. We have established an allowance for obsolete or slow moving inventory. At December 31, 2021, ifthis allowance was $278,000. There can be no assurance that this allowance will continue to be adequate for the ~~expected~~year ~~configuration~~ending ofDecember ~~sales orders~~31, is2022 or that it will not ~~received~~have atto ~~projected~~be ~~levels~~adjusted in the future.

We11 ~~had approximately~~Table ~~$534,000 in raw material components for the manufacture~~ of our products at December 31, 2020. The non-chemical raw material components may be retained and used in production indefinitely and the chemical raw materials components have lives in excess of 20 years. In addition to the raw material inventory, we had approximately $127,000 in “work in process” (manufactured testing strips) inventory at December 31, 2020. The components for much of this “work in process” inventory have lives of 12-36 months. If sales orders received are not for products that would utilize the raw material components, or if product developments make the raw materials obsolete, we may be required to dispose of these unused raw materials. In addition, since the components for much of the “work in process” inventory have lives of 12-36 months, if sales orders within the next 12-36 months are not for products that contain the components of the “work in process” inventory, we may need to discard this expired “work in process” inventory. We have established an allowance for obsolete or slow moving inventory. At December 31, 2020, this allowance was $279,000. There can be no assurance that this allowance will continue to be adequate for the year ending December 31, 2021 or that it will not have to be adjusted in the future.Contents

We may not be able to hire and retain qualified personnel in several important areas which could negatively impact our growth strategy.

We need skilled sales and marketing, technical and production personnel to maintain and/or grow our business. If we fail to retain our present staff or hire additional qualified personnel our business could suffer, specifically in the case of sales personnel. Recently, we have found it to be increasingly difficult to locate and hire individuals that have the experience required to sell toxicology and diagnostic products. An inability to find qualified sales representatives would negatively impact our ability to maintain and/or grow sales.

We incur costs as a result of operating as a public company, and our management ~~will~~is be required to devote substantial time to compliance initiatives.

We incur legal, accounting and other expenses as a result of our required compliance with certain regulations implemented by the SEC. Our executive management and other personnel devote a substantial amount of time to these compliance requirements, including but not limited to compliance with the Sarbanes-Oxley Act of 2002 that requires, among other things, that we maintain effective internal controls over financial reporting and disclosure controls and procedures. Our management is required to perform system and process evaluation and testing of the effectiveness of our internal controls over financial reporting, as required by Section 404(a) of the Sarbanes-Oxley Act (as a smaller reporting company, we are exempt from the requirements of Section 404(b) of the Sarbanes-Oxley Act requiring auditor’s attestation related to internal controls over financial reporting). If we are not able to comply with the requirements of Section 404(a), if we identify deficiencies in our internal controls over financial reporting, or if we are unable to comply with any other SEC regulations or requirements, the market price of our common stock could decline, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

Risks Related to Selling and Marketing

The drug testing market is highly competitive and we may not be able to compete successfully against lower cost producers.

The market for drug tests used at the point of collection is highly competitive. Several companies produce drug tests that compete directly with our drug test products and they produce their products outside the United State at a significantly +lower cost. Some of our competitors have greater financial resources, allowing them to devote substantially more resources to business and product development and marketing efforts. Our inability to successfully address any competitive risk factors could negatively impact sales and our ability to achieve profitability.

11Any adverse changes in our regulatory framework could negatively impact our business, and costs to obtain regulatory clearance are material.

~~Any adverse~~Although we are unaware of any recent or upcoming changes in regulatory standards related to the marketing of our drug tests, changes in regulatory ~~framework~~requirements could negatively impact our business if we are unable to comply with the changes. Typically, ~~and~~the ~~costs~~cost to ~~obtain~~comply with regulatory changes is significant, especially if additional applications for marketing clearance from FDA are required. The cost of filing a 510(k) marketing clearance is material and can have a negative impact on efforts to improve our financial performance. If regulatory standards change in the future, there can be no assurance that we will receive marketing clearances from FDA, if and when we apply for them.

~~Although~~12 weTable ~~are unaware~~ of any recent or upcoming changes in regulatory standards related to the marketing of our drug tests, changes in regulatory requirements could negatively impact our business if we are unable to comply with the changes. Typically, the cost to comply with regulatory changes is significant, especially if additional applications for marketing clearance from FDA are required. The cost of filing a 510(k) marketing clearance is material and can have a negative impact on efforts to improve our financial performance. If regulatory standards change in the future, there can be no assurance that we will receive marketing clearances from FDA, if and when we apply for them.Contents

We are marketing the Covid-19 tests we ~~distribute~~are distributing under the FDA EUA policy. ~~The~~and ~~Covid-19~~each ~~IgG/IgM~~product’s ~~Rapid~~individual ~~Test~~EUA ~~Cassette we are marketing was~~ issued ~~EUA~~by ~~on May 29, 2020~~FDA. ~~The~~Revocation ~~revocation~~ of ~~the~~individual product’s EUA could negatively impact our business and stop ~~any future~~ sales of the Covid-19 ~~antibody tests~~test(s). In addition, when/if the EUA policy is revoked by FDA (due to a downturn in the pandemic), the Covid-19 tests we are marketing would no longer be able to be sold in the United States since ~~they~~none of the tests we are ~~not~~distributing are 510(k) cleared.

We rely on intellectual property rights and contractual non-disclosure obligations to protect our proprietary information (including customer information). These rights and obligations may not adequately protect our proprietary information, and an inability to protect our proprietary information can harm our business.

We rely on confidentiality procedures and contractual provisions to protect our confidential and proprietary information. Confidential and proprietary information (such as components and product costing, customer pricing structures, customer information, vendor information, internal financial information, production processes, new product developments, product enhancements and other material, non-public information) is protected under non-disclosure agreements with our personnel and consultants. If these individuals do not comply with their obligations under these agreements, we may be required to incur significant costs to protect our confidential information and the use of this information by the breaching individual may cause harm to our business. In fact, until the latter part of Fiscal 2019, we were engaged in litigation with Todd Bailey (“Bailey”), a former Vice President, Sales & Marketing/Consultant of the Company. The complaint that we filed against Bailey was related to allegations that Bailey used our confidential and proprietary information to circumvent and interfere with long-standing ABMC customers. This interference resulted in contracts being awarded to Bailey’s company, Premier Biotech Inc., thereby causing harm to our business. We incurred ~~increased~~significant legal fees ~~in Fiscal 2019~~ as a result of this litigation and ultimately, the litigation was settled ~~in August 2019~~. The terms of the settlement remain confidential.

We also rely on a combination of patent, copyright, trademark and trade secret laws. Despite our efforts to protect our intellectual property rights, unauthorized parties may attempt to copy aspects of our products, dilute our trademarks, or otherwise infringe upon our rights. We may be required to incur significant costs to protect our intellectual property right under laws of the United States Patent and Trademark Office. In addition, the laws of some foreign countries do not ensure that our means of protecting our proprietary rights in the United States or abroad will be adequate. Policing and enforcement against the unauthorized use of our intellectual property and other confidential proprietary information could entail significant expenses and could prove difficult or impossible. Such significant expenditures could have a material adverse effect on our results of operations.

Risks Related to our Securities

~~The potential~~Potential issuance and exercise of new options and warrants and exercise of outstanding options could adversely affect the value of our securities.

We currently have 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. The shares of common stock underlying the exercise of the stock options under the 2001 Plan have been registered with the SEC making them freely tradeable when/if exercised by the holder; however, the shares underlying the exercise of the stock options under the 2013 Plan have not been registered with the SEC.

Both the 2001 Plan and the 2013 Plan have options available for future issuance. As of December 31, ~~2020~~2021, there were 1,~~987~~937,000 options issued and outstanding under the 2001 Plan. There were no options issued under the 2013 Plan, making the total issued and outstanding options 1,~~987~~937,000 as of December 31, ~~2020~~2021. Of the total options issued and outstanding, 1,~~987~~937,000 are fully vested as of December 31, ~~2020~~2021. As of December 31, ~~2020~~2021, there were 1,~~730~~780,000 options available for issuance under the 2001 Plan and 4,000,000 options available for issuance under the 2013 Plan. As of December 31, ~~2020~~ 2021, we had 0 warrants issued and outstanding.

1213 Table of Contents

If outstanding stock options are exercised, the common stock issued will be freely tradable, increasing the total number of shares of common stock issued and outstanding. If these shares are offered for sale in the public market, the sales could adversely affect the prevailing market price by lowering the bid price of our securities. The exercise of these stock options could also materially impair our ability to raise capital through the future sale of equity securities because issuance of the shares of common stock underlying the stock options would cause further dilution of our securities. In addition, in the event of any change in the outstanding shares of our common stock by reason of any recapitalization, stock split, reverse stock split, stock dividend, reorganization consolidation, combination or exchange of shares, merger or any other changes in our corporate or capital structure or our common stock, the number and class of shares covered by the stock options and/or the exercise price of the stock options may be adjusted as set forth in their plans.

Substantial resales of restricted securities may depress the market price of our securities.

There are 56,~~559~~135,~~306~~986 shares of common stock presently issued and outstanding as of the date of this ~~prospectus~~Annual Report on Form 10-K that are “restricted securities” as that term is defined under the Securities Act of 1933, as amended, (the “Securities Act”). These securities may be sold in compliance with Rule 144 of the Securities Act (“Rule 144”), or pursuant to a registration statement filed under the Securities Act. Rule 144 addresses sales of restricted securities by affiliates and non-affiliates of an issuer. An “affiliate” is a person, such as an officer, director or large shareholder, in a relationship of control with the issuer. “Control” means the power to direct the management and policies of the company in question, whether through the ownership of voting securities, by contract, or otherwise. If someone buys securities from a controlling person or an affiliate, they take restricted securities, even if they were not restricted in the affiliate's hands.

A person who is not an affiliate of the issuer (and who has not been for at least three months) and has held the restricted securities for at least one year can sell the securities without regard to restrictions. If the non-affiliate had held the securities for at least six months but less than one year, the securities may be sold by the non-affiliate as long as the current public information condition has been met (i.e. that the issuer has complied with the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)).

We are subject to reporting requirements of the Exchange Act. Under Rule 144, if a holder of securities is an affiliate of an issuer subject to Exchange Act reporting requirements, the securities must be held for at least six months. In addition, the number of equity securities sold during any three-month period cannot exceed 1% of the outstanding shares of the same class being sold. The securities must be sold in unsolicited, routine trading transactions and brokers may not receive more than normal commission. Affiliates must also file a notice with the SEC on Form 144 if a sale involves more than 5,000 shares or the aggregate dollar amount is greater than $50,000 in any three-month period. The sale must take place within three months of filing the Form 144 and, if the securities have not been sold, an amended notice must be filed. Investors should be aware that sales under Rule 144 or pursuant to a registration statement filed under the Securities Act might depress the market price of our securities in any market for such shares.

~~Until December~~Our ~~3, 2020, our~~ shares ~~were~~are quoted on the ~~OTC~~OTCQB ~~Pink~~Venture ~~Open~~ Market, and ~~they~~ are currently subject to SEC “penny stock,” rules, which could make it more difficult for a broker-dealer to trade our shares of common stock, for an investor to acquire or dispose of our shares in the secondary market and for us to retain or attract market makers.

The SEC has adopted regulations that define a “penny stock” to be any equity security that has a market price per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange or securities of an issuer in continuous operation for more than three years whose net tangible assets are in excess of $2 million, or an issuer that has average revenue of at least $6 million for the last three years. Our shares of common stock are currently trading on the OTCQB Venture Market. As of Fiscal ~~2020~~2021, our net tangible assets did not exceed $2 million, and our average revenue for the last three years was only $3,~~891~~340,000, so our securities do not currently qualify for exclusion from the “penny stock” definitions. Therefore, our shares of common stock are subject to “penny stock” rules. For any transaction involving a “penny stock,” unless exempt, the rules impose additional sales practice requirements on broker-dealers, subject to certain exceptions. For these reasons, a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock on the secondary market. Therefore, broker-dealers may be less willing or able to sell or make a market in our securities because of the penny stock disclosure rules. Not maintaining a listing on a major stock market may result in a decrease in the trading price of our securities due to a decrease in liquidity and less interest by institutions and individuals in investing in our securities, and could also make it more difficult for us to raise capital in the future. Furthermore, quotation on OTCQB Venture Market may make it more difficult to retain and attract market makers. In the event that market makers cease to function as such, public trading of our securities will be adversely affected or may cease entirely.

1314 Table of Contents

An active trading market for our common stock may not be sustained.

Although our common stock is currently quoted on the OTCQB Venture Market, the market for our shares has demonstrated varying levels of trading activity. Furthermore, the current level of trading may not be sustained in the future. The lack of an active market for our common stock may impair investors’ ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable, may reduce the fair market value of their shares and may impair our ability to raise capital to continue to fund operations by selling shares.

We do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any return on their investment.

We have never declared or paid cash dividends on our common stock and do not expect to do so in the foreseeable future. The declaration of dividends is subject to the discretion of our board of directors and limitations under applicable law, and will depend on various factors, including our operating results, financial condition, future prospects and any other factors deemed relevant by our board of directors. You should not rely on an investment in our company if you require dividend income from your investment in our company. The success of your investment will likely depend entirely upon any future appreciation of the market price of our common stock, which is uncertain and unpredictable. There is no guarantee that our common stock will appreciate in value.

The sale or issuance of our common stock to Lincoln Park ~~may~~causes ~~cause~~ dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause the price of our common stock to fall.

On December 9, 2020, we entered into the Purchase Agreement with Lincoln Park and on that date we sold 500,000 shares of our common stock to Lincoln Park in an initial purchase under the Purchase Agreement for a total purchase price of $125,000. We also issued 1,250,000 shares of our common stock to Lincoln Park as consideration for its irrevocable commitment to purchase our common stock under the Purchase Agreement. ~~The~~A ~~remaining~~Registration ~~shares~~Statement ofon ~~our common~~Form ~~stock~~S-1 ~~that~~was ~~may~~declared beeffective ~~issued~~by ~~under~~ the ~~Purchase~~SEC ~~Agreement~~on ~~may~~January ~~be sold~~11, by2021; usthereby toregistering ~~Lincoln Park at our discretion from time to time over a 24-month period commencing after~~ the ~~satisfaction~~shares of ~~certain conditions~~common ~~set~~stock ~~forth~~purchased inby ~~the~~Lincoln ~~Purchase Agreement~~Park. ~~One~~The ~~such~~Form ~~condition was~~S-1 ~~that~~registered ~~we had to file~~ a ~~registration~~total ~~statement~~of ~~and~~9,750,000 itshares ~~had~~of tocommon ~~be declared effective by the SEC~~stock. WeThe ~~filed~~remaining ~~the~~shares ~~Registration~~of ~~Statement on~~common ~~Form~~stock ~~S-1~~that onmay ~~December~~be ~~29,~~issued ~~2020~~under ~~and subsequently amended~~ the ~~Registration~~ ~~Statement~~Purchase onAgreement ~~January~~may 7,be ~~2021.~~sold ~~The~~by ~~SEC~~us ~~declared~~to ~~the Form~~Lincoln ~~S-1~~Park ~~effective~~at onour ~~January~~discretion ~~11,~~from ~~2021.~~time ~~The~~to ~~Form~~time ~~S-1~~over ~~registered~~ a ~~total~~ of24-month ~~9,750,000 shares of common stock (which includes the 1,750,000 shares previously noted)~~period.

The purchase price for the shares that we may sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock. Depending on market liquidity at the time, sales of such shares may cause the trading price of our common stock to fall.

Subject to the terms of the Purchase Agreement, we generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park. Additional sales of our common stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us. WeThrough ~~may~~Fiscal ~~ultimately~~2021, ~~decide~~we tosold ~~sell to Lincoln Park all~~8, ~~some~~250,000 ~~or none of the additional~~ shares of our common stock ~~that may be available for us~~ to ~~sell pursuant to the Purchase Agreement. If and when we do sell shares to~~ Lincoln Park, ~~after Lincoln~~(including ~~Park has acquired~~ the ~~shares~~1,250,000 ~~Lincoln~~commitment ~~Park may resell all or some of those~~ shares atreferenced ~~any~~previously) ~~time~~for orwhich ~~from~~we ~~time~~received togross ~~time~~proceeds inof ~~its discretion. Therefore~~$764,000; ~~sales~~leaving ~~to Lincoln Park by us could result in substantial dilution to the interests of other holders of our common stock. Additionally~~1,500,000 ~~the~~unpurchased ~~sale of a substantial number of~~ shares ofunder ~~our~~the ~~common~~Registration ~~stock~~Statement toand ~~Lincoln~~almost ~~Park~~$9, ~~or the anticipation of such sales~~500,000 ~~could~~in ~~make~~purchases itleft ~~more~~under ~~difficult for us to sell equity or equity-related securities in~~ the ~~future~~Purchase atAgreement auntil ~~time~~December ~~and at a price that we might otherwise wish to effect sales~~2022.

14If able, we may decide to sell to Lincoln Park all, some, or none of the additional shares of our common stock that may be available for us to sell pursuant to the Purchase Agreement. If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park may resell all or some of those shares at any time or from time to time in its discretion. Therefore, sales to Lincoln Park by us would result in dilution of our common stock. Additionally, the sale of a substantial number of shares of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

~~We may~~15 ~~require~~Table ~~additional financing to sustain our operations, without which we may not be able to continue operations, and the terms~~ of ~~subsequent~~ ~~financings may adversely impact our stockholders.~~Contents

We may ~~direct~~ ~~Lincoln~~require ~~Park~~additional tofinancing ~~purchase up~~ to ~~$10,250,000~~sustain ~~worth of shares of~~ our ~~common stock under our Purchase Agreement over a 24-month period generally in amounts up to 200~~operations,~~000~~ ~~shares~~without ofwhich ~~our~~we ~~common stock~~may ~~(such~~not ~~purchases, “Regular Purchases”), which may~~ be ~~increased~~able to upcontinue ~~to 250~~operations,~~000~~ ~~shares~~and orthe ~~500,000~~terms ~~shares~~ of ~~our common~~subsequent ~~stock~~financings ~~depending~~may onadversely ~~the~~impact ~~market price of~~ our ~~common stock at the time of sale~~stockholders.

~~The extent~~Under ~~we rely on Lincoln Park as a source of funding will depend on a number of factors including the prevailing market price of~~ our ~~common~~ ~~stock~~Purchase ~~and~~Agreement, ~~the extent to which~~ we ~~are~~may ~~able~~direct ~~to secure working capital from other sources. If obtaining sufficient funding from~~ Lincoln Park ~~were~~ to ~~prove~~purchase ~~unavailable~~up orto ~~prohibitively dilutive~~$10, we250,000 ~~will~~worth ~~need to secure another source~~ of ~~funding~~shares ~~in order to satisfy our working capital needs. Depending on the type and the terms~~ of ~~any financing we pursue, stockholders’ rights and the value of their investment in~~ our common stock ~~could~~over bea ~~reduced. A~~24-month ~~financing~~period ~~could~~(ending ~~involve~~in ~~one~~December or2022); ~~more types~~ of ~~securities~~which ~~including common~~almost ~~stock~~$9,500,000 ~~convertible~~is ~~debt~~left orin ~~warrants to acquire common stock~~purchases. ~~These~~ ~~securities~~Purchases ~~could~~are begenerally ~~issued~~in atamounts orup ~~below~~to ~~the~~200,000 ~~then~~shares ~~prevailing market~~of ~~price for~~ our common stock. In(such ~~addition~~purchases, we“Regular ~~currently have secured debt facilities~~Purchases”), ~~the holders of~~ which ~~have~~may abe ~~claim~~increased to ~~our assets~~up ~~that~~to ~~are~~250,000 ~~prior~~shares toor ~~the~~500,000 ~~rights~~shares of ~~stockholders~~our ~~until~~common ~~the~~stock ~~debt is~~depending ~~paid. Interest~~ on these debt facilities already increases operational costs and negatively impacts operating results. If we have to obtain additional secured debt facilities, this would further negatively impact operating results. Should the ~~financing we~~market ~~require~~price toof ~~sustain~~ our ~~working~~common ~~capital~~stock ~~needs~~at ~~be unavailable or prohibitively expensive when we require it,~~ the ~~consequences~~time ~~could be~~of ~~a material adverse effect on our business, operating results, financial condition and prospects~~sale.

~~ITEM~~The 1Bextent we rely on Lincoln Park as a source of funding will depend on a number of factors including the prevailing market price of our common stock (which, in the latter part of Fiscal 2021 was trading at levels that were too low to request Regular Purchases under the Purchase Agreement), and the extent to which we are able to secure working capital from other sources. ~~UNRESOLVED~~If ~~STAFF COMMENTS~~obtaining sufficient funding from Lincoln Park were to prove unavailable or prohibitively dilutive, we will need to secure another source of funding in order to satisfy our working capital needs. Depending on the type and the terms of any financing we pursue, stockholders’ rights and the value of their investment in our common stock could be reduced. A financing could involve one or more types of securities including common stock, convertible debt or warrants to acquire common stock. These securities could be issued at or below the then prevailing market price for our common stock. In addition, we currently have secured debt facilities, the holders of which have a claim to our assets that are prior to the rights of stockholders until the debt is paid. Interest on these debt facilities already increases operational costs and negatively impacts operating results. If we have to obtain additional debt facilities, this would further negatively impact operating results. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences could be a material adverse effect on our business, operating results, financial condition and prospects.

~~Not applicable~~ITEM 1B. UNRESOLVED STAFF COMMENTS

~~ITEM~~Not 2applicable. ~~PROPERTIES~~

WeITEM ~~own our property in Kinderhook, New York~~2. The property currently consists of a 30,000 square foot facility with approximately 22 surrounding acres. Our Kinderhook facility houses administration, customer service, inside sales, assembly and packaging, shipping and our warehouse. Our New York facility is encumbered by a lien by Cherokee (as it is collateral for the Loan and Security Agreement with Cherokee).PROPERTIES

We ~~lease~~ 5own our property in Kinderhook,~~200~~ ~~square~~New ~~feet~~York. ofThe ~~space~~property incurrently ~~Logan~~consists ~~Township~~of a 30,000 ~~New~~square ~~Jersey~~foot ~~that houses~~facility ~~our~~with ~~bulk~~approximately ~~test~~22 ~~strip~~surrounding ~~manufacturing~~acres. ~~and~~Our ~~research~~Kinderhook ~~and development.~~facility Onhouses ~~December~~administration, 24customer service, ~~2019~~inside sales, weassembly ~~amended~~and ~~the~~packaging, ~~term~~shipping ofand our ~~lease by~~warehouse. ~~extending~~Our itNew ~~through~~York ~~December~~facility ~~31,~~is ~~2022.~~encumbered ~~Both~~by ~~facilities~~a ~~are currently~~lien ~~adequate~~by ~~and~~Cherokee ~~meet~~(as it is collateral for the ~~needs~~Loan ofand ~~all~~Security ~~areas~~Agreement ofwith ~~the Company~~Cherokee).

~~ITEM~~We 3lease 5,200 square feet of space in Logan Township, New Jersey that houses our bulk test strip manufacturing and research and development. ~~LEGAL~~On ~~PROCEEDINGS~~December 24, 2019, we amended the term of our lease by extending it through December 31, 2022. Both facilities are currently adequate and meet the needs of all areas of the Company.

~~ABMC~~ITEM v3. ~~Todd~~LEGAL ~~Bailey~~PROCEEDINGS

~~On August~~From 5,time ~~2019~~to time, we ~~settled~~may ~~litigation~~be ~~with~~named ~~Todd~~in ~~Bailey,~~legal aproceedings ~~former Vice~~in ~~President,~~connection ~~Sales~~with &matters ~~Marketing~~that ~~and~~arose ~~sales~~during ~~consultant of~~ the ~~Company~~ ~~until~~normal ~~December~~course ~~23,~~of ~~2016~~business. ~~The~~While ~~litigation was filed by~~ the ~~Company~~ inultimate ~~the~~outcome ~~Northern District~~ of ~~New~~any ~~York~~such inlitigation ~~February~~cannot ~~2017.~~be ~~Our complaint~~predicted, ~~sought~~if ~~damages~~we ~~related~~are tounsuccessful ~~profits and revenues that resulted from actions taken by Bailey related to our customers. The settlement also addressed a counter-claim filed by Bailey~~ in ~~October~~ ~~2017~~defending ~~(filed~~any ~~originally~~such ~~in Minnesota but~~litigation, ~~transferred to~~ the ~~Norther~~ ~~District~~resulting offinancial ~~New~~losses ~~York~~are innot ~~January~~expected ~~2019). Bailey was seeking deferred commissions in the amount of $164,000 that he alleged were owed~~ to ~~him~~have ~~by the Company. These amounts were originally deferred under~~ a ~~deferred~~material ~~compensation~~adverse ~~program~~effect ~~initiated~~on inthe ~~2013;~~financial aposition, ~~program in~~results ~~which Bailey was one~~ of ~~the~~operations ~~participants.~~and Wecash ~~believed~~flows ~~the~~of ~~amount sought was not due to Bailey given the actions indicated in~~ our ~~litigation~~ company.

~~Under the~~ITEM ~~settlement, both parties elected to resolve the litigation and settle any and all claims made within the litigation~~4. ~~Neither~~MINE ~~party admitted~~SAFETY to any of the allegations contained within the ABMC v. Baily litigation (including any allegations made by Bailey in his counterclaim). Both parties also agreed to dismiss all claims made against each other.DISCLOSURE

~~Other~~Not Applicable.

~~From time~~16 toTable ~~time, we may be named in legal proceedings in connection with matters that arose during the normal course~~ of business. While the ultimate outcome of any such litigation cannot be predicted, if we are unsuccessful in defending any such litigation, the resulting financial losses are not expected to have a material adverse effect on the financial position, results of operations and cash flows of our company.Contents

~~ITEM~~PART ~~4. MINE SAFETY DISCLOSURE~~II

15Market Information

~~PART~~Our IIshares of common stock are quoted on the OTCQB Venture Market under the symbol “ABMC”. Prior to December 3, 2020, our common shares were traded on the OTC Markets Group under their OTC Pink® Open Market under the same symbol.

~~ITEM~~The 5following table sets forth the high and low closing bid prices of our securities as reported by the OTCQB Venture Market and the OTC Pink Open Market in Fiscal 2021 and Fiscal 2020. ~~MARKET~~The ~~FOR~~prices ~~REGISTRANT’S COMMON~~quoted ~~EQUITY~~reflect inter-dealer prices, ~~RELATED~~without ~~STOCKHOLDER~~retail ~~MATTERS~~mark-up, ~~AND~~markdown, ~~ISSUER~~or ~~PURCHASES~~commission ~~OF EQUITY~~and ~~SECURITIES~~may not necessarily represent actual transactions.

Market Information

Year ended December 31, 2021	High		Low

Quarter ended December 31, 2021	$	0.08	$	0.03
Quarter ended September 30, 2021	$	0.06	$	0.04
Quarter ended June 30, 2021	$	0.12	$	0.06
Quarter ended March 31, 2021	$	0.26	$	0.11

As of December 3, 2020, our shares of common stock are quoted on the OTCQB Venture Market under the symbol “ABMC”. Prior to December 3, 2020, our common shares were traded on the OTC Markets Group under their OTC Pink® Open Market under the same symbol.

Year ended December 31, 2020	High		Low

Quarter ended December 31, 2020	$	0.27	$	0.09
Quarter ended September 30, 2020	$	1.19	$	0.13
Quarter ended June 30, 2020	$	1.09	$	0.12
Quarter ended March 31, 2020	$	0.43	$	0.06

The following table sets forth the high and low closing bid prices of our securities as reported by the OTCQB Venture Market and the OTC Pink Open Market in Fiscal 2020 and Fiscal 2019. The prices quoted reflect inter-dealer prices, without retail mark-up, markdown, or commission and may not necessarily represent actual transactions.Holders

Year ended December 31, 2020	High	Low
Quarter ended December 31, 2020	$0.27	$0.09
Quarter ended September 30, 2020	$1.19	$0.13
Quarter ended June 30, 2020	$1.09	$0.12
Quarter ended March 31, 2020	$0.43	$0.06

Based upon the number of record holders and individual participants in security position listings, as of April 14, 2022, there were approximately 2,400 holders of our securities. As of April 14, 2022, there were 48,098,476 common shares outstanding.

Year ended December 31, 2019	High	Low
Quarter ended December 31, 2019	$0.09	$0.06
Quarter ended September 30, 2019	$0.08	$0.06
Quarter ended June 30, 2019	$0.10	$0.04
Quarter ended March 31, 2019	$0.10	$0.07

Dividends

~~Holders~~We have not declared any dividends on our common shares and do not expect to do so in the foreseeable future. Future earnings, if any, will be retained for use in our business.

~~Based upon~~Securities ~~the~~authorized ~~number~~for ofissuance ~~record~~under ~~holders~~equity ~~and~~compensation ~~individual~~plans ~~participants~~previously ~~in security~~approved ~~position~~by ~~listings,~~security ~~as of April 15, 2021 there were approximately 1,800~~ holders ~~of our securities. As of April 15, 2021, there were 40,003,476 common shares outstanding.~~

~~Dividends~~We currently have 2 Non-statutory Stock Option Plans (the 2001 Plan and the 2013 Plan, collectively the “Plans”) that have been adopted by our Board of Directors and subsequently approved by our shareholders. The Plans provide for the granting of options to employees, directors, and consultants (see Part I, Item 1A, Risk Factor titled, “Potential issuance and exercise…”).

WeSecurities ~~have not~~authorized ~~declared~~for ~~any~~issuance ~~dividends~~under onequity ~~our~~compensation ~~common~~plans ~~shares and do~~ not ~~expect to~~previously doapproved soby insecurity ~~the foreseeable future. Future earnings, if any, will be retained for use in our business.~~holders

~~Securities authorized for issuance under equity compensation plans previously approved by security holders~~None.

~~We currently~~The ~~have~~following 2table ~~Non-statutory~~summarizes ~~Stock~~information ~~Option~~as ~~Plans~~of ~~(the~~December ~~2001~~31, ~~Plan and the 2013 Plan~~2021, ~~collectively~~with ~~the~~respect ~~“Plans”)~~to ~~that~~compensation ~~have been~~plans ~~adopted~~(including byindividual ~~our~~compensation ~~Board~~arrangements) ofunder ~~Directors~~which ~~and subsequently approved by~~ our ~~shareholders.~~common ~~The~~stock ~~Plans~~is ~~provide~~authorized for ~~the granting of options to employees, directors, and consultants (see Part I, Item 1A, Risk Factor titled, “Potential~~ issuance: ~~and exercise…”).~~

Plan Category

Number of securities to be issued upon exercise of outstanding options, warrants and rights

(a)

Weighted-average exercise price

of outstanding options,

warrants and rights

(b)

Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))

(c)

Equity Compensation Plans approved by security holders*

1,937,000

0.13

5,780,000

~~Securities~~*All ~~authorized~~securities ~~for~~are ~~issuance~~related ~~under~~to ~~equity~~individual compensation ~~plans not previously approved by security holders~~arrangements.

~~None.~~17 Table of Contents

~~The following~~Performance ~~table summarizes information as of December 31, 2020, with respect to compensation plans (including individual compensation arrangements) under which our common stock is authorized for issuance:~~Graph

Plan Category	Number of securities to be issued upon exercise of outstanding options, warrants and rights (a)	Weighted-average exercise price of outstanding options, warrants and rights (b)	Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
Equity Compensation Plans approved by security holders*	1,987,000	$0.13	5,730,000

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

*All Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities, Purchases of equity securities ~~are~~by ~~related~~the toissuer ~~individual~~and ~~compensation arrangements.~~affiliated purchasers

~~Performance~~None ~~Graph~~that have not been previously reported in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K.

AsITEM ~~a smaller reporting company, we are not required to provide the information required under this item~~6. RESERVED

~~Recent~~ITEM ~~Sales~~7. ofMANAGEMENT’S ~~Unregistered~~DISCUSSION ~~Securities;~~AND ~~Use~~ANALYSIS ofOF ~~Proceeds~~FINANCIAL ~~from Registered~~CONDITION ~~Securities,~~AND ~~Purchases~~RESULTS ofOF ~~equity securities by the issuer and affiliated purchasers~~OPERATIONS

~~On December~~The 8,following ~~2020,~~discussion weand ~~issued~~analysis 1provides information,~~250,000~~ ~~common~~which ~~shares~~we believe is relevant to ~~Lincoln~~an ~~Park as~~assessment ~~consideration~~and ~~for~~understanding ~~Lincoln~~of ~~Park’s~~our ~~irrevocable~~financial ~~commitment~~condition ~~to purchase~~and ~~common~~results ~~shares~~of ~~upon~~operations. The discussion should be read in conjunction with the ~~terms~~financial ofstatements and ~~subject~~the notes to ~~satisfaction~~ ofthe ~~conditions~~financial ~~set~~statement ~~forth~~contained within this Annual Report on Form 10-K. Certain statements contained in athis ~~Purchase~~Annual ~~Agreement between~~Report ~~Lincoln~~on ~~Park~~Form ~~and~~10-K, ~~American~~including, ~~Bio~~without ~~Medica~~limitation, ~~Corporation.~~statements ~~On December~~containing 9the words “believes”, ~~2020~~“anticipates”, we“estimates”, ~~also~~“expects”, ~~sold~~“intends”, ~~500~~“projects”,~~000~~ ~~shares~~and words of ~~common~~similar ~~stock~~import, ~~to Lincoln~~are ~~Park~~forward-looking inas anthat ~~initial~~term ~~purchase~~is ~~under~~defined by the ~~Purchase~~Private ~~Agreement for~~Securities aLitigation ~~purchase~~Reform ~~price~~Act of ~~$125~~1995 (“1995 Act”),~~000~~ and in releases issued by the United States Securities and Exchange Commission (“SEC”). These 1statements 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 within this Annual Report on Form 10-K are not guarantees of future performance and in fact,~~750,000~~ ~~shares~~actual ~~were subsequently~~results ~~registered~~may differ materially from those results discussed in such forward-looking statements. This material difference can be a ~~Registration~~result ~~Statement~~of various factors, including, but not limited to, any risks detailed herein, including the “Risk Factors” section contained in Part I, Item 1A of this Form 10-K, or detailed in our most recent reports on Form S10-~~1 which~~Q ~~was~~and ~~declared~~Form ~~effective~~8-K byand from time to time in our other filings with the SEC and amendments thereto. Any forward-looking statement speaks only as of the date on ~~January~~which 11such statement is made, ~~2021~~ 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.

~~ITEM~~Overview 6.and ~~SELECTED~~Plan ~~FINANCIAL~~of ~~DATA~~Operations

AsIn Fiscal 2021, sales of drug tests were still being negatively impacted by the price competitiveness in our core markets (government, employment and clinical) and by the Covid-19 pandemic. Sales related to Covid-19 testing also declined dramatically in Fiscal 2021 compared to sales in Fiscal 2020. In addition to the marketing of our drug tests, in Fiscal 2021, we continued to market various Covid-19 rapid tests. In December 2020, we announced that were distributing a ~~smaller~~ ~~reporting~~rapid ~~company~~Covid-19 antigen test. Very early in Fiscal 2021, we ~~are~~were ~~not~~informed ~~required~~by tothe ~~provide~~manufacturer (Healgen Scientific, LLC) that we could no longer offer the ~~information~~ ~~required~~Covid-19 ~~under~~antigen ~~this~~test ~~item~~for sale in the United States. We were able to secure another distribution relationship for another rapid antigen test in May 2021 along with a few other rapid antigen tests throughout Fiscal 2021.

~~ITEM~~We 7are also distributing Covid-19 antibody tests, including but not limited to an antibody test via distribution with Healgen which is for use with whole blood, serum or plasma and can be used by laboratories able to perform moderate or highly complex testing (a more limited market), and an antibody test from another manufacturer which can be performed using finger stick blood at the point of care and by laboratories with a Certificate of CLIA waiver (a larger market). ~~MANAGEMENT’S~~However, ~~DISCUSSION~~the ~~AND~~need ~~ANALYSIS~~for ~~OF FINANCIAL~~rapid ~~CONDITION~~Covid-19 ~~AND~~antibody ~~RESULTS~~tests OFdeclined ~~OPERATIONS~~significantly in Fiscal 2021 due to widespread vaccine availability.

~~The~~In ~~following~~addition ~~discussion and analysis provides information, which we believe is relevant~~ to anrapid ~~assessment~~antigen and ~~understanding~~ ofantibody ~~our~~tests, ~~financial condition and results of operations. The discussion should be read~~ in ~~conjunction~~Fiscal ~~with~~2021 ~~the~~we ~~financial statements~~also ~~and~~marketed ~~the~~(via ~~notes~~distribution) to the ~~financial statement contained within this Annual Report on Form 10~~Co-K.Diagnostics ~~Certain~~Logix ~~statements contained~~Smart ~~in this Annual Report on Form 10~~Covid-K,19 ~~including~~test, ~~without limitation,~~a ~~statements containing the words “believes”, “anticipates”, “estimates”, “expects”, “intends”, “projects”, and words of similar import, are forward~~Covid-~~looking~~19-Influenza asA/B ~~that~~combination ~~term~~test ~~is defined by the Private Securities Litigation Reform Act of 1995 (“1995 Act”),~~ and ~~in releases~~at ~~issued~~home byrapid ~~the~~antigen ~~United~~tests ~~States Securities and Exchange Commission~~ (~~“SEC”).~~although ~~These~~lack ~~statements are being made pursuant to the provisions~~ of ~~the~~availability ~~1995 Act and with the intention~~ of ~~obtaining the benefits of the “Safe Harbor” provisions of the 1995 Act. We caution that any forward~~at-~~looking~~home ~~statements~~tests ~~made~~severely within this Annual Report on Form 10-K are not guarantees of future performance and in fact, actual results may differ materially from those results discussed in such forward-looking statements. This material difference can be a result of various factors, including, but not limited ~~to, any risks detailed herein, including the “Risk Factors” section contained in Part I, Item 1A of this Form 10-K, or detailed in~~ our ~~most~~ability ~~recent reports on Form 10-Q and Form 8-K and from time~~ to ~~time~~achieve insales ~~our other filings with the SEC and 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~~product). ~~Readers should not place undue reliance on these forward-looking statements.~~

17All of the Covid-19 tests we are offering are being marketed in accordance with the March 2020 Emergency Use Authorization (“EUA”) policy set forth by the United States Food and Drug Administration (FDA) and in accordance with the individual EUAs issued for the products.

~~Overview and~~18 ~~Plan~~Table of ~~Operations~~Contents

~~Sales in~~Throughout Fiscal ~~2020~~2021, ~~were~~we ~~positively~~continued ~~impacted by the sales and marketing of a Covid-19 IgG/IgM Rapid Test Cassette~~ to ~~detect~~offer ~~Covid-19 antibodies~~other inproducts ~~whole blood, serum or plasma (that we began selling~~ via a distribution ~~agreement~~relationships. ~~with~~We ~~Healgen~~currently ~~Scientific,~~offer ~~LLC~~a ~~in March 2020; hereinafter referred to as the “Covid~~lower-~~19 IgG/IgM~~cost ~~Rapid~~alternative ~~Test~~for ~~Cassette”)~~onsite ~~and~~drug ~~sales~~testing, ofpoint ~~a Rapid Covid-19 Antigen Test Cassette (that we began distributing in December 2020) while sales~~ of ~~our~~care ~~drugs of abuse testing~~ products ~~continued~~ tofor becertain ~~negatively~~infectious ~~impacted~~diseases ~~by the price competitiveness in our core markets (government, employment~~ and ~~clinical)~~alternative ~~and~~drug bytesting ~~the Covid-19~~sample ~~pandemic~~methods. ~~The~~With ~~Covid-19 testing products are being marketed in full compliance with~~ the ~~FDA~~exception ~~EUA~~of ~~policy and~~ the ~~Covid~~lower-19cost ~~IgG/IgM Rapid~~drug ~~Test~~test ~~Cassette~~alternative, isthese ~~being~~offerings ~~marketed~~have inyet ~~accordance with an EUA issued by FDA on May 29, 2020. Due~~ to ~~specific~~materially ~~regulatory~~positively ~~events that~~impact ~~occurred from March 2020 until May 2020, we did not record any~~ sales ~~of Covid-19 tests until later in May 2020, although we did take pre-orders (with payments) for Covid-19 tests prior to shipping product~~.

~~In addition~~We todo ~~the~~expect ~~Covid-19 antibody and antigen tests discussed above, in October 2020, we announced that we signed a distribution agreement with Co-Diagnostics, Inc. granting ABMC the right~~ to ~~market~~ ~~and~~ sell ~~the~~more ~~Logix Smart~~ Covid-19 ~~tests~~testing inproducts ~~the~~and ~~United~~positively ~~States on~~impact aour ~~non-exclusive~~revenues ~~basis.~~in ~~There were no sales of~~ the ~~Logix~~year ~~Smart Covid-19~~ending ~~test~~December in31, ~~Fiscal~~2022, ~~2020.~~however ~~This~~we isdo ~~primarily~~not ~~due~~expect to the ~~shortage of~~sales ~~PCR~~to ~~machines;~~materially ~~because~~impact ofour ~~this lack of supply~~business, weour ~~could~~financial ~~not~~condition ~~offer potential~~and/or ~~customers~~results aof ~~testing platform for the reagents to be used on~~operations.

~~In addition~~Due to the Covid-19 ~~testing platforms~~pandemic, ~~additional~~we ~~products and services~~ are still ~~being~~not ~~offered~~marketing ~~to diversify~~ our ~~revenue~~oral ~~stream through~~fluid ~~third party relationships. We currently offer a lower-cost alternative for onsite~~ drug ~~testing,~~tests ~~point~~(OralStat®) ofin ~~care products for certain infectious diseases and alternative drug testing sample methods. With~~ the ~~exception~~employment ~~of the lower-cost drug test alternative~~ and ~~Covid-19~~insurance ~~rapid~~markets antibody tests, these offerings have yet to materially positively impact sales. In the year ended December 31, 2020, we experienced reduced sales to our two contract manufacturing customers as a result of the Covid-19 pandemic. Beginning in ~~mid-2019, we can sell oral fluid drugs tests in~~ the ~~employment~~ ~~and~~United ~~insurance~~States ~~markets~~ (under a limited exemption set forth by the FDA). ~~Prior~~We toremain ~~this~~hopeful ~~point,~~that we ~~could~~can ~~only~~effectively ~~sell~~market our ~~oral fluid~~OralStat ~~drug tests~~ in the ~~forensic market in the~~ United States ~~and to~~ markets ~~outside~~given ~~the~~its ~~United~~superior ~~States.~~sensitivity Weand ~~are~~accuracy. ~~hopeful~~Initially ~~that gaining access to this market again will enable us to see revenue growth for our oral fluid drug tests in the future; however,~~ we ~~are uncertain~~may ~~when/if~~re-introduce in the ~~year~~product ~~ended December 31, 2021 we will see significant sales oral fluid drug testing~~ in ~~the employment market given the current global health crises and Covid-19. We are focusing our efforts on further penetration of~~ markets ~~with~~outside ~~new products, including, but not limited to,~~ the ~~Covid-19~~United ~~testing products~~States wevia ~~are~~distribution ~~offering, as well as other infectious disease products we are offering~~relationships. ~~We are also looking for avenues to capitalize on our US manufacturing operations; especially during this time of demand for diagnostic products for Covid-19.~~

~~Operating~~In ~~expenses increased $82,000 in Fiscal 2020 versus Fiscal 2019 due to commissions paid on sales of~~ the ~~Covid-19~~year rapid antibody tests as well as fees related to the Cherokee refinancing in February 2020. We continuously make efforts to control operational expenses to ensure they are in line with sales. We have consolidated job responsibilities in certain areas of the Company as a result of employee retirement and other departures and this has enabled us to implement personnel reductions. Throughout most of the six months ended ~~June~~December 3031, ~~2020~~2019, we ~~also~~expanded ~~maintained a 10% salary deferral program for~~ our ~~sole~~contract ~~executive~~manufacturing ~~officer,~~operations ~~our~~with ~~Chief~~two ~~Executive Officer/Principal Financial Officer Melissa Waterhouse. The 10% deferral program ceased in early June 2020 considering the length of time the deferral was in place for Waterhouse~~ (~~almost 7 years~~2) ~~and~~ ~~the~~new ~~balance owed~~customers. ~~Until his departure in November 2019~~Unfortunately, ~~another member of senior management participated in~~ the ~~program.~~Covid-19 Aspandemic ~~of December~~halted ~~31,~~sales ~~2020, we had total deferred compensation owed~~ to these ~~two~~ ~~individuals~~new incustomers ~~the~~and ~~amount~~resulted ~~of $138,000. We did not make any payments on deferred compensation to Melissa Waterhouse~~ in ~~Fiscal 2020~~no orsales in Fiscal ~~2019~~2020. ~~After the member of senior management retired in November 2019, we agreed to make payments for the deferred comp owed to this individual.~~ In Fiscal ~~2020~~2021, we ~~made payments~~started ~~totaling $57,000~~ to ~~this~~ship ~~individual~~orders ~~and in Fiscal 2019 we made payments of $4,000~~ to ~~this~~them ~~individual.~~again Weand ~~will~~our ~~continue~~contract ~~to make~~manufacturing ~~payments~~sales toincreased ~~the former member of senior management until the deferred compensation is paid~~ in ~~full;~~Fiscal ~~which is expected to be in May~~ 2021. Aswhen ~~cash~~compared ~~flow from operations allows, we intend~~ to ~~repay/make~~ ~~payments~~Fiscal ~~on the deferred compensation owed to Melissa Waterhouse~~2020.

~~Our continued~~In ~~existence~~Fiscal is2021 ~~dependent~~and ~~upon several factors~~beyond, ~~including our~~we ~~ability~~are ~~to:~~focusing 1)our ~~raise~~efforts ~~revenue~~on ~~levels~~further ~~even~~penetration ~~though~~of ~~the~~our ~~drug testing~~markets ~~market~~with ~~continues~~both tocurrent beand ~~infiltrated~~new byproducts ~~product~~(drug ~~manufactured outside~~testing, ofCovid-19 ~~the~~and ~~United~~other ~~States~~diagnostic astests). ~~well~~We asare ~~being~~also ~~impacted~~looking byfor ~~the global~~avenues ~~health~~to ~~crisis~~capitalize ~~caused~~on byour ~~Covid-19,~~US 2)manufacturing ~~further~~operations. ~~penetrate~~In ~~the markets~~early ~~(in~~2021 ~~and~~we ~~outside~~started ofexploring the ~~United~~retention ~~States)~~of ~~for~~a ~~Covid-19~~marketing ~~tests, 3)~~firm ~~secure~~that ~~new~~would ~~contract~~provide ~~manufacturing~~services ~~customers,~~related ~~4) control operational costs~~ to ~~generate~~public ~~positive~~relations/social ~~cash~~media ~~flows,~~to 5)effectively ~~maintain~~communicate our ~~current~~ ~~credit~~manufacturing ~~facilities~~capabilities. orThere ~~refinance~~was ~~our~~an ~~current~~unforeseen ~~credit facilities~~delay ifon ~~necessary,~~the ~~and~~part 6)of ifthe ~~needed,~~firm ~~obtain~~and ~~working~~presently ~~capital by~~discussions ~~selling~~are ~~additional shares of our common stock~~halted.

18Gross profit margin declined in Fiscal 2021 when compared to Fiscal 2020 primarily due to the increased costs of manufacturing in the United States and the widespread availability of product manufactured outside the United States; all of which are offered at significantly lower prices. We continually take actions to adjust our production schedules to try to mitigate future manufacturing inefficiencies and we closely examine our gross profit margins.

~~Critical Accounting~~Operating ~~Policies~~expenses declined in Fiscal 2021 when compared to Fiscal 2020. We continuously make efforts to control operational expenses to ensure they are in line with sales and ~~Estimates~~we will continue these efforts into the year ending December 31, 2022. We have continued to consolidate job responsibilities in certain areas of the Company as a result of employee retirement and other departures resulting in personnel reductions.

~~Our discussion~~From ~~and~~August ~~analysis~~2013 ofuntil ~~our~~June ~~financial~~2020, ~~condition~~we ~~and~~maintained ~~results~~a ~~of operations~~10% ~~are~~salary ~~based~~deferral ~~upon~~program for our ~~financial~~sole ~~statements~~executive officer, ~~which~~our ~~have~~Chief ~~been prepared~~Executive Officer/Principal Financial Officer Melissa Waterhouse. The salary deferral program was initiated by Ms. Waterhouse voluntarily. Another member of senior management participated in ~~accordance~~the ~~with~~program ~~accounting~~voluntarily ~~principles~~until ~~generally accepted~~his retirement in November 2019. After the ~~United~~member ~~States~~of senior management retired, we agreed to make payments on the deferred compensation owed to this individual. In Fiscal 2021 and Fiscal 2020, we made payments of ~~America~~$20,000 orand “U$57,000, respectively.S The deferred compensation owed to this individual was paid in full in May 2021. ~~GAAP”.~~ ~~Part~~Once ~~IV,~~the ~~Item~~deferred 15compensation was paid in full to this individual, ~~Note~~we Abegan to ~~our~~make ~~financial~~payments ~~statements describes~~at the ~~significant~~same ~~accounting~~rate ~~policies~~to ~~and~~Ms. ~~methods~~Waterhouse ~~used~~given in the ~~preparation~~length of ~~our~~time ~~financial~~the ~~statements.~~amount ~~The~~had ~~accounting policies~~been owed and that the last payment (prior to May 2021) made to Ms. Waterhouse was in August 2017. In Fiscal 2021, we ~~believe~~made ~~are~~payments ~~most~~totaling ~~critical~~$33,000 to ~~aid~~Ms. Waterhouse. We did not make any payments on deferred compensation to Ms. Waterhouse in ~~fully understanding~~Fiscal ~~and~~2020. ~~evaluating~~As ~~the~~of ~~financial~~December ~~statements~~31, ~~include~~2021, we had deferred compensation owed to Ms. Waterhouse in the ~~following:~~ amount of $74,000 and $5,000 in payroll taxes that are due as payments are made to Ms. Waterhouse; for a total of $79,000 in deferred compensation.

~~Inventory~~Our ~~and~~continued ~~Allowance~~existence ~~for~~is ~~Slow~~dependent ~~Moving~~upon ~~and Obsolete~~several ~~Inventory:~~factors, Weincluding ~~maintain~~our anability ~~allowance~~to: ~~for~~1) ~~slow~~raise ~~moving and~~revenue ~~obsolete~~levels ~~inventory.~~even Ifthough ~~necessary,~~the ~~actual~~drug ~~write-downs~~testing ~~to inventory~~market ~~are~~continues ~~made~~to ~~for~~be ~~estimated~~infiltrated ~~obsolescence~~by orproduct ~~unmarketable inventory~~manufactured ~~equal~~outside toof the ~~difference~~United ~~between~~States as well as being impacted by the ~~cost~~global ofhealth ~~inventory~~crisis caused by Covid-19, 2) further penetrate the markets (in and outside of the ~~net~~United ~~realizable~~States) ~~value~~for ~~based~~Covid-19 ~~upon~~tests, ~~assumptions~~3) ~~about~~secure ~~future~~new ~~demand and~~contract ~~market~~manufacturing ~~conditions.~~customers, If4) ~~actual~~control ~~market~~operational ~~conditions~~costs ~~are~~to ~~less favorable~~generate ~~than~~positive ~~those~~cash ~~projected~~flows, by5) ~~management~~maintain our current credit facilities or refinance our current credit facilities if necessary, and 6) if needed, obtain working capital by selling additional ~~inventory allowances~~shares of our common stock either to Lincoln Park or ~~write-downs~~through ~~may~~an bealternative ~~required~~method if necessary.

~~Valuation~~19 ofTable ~~Receivables: We estimate an allowance for doubtful accounts based on facts, circumstances and judgments regarding each receivable. Customer payment history and patterns, length~~ of relationship with the customer, historical losses, economic and political conditions, trends and individual circumstances are among the items considered when evaluating the collectability of the receivables. Accounts are reviewed regularly for collectability and those deemed uncollectible are written off. If our customers’ economic condition changes, we may need to increase our allowance for doubtful accounts.Contents

~~Estimates~~Critical ofAccounting ~~the~~Policies ~~fair value of stock options~~ and warrants at date of grant: The fair value of stock options issued to employees, members of our Board of Directors and consultants is estimated (on the date of grant) based on the Black-Scholes options-pricing model utilizing certain assumptions for a risk free interest rate; volatility; and expected remaining lives of the awards. The assumptions used in calculating the fair value of share-based payment awards represent management's best estimates, but these estimates involve inherent uncertainties and the application of management judgment. If factors change and we use different assumptions, our equity-based compensation expense could be materially different in the future. In addition, we are required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. In estimating our forfeiture rate, we analyzed our historical forfeiture rate, the remaining lives of unvested options, and the amount of vested options as a percentage of total options outstanding. If our actual forfeiture rate is materially different from its estimate, or if we reevaluate the forfeiture rate in the future, the equity-based compensation expense could be significantly different from what we have recorded in the current period.Estimates

~~Use~~Our ofdiscussion ~~Estimates:~~and Weanalysis ~~make~~of ~~estimates~~our financial condition and ~~assumptions~~ ~~that~~results ~~affect~~of ~~the~~operations ~~reported~~are ~~amounts~~based ofupon ~~assets~~our ~~and liabilities~~financial ~~and~~statements, ~~disclosures~~which ofhave ~~contingent~~been ~~assets~~prepared ~~and~~in ~~liabilities~~accordance at with accounting principles generally accepted in the ~~date~~United States of ~~the~~America, or “U.S. GAAP”. Part IV, Item 15, Note A to our financial statements ~~and~~describes the ~~reported~~significant ~~amounts~~accounting ~~of expenses~~policies ~~during~~and methods used in the ~~reporting~~preparation ~~period~~of our financial statements. ~~Actual~~The ~~results~~accounting ~~could~~policies ~~differ from~~that ~~those~~we ~~estimates.~~believe are most critical to aid in fully understanding and evaluating the financial statements include the following:

~~RESULTS~~Inventory OFand ~~OPERATIONS~~Allowance ~~FOR~~for ~~FISCAL~~Slow ~~2020~~Moving ~~COMPARED~~and TOObsolete ~~FISCAL 2019~~Inventory: We maintain an allowance for slow moving and obsolete inventory. If necessary, actual write-downs to inventory are made for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the net realizable value based on historical demand and past sales history of the products which utilize the inventory. We have reviewed all items within the allowance at December 31, 2021 and based upon that review, we do not expect any future additions to the allowance based on obsolescence, however if actual market conditions are less favorable for our products, additional inventory allowances or write-downs may be required to address slow-moving materials.

~~Net Sales~~Valuation of Receivables: ~~Net~~We ~~sales increased~~estimate ~~13.5%,~~an orallowance ~~$492,000,~~for indoubtful ~~Fiscal~~accounts ~~2020~~based ~~when~~on ~~compared~~facts, ~~to Fiscal~~circumstances ~~2019.~~and ~~Sales~~judgments ofregarding ~~the~~each ~~Covid-19~~receivable. Customer ~~tests~~payment inhistory ~~the~~and ~~amount~~patterns, length of ~~$1,573,000~~ ~~offset~~relationship ~~declines~~with inthe ~~drug~~customer, ~~test~~historical ~~product~~losses, ~~sales~~economic ~~which~~and ~~were negatively~~political ~~impacted~~conditions, bytrends ~~the~~and ~~Covid-19~~individual ~~pandemic.~~circumstances ~~The~~are ~~vast~~among ~~majority~~the ~~of Covid-19~~items ~~test~~considered ~~sales~~when ~~were~~evaluating ~~sales~~the collectability of the ~~Covid-19 IgG/IgM~~ ~~Rapid Test~~receivables. ~~Contract~~Accounts ~~manufacturing~~are ~~sales~~reviewed ~~declined~~regularly infor ~~Fiscal 2020~~collectability ~~when~~and ~~compared~~those todeemed ~~Fiscal~~uncollectible ~~2019~~are ~~due~~written tooff. aIf ~~shift~~our incustomers’ ~~focus~~economic ~~to Covid-19~~condition ~~tests~~changes, ~~within~~we ~~and~~may ~~outside~~need ~~the~~to ~~United~~increase ~~States~~our allowance for doubtful accounts.

~~We began~~Estimates ~~selling~~of ~~theCovid-19~~the ~~IgG/IgM~~fair ~~Rapid~~value ~~Test~~of ~~Cassette~~stock inoptions ~~late~~and ~~March 2020;~~warrants ~~however~~at ~~there~~date ~~were~~of agrant: ~~number~~The fair value of ~~regulatory~~stock ~~events~~options ~~that resulted~~(share-based inpayment anexpense) ~~inability~~issued to ~~get~~employees, ~~supply~~members of ~~the~~our ~~product~~Board ~~from~~of Directors and consultants is estimated (on the ~~manufacturing~~ ~~plant~~date inof ~~China~~grant) ~~until~~based ~~May~~on ~~2020.~~the ~~Once~~Black-Scholes ~~those~~options-pricing ~~events~~model ~~were addressed,~~utilizing wecertain ~~were~~assumptions ~~able~~for toa ~~receive~~risk ~~product~~free interest rate; volatility; and ~~ship~~expected ~~orders~~remaining lives of the ~~antibody~~ ~~tests~~awards. toThe ~~customers~~assumptions ~~throughout~~used ~~Fiscal~~in ~~2020.~~calculating Inthe ~~order~~fair ~~to provide~~value ~~our~~of ~~customers~~share-based ~~with~~payment aawards ~~diagnostic~~represent ~~option~~management's ~~for~~best ~~Covid~~estimates, but these estimates involve inherent uncertainties and the application of management judgment. Our share-19based payment expense in Fiscal 2021 was $0 and only $2,000 in ~~October~~ Fiscal 2020. However, we ~~began~~may ~~distributing~~issue stock options in the ~~Co-Diagnostic~~future. ~~Logix~~If ~~Smart Covid~~factors change and we use different assumptions, our equity-19based ~~tests~~compensation expense could be materially different in the ~~United States~~future. ~~This~~In ~~RT-PCR~~addition, ~~test~~we ~~enables~~are usrequired to ~~offer~~ ~~customers~~estimate athe ~~diagnostic~~expected ~~tool~~forfeiture ~~that~~rate ~~can~~and beonly ~~run~~recognize ~~on high-throughput~~expense ~~machines~~for inthose ~~clinical~~shares ~~laboratories~~expected ~~certified~~to ~~under CLIA~~vest. ~~Unfortunately~~In estimating our forfeiture rate, ~~due~~we toanalyzed aour ~~large~~historical ~~backorder~~forfeiture rate, the remaining lives of ~~high-throughput machines,~~unvested weoptions ~~did~~(if ~~not~~applicable), ~~record~~and ~~any~~the ~~sales~~amount of ~~the~~vested ~~Logix~~options ~~Smart~~as ~~Covid-19 test~~a percentage inof ~~Fiscal~~total ~~2020~~options outstanding. WeIf ~~are~~our ~~hopeful~~actual ~~that~~forfeiture ~~the~~rate ~~machine~~is ~~backorder~~materially ~~will subside~~different ~~and~~from our estimate, or if we ~~would~~reevaluate ~~then~~the forfeiture rate, equity-based compensation expense could be ~~able~~significantly todifferent ~~provide~~from ~~this~~what ~~testing~~we ~~resource to~~have ~~customers~~recorded in the current period.

~~In December~~Use ~~2020,~~of weEstimates: ~~started~~We ~~offering~~make aestimates ~~Rapid~~and ~~Covid-19~~assumptions ~~Antigen~~that ~~Test Cassette;~~affect the reported amounts of assets and weliabilities ~~were~~and ~~able~~disclosures toof ~~ship~~contingent ~~$103,000~~assets inand ~~orders~~liabilities toat ~~customers in~~the ~~Fiscal~~date ~~2020~~of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

~~When infection~~20 ~~surges~~Table occur, there is a higher demand for diagnostic tests (i.e. PCR’s or antigen tests) versus antibody tests (as antibody tests are not diagnostic tests).The CDC has indicated that antibody testing can help establish a clinical picture when patients have late complications of ~~Covid-19 illness, such as multisystem inflammatory syndrome in children.~~Contents

19RESULTS OF OPERATIONS FOR FISCAL 2021 COMPARED TO FISCAL 2020

~~We believe~~Net ~~that~~Sales: Net sales decreased 46.5%, or $1,929,000, in Fiscal 2021 when compared to Fiscal 2020. The majority of the ~~demand~~decline ~~for~~($1,559,000) is related to products that we distribute and $1,519,000 of that decline is related to distribution of Covid-19 ~~IgG/IgM~~tests. ~~Rapid~~In ~~Test~~Fiscal ~~Cassette can~~2020, ~~still~~we ~~increase~~sold ~~over~~$1,572,000 ~~time~~in asCovid-19 tests while in Fiscal 2021, we only sold $54,000. Throughout most of Fiscal 2020, rapid Covid-19 antibody tests dominated the ~~need~~market ~~for~~and ~~data~~the ~~increases;~~vast ~~that is~~majority of our rapid Covid-19 test sales in Fiscal 2020 were rapid antibody tests. However, ~~when~~in ~~testing~~Fiscal is2021, ~~used~~rapid Covid-19 antigen tests were becoming more sought after as more Covid-19 antigen tests were EUA issued and as vaccines became more widely available. In December 2020, we announced that were distributing a ~~means~~rapid toCovid-19 ~~determine~~antigen ~~the~~test. ~~full impact/extent~~Very ofearly ~~the~~in ~~virus~~Fiscal 2021, ~~its~~we ~~mortality~~were ~~rate~~informed by the manufacturer (Healgen Scientific, LLC) that their rapid Covid-19 antigen test could no longer be offered for sale in the ~~length~~United States. This resulted in an interruption in our supply chain negatively impacted our Covid-19 test sales as our current customers had to seek alternative suppliers for their Covid-19 antigen testing needs. We were able to secure another distribution relationship for another rapid antigen test in May 2021 along with a few other rapid antigen tests throughout Fiscal 2021. Sales of ~~time antibodies~~these ~~remain~~new tests did nominally offset the decline in Covid-19 test sales. In Fiscal 2021, we also distributed a rapid Covid-19 antibody test which can be performed using finger stick blood at the ~~body~~point of care and ~~the~~by ~~impact~~laboratories with a Certificate of ~~the~~CLIA ~~antibodies~~waiver on and at-home rapid Covid-19 antigen tests. However, the ~~virus~~supply chain for at home, asrapid ~~well~~antigen astests abecame ~~means~~very tounstable ~~monitor~~in the ~~efficacy~~latter part of ~~vaccines as~~Fiscal ~~they~~2021 ~~are~~and ~~released~~lack of availability of tests negatively impacted our ability to secure more sales of the tests.

~~Our core~~Drugs ~~markets~~of ~~for~~abuse ~~drug~~(“DOA”) ~~test~~manufacturing sales ~~are~~also ~~clinical~~decreased by $518,000 ~~government~~in Fiscal 2021 when compared to Fiscal 2020. Sales of drug tests continue to be negatively impacted by the Covid-19 pandemic along with the price competitive nature of our markets. In addition, throughout Fiscal 2021 we experienced supply chain issues; particularly with plastics and ~~workplace~~ other materials that are used to manufacture our drug tests; ~~all~~materials that are also used in the manufacture of ~~which~~lateral ~~require~~flow Covid-19 tests. The lead times for some materials increased significantly and in most cases without notice. These delays impacted our ability to complete manufacturing and ship products. Throughout Fiscal 2021, customers still requiring a lower amount of ~~testing~~tests due to ~~stay~~ ~~at home orders,~~ reduced workforce, telecommuting and reduced budgets (especially in the government market as financial resources are still being used for Covid-19 testing and vaccinations). InAlso contributing to the ~~latter~~ ~~part~~decline ofin ~~Fiscal~~DOA ~~2020~~manufacturing sales, wewhen ~~started~~comparing Fiscal 2021 to ~~see~~Fiscal ~~some~~2020, ~~rebound~~is a decline in ~~our drug~~clinical ~~testing~~sales ~~markets,~~and ~~however,~~the ~~our~~loss ~~core~~of ~~drug~~a ~~testing~~government ~~markets~~account ~~are still~~in ~~uncertain~~the ~~(as~~middle ~~they~~of ~~relate~~2020 (due to pricing) and sales declines in the ~~pandemic),~~international somarket wedue ~~are~~to ~~unsure at~~two ~~this~~orders ~~time~~received ~~whether~~in ~~this~~2020 ~~rebound~~that ~~will~~were ~~continue~~not received in 2021.

~~In addition~~Contract tomanufacturing ~~the negative~~ sales ~~impact~~increased ~~from~~by ~~the~~$141,000 ~~customer~~in ~~side,~~Fiscal ~~we also~~2021 ~~experienced~~compared ~~delays~~to inFiscal ~~materials~~2020. ~~required~~Sales ~~for~~to ~~the~~all ~~manufacturing~~ of our ~~drug~~contract ~~tests~~manufacturing ~~from~~customers ~~vendors~~increased ~~due~~year toover ~~decreased~~year. ~~production~~This ~~levels resulting~~includes sales from ~~stay~~two atcustomers ~~home~~whose orders ~~and~~halted ~~reduced~~in ~~workforce~~2020 ~~numbers. While our staff continues to work~~ due to the ~~essential~~pandemic. ~~nature~~The ~~of our~~most ~~manufacturing,~~significant ~~delays~~increase inwas ~~materials resulted~~ in ~~customer backorders~~sales ~~for~~of ~~specific~~RSV ~~products~~(Respiratory ~~that~~Syncytial ~~required~~Virus) ~~the~~test ~~materials~~and ~~in question~~malaria tests.

WeGross ~~do expect~~profit: ~~the~~Gross ~~marketing~~profit decreased to 24.7% of ~~Covid-19~~net ~~testing~~sales ~~products~~in toFiscal ~~further positively~~2021 ~~impact~~compared ~~our~~to ~~revenues~~29.8% of sales in ~~the~~Fiscal 2020. DOA manufacturing gross profit declined year ~~ending~~over ~~December~~year; 31most of which is due to increased costs of manufacturing (materials and labor costs associated with manufacturing), ~~2021~~ manufacturing inefficiencies due to decreased DOA sales and product mix (certain product lines, ~~however~~such weas doInCup, are more heavily impacted by increased costs associated with labor). Manufacturing inefficiencies occur when production levels decrease but, not ~~yet~~all ~~know~~costs ~~the~~can ~~full~~be ~~extent~~reduced ofto be in line with production levels because they are fixed. A price increase that went into effect in the ~~impact~~middle of ~~Covid-19~~ ~~test~~Fiscal ~~sales~~2021 ondid ~~our~~partially ~~business,~~offset ~~our~~these ~~financial~~increases. ~~condition~~Distribution ~~and/or results~~gross ofprofit ~~operations~~increased in Fiscal 2021 when compared to Fiscal 2020. The ~~extent~~primary toreason ~~which~~for the increase in distribution sales ofis Fiscal 2020 included high volume Covid-19 tests ~~may~~ ~~impact~~sales ~~our~~that ~~business,~~were ~~operating~~sold ~~results,~~at ~~financial~~lower ~~condition,~~profit ~~or liquidity~~margins inand ~~the~~sales ~~future~~of ~~will~~newly ~~depend~~sourced on(in ~~future~~Fiscal ~~developments~~2021) ~~which are~~Covid-19 ~~evolving~~tests ~~and~~are ~~uncertain~~being ~~including~~sold ~~the~~at ~~duration~~higher rate of ~~the~~gross ~~outbreak~~ profit. And finally, contract manufacturing gross profit declined between Fiscal 2020 and ~~the~~Fiscal ~~need~~2021. ~~for~~Increased ~~antibody~~material costs and ~~diagnostic~~product ~~testing~~mix inwere the ~~future~~ cause of the decrease in gross profit.

~~Gross profit~~Operating Expenses: ~~Gross profit~~ ~~decreased~~Operating toexpenses ~~29.8%~~for ~~of sales in~~ Fiscal ~~2020~~2021 ~~compared~~decreased ~~to 32~~7.41% of, ~~net~~or ~~sales~~$132,000, inwhen ~~Fiscal~~compared ~~2019.~~to ~~Although~~operating ~~net~~expenses ~~sales increased, the increase~~ in ~~sales~~Fiscal ~~was a result of products we distribute~~2020. ~~Sales~~Expenses ~~of products~~related ~~that~~to weResearch ~~manufactured~~and ~~(primarily~~Development ~~drug tests) decreased~~ and ~~this~~ ~~resulted~~Selling ~~in greater inefficiencies in manufacturing. Manufacturing inefficiencies typically occur when revenues decline (from manufacturing) because certain overhead costs are fixed~~ and ~~cannot~~ beMarketing ~~reduced;~~decreased, ifwhile ~~fewer~~expenses ~~testing~~related ~~strips~~to ~~are~~General ~~produced~~ and ~~fewer products~~Administrative ~~are assembled this results in higher~~ costs ~~being expensed through cost of goods~~increased. ~~Lower~~More product pricing to customers also negatively impacts gross profit. We are continually taking actions to adjust our production schedules to try to mitigate future inefficiencies and we closely examine our gross profit margins on our manufactured products.specifically:

~~Lower gross~~Research ~~margins~~and ~~from~~development ~~drug test sales~~ (~~due to the increased manufacturing inefficiencies~~“R&D”) were partially offset by higher margins related to Covid-19 tests. It is uncertain whether the current profit margins of Covid-19 test sales will continue at the present rate. Various factors can affect market pricing (such as an increased number of EUA issued products and their availability to customers, and costs of materials to manufacture the Covid-19 tests).

~~Operating~~R&D ~~Expenses: Operating~~ expenses for Fiscal ~~2020~~2021 ~~increased~~decreased 45.6%, or $825,000, when compared to ~~operating~~R&D expenses incurred in Fiscal ~~2019~~2020. ~~Expenses~~The primary reason for the decline in ~~all operation~~expense ~~areas~~is ofdecreased ~~the~~supplies ~~Company~~and ~~increased~~material costs due to a study that was conducted in Fiscal 2020 but, not required in Fiscal 2021. ~~More specifically:~~All other expenses remained relatively consistent year over year. Throughout Fiscal 2021, our R&D department primarily focused their efforts on the enhancement of our current products and required validations related to drug testing product components.

~~Research~~21 ~~and~~Table ~~development~~of ~~(“R&D”)~~Contents

~~R&D expenses~~Selling for Fiscal 2020 increased 9.8%, or $8,000, when compared to R&D expenses incurred in Fiscal 2019. The primary reason for the increase is increased FDA compliance costs (due to timing of payments made for our FDA facility registrations). All other expenses remained relatively consistent year over year. Throughout Fiscal 2020, our R&D department primarily focused their efforts on the enhancement of our current products and ~~the evaluation of potential contract manufacturing opportunities.~~marketing

Selling and marketing expenses for Fiscal 2021 decreased by 38.3%, or $189,000, when compared to selling and marketing expenses in Fiscal 2020. The primary reason for the decrease in selling and marketing expense is lower commissions paid related as sales of Covid-19 tests decreased. Also contributing to the decline in expense were reductions in sales salary expense and benefits (due to the termination of personnel) and car allowance expense (due to the same terminations). Partially offsetting the declines was increased promotional expense (i.e. fees paid to OTC Markets in Fiscal 2021).

~~Selling~~ In Fiscal 2021, we continued selling and marketing ~~expenses~~efforts ~~for~~related ~~Fiscal~~to ~~2020~~our ~~increased~~drug bytests 7and we continued to take actions to secure new contract manufacturing customers.~~4%,~~ ~~or $34~~In addition,~~000,~~ ~~when~~we ~~compared~~promoted tolower ~~selling~~cost alternatives for onsite drug testing and ~~marketing~~point ~~expenses~~of incare ~~Fiscal 2019~~products for infectious disease (through relationships with third parties). ~~The~~We ~~primary~~also ~~reason~~marketed ~~for~~and ~~the~~sold ~~increase~~rapid Covid-19 tests via distribution relationships. These offerings did not result in increased selling and marketing ~~expense~~ isexpenses ~~commissions~~when ~~paid~~comparing ~~related~~Fiscal 2021 to Fiscal 2020 due to lower sales of ~~the~~ Covid-19 tests~~. This~~ ~~increase~~in ~~was~~Fiscal ~~partially~~2021. ~~offset~~Although bywe decreased ~~sales~~the ~~salary expense~~size ~~and~~of ~~benefits~~our ~~(due~~sales toforce in Fiscal 2020, the ~~termination~~terminations of sales personnel) in Fiscal 2020 were made for performance reasons. Throughout Fiscal 2021, ~~decreased~~ we took steps to increase the size of our sales ~~travel~~team ~~and~~to ~~trade~~further ~~show~~penetrate ~~expense~~our ~~(as~~markets; ahowever, ~~result~~no ofnew ~~the Covid-19~~sales ~~pandemic)~~reps ~~and~~were ~~lower~~hired ~~auto~~in ~~allowance~~Fiscal ~~costs~~2021.

~~In Fiscal~~General ~~2020, we continued selling~~ and ~~marketing~~administrative efforts related to our drug tests and we continued to take actions to secure new contract manufacturing customers. In addition, we promoted lower cost alternatives for onsite drug testing and point of care products for infectious disease (~~through relationships with third parties~~“G&A”). The addition of these offerings did not result in increased selling and marketing expenses. In late March 2020, we also started selling a Covid-19 IgG/IgM Rapid Test via a distribution relationship and in the fourth quarter of Fiscal 2020, we started selling the Logix Smart Covid-19 test and a Rapid Covid-19 Antigen Test Cassette. As of result of these new offerings, we recorded increased sales commission rates. Although we decreased the size of our sales force in Fiscal 2020, those reductions were made for performance reasons. We are hoping to hire new personnel and ultimately increase the size of our sales team to further penetrate our markets. We will continue to take all steps necessary to ensure selling and marketing expenditures are in line with sales.

G&A expense increased 4.9%, or $62,000, in Fiscal 2021 when compared to G&A expense in Fiscal 2020. The majority of the increase is due to bank service fees, which increased $91,000 between Fiscal 2020 and Fiscal 2021. Most of this increase is due to $149,000 in expense related to the refinancing of the Cherokee facilities in February 2021. The expense consisted of penalties in the amount of $120,000, a fee paid to Cantone Research, Inc. in the amount of $28,000 and $1,000 in Cherokee legal fees. Fiscal 2020 only included a $20,000 penalty associated with the extension of the Cherokee facilities in February 2020 but, Fiscal 2020 also included higher bank fees associated with credit card payments received for a higher level of Covid-19 test sales in Fiscal 2020. Also increasing were insurance costs, cost associated with our ISO audit in Fiscal 2021, utility costs and costs associated with maintenance of our intellectual property. These increases were partially offset by decreased director’s fees and expenses (due to a smaller number of board members and meetings being held telephonically), G&A salaries and benefits (due to decreased personnel) and legal fees (due to completion of Lincoln Park financing in Jan 2021 and less securities counsel work).

~~General~~There ~~and~~was ~~administrative~~$0 ~~(“G&A”)~~in share based payment expense in Fiscal 2021 as all previously issued options have been completely amortized. There was $2,000 of share based payment expense in Fiscal 2020.

~~G&A expense~~Other ~~increased~~income ~~3.2%,~~and ~~or $40,000, in Fiscal 2020 when compared to G&A~~ expense: in Fiscal 2019. Costs associated with G&A employees (due to filling vacancy), patents and licenses (due to increased patent maintenance activity), repairs and maintenance (due to water damage and septic repairs at the Kinderhook, NY facility), and bank fees (due to Cherokee debt facility extension in February 2020) increased. These increases were partially offset by decreased salaries associated with quality assurance and warehouse employees (due to fewer employees and/or the consolidation of job responsibilities), supplies, insurance costs and utilities. We continuously examine all G&A expenses to look for lower cost alternatives to current services/products being used.

Other income ~~and expense: Other expense~~ of $~~173~~718,000 in Fiscal ~~2020~~2021 consisted of ~~interest~~income ~~expense~~related ~~associated~~to ~~with~~the forgiveness of our ~~credit~~PPP ~~facilities~~loan ~~(our~~in ~~line~~ the amount of ~~credit~~$335,000, ~~equipment~~other ~~loan~~income ~~with~~of ~~Crestmark~~$58,000; ~~Bank~~which ~~and~~is ~~our~~$50,000 ~~two~~related ~~loans with~~to ~~Cherokee~~certain ~~Financial,~~non-refundable ~~LLC~~prepayments (customer deposits) ~~nominally~~that ~~offset~~were byforfeited when the customer did not remit the remaining amounts due on the order and $28,000 in ~~other~~ income. ~~Other~~related ~~expense~~to ofgains on certain liabilities, $93619,000 in income from the Employee Retention Credit recognized in Fiscal ~~2019~~2021 ~~consisted~~(which is $44,000 in credits taken in Q3 2021, $38,000 in credit taken in Q4 2021 and $537,000 in refunds filed for credits in the first three quarters of 2021). This income was offset by interest expense associated with our credit facilities (our line of credit, ~~equipment loan with Crestmark Bank, and~~ our two loans with Cherokee Financial, LLC), ~~offset~~and bya ~~other~~shareholder ~~income~~loan) and a charge related to ~~gains on~~the ~~certain~~impairment ~~liabilities~~of our patent asset.

~~LIQUIDITY~~Other ~~AND~~expense ~~CAPITAL~~of ~~RESOURCES~~$173,000 ASin OFFiscal ~~DECEMBER~~2020 31consisted of interest expense associated with our credit facilities (our line of credit, ~~2020~~ equipment loan with Crestmark Bank and our two loans with Cherokee Financial, LLC) nominally offset by $2,000 in other income.

~~Our cash~~22 ~~requirements~~Table depend on numerous factors, including but not limited to manufacturing costs (such as raw materials, equipment, etc.), selling and marketing initiatives, product development activities, regulatory costs, legal costs, and effective management of inventory levels and production levels in response to sales history and forecasts. We expect to devote capital resources related to selling and marketing initiatives. We are examining other growth opportunities including strategic alliances and contract manufacturing. Given our current and historical cash position, such activities would need to be funded from the issuance of additional equity or additional credit borrowings, subject to market and other conditions.Contents

~~On February~~LIQUIDITY ~~20,~~AND ~~2020,~~CAPITAL weRESOURCES ~~entered~~AS ~~into~~OF aDECEMBER ~~Securities Purchase Agreement with Chaim Davis (the Chairman of our Board of Directors) and certain other accredited investors (the “Investors”)~~31, ~~pursuant~~ to which we agreed to issue and sell to the Investors in a private placement (the “Private Placement”), 2,842,856 Units (the “Units”). Each Unit consisted of one (1) share of our common stock, par value $0.01 per share (“Common Share”), at a price per Unit of $0.07 (the “Purchase Price”) for aggregate gross proceeds of approximately $199,000. We received net proceeds of $199,000 from the Private Placement as expenses related to the Private Placement were minimal. We did not utilize a placement agent for the Private Placement. We used the net proceeds for working capital and general corporate purposes. The Company does not intend to register the Units issued under the Private Placement; rather the Units issued will be subject to the holding period requirements and other conditions of Rule 144.2021

~~On December~~Our 9,cash ~~2020,~~requirements wedepend ~~entered~~on ~~into~~numerous afactors, ~~Purchase~~including ~~Agreement~~but ~~(the “Purchase~~not ~~Agreement”)~~limited ~~and~~to amanufacturing ~~Registration~~costs ~~Rights Agreement~~ (~~the~~such ~~“Registration~~as ~~Rights~~raw ~~Agreement”)~~materials, ~~with Lincoln~~labor, ~~Park Capital Fund~~equipment, ~~LLC (“Lincoln Park”~~etc.), ~~under which~~selling ~~Lincoln~~and ~~Park~~marketing ~~agreed~~initiatives, toproduct ~~purchase~~development ~~from the Company~~activities, ~~from~~regulatory ~~time to time~~costs, uplegal ~~to $10~~costs,~~250,000~~ ofand ~~our~~effective ~~shares~~management of ~~common~~inventory ~~stock,~~levels ~~par~~and ~~value $0.01~~production ~~per~~levels ~~share,~~in ~~subject~~response to ~~certain~~sales ~~limitations~~history ~~set~~and ~~forth in the Purchase Agreement, during the term of the Purchase Agreement~~forecasts. ~~Pursuant~~ toWe ~~the~~expect ~~terms of the Registration Rights Agreement, we were required~~ to ~~file~~devote ~~with~~capital ~~the~~resources ~~SEC,~~related ~~a registration statement on Form S-1 (the “Registration Statement”)~~ to ~~register~~selling ~~for~~and ~~resale under~~marketing ~~the~~initiatives. ~~Securities~~We ~~Act~~are ofexamining ~~1933,~~other asgrowth ~~amended~~opportunities ~~(the~~including ~~“Securities Act”),~~strategic ~~the~~alliances ~~shares~~and ofcontract ~~common~~manufacturing. ~~stock~~Given ~~that~~our wecurrent ~~had already issued~~ and ~~sold~~historical tocash ~~Lincoln Park (500~~position,~~000~~ ~~shares~~such ofactivities ~~common~~would ~~stock~~need ~~for~~to ~~a purchase~~be ~~price~~funded offrom ~~$125,000~~the ~~along~~issuance ~~with 1,250,000 shares~~ of ~~common stock~~additional ~~issued~~equity toor ~~Lincoln~~additional ~~Park’s~~credit ~~for~~borrowings, ~~their~~subject ~~irrevocable commitment~~ to ~~purchase~~market ~~common shares upon the terms of~~ and ~~subject to~~other ~~satisfaction~~conditions. ofThe ~~the~~following ~~conditions~~transactions ~~set~~materially ~~forth~~impacted inour ~~the~~liquidity ~~Purchase Agreement),~~ and ~~shares~~cash offlow ~~common stock we may~~ in ~~the~~Fiscal ~~future elect to issue and sell to Lincoln Park from time to time under the Purchase Agreement.~~2021:

Our financial statements for the year ended December 31, 2020 were prepared assuming we will continue as a going concern, which assumes the realization of assets and the satisfaction of liabilities in the normal course of business. Our current cash balances, together with cash generated from future operations and amounts available under our credit facilities (including the Lincoln Park ~~equity~~Equity ~~facility) may not be sufficient to fund operations through April 2022. At December 31, 2020, we have Stockholders’ Deficit of $1,256,000.~~Line

21On 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 Fiscal 2021, the Company sold 6,500,000 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 $639,000.

~~Our loan~~Employee ~~and~~Retention security agreement and 2020 Term Note with Cherokee for $900,000 and $220,000, respectively, expired on February 15, 2021; however, the credit facilities were extended for another 12 months, or until February 15, 2022 (which is less than 12 months from the date of this report); See Note K – Subsequent Events to our financial statements for Fiscal 2020. Our total debt at December 31, 2020 with Cherokee Financial, LLC was $1,120,000 and under the terms of the February 2021 extension, the total debt was increased to $1,240,000. 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 is due in full on February 15, 2022. We may be able to utilize the Lincoln Park equity facility to pay down a portion (or all) of the debt owed to Cherokee prior to the maturity date of February 15, 2022; however, as of the date of this report, that is not a certainty.Credit

~~Throughout~~As ~~Fiscal 2020~~indicated in Note K to our Financial Statements, wein ~~had~~August 2021, our payroll service provider processed and mailed a ~~line~~Form of941-X ~~credit~~to ~~with~~claim ~~Crestmark~~an ~~Bank.~~Employee ~~The~~Retention ~~maximum availability~~Credit on(“ERC”) refund in the ~~line~~amount of ~~credit~~$202,000 ~~through~~on aqualified ~~part~~wages paid in the first quarter of Fiscal ~~2020 was~~2021. Due to a change in the Form 941-X, our payroll service provider did not process and mail our Form 941-X to claim an ERC refund in the amount of $1198,~~500,~~000 ~~but~~on qualified wages paid in the second quarter of Fiscal 2021 until October 28, it2021. ~~was~~In ~~reduced~~the onmiddle ~~June~~of 22the third quarter of Fiscal 2021, ~~2020~~we tobegan taking the ERC in our current payroll; which reduced our payroll by approximately $144,000~~,000 under~~ in the ~~amendment~~third quarter of 2021 and ~~extension~~$38,000 in the fourth quarter of Fiscal 2021 (until the ~~line~~ERC program was ended early as part of ~~credit~~the Infrastructure bill signed into law on November 15, 2021). ~~However~~Given this, ~~because~~ we did not have to amend our Form 941 for the ~~amount~~third ~~available~~quarter ~~under~~of 2021; rather our Form 941 claiming a refund in the ~~line~~amount of ~~credit~~$137,000 iswas ~~based~~filed ~~upon~~ electronically with the IRS on November 1, 2021 by our ~~accounts~~payroll ~~receivable~~service provider. On December 28, 2021, we received our refund for the ~~amounts~~third ~~actually~~quarter ~~available~~of ~~under~~Fiscal ~~our line~~2021 in the amount of ~~credit~~$137,000. ~~(historically)~~Shortly ~~have~~before ~~been~~receiving ~~significantly~~our ~~less~~first ~~than~~refund, we spoke with the ~~maximum~~ ~~availability~~Internal Revenue Service (“IRS”) to obtain statuses of our filings. ~~When~~It ~~sales~~was ~~levels~~then ~~decline,~~that we were informed that they did not have ~~reduced availability~~record onof receiving our ~~line~~Form 941-X for the first quarter of ~~credit~~Fiscal ~~due~~2021 to(which ~~decreased~~was ~~accounts receivable~~mailed ~~balances~~by our service provider in August 2021). AsWe re-sent the Form 941-X for the first quarter of Fiscal 2021 via overnight service on December 31, ~~2020~~2021 and the IRS received it on January 5, ~~based~~2022. This lack of receipt will result in a delay in receiving our expected refund in the amount of $203,000. Based on our ~~availability~~ ~~calculation~~discussion with the IRS, ~~there~~we were noexpecting ~~additional~~the ~~amounts available~~refund ~~under~~payment for the ~~line~~second quarter of ~~credit~~Fiscal ~~because~~2020 sometime in February 2022; however, as of the date of this report, we ~~draw~~have ~~any~~not ~~balance available~~received onany afurther ~~daily~~refund ~~basis~~payments.

~~If availability~~Securities ~~under our line of credit and cash received from equity sales under the Lincoln Park~~ Purchase Agreement ~~are~~– ~~not~~October sufficient to satisfy our working capital and capital expenditure requirements, we will be required to obtain additional credit facilities or sell additional equity securities, or delay capital expenditures which could have a material adverse effect on our business. There is no assurance that such financing will be available or that we will be able to complete financing on satisfactory terms, if at all.2021

AsOn ~~of December~~October 3118, ~~2020~~2021, we ~~had~~entered into a Securities Purchase Agreement (the ~~following~~“SPA”) ~~debt/credit facilities:~~with a non-affiliated, accredited investor (the “Investor”), pursuant to which we sold to the Investor in a private placement (the “Private Placement”), 2,500,000 shares of our common stock, par value $0.01 per share (“Common Share”), at a price per Common Share of $0.04 (the “Purchase Price”) for gross (and net) proceeds of $100,000 as there were no costs associated with the Private Placement.

Facility	Debtor	Balance as of December 31, 2020	Due Date
Loan and Security Agreement	Cherokee Financial, LLC	$900,000	February 15, 2021
Revolving Line of Credit	Crestmark Bank	$277,000	June 22, 2021
Term Loan	Cherokee Financial, LLC	$220,000	February 15, 2021
PPP Loan	Crestmark Bank, SBA	$332,000	April 22, 2022
Term Loan	Individual	$50,000	May 4, 2021
Term Loan	Individual	$25,000	Not Applicable
Total Debt		$1,804,000

Shareholder Loans – December 2021

~~Working~~On ~~Capital~~December ~~Deficit~~14, 2021, we entered into six month 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. We paid one of the investors their first interest payment (due on March 15, 2022); however, the other investor agreed to waive their first interest payment and have the interest paid at the end of the term of the loan along with the final interest and principal; due June 15, 2022, or earlier as we receive further ERC refunds.

At23 ~~the end~~Table of Fiscal 2020, we were operating at a working capital deficit of $841,000. This compares to a working capital deficit of $463,000 at the end of Fiscal 2019. This increase in our working capital deficit was primarily a result of the PPP loan. We have historically satisfied working capital requirements through cash from operations and bank debt.Contents

~~Dividends~~Going Concern

WeOur ~~have never~~financial ~~paid~~statements ~~any~~for ~~dividends~~Fiscal on2021 ~~our~~were ~~common~~prepared ~~shares~~assuming we will continue as a going concern, which assumes the realization of assets and wethe ~~anticipate that~~satisfaction ~~all~~of ~~future~~liabilities ~~earnings~~in the normal course of business. Our current cash balances, iftogether ~~any~~with cash generated from future operations, ~~will~~ERC berefunds ~~retained~~and ~~for~~amounts ~~use~~available inunder our ~~business~~ credit facilities (including the Lincoln Park equity facility) may not be sufficient to fund operations through April 2023. At December 31, 2021, we have Stockholders’ Deficit of $944,000.

22Our loan 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, we completed a transaction with Cherokee related to (second) one-year Extension Agreements dated February 14, 2021 under which Cherokee extended the due date of the Cherokee LSA ($900,000) and the 2019 Term Loan with Cherokee ($220,000) again; the facilities were previously extended in February 2020). Under the terms of the (second) extensions, the $900,000 (secured) 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 in February 2021; a term that was included in the February 2020 extension. The annual interest rate on the (further) extended 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). In addition, 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 in February 2021; a term that was included in the February 2020 extension. Our total debt at December 31, 2021 with Cherokee Financial, LLC was $1,240,000. 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 was due in full on February 15, 2022. We were not able to these 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 to extend the due date of the loans. See Note L – Subsequent Events for information related to the status of the Cherokee loans.

~~Cash~~Throughout ~~Flow~~Fiscal 2021, ~~Outlook/Risk~~we had a line of credit with Crestmark Bank. The maximum availability on the line of credit is $1,000,000. However, because the amount available under the line of credit is based upon our accounts receivable, the amounts actually available under our line of credit (historically) have been significantly less than the maximum availability. When sales levels decline, we have reduced availability on our line of credit due to decreased accounts receivable balances. As of December 31, 2021, based on our availability calculation, there were no additional amounts available under the line of credit because we draw any balance available on a daily basis. 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 automatically renewed on June 22, 2021 for another one year term, or until June 22, 2022.

~~In Fiscal~~If ~~2020~~availability under our line of credit, wecash ~~had~~received afrom ~~net~~equity ~~loss~~sales ofunder ~~$796,000~~the ~~and~~Lincoln ~~net~~Park Purchase Agreement and/or cash ~~used~~received ~~by operating~~as ~~activities~~refunds ofunder ~~$483,000.~~the ~~Our~~ERC ~~cash~~program ~~position~~are ~~increased~~not ~~from $4,000~~sufficient atto ~~December~~satisfy 31our working capital and capital expenditure requirements, ~~2019~~we will be required to ~~$98,000~~obtain atadditional ~~December~~credit 31facilities or sell additional equity securities, ~~2020~~or asdelay capital expenditures which could have a ~~result~~ ofmaterial ~~proceeds~~adverse ~~from~~effect ~~the~~on ~~initial~~our ~~sale~~business. ofThere ~~common~~is ~~stock~~no ~~under~~assurance ~~the Lincoln~~that ~~Park~~such ~~Purchase~~financing ~~Agreement~~will inbe ~~December~~available ~~2020~~or that we will be able to complete financing on satisfactory terms, if at all.

~~In March~~As ~~2020, the World Health Organization declared Covid-19 to be a pandemic. Covid-19 has spread throughout the globe, including in the State~~ of ~~New~~December ~~York where our headquarters are located~~31, ~~and in the State of New Jersey where our strip manufacturing facility is located. In response to the outbreak~~2021, we ~~have~~had ~~followed~~ the ~~guidelines~~ offollowing ~~the~~debt/credit U.S. Centers for Disease Control and Prevention (“CDC”) and applicable state government authorities to protect the health and safety of our employees, families, suppliers, customers and communities. While these existing measures and, Covid-19 generally, have not materially disrupted our business operations to date, any future actions necessitated by the Covid-19 pandemic may result in disruption to our business. While we have not seen a disruption in our business operations to date, our drug testing sales have been negatively impacted by the pandemic.facilities:

While the Covid-19 pandemic continues to evolve and as surges continue to occur, we continue to assess the impact of the Covid-19 pandemic to best mitigate risk and continue the operations of our business. The extent to which the outbreak impacts our business, liquidity, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including new information that may emerge concerning the severity or longevity of the Covid-19 pandemic and actions that may be taken to contain it or treat its impact, among others. If we, our customers or suppliers experience (or in some cases continue to experience) prolonged shutdowns or other business disruptions, our business, liquidity, results of operations and financial condition are likely to be materially adversely affected, and our ability to access the capital markets may be limited.

Facility	Debtor	Balance as of December 31, 2021		Due Date
Loan and Security Agreement	Cherokee Financial, LLC	$	1,000,000	February 15, 2022⁽¹⁾
Revolving Line of Credit	Crestmark Bank	$	178,000	June 22, 2022
Term Loan	Cherokee Financial, LLC	$	240,000	February 15, 2022⁽¹⁾
Term Loan	Individual	$	50,000	November 4, 2022
Term Loan	Individuals	$	75,000	June 15, 2022
Total Debt		$	1,543,000

~~In other~~(1) ~~efforts~~Facility towas ~~reduce~~not ~~cash~~repaid ~~requirements,~~on weFebruary ~~have issued shares of restricted stock in lieu of cash. More specifically~~15, we2022 ~~issued 300,000 restricted shares of common stock to Cherokee in connection with a February 2020 debt extension~~ and ~~129,636~~we ~~restricted~~are ~~shares of~~currently ~~common stock to board members~~ in ~~connection~~discussions with ~~their attendance~~Cherokee atrelated ~~meetings~~to ofpossible ~~our~~payoff ~~Board~~ of ~~Directors in~~ the ~~six~~facility ~~months ended June 30, 2020~~ (~~there~~via ~~were~~a norefinance) ~~formal~~or ~~board~~to ~~meetings~~extend ~~held in~~ the ~~second~~due ~~half~~date of ~~Fiscal~~the ~~2020)~~facility.

~~On February~~24 ~~20,~~Table ~~2020, we entered into a Securities Purchase Agreement with Chaim Davis (then the Chairman~~ of our Board of Directors) and certain other accredited investors (the “Investors”), pursuant to which we agreed to issue and sell to the Investors in a private placement (the “Private Placement”), 2,842,856 Units (the “Units”). Each Unit consisted of one (1) share of our common stock, par value $0.01 per share (“Common Share”), at a price per Unit of $0.07 (the “Purchase Price”) for aggregate gross proceeds of approximately $199,000. We received net proceeds of $199,000 from the Private Placement as expenses related to the Private Placement were minimal.Contents

OnWorking ~~June 22,~~Capital 2020, we extended the Crestmark LOC until June 22, 2021. All terms and conditions of the Crestmark LOC remain unchanged under the extension period with the exception of the following, 1) the maximum availability under the Crestmark LOC was reduced from $1,500,000 to $1,000,000, 2) availability under the Crestmark LOC is based on receivables only (under the same terms), 3) the requirement for field audits of the Company was removed, and 4) the Tangible Net Worth (TNW) covenant was removed.Deficit

~~On December~~At 9,the ~~2020,~~end weof ~~entered~~Fiscal ~~into~~2021, awe ~~Purchase~~were ~~Agreement~~operating ~~(the “Purchase~~at ~~Agreement”) and~~ a ~~Registration~~working ~~Rights Agreement~~capital ~~(the~~deficit ~~“Registration~~of ~~Rights Agreement”) with Lincoln Park Capital Fund~~$1,484,000. ~~LLC~~This ~~(“Lincoln~~compares ~~Park”) under which Lincoln Park agreed~~ to ~~purchase~~a ~~from~~working ~~the~~capital ~~Company,~~deficit ~~from~~of ~~time to time, up to~~ $10841,~~250,~~000 ofat ~~our~~the ~~shares~~end of ~~common~~Fiscal ~~stock, par value $0~~2020.01 ~~per~~This ~~share,~~increase ~~subject~~in toworking ~~certain~~capital ~~limitations~~deficit ~~set~~is ~~forth~~primarily ina ~~the Purchase~~result ~~Agreement, during the term~~ of ~~the~~our ~~Purchase~~loans ~~Agreement.~~with ~~We registered~~Cherokee 9Financial,~~750,000~~ ~~shares~~LLC ofbeing ~~common~~classified ~~stock~~as ~~under~~long-term adebt ~~Registration Statement~~in onFiscal ~~Form~~2020 ~~S-1~~and ~~(as~~short ~~amended)~~term ~~and~~debt ~~the~~in ~~Form~~Fiscal ~~S-1~~2021, ~~was~~partially ~~declared effective~~offset by the ~~SEC~~forgiveness onof ~~January~~the ~~11,~~PPP ~~2021~~loan ~~and~~in ~~going~~Fiscal ~~forward~~2021. weWe ~~are able~~have tohistorically ~~utilize~~satisfied ~~the~~working ~~Lincoln~~capital ~~Park~~requirements ~~equity~~through ~~facility~~cash tofrom ~~fund~~ operations ~~(if necessary)~~, ~~pay~~bank ~~down other~~ debt ~~(whenever~~and ~~possible)~~private ~~and~~placements ~~fund~~ of our ~~growth initiatives~~securities.

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

23We have never paid any dividends on our common shares and we anticipate that all future earnings, if any, will be retained for use in our business.

WeCash will continue to take steps to ensure that operating expenses and manufacturing costs remain in line with sales levels. We have consolidated job responsibilities in certain areas of the Company and this enabled us to implement personnel reductions. Sales declines result in lower cash balances and lower availability on our line of credit at times. We are promoting new products and service offerings to diversify our revenue streamFlow, ~~including Covid-19 tests.~~Outlook/Risk

IfIn ~~we are~~Fiscal ~~forced to refinance our debt on less favorable terms~~2021, ~~our results of operations and financial condition could be adversely affected by increased costs and rates. There is also no assurance that~~ we ~~could~~had ~~obtain~~a ~~alternative~~net ~~debt~~loss ~~facilities.~~of ~~We may also be forced to pursue one or more alternative strategies~~$463,000 ~~such~~and ~~as restructuring,~~net ~~selling~~cash ~~assets,~~used ~~reducing~~in oroperating ~~delaying~~activities ~~capital expenditures or seeking additional equity capital. There can be no assurances that any~~ of ~~these strategies could be implemented on satisfactory terms~~$673, ~~if at all~~000.

~~If events~~Our ~~and~~cash ~~circumstances~~position ~~occur~~increased ~~such~~from ~~that~~$98,000 1)at weDecember do31, ~~not~~2020 ~~meet~~to ~~our current~~$115,000 ~~operating~~at ~~plans~~December ~~to increase sales~~31, 2)2021. weCash ~~are~~at ~~unable~~both ~~to raise~~December ~~sufficient~~31, ~~additional~~2020 ~~equity~~and orDecember ~~debt financing~~31, ~~3),~~2021 wewas ~~are unable~~positively toimpacted ~~utilize~~by ~~equity~~proceeds asreceived alate ~~form~~in ofeach ~~payment~~year; inthe ~~lieu~~Lincoln ofPark ~~cash,~~transaction ~~or 4)~~in ~~our~~December ~~credit~~2020 ~~facilities~~(in ~~are~~the ~~insufficient~~amount orof ~~not available~~$125,000) weand ~~may be~~an ~~required~~ERC torefund ~~further~~in ~~reduce~~December ~~expenses~~2021 or(in ~~take~~the ~~other~~amount ~~steps~~of ~~which could have a material adverse effect on our future performance~~$137,000).

~~ITEM~~In 7AFiscal 2020, along with the Lincoln Park proceeds previously discussed, we reserved cash by paying a refinance fee and director attendance fees in shares of restricted stock and converted a loan into restricted shares of stock. ~~QUANTITATIVE~~ ~~AND~~We ~~QUALITATIVE DISCLOSURES~~also ~~ABOUT~~completed ~~MARKET~~a ~~RISK~~private placement of securities in February 2020. In Fiscal 2021, along with the ERC refund previously discussed, we reserved cash by paying interest in shares of restricted stock. We also received proceeds from 1) sales of common stock under our equity line of credit with Lincoln Park ($639,000), 2) a private placement of securities in October 2021 ($100,000) and 3) two shareholder loans in December 2021 (totaling $75,000). Our PPP loan was also forgiven in Fiscal 2021. However, in February 2021, we also incurred penalties in the amount of $120,000 from Cherokee Financial, LLC because we could not pay back our loans in full on February 15, 2021.

AsWhile ~~a smaller~~the ~~reporting~~Covid-19 ~~company~~pandemic is seemingly winding down, we continue to be impacted by it in the form of material delays, cost increases (in both manufacturing and other business costs), labor shortages and decreased sales orders from customers. We are ~~not~~unsure ~~required~~as to ~~provide~~how long we will continue to be impacted negatively. The extent to which the ~~information~~ ~~required~~pandemic ~~under~~may ~~this~~continue ~~item~~to impact our business, liquidity, results of operations and financial condition will depend on future developments, which are still uncertain and cannot be predicted. If we, our customers or suppliers experience (or in some cases continue to experience) business disruptions, our business, liquidity, results of operations and financial condition are likely to be materially adversely affected, and our ability to access the capital markets may be limited.

~~ITEM~~We 8have been able to utilize the Lincoln Park Equity Line; however, in the latter part of Fiscal 2021, purchases were limited due to the downturn of our common stock. ~~FINANCIAL~~We ~~STATEMENTS~~only ~~AND~~completed ~~SUPPLEMENTARY DATA~~one regular purchase in the fourth quarter of Fiscal 2021. All proceeds have been used for working capital.

~~Our Financial~~In ~~Statements~~December 2021, we received one of our ERC refunds (in the amount of $137,000) from the IRS. In Fiscal 2022, we are ~~set~~expecting ~~forth~~two ~~beginning~~more onrefunds; ~~page F-1~~one in the amount of $203,000 and the other in the amount of $197,000; for a total of $400,000.

~~ITEM~~Our 9ability to repay our current debt and other liabilities may also be affected by general economic, financial, competitive, regulatory, legal, business and other factors beyond our control, including those discussed herein. ~~CHANGES~~If INwe ~~AND~~are ~~DISAGREEMENTS~~unable ~~WITH~~to ~~ACCOUNTANTS ON~~meet ~~ACCOUNTING~~our ~~AND~~credit ~~FINANCIAL~~facility ~~DISCLOSURE~~obligations and we are unable to facilitate purchases under our Purchase Agreement with Lincoln Park, we will be required to raise money through new equity and/or debt financing(s) and, there is no assurance that we would be able to find new financing, or that any new financing would be at favorable terms.

~~None.~~25 Table of Contents

~~ITEM~~We 9Awill continue to take steps to ensure that operating expenses and manufacturing costs remain in line with sales levels. ~~CONTROLS~~We ~~AND~~have ~~PROCEDURES~~consolidated job responsibilities in certain areas of the Company and this has enabled us to implement personnel reductions. Sales declines result in lower cash balances and lower availability on our line of credit at times. We are promoting new products and service offerings to diversify our revenue stream, including new Covid-19 tests.

~~Evaluation~~If we are forced to refinance our debt on less favorable terms, our results of ~~Disclosure~~operations ~~Controls~~and financial condition could be adversely affected by increased costs and ~~Procedures~~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.

~~Management~~If ~~has reviewed~~events ~~the~~and ~~effectiveness~~circumstances ofoccur such that 1) we do not meet our ~~“disclosure~~current ~~controls~~operating ~~and procedures”~~plans ~~(as~~to ~~defined~~increase insales, ~~the~~2) ~~Exchange~~we ~~Act~~are ~~Rules~~unable ~~13a-15(e~~to raise sufficient additional equity or debt financing, 3) ~~and~~ ~~15d-15(e~~we are unable to effect sales under the Lincoln Park Equity Line, 4)) we are unable to utilize equity as a form of ~~the~~payment ~~end~~in lieu of ~~the~~cash ~~period~~or ~~covered~~5) byour ~~this~~credit ~~report and~~facilities ~~have~~are ~~concluded~~insufficient ~~that~~or ~~the~~not ~~disclosure~~available, ~~controls~~we ~~and~~may ~~procedures~~be ~~are effective~~required to ~~ensure~~further ~~that~~reduce ~~material~~expenses ~~information~~or ~~relating~~take toother ~~the Company~~steps iswhich ~~recorded,~~could ~~processed,~~have ~~summarized,~~a ~~and~~material ~~reported~~adverse ineffect ~~a timely~~on ~~manner~~our future performance.

24ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

~~Management’s~~As ~~Report~~a onsmaller ~~Internal~~reporting ~~Control~~company, ~~Over~~we ~~Financial Reporting~~are not required to provide the information required under this item.

~~Management~~ITEM ~~is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act~~8. ~~Our~~FINANCIAL ~~internal~~STATEMENTS ~~control~~AND ~~over financial~~SUPPLEMENTARY reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that:DATA

~~(i) pertain~~Our toFinancial ~~the~~Statements ~~maintenance~~are ofset ~~records~~forth ~~that,~~beginning inon ~~reasonable~~page ~~detail, accurately and fairly reflect the transactions and dispositions of our assets;~~F-1.

~~(ii) provide~~Item ~~reasonable~~9. ~~assurance~~Changes ~~that transactions are recorded as necessary to permit preparation of financial statements~~ in ~~accordance~~ ~~with generally accepted accounting principles,~~ and ~~that receipts~~Disagreements ~~and expenditures of the Company are being made only in accordance~~ with ~~authorization~~Accountants ofon ~~Management;~~Accounting and Financial Disclosure

~~(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements~~None.

~~Because of~~ITEM ~~inherent limitations, internal control over financial reporting may not prevent or detect misstatements~~9A. ~~Also,~~CONTROLS ~~projections~~AND ~~of any evaluation of effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions, or the degree of compliance may deteriorate.~~PROCEDURES

~~Management~~Evaluation ~~assessed the effectiveness~~ of ~~our~~Disclosure ~~internal~~Controls ~~control~~and over financial reporting as of December 31, 2020. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organization of the Treadway Commission (COSO) in Internal Control-Integrated Framework. Based on that assessment, Management has concluded that our internal control over financial reporting was effective as of December 31, 2020.Procedures

~~Changes~~Management has reviewed the effectiveness of our “disclosure controls and procedures” (as defined in ~~Internal~~the ~~Control~~Exchange ~~Over~~Act ~~Financial~~Rules ~~Reporting~~13a-15(e) and 15d-15(e)) as of the end of the period covered by this report and have concluded that the 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.

~~There have~~Management’s ~~been~~Report noon ~~changes~~Internal inControl ~~our~~Over ~~internal~~Financial 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.Reporting

~~Attestation~~Management ~~Report~~is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of ~~Independent~~financial ~~Registered~~reporting ~~Public~~and ~~Accounting Firm~~the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that:

~~This annual~~(i) ~~report~~pertain ~~does~~to ~~not~~the ~~include~~maintenance ~~an attestation report~~ of ~~our independent~~records ~~registered~~that, ~~public~~in ~~accounting~~reasonable ~~firm~~detail, ~~regarding~~accurately ~~internal control~~and ~~over~~fairly ~~financial~~reflect ~~reporting.~~the ~~Management's~~transactions ~~report~~and ~~was~~dispositions ~~not subject~~of ~~to attestation by~~ our ~~independent registered public accounting firm pursuant to rules of the SEC that exempt smaller reporting companies from this requirement.~~assets;

~~ITEM~~26 ~~9B.~~Table ~~OTHER~~of ~~INFORMATION~~Contents

~~None.~~(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorization of Management; and

25(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

~~PART~~Because ~~III~~of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions, or the degree of compliance may deteriorate.

~~ITEM~~Management 10assessed the effectiveness of our internal control over financial reporting as of December 31, 2020. ~~DIRECTORS~~ In making this assessment, ~~EXECUTIVE~~management ~~OFFICERS~~used the criteria set forth by the Committee of Sponsoring Organization of the Treadway Commission (COSO) in Internal Control-Integrated Framework. Based on that assessment, ~~AND CORPORATE~~Management ~~GOVERNANCE~~has concluded that our internal control over financial reporting was effective as of December 31, 2020.

~~The information~~Changes ~~required by this item is contained~~ in ~~our~~Internal ~~definitive Proxy~~Control ~~Statement~~Over with respect to our Annual Meeting of Shareholders for Fiscal 2020, under the captions “Discussion of Proposal Recommended by Board”, “Directors that are not Nominees”, “Additional Executive Officers and Senior Management”, “Section 16(a) Beneficial Ownership Reporting Compliance”, “Code of Ethics”, “Nominating Committee”, “Audit Committee” and “Audit Committee Financial ~~Expert” and is incorporated herein by reference.~~Reporting

~~ITEM~~There ~~11. EXECUTIVE~~have ~~COMPENSATION~~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.

~~The information~~Attestation ~~required~~Report ~~by this item is contained in our definitive Proxy Statement with respect to our Annual Meeting~~ of ~~Shareholders for~~Independent ~~Fiscal~~Registered ~~2020,~~Public ~~under~~Accounting the captions “Executive Compensation”, “Compensation of Directors”, “Compensation Committee Interlocks and Insider Participation”, and “Compensation Committee Report”, and is incorporated herein by reference.Firm

~~ITEM~~This 12annual report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. ~~SECURITY~~ ~~OWNERSHIP~~Management's OFreport ~~CERTAIN BENEFICIAL~~was ~~OWNERS~~not ~~AND~~subject ~~MANAGEMENT~~to ~~AND~~attestation ~~RELATED~~by ~~STOCKHOLDER MATTERS~~our independent registered public accounting firm pursuant to rules of the SEC that exempt smaller reporting companies from this requirement.

~~The information~~ITEM ~~required by this item is contained within Part II, Item 5~~9B. ~~Market~~ ~~for Registrant’s~~OTHER Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities earlier in this Annual Report on Form 10-K and in our definitive Proxy Statement with respect to the Annual Meeting of Shareholders for Fiscal 2020, under the caption “Security Ownership of Certain Beneficial Owners and Management” and is incorporated herein by reference.INFORMATION

~~ITEM 13~~None. ~~CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE~~

~~The information~~ITEM ~~required~~9C. byDISCLOSURE ~~this~~REGARDING ~~item~~FOREIGN isJURISDICTIONS ~~contained~~THAT inPREVENT our definitive Proxy Statement with respect to the Annual Meeting of Shareholders for Fiscal 2020, under the captions “Certain Relationships and Related Transactions” and “Independent Directors”, and is incorporated herein by reference.INSPECTIONS

~~ITEM~~Not 14applicable. ~~PRINCIPAL ACCOUNTING FEES AND SERVICES~~

~~The information~~27 ~~required~~Table ~~by this item is contained in our definitive Proxy Statement with respect to the Annual Meeting~~ of ~~Shareholders for Fiscal 2020, under the caption “Independent Public Accountants”, and is incorporated herein by reference.~~Contents

26PART III

~~PART~~ITEM IV10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE

~~ITEM~~The ~~15. EXHIBITS~~information required by this item is contained in our definitive Proxy Statement with respect to our Annual Meeting of Shareholders for Fiscal 2021, ~~FINANCIAL~~under ~~STATEMENT SCHEDULES~~the captions “Information about the Board of Directors” “Executive Officer”, “Additional Senior Management”, “Section 16(a) Beneficial Ownership Reporting Compliance”, “Code of Ethics”, “Nominating Committee”, “Audit Committee” and “Audit Committee Financial Expert” and is incorporated herein by reference.

~~(a) The following~~ITEM ~~documents~~11. ~~are~~EXECUTIVE ~~filed as part of this Annual Report on Form 10-K:~~COMPENSATION

~~(1) Our financial~~The ~~statements~~information required by this item is contained in our definitive Proxy Statement with respect to our Annual Meeting of Shareholders for Fiscal 2021, under the captions “Executive Compensation”, “Compensation of Directors”, “Compensation Committee Interlocks and Insider Participation”, and “Compensation Committee Report”, and is incorporated herein by reference.

	PAGE
Report of Independent Registered Public Accounting Firm – UHY LLP	F-2
Balance Sheets	F-4
Statements of Operations	F-5
Statements of Changes in Stockholders’ Deficit	F-6
Statements of Cash Flows	F-7
Notes to Financial Statements	F-8

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

~~(2) Financial~~ The information required by this item is contained within Part II, Item 5.Market for Registrant’s Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities earlier in this Annual Report on Form 10-K and in our definitive Proxy Statement ~~Schedule~~with respect to the Annual Meeting of Shareholders for Fiscal 2021, under the caption “Security Ownership of Certain Beneficial Owners and Management” and is incorporated herein by reference.

~~(3)~~ The information required by this item is contained in our definitive Proxy Statement with respect to the Annual Meeting of Shareholders for Fiscal 2021, under the captions “Certain Relationships and Related Transactions” and “Independent Directors”, and is incorporated herein by reference.

~~See~~ITEM ~~Item~~14. ~~15(b)~~PRINCIPAL ~~of this~~ACCOUNTING ~~Annual~~FEES ~~Report~~AND ~~on Form 10-K.~~SERVICES

~~ITEM~~The ~~16.~~information ~~FORM~~required ~~10-K~~by ~~SUMMARY~~this item is contained in our definitive Proxy Statement with respect to the Annual Meeting of Shareholders for Fiscal 2021, under the caption “Independent Public Accountants”, and is incorporated herein by reference.

We28 ~~are not~~Table ~~required~~of ~~to provide this information.~~Contents

27PART IV

~~(b)~~ ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

~~Exhibits~~(a) The following documents are filed as part of this Annual Report on Form 10-K:

Number	Description of Exhibits
3.1	Certificate of Incorporation(1)
3.5	Amended and Restated Bylaws (2)
3.51	Amended and Restated Bylaws (3)
3.7	Sixth amendment to the Certificate of Incorporation (2)
4.26	Securities Purchase Agreement(4)
10.8	Lease dated August 1, 1999/New Jersey facility (5)
10.40	Employment Contract between the Company and Melissa A. Waterhouse(6)
10.43	Amendment No. 11 to New Jersey facility lease, dated November 20, 2017(7)
10.44	Amendment No. 12 to New Jersey facility lease, dated December 24, 2019(8)
10.45	Purchase Agreement dated December 8, 2020 by and between the Company and Lincoln Park Capital Fund, LLC(9)
10.46	Registration Rights Agreement dated December 8, 2020 by and between the Company and Lincoln Park Capital Fund, LLC(9)
10.49	Fiscal 2001 Nonstatutory Stock Option Plan (filed as part of the Company’s Proxy Statement for its Fiscal 2002 Annual Meeting and incorporated herein by reference) (a)(b)
10.50	2013 Equity Compensation Plan (filed as Appendix A to the Company’s Proxy Statement for its fiscal year ended December 31, 2012 and incorporated herein by reference)(a)(c)
31.1 & 31.2	Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer/Chief Financial Officer
32.1 & 32.2	Section 1350 Certification of the Chief Executive Officer/Chief Financial Officer
101	The following materials from our Annual Report on Form 10-K for the year ended December 31, 2020, formatted in XBRL (Extensible Business Reporting Language): (i) Balance Sheet, (ii) Statements of Income (iii) Statements of Cash Flows, (iv) Statements of Changes in Stockholders’ Equity and (v) Notes to Financial Statements.

(1) Our financial statements

(a)

			PAGE
Report of Current Independent Registered Public Accounting Firm – Rosenfield & Co., PLLC			F-2
Report of Prior Independent Registered Public Accounting Firm – UHY LLP			F-3
Balance Sheets			F-4
Statements of Operations			F-5
Statements of Changes in Stockholders’ Deficit			F-6
Statements of Cash Flows			F-7
Notes to Financial Statements			F-8

~~Indicates~~(2) ~~an employee~~Financial ~~benefits~~Statement ~~plan, management contract or compensatory plan or arrangement in which a named executive officer participates.~~Schedule

As a smaller reporting company, we are only required to provide financial statements required by Article 8 of Regulation S-X in lieu of financial statements that may be required under Part II, Item 8 of this Annual Report on Form 10-K, and these financial statements are noted under Item 15(ba)(1).

~~Previously~~(3) ~~noted~~See ~~as Exhibit~~Item ~~4.17~~15(b) inof ~~the~~this ~~Company’s~~Annual Report on Form 10-K ~~filed on June 26, 2020~~.

~~(c)~~ITEM 16. FORM 10-K SUMMARY

~~Previously~~We ~~noted~~are ~~as Exhibit~~not ~~4.25~~required into ~~the~~provide ~~Company’s~~this ~~Form 10-K filed on June 26, 2020~~information.

~~(1)~~29 Table of Contents

~~Filed~~(b) ~~as the exhibit number listed to the Company’s Form 10-SB filed on November 21, 1996.~~Exhibits

(2)

Number		Description of Exhibits

3.1		Certificate of Incorporation⁽¹⁾
3.5		Amended and Restated Bylaws ⁽²⁾
3.51		Amended and Restated Bylaws ⁽³⁾
3.7		Sixth amendment to the Certificate of Incorporation ⁽²⁾
3.8		Seventh amendment to the Certificate of Incorporation⁽⁴⁾
4.26		Securities Purchase Agreement⁽⁵⁾
4.28		Securities Purchase Agreement⁽⁶⁾
10.8		Lease dated August 1, 1999/New Jersey facility ⁽⁷⁾
10.40		Employment Contract between the Company and Melissa A. Waterhouse⁽⁸⁾
10.43		Amendment No. 11 to New Jersey facility lease, dated November 20, 2017⁽⁹⁾
10.44		Amendment No. 12 to New Jersey facility lease, dated December 24, 2019⁽¹⁰⁾
10.45		Purchase Agreement dated December 8, 2020 by and between the Company and Lincoln Park Capital Fund, LLC⁽¹¹⁾
10.46		Registration Rights Agreement dated December 8, 2020 by and between the Company and Lincoln Park Capital Fund, LLC⁽¹¹⁾
10.49		Fiscal 2001 Nonstatutory Stock Option Plan (filed as part of the Company’s Proxy Statement for its Fiscal 2002 Annual Meeting and incorporated herein by reference) ^(a)(b)
10.50		2013 Equity Compensation Plan (filed as Appendix A to the Company’s Proxy Statement for its fiscal year ended December 31, 2012 and incorporated herein by reference)^(a)(c)
31.1 & 31.2		Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer/Chief Financial Officer
32.1 & 32.2		Section 1350 Certification of the Chief Executive Officer/Chief Financial Officer
101		The following materials from our Annual Report on Form 10-K for the year ended December 31, 2021, formatted in XBRL (Extensible Business Reporting Language): (i) Balance Sheet, (ii) Statements of Income (iii) Statements of Cash Flows, (iv) Statements of Changes in Stockholders’ Equity and (v) Notes to Financial Statements.

~~Filed~~(a) asIndicates ~~the exhibit~~an ~~number~~employee ~~listed~~benefits toplan, ~~the~~management ~~Company’s~~contract ~~Form~~or ~~10-KSB~~compensatory ~~filed April~~plan ~~15,~~or ~~2002~~arrangement ~~and~~in ~~incorporated~~which ~~herein~~a bynamed ~~reference~~executive officer participates.

(3b) Previously noted as Exhibit 4.17 in the Company’s Form 10-K filed on June 26, 2020.

~~Filed~~(c) asPreviously ~~the exhibit~~noted ~~number~~as ~~listed~~Exhibit to4.25 in the Company’s ~~Current Report on~~ Form 8 10-K filed on ~~October~~June 1826, ~~2007 and incorporated herein by reference~~2020.

(41) Filed as the exhibit number listed to the Company’s Form 10-SB filed on November 21, 1996.

(2) Filed as the exhibit number listed to the Company’s ~~Current Report on~~ Form 8 10-KKSB filed onApril ~~December 26~~15, ~~2018~~2002 and incorporated herein by reference.

(53) Filed as the exhibit number listed to the Company’s Current Report on Form 8-K filed on October 18, 2007 and incorporated herein by reference.

(4) Filed as the exhibit number listed to ~~the~~this ~~Company’s~~Annual ~~Form~~Report ~~10-KSB filed~~ on ~~August~~ ~~11,~~Form ~~2000 and incorporated herein by reference~~10-K.

(65) Filed as the exhibit number listed to the Company’ Current Report on Form 8-K filed on December 26, 2018 and incorporated herein by reference.

~~Filed~~(6) Files as the exhibit number listed to the Company’s Current Report on Form 8-K filed ~~with~~on ~~the~~October ~~Commission~~22, on2021 ~~June~~and ~~24,~~incorporated ~~2014~~herein by reference.

(7) Filed as the exhibit number listed to the Company’s Form 10-KSB filed on August 11, 2000 and incorporated herein by reference.

(8) Filed as the exhibit number listed to the Company’s Current Report on Form 108-K filed ~~on April~~with ~~12,~~the ~~2018~~Commission ~~and~~on ~~incorporated~~June ~~herein~~24, ~~by reference~~2014.

(89) Filed as the exhibit number listed to the Company’s Form 10-K filed on April 12, 2018 and incorporated herein by reference.

(10) Filed as the exhibit number listed to the Company’s Annual Report on Form 10-K filed on June 26, 2020.

(911) Filed as the exhibit number listed to the Company’s Current Report on Form 8-K filed on December 10, 2020.

~~Filed~~30 asTable ~~the exhibit~~of ~~number listed to the Company’s Current Report on Form 8-K filed on December 10, 2020.~~Contents

28SIGNATURES

~~SIGNATURES~~In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

~~In accordance~~AMERICAN ~~with~~BIO ~~Section~~MEDICA 13CORPORATION orBy: ~~15(d)~~/s/ ofMelissa ~~the~~A. ~~Exchange~~Waterhouse ~~Act,~~Melissa ~~the registrant~~A. ~~caused~~Waterhouse ~~this~~Chief ~~report~~Executive toOfficer be(Principal ~~signed~~Executive onOfficer) ~~its~~Principal ~~behalf~~Financial byOfficer ~~the undersigned~~Principal ~~thereunto~~Accounting ~~duly authorized.~~Officer

	AMERICAN BIO MEDICA CORPORATION
Date: April 15, 2021	By:	/s/ Melissa A. Waterhouse
		Melissa A. Waterhouse
		Chief Executive Officer (Principal Executive Officer) Principal Financial Officer Principal Accounting Officer Title

Date: April 14, 2022

In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on April 1514, ~~2021~~2022:

~~By:~~ /s/ Melissa A. Waterhouse ~~Melissa A. Waterhouse~~ Chief Executive Officer (Principal Executive Officer) Melissa A. Waterhouse Principal Financial Officer Principal Accounting Officer ~~Title~~/s/ Peter Jerome Director Peter Jerome /s/ Jean Neff Director and Corporate Secretary Jean Neff

~~By:~~S-1 ~~/s/~~Table ~~Peter~~of ~~Jerome Peter Jerome Director~~Contents

~~By:~~AMERICAN ~~/s/~~BIO ~~Jean~~MEDICA ~~Neff Jean Neff Director and Corporate Secretary~~CORPORATION

~~S-1~~INDEX TO FINANCIAL STATEMENTS AND NOTES TO FINANCIAL STATEMENTS

AMERICAN BIO MEDICA CORPORATION

		PAGE

Report of Current Independent Registered Public Accounting Firm – Rosenfield & Co. , PLLC		F-2

Report of Prior Independent Registered Public Accounting Firm – UHY LLP		F-3

Balance Sheets		F-4

Statements of Operations		F-5

Statements of Changes in Stockholders’ Deficit		F-6

Statements of Cash Flows		F-7

Notes to Financial Statements		F-8

~~INDEX~~F-1 TOTable ~~FINANCIAL~~of ~~STATEMENTS AND NOTES TO FINANCIAL STATEMENTS~~Contents

	PAGE
Report of Independent Registered Public Accounting Firm – UHY LLP	F-2
Balance Sheets	F-4
Statements of Operations	F-5
Statements of Changes in Stockholders’ Deficit	F-6
Statements of Cash Flows	F-7
Notes to Financial Statements	F-8

REPORT OF CURRENT INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

~~F-1~~Board of Directors and Stockholders

~~REPORT~~American OFBio ~~INDEPENDENT~~Medica ~~REGISTERED PUBLIC ACCOUNTING FIRM~~Corporation

ToOpinion on the ~~Board~~Financial ~~of Directors and~~Statements

~~Stockholders~~We have audited the accompanying balance sheet of American Bio Medica Corporation (the “Company”) as of December 31, 2021, and the related statements of operations, changes in stockholders’ deficit, and cash flows for the year then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021, and the results of its operations and its cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America.

~~Opinion~~Substantial onDoubt about the ~~Financial~~Company’s ~~Statements~~ability to Continue as a Going Concern

WeThe accompanying financial statements have ~~audited~~been prepared assuming that the ~~accompanying~~Company ~~balance~~will ~~sheets~~continue ofas ~~American~~a ~~Bio Medica~~going ~~Corporation~~concern. ~~(the~~As ~~Company)~~discussed asin ofNote ~~December~~A 31to the financial statements, ~~2020~~the ~~and~~entity ~~2019~~has suffered recurring losses from operations, ~~and~~ has had to rely on the ~~related~~continued ~~statements~~forbearance of ~~operations~~its creditors, ~~changes~~has in a stockholders’ deficit, and its current cash ~~flows~~position ~~for~~and ~~each~~lack of ~~the~~access ~~years in~~to ~~the~~capital ~~two-year~~raise ~~period~~substantial ~~ended~~doubt ~~December 31,~~about ~~2020,~~its ~~and~~ability ~~the related~~to ~~notes~~continue ~~(collectively~~as ~~referred~~a togoing asconcern. ~~the~~Management's ~~financial statements).~~plans Inin ~~our~~regard ~~opinion,~~to ~~the~~these ~~financial~~matters ~~statements present~~are ~~fairly,~~also described in ~~all~~Note ~~material~~A. ~~respects~~Also, ~~the~~discussed ~~financial~~in ~~position~~Note of L, the Company asdid not make the required payments on debt obligations of ~~December 31~~$1,240,000 ~~2020~~plus ~~and~~interest ~~2019~~of $38,300 ~~and~~that ~~the~~was ~~results of~~due ~~its~~in ~~operations~~February 2022 and ~~its~~are ~~cash~~currently ~~flows~~in ~~for~~negotiations ~~each~~with oftheir ~~the~~lender. ~~years~~The infinancial ~~the two-year~~statements ~~period~~do ~~ended~~not ~~December~~include ~~31,~~any ~~2020,~~adjustments inthat ~~conformity~~might ~~with accounting~~result ~~principles~~from ~~generally~~the ~~accepted~~outcome inof ~~the~~this ~~United~~uncertainty. ~~States~~Our ~~of America~~opinion is not modified with respect to this matter.

~~Substantial~~Basis ~~Doubt~~for ~~about the Company’s Ability to Continue as a Going Concern~~Opinion

~~The~~These ~~accompanying~~ financial statements ~~have~~are ~~been~~the ~~prepared~~responsibility ~~assuming that~~of ~~American~~the ~~Bio~~Company’s ~~Medica~~management. ~~Corporation~~Our ~~will~~responsibility ~~continue~~is asto aexpress ~~going concern.~~an Asopinion ~~discussed~~on inthese ~~Note A to the~~ financial statements, ~~the Company~~based ~~has~~on ~~incurred~~our ~~recurring~~audit. ~~operating~~We ~~losses~~are ~~and~~a ~~its~~public ~~current cash~~accounting ~~position~~firm ~~and~~registered ~~lack~~with ofthe ~~access~~Public toCompany ~~capital~~Accounting ~~raise~~Oversight ~~substantial~~Board ~~doubt about~~(United ~~the~~States) ~~Company’s~~("PCAOB") ~~ability~~and toare ~~continue~~required asto abe ~~going concern.~~independent ~~Management’s~~with ~~evaluation~~respect ofto the ~~events~~Company ~~and conditions~~in ~~and~~accordance ~~management’s~~with ~~plans~~the ~~regarding those matters also are described in Note A~~U.S. ~~The~~federal ~~financial~~securities ~~statements~~laws ~~do not~~and ~~include~~the ~~any~~applicable ~~adjustments~~rules ~~that~~and ~~might~~regulations ~~result~~of ~~from~~ the ~~outcome~~Securities ~~of this~~and ~~uncertainty.~~Exchange ~~Our~~Commission ~~opinion~~and isthe ~~not modified with respect to that matter~~PCAOB.

~~Basis~~We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for ~~Opinion~~the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

~~These financial~~Our ~~statements~~audits ~~are~~included performing procedures to assess the ~~responsibility~~risks of material misstatement of the ~~Company’s management.~~financial ~~Our~~statements, ~~responsibility~~whether isdue to ~~express~~error anor ~~opinion~~fraud, onand ~~the Company’s~~performing ~~financial~~procedures ~~statements~~that ~~based~~respond onto ~~our~~those ~~audits~~risks. WeSuch ~~are~~procedures included examining, on a ~~public~~ ~~accounting~~test ~~firm~~basis, ~~registered~~evidence ~~with~~regarding the ~~Public~~amounts ~~Company Accounting~~and ~~Oversight~~disclosures ~~Board~~in ~~(United~~the ~~States)~~financial ~~(PCAOB)~~statements. ~~and~~Our ~~are~~audit ~~required to~~also beincluded ~~independent~~evaluating ~~with~~the ~~respect~~accounting toprinciples ~~the~~used ~~Company~~and insignificant ~~accordance~~estimates ~~with the~~made ~~U.S.~~by ~~federal~~management, ~~securities~~as ~~laws~~well ~~and~~as evaluating the ~~applicable~~overall ~~rules~~presentation ~~and regulations~~ of the ~~Securities~~financial ~~and~~statements. ~~Exchange~~We ~~Commission~~believe ~~and~~that ~~the PCAOB~~our audit provides a reasonable basis for our opinion.

~~We conducted~~Critical ~~our~~Audit audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.Matters

~~Our audits~~The ~~included~~critical ~~performing~~audit ~~procedures~~matter tocommunicated ~~assess~~below is a matter arising from the ~~risks~~current ~~of material~~period ~~misstatement~~audit of the financial statements, ~~whether~~that ~~due~~was ~~to error~~communicated or ~~fraud,~~required to be communicated to the audit committee and ~~performing~~that: ~~procedures~~(1) relate to accounts or disclosures that ~~respond~~are material to ~~those risks.~~the ~~Such~~financial ~~procedures~~statements ~~included~~and ~~examining,~~(2) oninvolved aour ~~test~~especially ~~basis~~challenging, ~~evidence~~ ~~regarding~~subjective, ~~the~~or ~~amounts~~complex ~~and~~judgments. ~~disclosures~~The incommunication ~~the~~of ~~financial statements.~~critical ~~Our~~audit ~~audits~~matters ~~also~~does ~~included~~not ~~evaluating~~alter ~~the~~in ~~accounting principles~~any ~~used~~way ~~and~~our ~~significant~~opinion ~~estimates~~on ~~made~~the byfinancial ~~management~~statements, ~~as well~~taken as ~~evaluating~~a whole, and we are not, by communicating the ~~overall~~critical ~~presentation~~audit ofmatter below, providing a separate opinion on the ~~financial statements.~~critical Weaudit ~~believe~~matter ~~that~~or ~~our~~on ~~audits~~the ~~provide~~accounts aor ~~reasonable~~disclosures ~~basis for~~to ~~our~~which ~~opinion~~it relates.

~~Critical~~Inventory ~~Audit Matters~~Valuation

~~The critical~~As ~~audit~~discussed ~~matters~~in ~~communicated~~Note ~~below~~A ~~are~~to ~~matters~~the ~~arising~~financial ~~from the~~statements, ~~current~~inventory ~~period~~is ~~audit~~stated ofat the ~~financial~~lower ~~statements~~of ~~that~~cost ~~were communicated~~ or ~~required~~net torealizable bevalue. ~~communicated~~Work toin ~~the~~process ~~audit committee~~ and ~~that:~~finished ~~(1)~~goods ~~relate~~are tocomprised ~~accounts~~of orlabor, ~~disclosures~~overhead ~~that~~and ~~are~~raw material to ~~the~~costs. ~~financial~~Labor ~~statements,~~ and ~~(2)~~overhead ~~involved~~costs ~~especially challenging,~~are ~~subjective,~~determined oron ~~complex~~a ~~judgments.~~rolling ~~The~~month ~~communication~~average ~~of critical~~cost ~~audit~~basis ~~matters~~and ~~does~~raw ~~not~~materials ~~alter~~are indetermined ~~any~~on ~~way~~an ~~our~~average ~~opinion~~cost onbasis. ~~the financial~~The ~~statements,~~Company ~~taken~~performs asanalyses ato ~~whole,~~identify and weestimate ~~are not by communicating~~ the ~~critical~~net ~~audit~~realizable ~~matters~~value ~~below,~~of ~~providing~~excess ~~separate opinions~~or onslow-moving ~~the~~inventory ~~critical~~based ~~audit matter or~~ on ~~the~~assumptions ~~accounts~~about ~~or disclosures~~obsolescence toand ~~which~~deterioration ~~they~~and ~~relate~~historical demand.

FWe identified the assessment of lower of cost or net realizable value of inventory as a critical audit matter. The costs incurred and transferred throughout the steps in the production cycle and the estimate for excess or slow-2moving inventory is difficult to assess and required significant auditor judgment. In addition, if future market conditions and demand do not materialize, additional inventory allowances and/or write downs may be required.

~~Inventory~~The ~~Valuation~~following are the primary procedures we performed to address the critical audit matter. We performed statistical sampling to assess the actual costs incurred and the transfer of costs throughout production process by obtaining evidence supporting the actual cost of raw materials, labor and overhead. We also evaluated the Company’s determination of lower of cost or net realizable value of excess or slow-moving inventory by testing the completeness and accuracy of the underlying data used in the estimates. We also evaluated for reasonableness, based on historical sales of its products and its plans to increase sales.

AsWe ~~discussed~~have inserved ~~Note~~as ~~1 to~~ the financial statements, inventory is stated at the lower of cost or net realizable value. Work in process and finished goods are comprised of labor, overhead and raw material costs. Labor and overhead costs are determined on a rolling month average cost basis and raw materials are determined on an average cost basis. The Company’s ~~maintains~~auditor ansince ~~allowance for slow moving and obsolete inventory based upon its assumptions about obsolescence, excessive levels of inventory, deterioration, future demand and market conditions~~2021.

We/s/ Rosenfield ~~identified the inventory valuation as a critical audit matter. Due to the frequent movement of products, the steps that a product takes through the production cycle, assumptions~~ and ~~estimates regarding product yields and inefficiency rates~~Company, ~~and the variety of costs incurred, significant auditor judgement was required to evaluate the amounts recorded as the costs are incurred and transferred throughout steps in the production process.~~PLLC

InNew ~~addition~~York, ifNew actual market conditions are less favorable than those projected by management, additional inventory allowances or write-downs of inventory may be required. A significant amount of judgement is required by management in developing the assumptions of the excess and obsolete inventories, as well as its estimates of forecasted product demand, which in turn led to significant auditor judgement and effort in performing audit procedures and evaluating audit evidence relating to inventory valuation.York

~~The~~April ~~following are the primary procedures we performed to address this critical audit matter. For a sample of transactions~~12, we assessed the actual costs incurred and the transfer of costs throughout production process by obtaining evidence supporting the actual cost of raw materials, labor and overhead. We traced the accumulation of actuals costs to bills of materials, and tested management’s average costs calculations based upon the underlying actual cost data. In addition, we tested management’s process for developing its estimate of excess or obsolete inventory, and tested the completeness and accuracy of the underlying data used in the estimate, and we evaluated management’s assumptions of forecasted product demand. Evaluating management’s demand forecast for reasonableness involved considering historical sales of its products, and determining whether the demand forecast used was consistent with evidence obtained in other areas of the audit.2022

~~/s/~~(PCAOB ~~UHY LLP~~id 5905)

WeF-2 ~~have served~~Table asof ~~the Company’s auditor since 2015.~~Contents

~~Albany, New~~REPORT ~~York~~OF PRIOR INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

~~April 15,~~Consent ~~2021~~of Independent Registered Public Accounting Firm

FWe hereby consent to use of our report dated April 15, 2021, with respect to the balance sheets of American Bio Medica Corporation (the “Company”), as of December 31, 2020 and 2019, and the related statements of operations, stockholders’ deficit, and cash flows for each of the two years in the period ended December 31, 2020, included in American Bio Medica Corporation’s annual report on Form 10-3K for the fiscal year ended December 31, 2021.

~~AMERICAN BIO~~/s/ ~~MEDICA~~UHY ~~CORPORATION~~ LLP

~~Balance Sheets~~Albany, New York

	December 31,	December 31,
	2020	2019
ASSETS
Current assets
Cash and cash equivalents	$98,000	$4,000
Accounts receivable, net of allowance for doubtful accounts of $22,000 at December 31, 2020 and $34,000 at December 31, 2019	407,000	370,000
Inventory, net of allowance of $279,000 at December 31, 2020 and $291,000 at December 31, 2019	536,000	810,000
Prepaid expenses and other current assets	104,000	6,000
Right of use asset – operating leases	35,000	34,000
Total current assets	1,180,000	1,224,000
Property, plant and equipment, net	576,000	644,000
Patents, net	108,000	116,000
Right of use asset – operating leases	41,000	73,000
Other assets	21,000	21,000
Total assets	$1,926,000	$2,078,000
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities
Accounts payable	$577,000	$652,000
Accrued expenses and other current liabilities	620,000	518,000
Right of use liability – operating leases	33,000	34,000
Wages payable	107,000	104,000
Line of credit	277,000	337,000
PPP Loan	332,000	0
Current portion of long-term debt, net of deferred finance costs	75,000	42,000
Total current liabilities	2,021,000	1,687,000
Long-term debt/other liabilities, net of current portion and deferred financing costs	1,120,000	1,108,000
Right of use liability – operating leases	41,000	73,000
Total liabilities	3,182,000	2,868,000
COMMITMENTS AND CONTINGENCIES
Stockholders’ deficit:
Preferred stock; par value $.01 per share; 5,000,000 shares authorized, none issued and outstanding	0	0
Common stock; par value $.01 per share; 50,000,000 shares authorized; 37,703,476 issued and outstanding as of December 31, 2020 and 32,680,984 issued and outstanding as of December 31, 2019	377,000	327,000
Additional paid-in capital	21,717,000	21,437,000
Accumulated deficit	(23,350,000)	(22,554,000)
Total stockholders’ (deficit)	(1,256,000)	(790,000)
Total liabilities and stockholders’ (deficit)	$1,926,000	$2,078,000

April 14, 2022

~~The accompanying~~F-3 ~~notes~~Table ~~are an integral part~~ of ~~the financial statements.~~Contents

~~F-4~~AMERICAN BIO MEDICA CORPORATION

~~AMERICAN BIO~~Balance ~~MEDICA CORPORATION~~Sheets

Statements of Operations

	December 31,			December 31,
	2021			2020
ASSETS
Current assets
Cash and cash equivalents	$	115,000		$	98,000
Accounts receivable, net of allowance for doubtful accounts of $3,000 at December 31, 2021 and $22,000 at December 31, 2020		323,000			407,000
Inventory, net of allowance of $278,000 at December 31, 2021 and $279,000 at December 31, 2020		443,000			536,000
Employee retention credit receivable		400,000			0
Prepaid expenses and other current assets		24,000			104,000
Right of use asset – operating leases		35,000			35,000
Total current assets		1,340,000			1,180,000
Property, plant and equipment, net		517,000			576,000
Patents, net		0			108,000
Right of use asset – operating leases		5,000			41,000
Other assets		21,000			21,000
Total assets	$	1,883,000		$	1,926,000
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities
Accounts payable	$	682,000		$	577,000
Accrued expenses and other current liabilities		467,000			620,000
Right of use liability – operating leases		35,000			33,000
Wages payable		97,000			107,000
Line of credit		178,000			277,000
PPP loan		0			332,000
Current portion of long-term debt, net of deferred finance costs		1,365,000			75,000
Total current liabilities		2,824,000			2,021,000
Long-term debt/other liabilities, net of current portion and deferred financing costs		0			1,120,000
Right of use liability – operating leases		3,000			41,000
Total liabilities		2,827,000			3,182,000
COMMITMENTS AND CONTINGENCIES
Stockholders’ (deficit):
Preferred stock; par value $0.01 per share; 5,000,000 shares authorized, issued and outstanding		0			0
Common stock; par value $0.01 per share; 50,000,000 shares authorized; 47,598,476 issued and outstanding as of December 31, 2021 and 37,703,476 issued and outstanding as of December 31, 2020		476,000			377,000
Additional paid-in capital		23,393,000			21,717,000
Accumulated deficit		(23,813,000	)		(23,350,000	)
Total stockholders’ (deficit)		(944,000	)		(1,256,000	)
Total liabilities and stockholders’ (deficit)	$	1,883,000		$	1,926,000

	Year Ended December 31,
	2020	2019
Net sales	$4,147,000	$3,655,000
Cost of goods sold	2,909,000	2,471,000
Gross profit	1,238,000	1,184,000
Operating expenses:
Research and development	90,000	82,000
Selling and marketing	493,000	459,000
General and administrative	1,276,000	1,236,000
	1,859,000	1,777,000
Operating loss	(621,000)	(593,000)
Other income / (expense):
Interest expense	(175,000)	(265,000)
Other income, net	2,000	172,000
	(173,000)	(93,000)
Net loss before tax	(794,000)	(686,000)
Income tax (expense) / benefit	(2,000)	5,000
Net loss	$(796,000)	$(681,000)
Basic and diluted loss per common share	$(0.02)	$(0.02)
Weighted average number of shares outstanding – basic and diluted	35,558,105	32,526,669


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

~~The accompanying~~F-4 ~~notes~~Table ~~are an integral part~~ of ~~the financial statements.~~Contents

~~F-5~~AMERICAN BIO MEDICA CORPORATION

~~AMERICAN BIO~~Statements ~~MEDICA~~of ~~CORPORATION~~Operations

Statements of Changes in Stockholders’ Deficit

	Year Ended December 31,
	2021			2020

Revenue, net	$	2,218,000		$	4,147,000

Cost of goods sold		1,670,000			2,909,000

Gross profit		548,000			1,238,000

Operating expenses:
Research and development		85,000			90,000
Selling and marketing		304,000			493,000
General and administrative		1,338,000			1,276,000
Total Operating Expenses		1,727,000			1,859,000

Operating loss		(1,179,000	)		(621,000	)

Other income / (expense):
Interest expense		(194,000	)		(175,000	)
Other income, net		58,000			2,000
Gain on forgiveness of PPP loan		335,000			0
Employee retention credit		619,000			0
Patent asset impairment		(100,000	)		0
Total other income / (expense)		718,000			(173,000	)

Loss before income tax expense		(461,000	)		(794,000	)

Income tax expense		(2,000	)		(2,000	)

Net loss	$	(463,000	)	$	(796,000	)

Basic and diluted loss per common share	$	(0.01	)	$	(0.02	)

Weighted average number of shares outstanding – basic and diluted		42,761,065			35,558,105

	Common Stock
	Shares	Amount	Additional Paid-in Capital	Accumulated Deficit	Total
Balance – January 1, 2019	32,279,368	$323,000	$21,404,000	$(21,873,000)	$(146,000)
Shares issued to Cherokee in connection with loan	200,000	2,000	12,000		14,000
Shares issued for board meeting attendance in lieu of cash	201,616	2,000	15,000		17,000
Share based payment expense			6,000		6,000
Net loss				(681,000)	(681,000)
Balance – December 31, 2019	32,680,984	$327,000	$21,437,000	$(22,554,000)	$(790,000)
Shares issued to Cherokee in connection with loan	300,000	3,000	18,000		21,000
Shares issued under February 2020 Private Placement	2,842,856	28,000	171,000		199,000
Shares issued to Lincoln Park for purchases under the 2020 Lincoln Park equity line	500,000	5,000	120,000		125,000
Shares issued to Lincoln Park for commitment under the 2020 Lincoln Park equity line	1,250,000	13,000	125,000		138,000
Non cash costs of commitment shares under Lincoln Park equity line			(138,000)		(138,000)
Expenses related to the 2020 Lincoln Park equity line			(48,000)		(48,000)
Shares issued for board meeting attendance in lieu of cash	129,636	1,000	30,000		31,000
Share based payment expense			2,000		2,000
Net loss				(796,000)	(796,000)
Balance – December 31, 2020	37,703,476	$377,000	$21,717,000	$(23,350,000)	$(1,256,000)


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

~~The~~F-5 ~~accompanying~~Table ~~notes are an integral part~~ of ~~the financial statements.~~Contents

~~F-6~~AMERICAN BIO MEDICA CORPORATION

~~AMERICAN BIO~~Statements ~~MEDICA~~of ~~CORPORATION~~Changes in Stockholders’ Deficit

Statements of Cash Flows

	Common Stock				Additional Paid-in			Accumulated
	Shares		Amount		Capital			Deficit			Total
Balance – January 1, 2020		32,680,984	$	327,000	$	21,437,000		$	(22,554,000	)	$	(790,000	)
Shares issued to Cherokee in connection with loan		300,000		3,000		18,000						21,000
Shares issued under February 2020 Private Placement		2,842,856		28,000		171,000						199,000
Shares issued to Lincoln Park for Initial Purchase under the 2020 Lincoln Park equity line		500,000		5,000		120,000						125,000
Shares issued to Lincoln Park for commitment under the 2020 Lincoln Park equity line		1,250,000		13,000		125,000						138,000
Non cash costs of commitment shares under Lincoln Park equity line						(138,000	)					(138,000	)
Expenses related to the 2020 Lincoln Park equity line						(48,000	)					(48,000	)
Shares issued for board meeting attendance in lieu of cash		129,636		1,000		30,000						31,000
Share based payment expense						2,000						2,000
Net loss									(796,000	)		(796,000	)
Balance – December 31, 2020		37,703,476	$	377,000	$	21,717,000		$	(23,350,000	)	$	(1,256,000	)
Shares issued to Lincoln Park for balance of Initial Purchase under the 2020 Lincoln Park Equity line		500,000		5,000		120,000						125,000
Shares issued to Lincoln Park for regular purchases under the 2020 Lincoln Park Equity line		6,000,000		60,000		454,000						514,000
Shares issued to Cherokee in lieu of cash for interest		895,000		9,000		27,000						36,000
Shares issued in connection with October 2021 private placement		2,500,000		25,000		75,000						100,000
Net loss									(463,000	)		(463,000	)
Balance – December 31, 2021		47,598,476	$	476,000	$	22,393,000		$	(23,813,000	)	$	(944,000	)

	Year Ended	Year Ended
	December 31,	December 31,
	2020	2019
Cash flows from operating activities:
Net loss	$(796,000)	$(681,000)
Adjustments to reconcile net loss to net cash (used in) / provided by operating activities:
Depreciation and amortization	79,000	81,000
Amortization of debt issuance costs	17,000	108,000
Penalty added Cherokee loan balance	20,000	0
Provision for bad debts	3,000	(2,000)
Provision for slow moving and obsolete inventory	157,000	96,000
Share-based payment expense	2,000	6,000
Director fee paid with restricted stock	31,000	17,000
Refinance fee paid with restricted stock	21,000	0
Changes in:
Accounts receivable	(40,000)	84,000
Inventory	117,000	113,000
Prepaid expenses and other current assets	(67,000)	23,000
Accounts payable	(75,000)	293,000
Accrued expenses and other current liabilities	45,000	94,000
Wages payable	3,000	(174,000)
Net cash (used in) / provided by operating activities	(483,000)	58,000
Cash flows from investing activities:
Purchase of property, plant, and equipment	(4,000)	0
Net cash used in investing activities	(4,000)	0
Cash flows from financing activities:
Proceeds from debt financing	407,000	86,000
Payments on debt financing	(42,000)	(88,000)
Proceeds from private placement	199,000	0
Proceeds from Lincoln Park Financing	125,000	0
Expenses from Lincoln Park Financing	(48,000)	0
Proceeds from lines of credit	3,949,000	3,835,000
Payments on lines of credit	(4,009,000)	(4,000,000)
Net cash provided by / (used in) financing activities	581,000	(167,000)
Net increase in/ (decrease in) cash and cash equivalents	94,000	(109,000)
Cash and cash equivalents – beginning of period	4,000	113,000
Cash and cash equivalents – end of period	$98,000	$4,000
Supplemental disclosures of cash flow information:
Non-Cash transactions:
Debt issuance cost paid with restricted stock	$0	$14,000
Loans converted to stock	$35,000	$0
Commitment shares issued to Lincoln park, charged to Paid in Capital	$138,000	$0
Cash paid during the year for interest	$152,000	$155,000
Cash paid for taxes	$2,000	$0

The accompanying notes are an integral part of the financial statements

~~The accompanying~~F-6 ~~notes~~Table ~~are an integral part~~ of ~~the financial statements.~~Contents

~~F-7~~AMERICAN BIO MEDICA CORPORATION

~~Note~~Statements Aof -Cash ~~The Company and its Significant Accounting Policies~~Flows

The Company:

	Year Ended			Year Ended
	December 31,			December 31,
	2021			2020
Cash flows from operating activities:
Net loss	$	(463,000	)	$	(796,000	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		68,000			79,000
Patent asset impairment		100,000			0
Amortization of debt issuance costs		0			17,000
Non-cash loan penalty		120,000			20,000
Bad debt (reduction) expense		(19,000	)		3,000
Provision for slow moving and obsolete inventory		1,000			157,000
Share-based payment expense		0			2,000
Director fee paid with restricted stock		0			31,000
Refinance fee paid with restricted stock		0			21,000
Interest paid with restricted stock		36,000			0
Gain on forgiveness of PPP loan		(335,000	)		0
Changes in:
Accounts receivable		103,000			(40,000	)
Inventory		92,000			117,000
Employee retention credit refund		(400,000	)		0
Prepaid expenses and other current assets		80,000			(37,000	)
Right of use asset – Operating leases		36,000			30,000
Accounts payable		105,000			(75,000	)
Accrued expenses and other current liabilities		(151,000	)		15,000
Right of use liability – operating leases		(36,000	)		(30,000	)
Wages payable		(10,000	)		3,000
Net cash used in operating activities		(673,000	)		(483,000	)
Cash flows from investing activities:
Purchase of property, plant, and equipment		0			(4,000	)
Net cash used in investing activities		0			(4,000	)
Cash flows from financing activities:
Proceeds from PPP loan		0			332,000
Proceeds from debt financing		75,000			75,000
Payments on debt financing		(25,000	)		(42,000	)
Proceeds from private placement		100,000			199,000
Proceeds from Lincoln Park financing		639,000			125,000
Expenses from Lincoln Park financing		0			(48,000	)
Proceeds from lines of credit		2,119,000			3,949,000
Payments on lines of credit		(2,218,000	)		(4,009,000	)
Net cash provided by financing activities		690,000			581,000
Net increase in cash and cash equivalents		17,000			94,000
Cash and cash equivalents – beginning of period		98,000			4,000
Cash and cash equivalents – end of period	$	115,000		$	98,000
Supplemental disclosures of cash flow information:
Non-Cash transactions:
Loans converted to stock	$	0		$	35,000
Commitment shares issued to Lincoln park, charged to Paid in Capital	$	0		$	138,000
Patent asset impairment	$	100,000		$	0
Cash paid during the year for interest	$	190,000		$	152,000
Cash paid for taxes		2,000		$	2,000

~~American~~The ~~Bio~~accompanying ~~Medica Corporation~~notes ~~(the~~are ~~“Company”)~~an 1)integral ~~manufactures~~part ~~and sells lateral flow immunoassay tests, primarily for the immediate detection~~ of ~~drugs in urine and oral fluid, 2) provides strip manufacturing and assembly and packaging services for unaffiliated third parties and 3) sells (via distribution) a number of other products related to~~ the ~~immediate~~financial ~~detection of drugs in urine and oral fluid as well as point of care diagnostic products via distribution~~statements.

~~Going~~F-7 ~~Concern:~~Table of Contents

~~The Company’s~~AMERICAN ~~financial~~BIO ~~statements~~MEDICA have been prepared assuming the Company will continue as a going concern, which assumes the realization of assets and the satisfaction of liabilities in the normal course of business. For the year ended December 31, 2020 (“Fiscal 2020”), the Company had a net loss of $796,000 and net cash used in operating activities of $483,000, compared to a net loss of $681,000 and net cash provided by operating activities of $58,000 in the year ended December 31, 2019 (“Fiscal 2019”). The Company’s cash position increased by $94,000 in Fiscal 2020 and decreased by $109,000 in Fiscal 2019. The Company had a working capital deficit of $841,000 at December 31, 2020 compared to a working capital deficit of $463,000 at December 31, 2019. This increase in working capital deficit is primarily due to the PPP loan amount in 2020 that is expected to be forgiven in 2021.CORPORATION

AsNotes ~~of December~~to ~~31,~~financial 2020, the Company had an accumulated deficit of $23,350,000. Over the course of the last several fiscal years, the Company has implemented a number of expense and personnel cuts, implemented a salary and commission deferral program, consolidated certain manufacturing operations of the Company, refinanced debt and entered into an equity line of credit with Lincoln Park Capital Fund, LLC.statements

~~Throughout~~Note ~~most~~A ~~of the~~– ~~six months ended June 30, 2020, we maintained a 10% salary deferral program for our sole executive officer, our Chief Executive Officer/Principal Financial Officer Melissa Waterhouse.~~ The ~~10%~~Company ~~deferral program ceased in early June 2020 considering the length of time the deferral was in place for Waterhouse (almost 7 years)~~ and ~~the~~its ~~balance~~Significant ~~owed.~~Accounting Until his departure in November 2019, another member of senior management participated in the program. As of December 31, 2020, we had total deferred compensation owed to these two individuals in the amount of $138,000. We did not make any payments on deferred compensation to Melissa Waterhouse in Fiscal 2020 or in Fiscal 2019. After the member of senior management retired in November 2019, we agreed to make payments for the deferred comp owed to this individual. In Fiscal 2020, we made payments totaling $57,000 to this individual and in Fiscal 2019 we made payments of $4,000 to this individual. We will continue to make payments to the former member of senior management in the year ended December 31, 2021 in the amount of $20,000 until the deferred compensation is paid in full; which is expected to be in May 2021. As cash flow from operations allows, we intend to repay/make payments on the deferred compensation owed to Melissa Waterhouse.Policies

The ~~Company’s~~ current cash balances, together with cash generated from future operations and amounts available under its credit facilities may not be sufficient to fund operations through April 2022. At December 31, 2020, the Company ~~had negative Stockholders’ Equity of $1,256,000.~~:

~~The~~ American Bio Medica Corporation (the “Company’s”) ~~loan~~1) manufactures and ~~security~~sells ~~agreement~~lateral flow immunoassay tests, primarily for the immediate detection of drugs in urine and ~~2020~~oral ~~Term~~fluid, ~~Note~~2) ~~with Cherokee~~provides strip manufacturing and assembly and packaging services for ~~$900,000~~unaffiliated third parties and ~~$220,000,~~3) ~~respectively,~~sells ~~expired~~(via ~~on February~~distribution) ~~15,~~a ~~2021.~~number ~~The~~of ~~Company~~other ~~did~~products ~~extend~~related to the ~~facilities~~immediate ~~with Cherokee~~detection of drugs in ~~February~~urine ~~2021.~~and ~~(See~~oral ~~Note~~fluid, Kpoint –of ~~Subsequent Events)~~care diagnostic products and rapid Covid-19 tests.

OnGoing June 22, 2020, the Company extended the Crestmark line of credit until June 22, 2021. All terms and conditions of the Crestmark line of credit remain unchanged under the extension period with the exception of the following, 1) the maximum availability under the Crestmark line of credit was reduced from $1,500,000 to $1,000,000, 2) availability under the Crestmark line of credit is based on receivables only (under the same terms), 3) the requirement for field audits of the Company was removed, and 4) the Tangible Net Worth (TNW) covenant was removed. With the exception of the quarter ended June 30, 2019, the Company did not historically comply with the TNW covenant and Crestmark previously provided a number of waivers (for which the Company was charged $5,000 each).Concern:

The ~~Crestmark~~ ~~line~~Company’s financial statements have been prepared assuming the Company will continue as a going concern, which assumes the realization of ~~credit~~assets ~~has~~and the satisfaction of liabilities in the normal course of business. For the year ended December 31, 2021 (“Fiscal 2021”), the Company had a ~~maximum~~net ~~availability~~loss of $1463,000 and net cash used in operating activities of $673,000~~; however~~, ~~the~~compared ~~amount~~to ~~available~~a ~~under~~net ~~the~~loss ~~line~~ of ~~credit~~$796,000 isand ~~much lower~~net ascash itused isin ~~based~~operating ~~upon~~activities ~~the~~of ~~balance~~$483,000 offor the year ended December 31, 2020 (“Fiscal 2020”). The Company’s ~~accounts~~ ~~receivable~~cash position increased by $17,000 in Fiscal 2021 and $94,000 in Fiscal 2020. AsThe Company had a working capital deficit of $(1,484,000) at December 31, ~~2020~~2021, ~~based~~compared onto ~~an availability~~a ~~calculation,~~working ~~there~~capital ~~were~~deficit noof ~~additional~~$(841,000) ~~amounts available~~at ~~under~~December ~~the~~31, ~~Crestmark~~2020. ~~line~~This ofincrease ~~credit~~in ~~because~~working ~~the~~capital ~~Company draws~~deficit ~~any~~is ~~balance~~primarily ~~available~~a onresult aof ~~daily~~our ~~basis.~~loans Ifwith ~~sales~~Cherokee ~~levels decline~~Financial, ~~the~~LLC ~~Company~~being ~~will~~classified ~~have~~as ~~reduced~~long-term ~~availability~~debt onin ~~the~~Fiscal ~~line~~2020 ~~of credit~~and ~~due~~as toshort ~~decreased~~term ~~accounts~~debt ~~receivable~~in ~~balances.~~Fiscal ~~The~~2021, ~~line~~partially ~~of credit~~offset ~~with~~by ~~Crestmark~~the ~~expires~~forgiveness onof ~~June~~the ~~22,~~PPP loan in Fiscal 2021.

~~F-8~~As of December 31, 2021, the Company had an accumulated deficit of $23,813,000. Over the course of the last several fiscal years, the Company has implemented a number of expense and personnel cuts, had a salary deferral program, consolidated certain manufacturing operations of the Company, refinanced debt, consummated private placements of shares of Company common stock and entered into an equity line of credit with Lincoln Park Capital Fund, LLC.

~~On December~~From 9,August 2013 until June 2020, the Company ~~entered~~maintained ~~into~~ a ~~Purchase~~10% ~~Agreement (the~~salary ~~“Purchase~~deferral ~~Agreement”)~~program ~~and~~for aits ~~Registration~~sole ~~Rights Agreement~~executive (officer, Chief Executive Officer/Principal Financial Officer Melissa Waterhouse. The salary deferral program was initiated by Ms. Waterhouse voluntarily. Another member of senior management participated in the ~~“Registration~~program ~~Rights~~voluntarily ~~Agreement”)~~until ~~with Lincoln~~his ~~Park~~retirement ~~Capital~~in ~~Fund,~~November ~~LLC~~2019. ~~(“Lincoln~~After ~~Park”)~~the ~~under which~~member ~~Lincoln~~of ~~Park~~senior management retired, the Company agreed to ~~purchase~~make ~~from~~payments on the ~~Company,~~deferred ~~from~~compensation ~~time~~ owed to ~~time,~~this upindividual. toIn ~~$10~~Fiscal 2021 and Fiscal 2020,~~250,000~~ ofthe ~~our~~Company ~~shares~~made payments of ~~common stock~~$20,000 ~~par~~and ~~value~~ $057,000, respectively.01 ~~per~~The ~~share,~~deferred ~~subject~~compensation owed to ~~certain~~this ~~limitations~~individual ~~set~~was ~~forth~~paid in full in May 2021. Once the ~~Purchase~~ ~~Agreement,~~deferred ~~during~~compensation was paid in full to this individual, the ~~term~~Company ofbegan to make payments at the ~~Purchase~~same ~~Agreement. Pursuant~~rate to Ms. Waterhouse given the ~~terms~~length of time the ~~Registration~~amount ~~Rights~~had ~~Agreement,~~been owed and that the ~~Company~~ ~~was~~last ~~required~~payment (prior to ~~file~~May ~~with~~2021) ~~the~~made Uto Ms.S Waterhouse was in August 2017. ~~Securities~~In ~~and~~Fiscal ~~Exchange Commission~~2021, (the ~~“SEC”)~~Company amade ~~registration~~payments ~~statement~~totaling on$33,000 ~~Form S-1~~to ~~(the~~Ms. ~~“Registration~~Waterhouse. ~~Statement”)~~The toCompany ~~register~~did ~~for resale~~not ~~under~~make ~~the~~any ~~Securities~~payments ~~Act~~on ofdeferred ~~1933,~~compensation asto ~~amended~~Ms. ~~(the “Securities~~Waterhouse ~~Act”)~~in Fiscal 2020. As of December 31, 2021, the ~~shares~~Company ofhad ~~common~~deferred ~~stock~~compensation ~~issued and~~owed ~~sold~~to asMs. ~~well~~Waterhouse asin the ~~shares~~amount of ~~common~~$74,000 ~~stock~~and $5,000 in payroll taxes that ~~the~~are ~~Company~~due ~~may elect~~as inpayments ~~the~~are ~~future~~made to ~~issue~~Ms. ~~and~~Waterhouse; ~~sell~~for a total of $79,000 in deferred compensation. The Company intends to ~~Lincoln~~continue ~~Park~~to ~~from~~make ~~time~~payments to ~~time~~ ~~under~~Ms. Waterhouse until the ~~Purchase~~deferred ~~Agreement~~compensation is paid in full.

~~If availability~~The ~~under the Crestmark line of credit and the Lincoln Park equity line of credit is not sufficient to satisfy the~~ Company’s ~~working~~current ~~capital~~cash ~~and capital expenditure requirements~~balances, ~~the~~together ~~Company~~with ~~will~~cash begenerated ~~required~~from tofuture ~~obtain~~operations ~~additional credit~~and ~~facilities~~amounts oravailable ~~sell~~under ~~additional~~its ~~equity~~credit ~~securities,~~facilities ormay ~~delay capital~~not ~~expenditures~~be ~~which~~sufficient ~~could~~to ~~have~~fund aoperations ~~material~~through ~~adverse~~April ~~effect on the Company’s business~~2023. ~~There~~At isDecember no31, ~~assurance~~2021, ~~that such financing will be available or that~~ the Company ~~will~~had bea ~~able~~Stockholders’ ~~to complete~~deficit ~~financing~~of ~~on satisfactory terms~~$(944, ~~if at all~~000).

The ~~Company’s~~ ~~ability to be in compliance with the obligations under its current credit facilities will depend on the~~ Company’s ~~ability~~loan toand ~~further~~security ~~increase~~agreement ~~sales.~~and ~~The Company’s~~2020 ~~ability~~Term toNote ~~repay~~with ~~its~~Cherokee ~~current~~for ~~debt may also be affected by general economic~~$1, ~~financial~~000,000 ~~competitive,~~and ~~regulatory~~$240, ~~legal~~000, ~~business~~respectively, ~~and~~expired ~~other~~on ~~factors~~February ~~beyond the Company’s control~~15, ~~including those discussed herein~~2022. IfSee ~~the~~Note ~~Company~~L is– ~~unable to~~Subsequent ~~meet~~Events ~~its~~for ~~credit~~more ~~facility~~information ~~obligations,~~on the ~~Company~~status ~~would~~of ~~be required to raise money through new equity and/or debt financing(s) and, there is no assurance that~~ the ~~Company~~Cherokee ~~would be able to find new financing, or that any new financing would be at favorable terms~~loans.

The Company’s ~~history~~line of ~~limited~~credit ~~cash~~with ~~flow~~Crestmark ~~and/or~~Bank ~~operating~~has ~~cash flow~~a ~~deficits~~maximum ~~and~~availability ~~its~~of ~~current~~$1,000,000; ~~cash~~however, ~~position~~the ~~raise~~amount ~~doubt~~available ~~about~~under ~~its ability~~the toline ~~continue~~of ascredit ais ~~going~~much ~~concern~~lower ~~and~~as ~~its~~it ~~continued existence~~ is ~~dependent~~based upon ~~several~~the ~~factors,~~balance ~~including~~of ~~its~~the ~~ability~~Company’s toaccounts ~~raise revenue~~receivable. ~~levels~~As ~~and~~of ~~control~~December ~~costs~~31, to2021, ~~generate~~based ~~positive~~on ~~cash~~an ~~flows~~availability calculation, to ~~facilitate~~there ~~purchase~~were ~~under~~no ~~the~~additional ~~Lincoln~~amounts ~~Park~~available ~~equity~~under the Crestmark line of credit because the Company draws any balance available on a daily basis. If sales levels continue to ~~operations~~decline, ~~and/or~~the ~~obtain~~Company ~~additional~~will have reduced availability on the line of credit ~~facilities~~due to decreased accounts receivable balances. ~~Obtaining additional~~The line of credit ~~facilities~~with ~~may~~automatically berenew ~~more~~on ~~difficult~~June as22, a2022 ~~result~~for an additional one year term unless notice of termination from the ~~tightening~~Company ofis ~~credit~~received ~~markets~~by ~~and~~Crestmark not less than sixty (60) days prior to the ~~Company’s~~end ~~operating losses~~of the renewal term.

~~If events~~F-8 ~~and~~Table circumstances occur such that 1) the Company cannot raise revenue levels, 2) the Company is unable to control operational costs to generate positive cash flows, 3) the Company cannot maintain its current credit facilities or refinance its current credit facilities, 4) the Company is unable to utilize its common stock as a form of payment in lieu of cash and 4) the Company is unable to facilitate purchases under the Lincoln Park equity line of credit, the Company may be required to further reduce expenses or take other steps which could have a material adverse effect on the Company’s future performance. The Company’s financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amount of or classification of liabilities that might be necessary as a result of this uncertainty.Contents

~~In March~~AMERICAN ~~2020,~~BIO ~~the~~MEDICA World Health Organization declared Covid-19 to be a pandemic. Covid-19 has spread throughout the globe, including in the State of New York where the Company’s headquarters are located, and in the State of New Jersey where the Company’s strip manufacturing facility is located. The primary markets for the Company’s DOA products were all negatively impacted by the Covid-19 pandemic in Fiscal 2020 and this negative impact continues in the early part of the year ending December 31, 2021 although the negative impact does appear to have diminished as areas of the economy open up. This decline in DOA sales was offset by sales of Covid-19 tests in Fiscal 2020.CORPORATION

~~While the~~Notes ~~Covid-19 pandemic continues~~ to evolve and as surges continue to occur, we continue to assess the impact of the Covid-19 pandemic to best mitigate risk and continue the operations of our business. The extent to which the outbreak impacts our business, liquidity, results of operations and financial condition will depend on future developments, which are still uncertain and cannot be predicted, including new information that may emerge concerning the severity or longevity of the Covid-19 pandemic and actions that may be taken to contain it or treat its impact, among others. There are still numerous uncertainties associated with this outbreak, including the number of individuals who will become infected, whether the vaccines recently introduced will significantly mitigate the effect of the virus, the extent of the protective and preventative measures that have been put in place by both governmental entities and other businesses and those that may be put in place in the future, the further impact on the U.S. and world economy, and various other uncertainties. Further, even after containment of the virus any significant reduction in employee willingness to return to work would result in a reduction of manufacturing capacity.statements

~~We expect~~On December 9, 2020, the ~~Covid-19~~Company ~~pandemic~~entered ~~will~~into ~~continue~~a toPurchase ~~negatively~~Agreement ~~affect customer~~(the ~~demand~~“Purchase ofAgreement”) ~~our~~and ~~DOA~~a ~~products~~Registration inRights ~~Fiscal~~Agreement ~~2021~~(the or“Registration atRights ~~least~~Agreement”) ~~part of~~with ~~Fiscal~~Lincoln ~~2021~~Park Capital Fund, ~~but~~LLC (“Lincoln Park”) under which Lincoln Park agreed to purchase from the ~~final~~Company, ~~duration~~from time to time, up to $10,250,000 of ~~this~~our ~~negative~~shares ~~impact~~of ~~is uncertain~~common stock, par value $0.01 ~~The~~per ~~extent~~share, subject to ~~which~~certain ~~the~~limitations ~~Covid-19~~set ~~pandemic~~forth ~~may~~in ~~further impact~~the ~~our~~Purchase ~~business~~Agreement, ~~operating~~during ~~results,~~the ~~financial~~term ~~condition~~of the Purchase Agreement. Pursuant to the terms of the Registration Rights Agreement, ~~or liquidity~~the inCompany was required to file with the ~~future~~U.S. ~~will~~Securities ~~depend~~and Exchange Commission (the “SEC”) a registration statement on ~~future~~Form ~~developments~~S-1 ~~which are~~(the ~~evolving~~“Registration ~~and~~Statement”) ~~highly~~to ~~uncertain~~register ~~including~~for resale under the ~~duration~~Securities Act of ~~the outbreak~~1933, ~~travel~~as ~~restrictions~~amended (the “Securities Act”), ~~business~~the shares of common stock issued and ~~workforce~~sold ~~disruptions,~~ as well as the ~~timing~~shares of ~~reopening~~common stock that the ~~economic~~Company ~~regions~~may elect in ~~which~~the wefuture to issue and ~~our customers~~sell doto ~~business~~Lincoln ~~and~~Park from time to time under the ~~effectiveness~~Purchase Agreement. In Fiscal 2021, the Company, the Company received gross proceeds of ~~actions~~$125,000 ~~taken~~from ~~to contain~~Lincoln ~~and~~Park ~~treat~~as an Initial Purchase under the ~~disease~~Purchase Agreement. In ~~addition~~Fiscal 2021, ~~resurgence~~the inCompany ~~the number~~received gross proceeds of ~~cases~~$639,000 for the balance of ~~Covid-19~~the ~~could~~Initial ~~further~~Purchase ~~negatively~~and ~~impact~~Regular ~~our business~~Purchase under the Purchase Agreement.

FIn Fiscal 2021, the Company, through its payroll service provider, processed and mailed a Form 941-9X to claim an Employee Retention Credit (“ERC”) 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 payroll service provider did not process and mail the Company’s Form 941-X to claim an ERC 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 Fiscal 2021, the Company began taking the ERC in its current payroll; which reduced payroll by approximately $44,000 in the third quarter of 2021 and $38,000 in the fourth quarter of Fiscal 2021 (until the ERC program was ended early as part of the Infrastructure bill signed into law on November 15, 2021). Given this, the Company did not have to amend its Form 941 for the third quarter of 2021; rather 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. 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. It was then that 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 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 $203,000. Based on our discussion with the IRS, we were expecting the refund payment for the second quarter of Fiscal 2020 sometime in February 2022; however, as of the date of this report, we have not received any further refund payments.

~~Significant~~If ~~Accounting~~availability ~~Policies:~~under the Crestmark line of credit, cash received from equity sales under the Lincoln Park Purchase Agreement and/or cash received as refunds under the ERC program are not sufficient to satisfy working capital and capital expenditure requirements, the Company will be required to obtain additional credit facilities or sell additional equity securities, or delay capital expenditures which could have a material adverse effect on the Company’s business. There is no assurance that such financing will be available or that the Company will be able to complete financing on satisfactory terms, if at all.

~~[1] Cash equivalents:~~ The Company’s ~~considers~~ability ~~all~~to ~~highly~~repay ~~liquid~~ its current debt may also be affected by general economic, financial, ~~instruments~~competitive, ~~purchased~~regulatory, ~~with~~legal, abusiness ~~maturity~~and ofother ~~three~~factors ~~months~~beyond the Company’s control, including those discussed herein. If the Company is unable to meet its credit facility obligations, the Company would be required to raise money through new equity and/or ~~less~~ debt financing(s) and, there is no assurance that the Company would be able to find new financing, or that any new financing would be ~~cash~~at ~~equivalents~~favorable terms.

~~[2]~~The ~~Accounts~~Company’s ~~Receivable:~~history ~~Accounts receivable consists~~ of ~~mainly~~limited ~~trade~~cash ~~receivables~~flow ~~due~~and/or ~~from~~operating ~~customers~~cash ~~for~~flow ~~the sale~~deficits ~~of our products. Payment terms vary on a customer-by-customer basis,~~ and ~~currently~~its ~~range~~current ~~from~~ cash ~~on delivery~~position toraise ~~net~~doubt 60about ~~days. Receivables~~its ~~are~~ability ~~considered~~to ~~past~~continue ~~due when~~as ~~they~~a ~~have~~going ~~exceeded~~concern ~~their~~and ~~payment~~its ~~terms. Accounts receivable~~continued ~~have~~existence ~~been~~is ~~reduced~~dependent byupon anseveral ~~estimated~~factors, ~~allowance~~including ~~for doubtful accounts. The Company estimates~~ its ~~allowance~~ability ~~for~~to ~~doubtful~~raise ~~accounts based~~revenue onlevels ~~facts, circumstances~~ and ~~judgments~~control ~~regarding~~costs ~~each receivable. Customer~~to ~~payment~~generate ~~history~~positive ~~and~~cash ~~patterns~~flows, ~~length~~to ~~of relationship~~facilitate ~~with~~purchases ~~the~~under ~~customer, historical losses, economic and political conditions, trends and individual circumstances are among~~ the ~~items~~Lincoln ~~considered~~Park ~~when~~equity ~~evaluating~~line ~~the collectability~~ of ~~the receivables.~~credit ~~Accounts~~to ~~are~~operations ~~reviewed regularly for collectability~~ and ~~those~~/or ~~deemed~~obtain ~~uncollectible~~additional ~~are~~credit ~~written off~~facilities. AtObtaining ~~December~~additional ~~31,~~credit ~~2020 and~~facilities ~~December~~may ~~31,~~be ~~2019,~~more ~~the~~difficult ~~Company~~as ~~had~~a anresult ~~allowance for doubtful accounts~~ of ~~$22,000~~the ~~and~~Company’s ~~$34,000,~~operating ~~respectively~~losses.

~~[3]~~F-9 ~~Inventory:~~Table ~~Inventory is stated at the lower~~ of cost or net realizable value. Work in process and finished goods are comprised of labor, overhead and raw material costs. Labor and overhead costs are determined on a rolling average cost basis and raw materials are determined on an average cost basis. At December 31, 2020 and December 31, 2019, the Company established an allowance for slow moving and obsolete inventory of $279,000 and $291,000, respectively.Contents

~~[4]~~AMERICAN ~~Income~~BIO ~~taxes:~~MEDICA 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 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 period 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 benefit that is greater than 50 percent likely to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards.CORPORATION

~~On December~~Notes ~~22, 2017, the Tax Reform Act was signed into law. Among the provisions, the Tax Reform ACT reduces the U.S. federal corporate income tax rate from a maximum of 35%~~ to afinancial flat 21% effective January 1, 2018, requires companies to pay a one-time transition tax on deemed repatriated earnings of certain foreign subsidiaries that were previously tax deferred, and creates new taxes on certain foreign sourced earnings. At December 31, 2019, the Company has completed its accounting for the tax effects of the enactment of the Tax Reform Act. The Company has finalized the tax effects on its existing deferred tax balances and the one-time transition tax under Staff Accounting Bulletin No. 118 ("SAB 118"). The Company has also included current year impacts of the Tax Reform Act in our tax provision. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to reverse.statements

~~[5]~~If ~~Depreciation~~events and ~~amortization:~~circumstances ~~Property, plant~~occur ~~and~~such ~~equipment~~that ~~are~~1) ~~depreciated~~the onCompany cannot raise revenue levels, 2) the ~~straight-line~~Company ~~method over~~is ~~their~~unable ~~estimated~~to ~~useful~~control ~~lives;~~operational ~~generally~~costs to generate positive cash flows, 3-5) ~~years~~the ~~for equipment~~Company ~~and~~cannot 30maintain ~~years~~its ~~for~~current ~~buildings.~~credit ~~Leasehold~~facilities ~~improvements~~or ~~and capitalized~~refinance ~~lease~~its ~~assets~~current ~~are~~credit ~~amortized~~facilities, by4) the ~~straight-line~~Company ~~method over~~is ~~the~~unable ~~shorter~~to ofraise ~~their~~sufficient ~~estimated~~additional ~~useful~~equity ~~lives~~or debt financing, or 5) the ~~term~~Company ofis ~~the lease.~~unable ~~Intangible~~to ~~assets~~effect ~~include~~sales under the ~~cost~~Lincoln ofPark ~~patent~~Equity ~~applications~~Line, ~~which~~ ~~are~~we ~~deferred~~may ~~and~~be ~~charged~~required to ~~operations~~further ~~over~~reduce 19expenses ~~years~~or take other steps which could have a material adverse effect on our future performance. The ~~accumulated~~ ~~amortization~~Company’s offinancial ~~patents~~statements isdo ~~$198,000~~not atinclude ~~December~~any ~~31, 2020~~adjustments relating to the recoverability and ~~$190,000~~classification atof ~~December~~recorded ~~31,~~asset ~~2019.~~amounts ~~Annual~~or ~~amortization~~the ~~expense~~ amount of ~~such~~or ~~intangible~~classification ~~assets~~of isliabilities ~~expected~~that tomight be ~~$8,000~~necessary ~~per~~as ~~year~~a ~~for~~result ~~the next~~of 5this ~~years~~uncertainty.

~~[6]~~While ~~Revenue~~the ~~recognition:~~Covid-19 ~~The~~pandemic ~~Company~~is ~~adopted ASU~~seemingly ~~2014-09~~winding down, ~~“Revenue~~the ~~from~~Company ~~Contracts~~continues ~~with~~to ~~Customers”~~be ~~in the~~impacted ~~first~~by ~~quarter~~it ofin ~~Fiscal~~the ~~2018.The~~form ~~Company's~~of ~~revenues~~material ~~result~~delays, ~~from the~~cost ~~sale~~increases of(in ~~goods~~both manufacturing and ~~reflect~~other ~~the~~business ~~consideration~~costs), tolabor ~~which~~shortages ~~the Company~~and ~~expects~~decreased tosales beorders ~~entitled~~from customers. The Company ~~records~~is ~~revenues~~unsure ~~based on~~as ato ~~five-step~~how ~~model~~long inthe ~~accordance~~Company ~~with~~will ~~ASU~~continue ~~2014-09.~~to ~~The~~be ~~Company has~~impacted ~~defined~~negatively. ~~purchase~~The ~~orders~~extent asto ~~contracts~~which inthe ~~accordance~~pandemic ~~with~~may ~~ASU 2014-09.~~continue ~~For~~to ~~its~~impact ~~customer contracts,~~ the Company’s ~~performance~~ ~~obligations~~business, ~~are~~liquidity, ~~identified;~~results ~~which~~of isoperations ~~delivering~~and ~~goods at~~financial acondition ~~determined~~will ~~transaction~~depend ~~price~~on future developments, ~~allocation~~which ofare ~~the~~still ~~contract transaction~~uncertain ~~price~~and ~~with~~cannot ~~performance~~be ~~obligations~~predicted. ~~(when~~If ~~applicable)~~the Company, ~~and~~ ~~recognition~~its ofcustomers ~~revenue~~or ~~when~~suppliers experience (or ~~as)~~in ~~the~~some ~~performance~~cases ~~obligation is~~continue ~~transferred~~ to ~~the~~experience) ~~customer.~~business ~~Goods~~disruptions, ~~are~~the ~~transferred~~Company’s ~~when~~business, ~~the customer~~liquidity, ~~obtains~~results ~~control~~ of ~~the~~operations ~~goods~~and ~~(which~~financial iscondition ~~upon~~are ~~shipment~~likely to ~~the~~ ~~customer).~~be ~~The~~materially ~~Company's~~adversely ~~revenues~~affected, ~~are~~and ~~recorded~~the atCompany’s aability ~~point~~to ~~in time~~access ~~from~~ the ~~sale~~capital ofmarkets ~~tangible~~may ~~products.~~be ~~Revenues are recognized when products are shipped~~limited.

~~F-10~~Significant Accounting Policies:

~~Product returns,~~[1] ~~discounts~~Cash ~~and~~equivalents: ~~allowances are variable consideration and are recorded as a reduction of revenue in the same period that the related sale is recorded.~~ The Company ~~has~~considers ~~reviewed~~all ~~the~~highly ~~overall sales~~liquid ~~transactions~~financial ~~for~~instruments ~~variable~~purchased ~~consideration~~with ~~and~~a ~~has~~maturity ~~determined that~~of ~~these~~three ~~costs~~months ~~are~~or ~~not~~less ~~significant. The Company has not experienced any impairment losses, has no future performance obligations and does not capitalize costs~~ to ~~obtain~~be orcash ~~fulfill contracts~~equivalents.

[72] ~~Shipping~~Accounts ~~and handling~~Receivable: ~~Shipping~~Accounts receivable consists of mainly trade receivables due from customers for the sale of our products. Payment terms vary on a customer-by-customer basis, and ~~handling~~ ~~fees~~currently ~~charged~~range from cash on delivery to ~~customers~~net 60 days. Receivables are ~~included~~considered inpast ~~net~~due ~~sales~~when they have exceeded their payment terms. Accounts receivable have been reduced by an estimated allowance for doubtful accounts. The Company estimates its allowance for doubtful accounts based on facts, circumstances and ~~shipping~~ judgments regarding each receivable. Customer payment history and ~~handling~~patterns, ~~costs~~length ~~incurred~~of byrelationship with the ~~Company~~customer, tohistorical losses, economic and political conditions, trends and individual circumstances are among the ~~extent~~ items considered when evaluating the collectability of the receivables. Accounts are reviewed regularly for collectability and those ~~costs~~deemed ~~charged~~uncollectible toare ~~customers~~written off. At December 31, ~~are~~2021 ~~included~~and inDecember ~~cost~~31, 2020, the Company had an allowance for doubtful accounts of ~~sales~~ $3,000 and $22,000, respectively.

[3] Inventory: Inventory is stated at the lower of cost or net realizable value. Work in process and finished goods are comprised of labor, overhead and raw material costs. Labor and overhead costs are determined on a rolling average cost basis and raw materials are determined on an average cost basis. At December 31, 2021 and December 31, 2020, the Company established an allowance for slow moving and obsolete inventory of $278,000 and $279,000, respectively.

[84] ~~Research~~Income ~~and development~~taxes: ~~Research~~The ~~and development~~Company applies Financial Accounting Standards Board (“~~R&D~~FASB”) ~~costs~~Accounting Standard Codification (“ASC”) ASC 740Income Taxes (“ASC 740”) which prescribes the asset and liability method whereby deferred tax assets and liabilities are ~~charged~~determined tobased ~~operations~~ on differences between financial reporting and tax bases of assets and liabilities, provided for operating loss carryforwards and are measured using the enacted laws and tax rates that will be in effect when ~~incurred~~the differences are expected to reverse. ~~These~~The ~~costs~~measurement ~~include~~of ~~salaries~~deferred tax assets is reduced, ~~benefits~~if necessary, ~~travel~~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 period that such tax rate changes are enacted. Under ASC 740, ~~costs~~ ~~associated~~tax ~~with~~benefits ~~regulatory~~are ~~applications~~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 benefit that is greater than 50 percent likely to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards. ASU 2019-12, ~~supplies~~issued in December 2019 was adopted by the Company on January 1, ~~depreciation~~ 2021. ASU 2019-12 reduced the complexity of ~~R&D~~ASC ~~equipment~~740 by removing exemptions and ~~other~~simplifying ~~miscellaneous expenses~~the accounting for franchise taxes, deferred taxes and taxes related to employee’s stock ownership plan.

~~[9]~~F-10 ~~Net loss~~Table ~~per common share: Basic loss per common share is calculated by dividing net loss by the weighted average number~~ of ~~outstanding~~ ~~common shares during the period.~~Contents

~~Potential~~AMERICAN ~~common shares~~BIO ~~outstanding~~MEDICA ~~as of December 31, 2020 and 2019:~~CORPORATION

	December 31, 2020	December 31, 2019
Warrants	0	2,000,000
Options	1,987,000	2,252,000
Total	1,987,000	4,252,000

Notes to financial statements

~~For Fiscal~~[5] ~~2020~~Advertising ~~and~~expense: ~~Fiscal~~Advertising ~~2019,~~costs ~~the~~are ~~number~~expensed ~~of securities not included in the diluted loss per share was 1,987,000 and 4,252,000, respectively,~~ as ~~their effect was anti-dilutive due to a net loss in each year~~incurred.

[106] ~~Use of estimates~~Leases: The ~~preparation~~Company ofapplies ~~financial~~FASB ~~statements~~ASC ~~in conformity~~842 ~~with~~– ~~accounting~~Leases ~~principles~~(Topic ~~generally~~842) ~~accepted~~and inrecognizes ~~the United~~a ~~States~~lease “right of ~~America~~use” ~~requires~~asset ~~management~~and toa ~~make~~lease ~~estimates~~liability ~~and assumptions~~on ~~that~~its ~~affect~~balance ~~the~~sheet ~~reported~~related ~~amounts~~to ofits ~~assets~~operating ~~and liabilities~~leases, and ~~disclosure~~discloses ofkey ~~contingent~~information ~~assets~~about ~~and~~its ~~liabilities~~leasing ~~at the~~arrangements. ~~date~~At ofDecember ~~the~~31, ~~financial~~2021, ~~statements~~the ~~and~~Company’s ~~the~~current ~~reported~~lease ~~amounts~~asset ~~of revenues~~was $35,000 and ~~expenses~~its ~~during~~current ~~the~~lease ~~reporting~~liability ~~period~~was $35,000. ~~Our~~At ~~management believes~~December 31, 2021, the ~~major~~Company’s ~~estimates~~long-term lease asset was $5,000 and ~~assumptions~~its ~~impacting~~long-term ~~our financial~~lease ~~statements~~liability ~~are~~was ~~the~~$3,000. ~~following:~~

● [7] Depreciation and amortization: Property, plant and equipment are depreciated utilizing the straight-line method over their estimated useful lives; generally 3-5 years for equipment and 30 years for buildings. Leasehold improvements and capitalized lease assets are amortized by the straight-line method over the shorter of their estimated useful lives or the term of the lease. Intangible assets include the cost of patent applications, which are deferred and charged to operations over 19 years. The accumulated amortization of patents is $206,000 at December 31, 2021 and $198,000 at December 31, 2020. At December 31, 2021, the Company determined that its patent asset was impaired and recorded a $100,000 write off of the patent asset. Due to the write-off, no future amortization expense is expected related to the specific patents within the asset.

~~estimates~~[8] Revenue recognition: The Company recognizes revenue in accordance with ASC Topic 606.The Company’s revenues result from the sale of goods and reflects the ~~fair~~ ~~value~~consideration to which the Company expects to be entitled. For its customer contracts, the Company’s performance obligations are identified; which is delivering goods at a determined transaction price, allocation of ~~stock~~the ~~options~~contract transaction price with performance obligations (when applicable), and ~~warrants~~recognition of revenue when (or as) the performance obligation is transferred to the customer. Goods are transferred when the customer obtains control of the goods (which is upon shipment to the customer). The Company’s revenues are recorded at ~~date~~a point in time from the sale of ~~grant; and~~tangible products. Revenues are recognized when products are shipped.

●Product returns, discounts and allowances are variable consideration and are recorded as a reduction of revenue in the same period that the related sale is recorded. The Company has reviewed the overall sales transactions for variable consideration and has determined that these costs are not significant. The Company has not experienced any impairment losses, has no future performance obligations and does not capitalize costs to obtain or fulfill contracts.

~~estimates~~ [9] ~~of accounts~~Shipping ~~receivable~~and ~~reserves;~~handling: Shipping and handling fees charged to customers are included as a reduction to revenue, and shipping and handling costs incurred by the Company, to the extent of those costs charged to customers, are included in cost of sales.

● [10] Research and development: Research and development (“R&D”) costs are charged to operations when incurred. These costs include salaries, benefits, travel expense, costs associated with regulatory applications, supplies, depreciation of R&D equipment and other miscellaneous expenses.

~~estimates~~[11] Net loss per common share: Basic loss per common share is calculated by dividing net loss by the weighted average number of outstanding common shares during the ~~inventory~~ ~~reserves;~~period. ~~and~~

●Potential common shares outstanding as of December 31, 2021 and 2020:

estimates of accruals and liabilities; and

	December 31, 2021		December 31, 2020
Options		1,937,000		1,987,000
Total		1,937,000		1,987,000

●F-11 Table of Contents

~~deferred~~AMERICAN ~~tax valuation.~~BIO MEDICA CORPORATION

~~F-11~~Notes to financial statements

~~The fair~~For ~~value~~Fiscal of2021 ~~stock~~and ~~options~~Fiscal ~~issued to employees~~2020, ~~members~~the ofnumber ~~our Board~~ of ~~Directors,~~securities ~~and~~not ~~consultants~~included ~~and of warrants issued~~ in ~~connection~~ ~~with debt financings is estimated on~~ the ~~date~~diluted ofloss ~~grant based~~per onshare ~~the~~was ~~Black-Scholes~~1,937,000 ~~options-pricing model utilizing certain assumptions for a risk free interest rate; volatility;~~ and ~~expected remaining~~1,987,000, ~~lives~~respectively, ofas ~~the~~their ~~awards.~~effect ~~The~~was ~~assumptions used in calculating the fair value of share~~anti-~~based~~dilutive ~~payment~~due ~~awards~~to ~~represent~~a ~~management's best~~net ~~estimates,~~loss ~~but~~in ~~these~~each ~~estimates involve inherent uncertainties and the application of management judgment~~year.

As[12] ~~a result,~~Use ifof ~~factors~~estimates: ~~change~~The ~~and~~preparation ~~the~~of ~~Company~~financial ~~uses~~statements ~~different assumptions,~~in ~~the~~conformity ~~Company's~~with ~~equity-based~~accounting ~~compensation~~principles ~~expense~~generally ~~could be~~accepted ~~materially different~~ in the ~~future.~~United InStates ~~addition,~~of ~~the~~America ~~Company~~requires ~~is required~~management to ~~estimate~~make estimates and assumptions that affect the ~~expected~~reported ~~forfeiture~~amounts ~~rate~~of assets and ~~only recognize~~liabilities ~~expense~~and ~~for~~disclosure ~~those~~of ~~shares~~contingent ~~expected~~assets toand ~~vest.~~liabilities Inat ~~estimating~~ the ~~Company's~~date ~~forfeiture~~of ~~rate,~~the financial statements and the ~~Company~~reported ~~analyzed~~amounts ~~its~~of ~~historical forfeiture~~revenues ~~rate,~~and expenses during the ~~remaining~~reporting ~~lives~~period. ofOur ~~unvested~~management ~~options,~~believes the major estimates and ~~the amount~~assumptions ofimpacting ~~vested~~our ~~options~~financial asstatements ~~a percentage~~are ofthe ~~total~~following: ~~options outstanding.~~

If· Estimates of the ~~Company's~~ ~~actual~~fair ~~forfeiture~~value ~~rate~~of isstock ~~materially~~options ~~different~~and ~~from~~warrants ~~its estimate,~~at ordate ifof ~~the~~grant; ~~Company~~· ~~reevaluates~~Allowance ~~the~~for ~~forfeiture~~doubtful ~~rate~~accounts; in· ~~the future,~~Allowance ~~the~~for ~~equity-based~~slow ~~compensation~~moving ~~expense~~and ~~could~~obsolete ~~be significantly~~inventory; ~~different~~· ~~from~~Estimates ~~what~~of weaccruals ~~have~~and ~~recorded~~liabilities; inand ~~the~~· ~~current period~~Deferred income tax valuation allowance.

~~Actual results~~Estimates ~~may~~are ~~differ~~determined ~~from~~using available information. Considerable judgment is required to interpret the specific data used to develop the estimates. ~~and~~The use of different assumptions and/or different valuation techniques may have a material effect on the value of ~~future events~~our assets, liabilities and taxes.

~~[11]~~The ~~Impairment~~fair value of ~~long-lived~~stock ~~assets:~~options ~~The Company~~issued ~~records~~to ~~impairment~~employees, ~~losses~~members onof ~~long-lived~~our ~~assets~~Board ~~used~~of ~~in operations~~Directors, ~~when~~and ~~events~~consultants and ~~circumstances~~of ~~indicate~~warrants ~~that~~issued ~~the~~in ~~assets might~~connection bewith ~~impaired~~debt ~~and~~financings is estimated on the ~~undiscounted~~date ~~cash~~of ~~flows~~grant ~~estimated~~based toon ~~be generated~~the byBlack-Scholes ~~those~~options-pricing ~~assets~~model ~~are~~utilizing ~~less~~certain ~~than~~assumptions ~~the~~for ~~carrying~~a ~~amounts~~risk ~~of those~~free ~~assets.~~interest ~~The~~rate; ~~Company~~volatility; ~~has~~and ~~performed~~expected anremaining ~~analysis~~lives of the ~~undiscounted~~ ~~cash~~awards. ~~flows~~The ~~expected~~assumptions toused bein ~~generated~~calculating ~~from~~ the ~~Company’s~~ ~~fixed~~fair ~~assets~~value ~~and~~of ~~intangibles.~~share-based ~~Based~~payment onawards ~~the Company’~~represent management's ~~analysis~~best estimates, ~~the~~but ~~Company~~these ~~believes~~estimates ~~the~~involve ~~carrying~~inherent ~~values of~~uncertainties ~~these~~and ~~assets~~the ~~are~~application ~~recoverable~~of ~~and~~management ~~impairment does not exist~~judgment.

~~[12]~~As ~~Financial~~a ~~Instruments:~~result, ~~The~~if ~~carrying amounts~~factors ofchange ~~cash,~~and ~~accounts~~the ~~receivable,~~Company ~~accounts~~uses ~~payable~~different assumptions, ~~accrued expenses~~the Company's equity-based compensation expense could be materially different in the future. In addition, the Company is required to estimate the expected forfeiture rate and ~~other~~only ~~assets/liabilities~~recognize ~~approximate~~expense ~~their~~for ~~fair~~those ~~value based~~shares onexpected to vest. In estimating the ~~short~~Company's ~~term~~forfeiture ~~nature~~rate, the Company analyzed its historical forfeiture rate, the remaining lives of ~~those~~unvested ~~items~~options, and the amount of vested options as a percentage of total options outstanding.

~~Estimated~~If ~~fair value~~the ofCompany's ~~financial~~actual ~~instruments~~forfeiture rate is ~~determined~~materially ~~using~~different ~~available~~from ~~market information.~~its ~~In evaluating the fair value information~~estimate, ~~considerable judgment~~or isif ~~required~~the toCompany ~~interpret~~reevaluates the ~~market~~forfeiture ~~data~~rate ~~used~~in ~~to develop~~ the ~~estimates.~~future, ~~The~~the ~~use~~equity-based ofcompensation ~~different~~expense ~~market~~could ~~assumptions~~be ~~and/or~~ significantly different ~~valuation~~from ~~techniques~~what ~~may~~we have arecorded ~~material~~in ~~effect on~~ the ~~estimated~~ ~~fair~~current ~~value amounts~~period.

~~Accordingly,~~Actual ~~the estimates~~results ofmay ~~fair~~differ ~~value~~from ~~presented~~estimates ~~herein~~and ~~may~~assumptions ~~not be indicative~~ of ~~the~~ ~~amounts~~future ~~that could be realized in a current market exchange~~events.

~~ASC Topic~~[13] ~~820,~~Impairment ~~“Fair~~of ~~Value~~long-lived ~~Measurements~~ and ~~Disclosures”~~ intangible (~~“ASC~~patent) ~~Topic~~assets: ~~820”)~~When ~~establishes~~the acarrying ~~hierarchy~~balance of the Company’s patents is more than what it could be sold for ~~ranking~~ on the ~~quality~~open market and/or ~~reliability~~is not recoverable through future use, the Company decreases its value. In determining whether the carrying value is not recoverable, the Company estimates the sum of the ~~information~~undiscounted ~~used~~expected tocash ~~determine fair~~flows ~~values~~from the use of the patent or its possible sale. ~~ASC~~If ~~Topic~~the ~~820~~results ~~requires~~in an amount less that ~~assets~~the ~~and~~patents’ ~~liabilities carried~~value aton the financial statements, the Company will deem the patent’s carrying value on the balance sheet to be impaired by the amount that the carrying value exceeds the fair market value of the asset. The decrease in the patent’s value will then be ~~classified~~included as a loss in the Company’s profit and ~~disclosed~~loss statement. Because it is difficult to determine and support what our patents could be sold for on the open market, we performed an expected cash flow analysis to determine impairment. Due to the nature of the patents included in ~~one~~the Company’s patent asset and expected revenue specifically related to the patents known at the time of the ~~following~~ ~~three~~analysis, ~~categories:~~the Company determined the patent asset was impaired at December 31, 2021 and recorded a loss of $100,000 in its statement of operations for Fiscal 2021. The Company did not record any loss related to patent impairment in Fiscal 2020. The Company believes the carrying values of its fixed assets are recoverable and impairment does not exist.

~~Level 1:~~F-12 ~~Unadjusted~~Table ~~quoted~~of ~~market prices in active markets for identical assets or liabilities.~~Contents

~~Level 2:~~AMERICAN ~~Unadjusted~~BIO ~~quoted~~MEDICA prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices are observable for the asset or liability.CORPORATION

~~Level 3:~~Notes ~~Unobservable~~to ~~inputs~~financial ~~for the asset or liability.~~statements

F[14] Financial Instruments: The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and short and long-12term debt. The fair values of these financial instruments approximate their stated amounts because of the short maturity of the instruments.

The ~~Company~~ ~~endeavors~~valuation tohierarchy ~~utilize~~is ~~the~~composed ~~best~~of ~~available~~three ~~information~~levels. ~~in measuring~~The ~~fair~~classification ~~value.~~within ~~Financial~~the ~~assets~~valuation ~~and~~hierarchy ~~liabilities~~is ~~are classified~~ based on the lowest level of input that is significant to the fair value measurement. The ~~following~~levels ~~methods~~within ~~and assumptions were used by~~ the ~~Company~~valuation inhierarchy ~~estimating~~under ~~its~~ASC ~~fair~~820 ~~value disclosures~~are ~~for~~described ~~financial instruments~~below:

~~Cash —The~~Level ~~carrying~~1: ~~amount~~Assets ~~reported~~and inliabilities ~~the~~with ~~balance~~unadjusted, ~~sheet~~quoted ~~for~~prices ~~cash and~~listed ~~cash~~on ~~equivalents~~active ~~approximates~~market ~~its~~exchanges. Inputs to the fair value ~~due~~measurement toare ~~the short-term~~observable ~~maturity~~inputs, ofsuch ~~these~~as ~~instruments~~quoted prices in active markets for identical assets or liabilities.

~~Line~~Level ~~of Credit~~2: ~~and~~Inputs ~~Long-Term~~to ~~Debt—The~~the ~~carrying~~fair ~~amounts~~value ofmeasurement ~~the Company’s~~are ~~borrowings~~determined ~~under~~using ~~its~~prices ~~line~~for ofrecently ~~credit~~traded ~~agreement~~assets and ~~other~~ ~~long-term~~liabilities ~~debt~~with ~~approximates~~similar ~~fair~~underlying ~~value~~terms, ~~based~~as ~~upon~~well ~~current~~ as direct or indirect observable inputs, such as interest rates, ~~some~~and ofyield ~~which~~curves that are ~~variable~~observable ~~interest rates~~at commonly quoted intervals.

~~Other Asset/liabilities~~Level –3: ~~The~~Inputs ~~carrying~~to ~~amounts~~the ~~reported~~fair invalue ~~the balance~~measurement ~~sheet~~are ~~for~~unobservable ~~other~~inputs, ~~current~~such ~~assets~~as estimates, assumptions, and ~~liabilities~~valuation ~~approximates their~~techniques ~~fair~~when ~~value,~~little ~~based~~or onno ~~the~~market ~~nature~~data ofexists for the assets ~~and~~ or liabilities.

~~In August~~The ~~2018,~~Company ~~ASU~~endeavors ~~2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework - Changes~~ to utilize the ~~Disclosure~~best ~~Requirements for~~available ~~Fair~~information ~~Value~~in ~~Measurement”,~~measuring ~~was~~fair ~~issued~~value. ~~ASU~~Financial ~~2018-03~~assets ~~adds, modifies~~ and ~~removes~~liabilities ~~several~~are ~~disclosure~~classified ~~requirements~~based ~~relative~~on to the ~~three~~lowest ~~levels~~level of ~~inputs~~input ~~used~~that is significant to ~~measure~~the fair value ~~in accordance with Topic 820, “Fair Value Measurement~~measurement.” ~~ASU 2018-13 was effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year.~~ The ~~Company adopted~~following ~~ASU~~methods ~~2018~~and onassumptions ~~January~~were 1,used ~~2020~~by ~~and~~ the ~~adoption~~Company ~~did~~in ~~not~~estimating ~~have an~~its ~~impact~~fair onvalue ~~its~~disclosures for financial ~~position~~instruments: ~~or results of operations.~~

~~[13]~~Cash ~~Accounting~~—The ~~for~~carrying ~~share-based~~amount ~~payments~~reported ~~and stock~~in ~~warrants: In accordance with~~ the ~~provisions~~balance ofsheet ~~ASC Topic 718, “Accounting~~ for ~~Stock~~cash ~~Based Compensation”, the Company recognizes share-based payment expense for stock options~~ and ~~warrants.~~cash Inequivalents ~~June 2018, ASU~~approximates ~~2018-07, “Compensation~~its -fair ~~Stock~~value ~~Compensation/Improvements~~due to ~~Nonemployee~~ ~~Share-Based Payment Accounting”, was issued. ASU 2018-07 expanded~~ the ~~scope of ASC Topic 718 to include share~~short-~~based payment~~term ~~transactions~~maturity ~~for acquiring goods and services from nonemployees. The requirements~~ of ~~Topic~~these ~~718 must be applied to nonemployee awards except for certain exemptions specified in the amendment~~instruments. ASU 2018-07 was effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that fiscal year. The Company adopted ASU 2018-07 in the First Quarter 2019 and the adoption did not have a material impact on its financial position or results of operations considering the limited occasions where the Company has issued share based awards to nonemployees for goods or services.

~~The weighted~~Line ~~average~~of ~~fair~~Credit ~~value~~and short term and long-term debt—The carrying amounts of ~~options~~the ~~issued~~Company’s ~~and~~borrowings ~~outstanding~~under ~~in Fiscal~~its ~~2020~~line of credit and ~~Fiscal~~other ~~2019~~long-term ~~was~~debt ~~$0.13~~approximates infair ~~each~~value, ~~year.~~based ~~(See~~upon ~~Note~~current Hinterest ~~[2] –~~rates, ~~Stockholders’~~some ~~Equity)~~of which are variable interest rates.

~~The Company~~Other ~~accounts~~Asset/liabilities– ~~for derivative instruments in accordance with ASC Topic 815 “Derivatives and Hedging” (“ASC Topic 815”).~~ The ~~guidance~~carrying ~~within~~amounts ~~ASC~~reported ~~Topic~~in ~~815 requires~~ the ~~Company to~~balance ~~recognize~~sheet ~~all~~for ~~derivatives~~other ascurrent ~~either~~ assets orand liabilities onapproximates ~~the statement~~their of financial position unless the contract, including common stock warrants, settles in the Company’s own stock and qualifies as an equity instrument. A contract designated as an equity instrument is included in equity at its fair value, ~~with~~based ~~no further~~on ~~fair value adjustments required; and if designated as an asset or liability is carried at fair value with any changes in fair value recorded in~~ the ~~results~~nature of ~~operations.~~the ~~There~~assets ~~were no warrants issued~~ and ~~outstanding at December 31, 2020~~liabilities. ~~The weighted average fair value of warrants issued and outstanding at December 31, 2019 was $0.18. (See Note H [3] – Stockholders’ Equity)~~

[1415] ~~Concentration~~Accounting offor ~~credit~~share-based ~~risk~~payments and stock warrants: The Company ~~sells~~accounts ~~products~~for ~~primarily~~stock-based tocompensation ~~United~~in ~~States~~accordance ~~customers~~with ~~and distributors~~ASC No. ~~Credit~~718, is“Compensation-Stock ~~extended~~Compensation.” ASC No. 718 requires companies to estimate the fair value of equity-based payment awards on the date of grant using an ~~evaluation~~Option-Pricing Model. The Company uses the Black-Scholes option pricing model to determine the fair value of stock options and warrants and recognizes compensation expenses starting on the ~~customer’s~~ ~~financial~~date ~~condition~~of the grant and over the vesting period of the stock option/warrant. There were 1,937,000 stock options issued and outstanding as of December 31, 2021, all of which are completely vested.

~~At December~~ [16] ~~31,~~Concentration ~~2020,~~of ~~one~~credit ~~customer~~risk: ~~accounted~~The ~~for 68.0% of the~~ Company’s ~~net~~sells ~~accounts~~products ~~receivable.~~primarily Ato ~~substantial~~United ~~portion~~States ~~of this~~customers ~~balance~~and ~~was collected in the first quarter of the year ending December 31, 2021~~distributors. ~~Due~~Credit tois ~~the~~extended ~~long~~based ~~standing~~on ~~nature~~an evaluation of the ~~Company~~ customer’s ~~relationship~~financial ~~with this customer and contractual obligations, the Company is confident it will recover these amounts~~condition.

At December 31, ~~2019~~2021, one customer accounted for 5564.65%, ofone ~~the Company’s~~customer ~~net~~accounted ~~accounts~~for ~~receivable~~12.7% and ~~another~~one customer accounted for 1510.04% of accounts receivable. ~~All~~A substantial portion of these ~~amounts~~balances ~~were~~was ~~recovered~~collected in ~~Fiscal 2020~~the first quarter of the year ending December 31, 2022.

~~The Company~~At ~~has~~December ~~established~~31, an2020, ~~allowance~~one customer accounted for ~~doubtful~~68.0% of the Company’s accounts receivable. A substantial portion of ~~$22,000~~ ~~and~~this ~~$34,000~~balance atwas ~~December~~collected ~~31,~~in ~~2020~~the ~~and~~first quarter of the year ending December 31, ~~2019, respectively,~~2021. ~~based~~Due onto ~~factors~~the ~~surrounding~~long standing nature of the ~~credit~~Company’s ~~risk~~relationship ofwith ~~our customers~~this customer and ~~other~~contractual ~~information~~obligations, the Company is confident it will recover these amounts.

~~F-13~~The Company has established an allowance for doubtful accounts of $3,000 and $22,000 December 31, 2021 and December 31, 2020, respectively, based on factors surrounding the credit risk of our customers and other information.

~~One~~The ~~of the~~ Company’s ~~customers~~maintains ~~accounted~~certain ~~for~~cash ~~35.2%~~balances ofat ~~net~~financial ~~sales~~institutions ~~in Fiscal~~that ~~2020~~are ~~and~~federally ~~44.8%~~insured ofand ~~net~~at ~~sales~~times ~~in Fiscal 2019. Excluding sales of Covid testing products,~~ the ~~same~~balances ~~customer~~have ~~accounted~~exceeded ~~for~~federally ~~59.0%~~insured ~~of net sales in Fiscal 2020~~limits.

~~The Company~~F-13 ~~maintains~~Table ~~certain~~of ~~cash balances at financial institutions that are federally insured and at times the balances have exceeded federally insured limits.~~Contents

~~[15]~~AMERICAN ~~Reporting~~BIO ~~comprehensive~~MEDICA income: The Company reports comprehensive income in accordance with the provisions of ASC Topic 220, “Reporting Comprehensive Income” (“ASC Topic 220”). The provisions of ASC Topic 220 require the Company to report the change in the Company's equity during the period from transactions and events other than those resulting from investments by, and distributions to, the shareholders. For Fiscal 2020 and Fiscal 2019, comprehensive income was the same as net income.CORPORATION

~~[16]~~Notes ~~Reclassifications: Certain items have been reclassified from the prior years~~ to ~~conform~~financial ~~to the current year presentation.~~statements

[17] New accounting pronouncements:

In the year ended December 31, ~~2020~~2021, we adopted the following accounting standards set forth by the Financial Accounting Standards Board (“FASB”):

ASU ~~2018~~2019-1312, “~~Fair~~Income ~~Value Measurement~~Taxes (Topic ~~820~~740): ~~Disclosure~~Simplifying ~~Framework - Changes to~~ the ~~Disclosure~~ ~~Requirements~~Accounting for ~~Fair~~Income ~~Value Measurement~~Taxes”, issued in ~~August~~December ~~2018,~~2019 ~~adds,~~reduces ~~modifies~~the ~~and~~complexity ~~removes~~by ~~several disclosure~~removing ~~requirements~~exemptions ~~relative~~and tosimplifying the ~~three~~accounting ~~levels~~for offranchise ~~inputs~~taxes, ~~used to~~deferred ~~measure~~taxes ~~fair~~and ~~value~~taxes inrelated ~~accordance~~to ~~with~~employee’s ~~Topic~~stock ~~820,~~ownership ~~“Fair Value Measurement~~plan.” The requirements in ASU ~~2018~~2019-1312 iswere effective for public companies for fiscal years beginning after December 15, ~~2019~~2020, including interim periods ~~within that fiscal year~~. The Company adopted ASU ~~2018~~2019-1302 inon ~~the~~January ~~First Quarter~~1, ~~2020~~2021 and the adoption did not have an impact on the Company’s financial condition or ~~its~~ results of ~~operations~~ operation.

ASU ~~2019~~2020-0801, ~~Compensation~~“Investments-Equity ~~– Stock~~Securities ~~Compensation~~ (Topic ~~718~~321), Investments-Equity Method and ~~Revenue~~Joint ~~from~~Ventures ~~Contracts~~(Topic ~~with Customers~~323), and Derivatives and Hedging (Topic ~~606~~815)”, issued in ~~November~~January ~~2019~~2020, clarifies ~~that~~certain interactions between the guidance to account for certain equity securities under Topic 321, the guidance to account for investments under the equity method of accounting in Topic 323, and the guidance in Topic 815, which could change how an entity ~~must~~accounts ~~measure~~for ~~and~~an ~~classify~~equity ~~share-based payment~~security ~~awards~~under ~~granted~~the tomeasurement alternative or a ~~customer~~forward bycontract ~~applying~~or purchased option to purchase securities that, upon settlement of the ~~guidance~~forward contract or exercise of the purchased option, would be accounted for under the equity method of accounting or the fair value option in accordance with Topic ~~718~~825, Financial Instruments. These amendments improved current GAAP by reducing diversity in practice and increasing comparability of the accounting for these interactions. The requirements in ASU ~~2019~~2021-0801 iswere effective for public companies for fiscal years beginning after December 15, ~~2019~~2020, including interim ~~reporting~~ periods within ~~those~~ the fiscal ~~years~~year. The Company adopted ASU ~~2019~~2020-0801 inon ~~the~~January ~~First Quarter~~1, ~~2020~~2021 and the adoption did not have an impact on the Company’s financial condition or ~~its~~ results of ~~operations~~ operation.

ASU 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting ~~Standards~~ ~~Issued;~~for ~~Not~~Convertible ~~Yet~~Instruments ~~Adopted~~and Contracts in an Entity’s Own Equity”, issued in August 2020 simplifies the accounting for convertible debt and convertible preferred stock by removing the requirements to separately present certain conversion features in equity. In addition, the amendments also simplify the guidance in ASC Subtopic 815-40, Derivatives and Hedging: Contracts in Entity’s Own Equity, by removing certain criteria that must be satisfied in order to classify a contract as equity, which is expected to decrease the number of freestanding instruments and embedded derivatives accounted for as assets or liabilities. Finally, the amendments revise the guidance on calculating earnings per share, requiring use of the if-converted method for all convertible instruments and rescinding an entity’s ability to rebut the presumption of share settlement for instruments that may be settled in cash or other assets. The amendments were effective for public companies for fiscal years beginning after December 15, 2021. Early adoption was permitted, but no earlier than fiscal years beginning after December 15, 2020. The guidance must be adopted as of the beginning of the fiscal year of adoption. The Company adopted ASU 2020-06 on January 1, 2021 and the adoption did not have an impact on the Company’s financial condition or results of operation.

ASU ~~2019~~2021-1204, ~~“Income~~Earnings ~~Taxes~~ Per Share (Topic ~~740~~260):, ~~Simplifying~~Debt-Modifications ~~the~~and ~~Accounting~~Extinguishments ~~for~~(Subtopic ~~Income Taxes”~~470-50), ~~issued~~Compensation-Stock inCompensation ~~December~~(Topic ~~2019~~718), ~~reduces~~and ~~the~~Derivatives ~~complexity by~~and ~~removing~~Hedging-Contracts ~~exemptions~~in ~~and~~Entity’s ~~simplifying~~Own ~~the~~Equity ~~accounting~~(Subtopic ~~for franchise taxes~~815-40), ~~deferred~~issued ~~taxes~~in ~~and~~May ~~taxes~~2021, ~~related~~addresses toan ~~employee~~issuer’s ~~stock ownership~~accounting ~~plan.~~for ~~The~~certain ~~requirements~~modifications inor ~~ASU~~exchanges ~~2019~~of freestanding equity-12classified ~~are~~written call options. This amendment is effective for ~~public~~ ~~companies~~all entities, for fiscal years beginning after December 15, ~~2020~~ 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company adopted ASU ~~2019~~2021-0204 on January 1, ~~2021~~2022 and the adoption did not have an impact on the Company’s financial condition or results of ~~operation~~ operations.

ASU ~~2020~~2021-0110, ~~“Investments-Equity Securities~~Government Assistance (Topic ~~321~~832), ~~Investments-Equity~~Disclosures ~~Method~~by ~~and~~Business ~~Joint Ventures~~Entities ~~(Topic~~About ~~323),~~Government ~~and Derivatives and Hedging (Topic 815)”~~Assistance, issued in ~~January~~November ~~2020,~~2021 ~~clarifies~~requires ~~certain interactions~~entities ~~between~~to ~~the~~provide ~~guidance~~disclosures toon ~~account~~material ~~for~~government ~~certain~~assistance ~~equity securities~~transactions ~~under~~for ~~Topic~~annual ~~321,~~reporting ~~the~~periods. ~~guidance~~The todisclosures ~~account~~include ~~for~~information ~~investments under~~around the ~~equity~~nature ~~method~~ of ~~accounting in Topic 323, and~~ the ~~guidance~~ ~~in Topic 815~~assistance, ~~which could change how an entity accounts for an equity security under~~ the ~~measurement~~related ~~alternative~~accounting orpolicies ~~a forward~~used ~~contract or purchased option~~ to ~~purchase~~account ~~securities~~for ~~that~~government assistance, ~~upon~~ ~~settlement of~~ the ~~forward~~effect ~~contract or exercise~~ of ~~the purchased~~government ~~option,~~assistance ~~would~~on ~~be accounted for under~~ the ~~equity~~entity’s ~~method~~financial ~~of accounting or the fair value option in accordance with Topic 825~~statements, ~~Financial~~ ~~Instruments.~~and ~~These~~any ~~amendments~~significant ~~improve~~terms ~~current GAAP by reducing diversity in practice~~ and ~~increasing~~conditions ~~comparability~~ of the ~~accounting~~ ~~for these interactions. The requirements in ASU 2021-01 are effective for public companies for fiscal years beginning after December 15~~agreements, ~~2020,~~ including ~~interim periods~~commitments ~~within~~and ~~the fiscal year~~contingencies. The Company adopted ASU ~~2020~~2021-0110 on January 1, ~~2021~~2022 and the adoption did not have an impact on ~~the Company’s~~our financial condition or results of ~~operation~~ operations as ASU-2021-10 only impacts annual financial statement footnote disclosures.

F-14 Table of Contents

~~ASU~~AMERICAN ~~2020-06,~~BIO ~~“Debt~~MEDICA – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, issued in August 2020 simplifies the accounting for convertible debt and convertible preferred stock by removing the requirements to separately present certain conversion features in equity. In addition, the amendments also simplify the guidance in ASC Subtopic 815-40, Derivatives and Hedging: Contracts in Entity’s Own Equity, by removing certain criteria that must be satisfied in order to classify a contract as equity, which is expected to decrease the number of freestanding instruments and embedded derivatives accounted for as assets or liabilities. Finally, the amendments revise the guidance on calculating earnings per share, requiring use of the if-converted method for all convertible instruments and rescinding an entity’s ability to rebut the presumption of share settlement for instruments that may be settled in cash or other assets. The amendments are effective for public companies for fiscal years beginning after December 15, 2021. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The guidance must be adopted as of the beginning of the fiscal year of adoption. The Company adopted ASU 2020-06 on January 1, 2021 and the adoption did not have an impact on the Company’s financial condition or results of operation.CORPORATION

~~Any other~~Notes ~~new accounting pronouncements recently 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 adoption of such new accounting pronouncements, when effective, is not expected to have a material effect on the Company’s financial ~~position or results of operations.~~statements

~~NOTE~~Accounting BStandards -Issued; ~~INVENTORY~~Not Yet Adopted

~~Inventory~~Any ~~is comprised~~other new accounting pronouncements recently 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 adoption of such new accounting pronouncements, when effective, is not expected to have a material effect on the ~~following:~~Company’s financial position or results of operations.

	December 31, 2020	December 31, 2019
Raw Materials	$534,000	$670,000
Work In Process	127,000	141,000
Finished Goods	154,000	290,000
Allowance for slow moving and obsolete inventory	(279,000)	(291,000)
	$536,000	$810,000

NOTE B - INVENTORY

~~NOTE~~Inventory Cis –comprised ~~PROPERTY,~~of ~~PLANT~~the ~~AND~~following: ~~EQUIPMENT~~

Property, plant and equipment, at cost, are as follows:

	December 31, 2021			December 31, 2020

Raw materials	$	462,000		$	534,000
Work in process		109,000			127,000
Finished goods		150,000			154,000
Allowance for slow moving and obsolete inventory		(278,000	)		(279,000	)
	$	443,000	)	$	536,000

	December 31, 2020	December 31, 2019
Land	$102,000	$102,000
Buildings and improvements	1,352,000	1,352,000
Manufacturing and warehouse equipment	2,110,000	2,107,000
Office equipment (incl. furniture and fixtures)	412,000	412,000
	3,976,000	3,973,000
Less accumulated depreciation	(3,400,000)	(3,329,000)
	$576,000	$644,000

NOTE C – PROPERTY, PLANT AND EQUIPMENT

~~Depreciation expense~~Property, ~~was~~plant ~~$71~~and equipment,~~000~~ inis ~~Fiscal~~comprised ~~2020~~of ~~and~~the ~~$74,000~~following: ~~in Fiscal 2019.~~

NOTE D – ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

	December 31, 2021			December 31, 2020

Land	$	102,000		$	102,000
Buildings and improvements		1,352,000			1,352,000
Manufacturing and warehouse equipment		2,110,000			2,110,000
Office equipment (incl. furniture and fixtures)		412,000			412,000
		3,976,000			3,976,000
Less accumulated depreciation		(3,459,000	)		(3,400,000	)
	$	517,000		$	576,000

~~Accrued expenses~~Depreciation ~~and~~expense ~~other~~was ~~current~~$60,000 ~~liabilities~~in ~~consisted~~Fiscal of2021 ~~the following:~~and $71,000 in Fiscal 2020.

	December 31, 2020	December 31, 2019
Accounting fees	$80,000	$77,000
Interest payable	22,000	15,000
Accounts receivable credit balances	5,000	55,000
Sales tax payable	164,000	142,000
Deferred compensation	138,000	191,000
Customer Deposits	167,000	10,000
Other current liabilities	44,000	28,000
	$620,000	$518,000

NOTE D – ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

~~F-15~~ Accrued expenses and other current liabilities consisted of the following as of December 31, 2021 and December 31, 2020:

NOTE E – DEBT AND LINE OF CREDIT

	December 31, 2021		December 31, 2020
Accounting fees	$	70,000	$	80,000
Interest payable		25,000		22,000
Accounts receivable credit balances		18,000		5,000
Sales tax payable		185,000		164,000
Deferred compensation		79,000		138,000
Customer deposits		52,000		167,000
Other current liabilities		38,000		44,000
	$	467,000	$	620,000

~~The Company’s~~F-15 ~~Line~~Table of ~~Credit and Debt consisted of the following as of December 31, 2020 and December 31, 2019:~~Contents

	December 31, 2020		December 31, 2019
Loan and Security Agreement with Cherokee Financial, LLC: 5 year note executed on February 15, 2015, at a fixed annual interest rate of 8% plus a 1% annual oversight fee, interest only and oversight fee paid quarterly with first payment being made on May 15, 2015, annual principal reduction payment of $75,000 due each year beginning on February 15, 2016, with a final balloon payment being due on February 15, 2020. Loan was extended for one year (until February 15, 2021) on February 15, 2020 under the same terms and conditions as original loan. Loan was further extended in February 2021 to February 15, 2022; see Note K; Subsequent Events. Loan is collateralized by a first security interest in building, land and property.		$ 900,000	$	900,000
Crestmark Line of Credit: Line of credit maturing on September 22, 2021 with interest payable at a variable rate based on WSJ Prime plus 3% with a floor or 5.25%; loan fee of 0.5% annually & monthly maintenance fee of 0.3% on actual loan balance from prior month. Early termination fee of 2% if terminated prior to natural expiration. Loan is collateralized by first security interest in receivables and inventory and the all-in interest rate as of the date of this report is 12.08%.		277,000		337,000
Crestmark Equipment Term Loan: 38 month equipment loan related to the purchase of manufacturing equipment, at an interest rate of WSJ Prime Rate plus 3%; or 6.25%. The loan was satisfied in the quarter ended September 30, 2020.		0		7,000
2019 Term Loan with Cherokee Financial, LLC: 1 year note at an annual fixed interest rate of 18% paid quarterly in arrears with first interest payment being made on May 15, 2019 and a balloon payment being due on February 15, 2020. Loan was extended for another until February 15, 2021 under the same terms and conditions. A penalty of $20,000 was added to the loan principal on February 15, 2020 in connection with the extension of the loan. Loan was further extended in February 2021 to February 15, 2022; see Note K; Subsequent Events.		220,000		200,000
July 2019 Term Loan with Chaim Davis, et al: Notes at an annual fixed interest rate of 7.5% paid monthly in arrears with the first payment being made on September 1, 2019 and the final payment being made on October 1, 2020. Loan principal was fully converted into restricted common shares on March 2, 2020 as part of the February 2020 private placement. December 2019 Convertible Note: Convertible note with a conversion date of 120 days or upon the closing of a 2020 funding transaction (whichever is sooner). Note principal was fully converted into restricted common shares on March 2, 2020 as part of our February 2020 private placement. April 2020 PPP Loan with Crestmark: 2 year SBA loan at 1% interest with first payment due October 2020. Company intends to apply for forgiveness of loan under PPP guidelines after 24 weeks, or after October 2020.		0 0 332,000		10,000 25,000 0
November 2020 Shareholder Note with Chaim Davis; no terms, note was paid on February 24, 2021 with proceeds from Lincoln Park financing.		25,000		0
November 2020 Shareholder Note: 6 month term loan at 7% interest (Prime + 3.75%) with the first interest only payment being made on February 4, 2021 and the final interest and 50,000 principal due on May 4, 2021.		50,000		0
		$ 1,804,000	$	1,479,000
Less debt discount & issuance costs (Cherokee Financial, LLC loans)		0		(17,000)
Total debt, net		$ 1,804,000	$	1,462,000
Current portion		$ 684,000	$	354,000
Long-term portion, net of current portion		$ 1,120,000	$	1,125,000

AMERICAN BIO MEDICA CORPORATION

~~At December~~Notes ~~31,~~to ~~2020,~~financial ~~the following are the debt maturities for each of the next five years:~~statements

2021	$684,000
2022	1,120,000
2023	0
2024	0
2025	0
	$1,804,000

NOTE E – DEBT AND LINE OF CREDIT

~~F-16~~The Company’s Line of Credit and Debt consisted of the following as of December 31, 2021 and December 31, 2020:

AMERICAN BIO MEDICA CORPORATION

	December 31, 2021		December 31, 2020
Loan and Security Agreement with Cherokee Financial, LLC: 5 year note executed on February 15, 2015, at a fixed annual interest rate of 8% plus a 1% annual oversight fee, interest only and oversight fee paid Loan was extended for one year (until February 15, 2021) on February 15, 2020 under the same terms and conditions as original loan. Loan was further extended in February 2021 to February 15, 2022. A penalty of $100,000 was added to the loan principal and the annual interest rate was increased to 10% on February 15, 2021 in connection with the extension. Loan is collateralized by a first security interest in building, land and property. See Note L – Subsequent Events	$	1,000,000	$	900,000
Crestmark Line of Credit: Line of credit that will auto-renew on June 22, 2022 for another 12 months unless the Company provides 60 days advance notice of non-renewal. Interest is payable at a variable rate based on WSJ Prime plus 3% with a floor or 5.25%; loan fee of 0.5% annually & monthly maintenance fee of 0.3% on actual loan balance from prior month. Early termination fee of 2% if terminated prior to natural expiration. Loan is collateralized by first security interest in receivables and inventory and the all-in interest rate as of the date of this report is 11.95%.		178,000		277,000
2019 Term Loan with Cherokee Financial, LLC: 1 year note at an annual fixed interest rate of 18% paid quarterly in arrears and a balloon payment being due on February 15, 2020. Loan was extended in February 2020, until February 15, 2021, under the same terms and conditions. A penalty of $20,000 was added to the loan principal on February 15, 2020 in connection with the extension of the loan. Loan was further extended in February 2021 to February 15, 2022. Another penalty of $20,000 was added to the loan principal on February 15, 2021 in connection with the additional extension of the loan. See Note L – Subsequent Events		240,000		220,000
April 2020 PPP Loan with Crestmark: 2 year SBA loan at 1% interest with first payment due October 2020. Entire Loan principal and all interest were forgiven on August 3, 2021.		0		332,000
November 2020 Shareholder Note; no terms, note was paid on February 24, 2021 with proceeds from Lincoln Park financing.		0		25,000
November 2020 Shareholder Note: Term loan at 7% interest (Prime + 3.75%), with an initial term of 6 months which was extended for another 6 months on May 4, 2021 to November 4, 2021. Interest only payments are being made on the loan. Loan was extended on November 3, 2021 to November 4, 2022 with no changes to any terms of the note.		50,000		50,000
December 2021 Shareholder Notes: Two term loans with two non-affiliated shareholders at 7% interest until principal and interest are both due in full, or until June 15, 2022. The first interest payments are 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.		75,000		0
Total Debt	$	1,543,000	$	1,804,000
Current portion	$	1,543,000	$	684,000
Long-term portion, net of current portion	$	0	$	1,120,000

~~Notes to~~F-16 ~~financials~~Table of Contents

~~LOAN~~AMERICAN ~~AND~~BIO ~~SECURITY~~MEDICA ~~AGREEMENT WITH CHEROKEE FINANCIAL, LLC. (“CHEROKEE”)~~CORPORATION

~~On March~~Notes 26, 2015, the Company entered into a LSA with Cherokee (the “Cherokee LSA”). The debt with Cherokee 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 a fixed annual interest rate of 8%. The Company received net proceeds of $80,000 after $1,015,000 of debt payments, and $105,000 in other expenses and fees. The expenses and fees (with the exception of the interest expense) were deducted from the balance on the Cherokee LSA and were amortized over the initial term of the debt (in accordance with ASU No. 2015-03). The Company was required to ~~make annual~~financial 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 new, larger term loan with Cherokee (See 2019 Term Loan with Cherokee within this Note E).statements

~~On February~~LOAN ~~24,~~AND ~~2020~~SECURITY ~~(the~~AGREEMENT ~~“Closing~~WITH ~~Date”),~~CHEROKEE ~~the Company completed a transaction related to a one-year Extension Agreement dated February 14~~FINANCIAL, ~~2020~~LLC. (~~the~~ “~~Extension Agreement~~CHEROKEE”) with Cherokee under which Cherokee 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 under the Extension Agreement. For consideration of the Extension Agreement, the Company issued 2% of the $900,000 principal, or $18,000, in 257,143 restricted shares of the Company’s common stock to Cherokee on behalf of their investors.

InOn ~~the event~~March of26, ~~default~~2015, ~~this~~the ~~includes,~~Company ~~but~~entered isinto ~~not~~a ~~limited~~LSA ~~to;~~with Cherokee (the ~~Company’s~~ ~~inability~~“Cherokee toLSA”). ~~make~~The ~~any~~debt ~~payments~~with ~~due~~Cherokee ~~under~~is collateralized by a first security interest in real estate and machinery and equipment. Under the Cherokee LSA, ~~(as~~the ~~amended)~~Company ~~Cherokee~~was ~~has~~provided the ~~right~~sum toof ~~increase~~$1,200,000 in the form of a 5-year Note at a fixed annual interest rate onof 8%; paid quarterly in arrears. In addition to the ~~financing~~8% interest, the Company is required to 18pay Cherokee a 1%. Ifannual fee for oversight and administration of the ~~amount~~loan. ~~due~~This oversight fee is ~~not~~ paid byin cash and is paid contemporaneously with the ~~extended~~quarterly ~~due~~interest ~~date~~payments. The Company received net proceeds of $80,000 after $1,015,000 of debt payments, and $105,000 in other expenses and fees which, were deducted from the balance on the Cherokee ~~will~~LSA ~~automatically~~and ~~add~~amortized ~~a delinquent~~over ~~payment~~the ~~penalty~~initial term of the debt (in accordance with ASU No. 2015-03). The Company was required to make annual principal reduction payments of $~~100~~75,000 toon each anniversary of the ~~outstanding~~ 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).

~~The Company~~In ~~will~~February ~~continue~~2020, tothe ~~make~~Company ~~interest~~extended ~~only~~the ~~payments~~due ~~quarterly~~date on of the Cherokee LSA. In(with ~~addition~~a tobalance ~~the~~of ~~8% interest~~$900,000) ~~the~~to ~~Company~~February ~~pays Cherokee~~15, a2021. 1%No ~~annual~~terms ~~fee for oversight and administration~~ of the ~~loan.~~ ~~This~~facility ~~oversight~~were ~~fee~~changed ~~is paid~~ in ~~cash~~February ~~and~~2020. isIn ~~paid contemporaneously~~connection with ~~the~~this ~~quarterly~~extension, ~~interest~~the ~~payments. The~~ Company ~~can~~ ~~pay~~was ~~off~~required ~~the~~to ~~Cherokee~~issue ~~loan~~2% atof ~~any~~the ~~time~~$900,000 ~~with~~principal, noor ~~penalty;~~$18,000, ~~except that~~in a257,143 1%restricted ~~administration~~shares ~~fee~~of ~~would~~the beCompany’s ~~required~~common tostock ~~be paid~~ to ~~Cherokee~~ ~~to close out all participations~~Cherokee.

~~The Company~~On ~~recognized~~February ~~$89~~24,~~000~~ in2021, ~~interest~~the ~~expense~~Company completed a transaction related to ~~the Cherokee~~another ~~LSA~~one-year inExtension ~~Fiscal~~Agreement ~~2020~~dated ~~(of~~February ~~which $16~~14,~~000~~ is2021 ~~debt~~(the ~~issuance~~“Second ~~cost amortization~~Extension”) ~~recorded~~with asCherokee ~~interest~~under ~~expense)~~which ~~and~~Cherokee ~~$166,000~~extended inthe ~~interest expense~~due ~~related~~date toof the Cherokee LSA into ~~Fiscal~~February ~~2019 (of which $94~~15,~~000~~ ~~is debt issuance cost amortization recorded as interest expense)~~2022.

~~The Company~~Under ~~had~~the terms of the Second Extension, the Cherokee LSA was increased to $121,000,000 into ~~accrued~~include ~~interest~~a ~~expense~~$100,000 atpenalty ~~December~~that ~~31, 2020~~was ~~related~~due as a result of the Company being unable to pay back the principal balance to Cherokee ~~LSA~~on ~~and~~February ~~$10~~15,~~000~~ in2021. ~~accrued~~Under the Second Extension, the annual interest ~~expense~~ atrate ~~December~~on 31the 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 being paid quarterly with the first payment being made on May 15, ~~2019~~2021.

AsUnder the terms of ~~December~~ ~~31,~~the ~~2020~~Second Extension Agreement, if the ~~balance~~Company ondoesn’t ~~the~~pay ~~Cherokee~~off ~~LSA~~the ~~was~~principal ~~$900,000.~~on ~~As of~~or ~~December~~before 31February 15, ~~2019~~2022, ~~the~~Cherokee ~~balance~~may onimpose ~~the~~an ~~Cherokee~~8% ~~LSA~~delinquent ~~was~~fee. ~~$900,000; however,~~This delinquent fee would only apply to the ~~discounted~~principal balance ~~was~~is ~~$884~~on February 15,~~000~~ 2022.

ACantone ~~final balloon~~Research, ~~payment~~Inc. ~~was~~earned ~~due~~a 3% fee on ~~February~~the 15extended principal of $900,000 ~~2021;~~(or ~~however~~$27,000) ~~the~~for ~~Company further~~their ~~extended~~services related to securing the Second Extension with Cherokee ~~LSA~~investors. ~~See~~This ~~“Note~~3% Kservice ~~– Subsequent~~fee ~~Events~~would be “rebated” ~~for~~if ~~information~~the ~~regarding~~Company prepaid any, or a portion, of the ~~extension~~loan. As an example, if the Company made a principal reduction payment of $100,000, only $97,000 in cash would need to be remitted to Cherokee to have the $100,000 taken off the principal balance. The fee paid to Cantone Research, Inc. was recorded as a bank fee and is included in general and administrative expenses. The Company also paid Cherokee’s ~~LSA~~legal fees in the amount of $1,000.

~~F-17~~The Company recognized $98,000 in interest expense related to the Cherokee LSA in Fiscal 2021 and, $89,000 in interest expense related to the Cherokee LSA in Fiscal 2020 (of which $16,000 is debt issuance cost amortization recorded as interest expense).

~~LINE~~On OFAugust ~~CREDIT~~18, ~~WITH~~2021, ~~CRESTMARK~~we ~~BANK (“CRESTMARK”)~~issued 625,000 restricted shares of common stock to Cherokee in lieu of paying the $25,000 August 2021 interest payment in cash. The closing price of the Company’s common shares on the date of the payment in lieu of cash was $0.04.

OnThe ~~June 29,~~Company ~~2015~~incurred ~~(the “Closing Date”)~~$8,000 ~~the~~in ~~Company~~accrued ~~entered~~interest ~~into a~~expense ~~Loan~~at ~~and~~December ~~Security~~31, ~~Agreement~~2021 ~~(“LSA”) with Crestmark~~ related to ~~a revolving line of credit (~~the ~~“Crestmark LOC”).~~Cherokee ~~The~~LSA ~~Crestmark LOC is used for working capital~~ and ~~general~~, ~~corporate purposes. The Company amended the Crestmark LOC on June 22~~$12,000 ~~2020~~in ~~and~~accrued asinterest aexpense ~~result~~at ofDecember ~~this amendment~~31, ~~the Crestmark LOC expires on June 22, 2021~~2020.

~~Until the~~As ~~amendment on June 22, 2020, the Crestmark LOC provided the Company with a revolving line~~ of ~~credit~~December ~~up to $1~~31,~~500,000 (“Maximum~~ ~~Amount”).~~2021 ~~The~~and ~~Maximum~~December ~~Amount was subject to an Advance Formula comprised of: 1) 90% of Eligible Accounts Receivables (excluding~~31, ~~receivables remaining unpaid for more than 90 days from the date of invoice and sales made to entities outside of the United States)~~2020, ~~and 2) up to 40% of eligible inventory plus up to 10% of Eligible Generic Packaging Components not to exceed~~ the ~~lesser~~balance ~~of $350,000, or 100% of Eligible Accounts Receivable. However, as a result of an amendment executed~~ on ~~June 25, 2018,~~ the ~~amount~~ ~~available~~Cherokee ~~under~~LSA ~~the inventory component of the line of credit~~ was ~~changed to 40% of eligible inventory plus up to 10% of Eligible Generic Packaging Components not to exceed the lesser of~~ $~~250~~1,000 ~~(“Inventory Sub-Cap Limit”) or 100% of Eligible Accounts Receivable. In addition~~, ~~the Inventory Sub-Cap Limit was reduced by $10,~~000 ~~per month as of July 1, 2018~~ and ~~thereafter~~ ~~on the first day of the month until the Inventory Sub-Cap Limit was reduced to $0~~900, (making the Crestmark LOC an accounts-receivable based line only). This means that as of June 30, 2020, there is no inventory sub-cap. Upon execution of the amendment, the Maximum Amount was reduced to $1,000,~~000~~ ~~and with the Inventory Sub-Cap Limit gone as of July 1, 2020; the Crestmark LOC is a receivables-based only line of credit~~respectively.

~~The Crestmark~~F-17 ~~LOC~~Table ~~has a minimum loan balance requirement~~ of $500,000. At September 30, 2020, the Company did not meet the minimum loan balance requirement as our balance was $208,000. 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 Crestmark 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).Contents

~~Prior to~~AMERICAN ~~the~~BIO ~~amendment~~MEDICA on June 22, 2020, the Crestmark LOC contained a minimum Tangible Net Worth (“TNW”) covenant (previously defined in other periodic reports). With the exception of the quarter ended June 30, 2019, the Company did not historically comply with the TNW covenant and Crestmark previously provided a number of waivers (for which the Company was charged $5,000 each). The TNW covenant was removed effective with the quarter ended June 30, 2020.CORPORATION

InNotes ~~the event of a default under the LSA, which includes but is not limited~~ to, ~~failure~~financial ~~of the Company to make any payment when due, Crestmark is permitted to charge an Extra Rate. The Extra Rate is the Company’s then current interest rate plus 12.75% per annum.~~statements

~~Interest~~In on the ~~Crestmark~~ ~~LOC~~event ~~is at a variable rate based on the Prime Rate plus 3% with a floor~~ of ~~5.25%.~~default, Asthis ~~of December 31~~includes, ~~2020,~~but ~~the~~is ~~interest~~not ~~only rate~~limited onto; the ~~Crestmark~~Company’s ~~LOC~~inability ~~was~~to ~~6.25%~~make ~~due~~any topayments adue ~~decrease~~under in the ~~Prime Rate~~Cherokee ~~effective~~LSA ~~March~~(as ~~15,~~amended) ~~2020.~~Cherokee Ashas of the ~~date~~right ofto ~~this~~increase ~~report, with all fees considered (~~the interest rate +on anthe ~~Annual~~financing ~~Loan~~to ~~Fee~~18%. ~~of $7,500~~A +final aballoon ~~monthly~~payment ~~maintenance~~was ~~fee~~due ofon ~~0.30%~~February of15, ~~the~~2022. ~~actual~~See ~~average monthly~~Note ~~balance~~L ~~from~~– ~~the~~Subsequent ~~prior~~Events ~~month),~~for ~~the~~more ~~interest~~information ~~rate~~ on the ~~Crestmark~~ ~~LOC~~status ~~was~~of 13the Cherokee LSA.~~2%.~~

~~The Company~~LINE ~~recognized~~OF ~~$41,000~~CREDIT inWITH ~~interest~~CRESTMARK ~~expense~~BANK ~~related to the Crestmark LOC in Fiscal 2020 and $46,000 in interest expense related to the Crestmark LOC in Fiscal 2019.~~(“CRESTMARK”)

~~Given~~ On June 29, 2015 (the ~~nature~~“Closing ofDate”), the ~~administration~~Company entered into a Loan and Security Agreement (“LSA”) with Crestmark related to a revolving line of credit (the “Crestmark LOC,”). atThe ~~December 31,~~Crestmark ~~2020~~LOC is used for working capital and general corporate purposes. 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 ~~had~~is $0received inby ~~accrued~~Crestmark ~~interest~~not ~~expense~~less ~~related~~than sixty (60) days prior to the ~~Crestmark~~end ~~LOC,~~of ~~and~~the ~~there~~renewal isterm. $0The incurrent ~~additional~~maturity ~~availability~~date ~~under~~ of the Crestmark LOC is June 22, 2022.

~~As of December 31~~Originally, ~~2020,~~availability under the ~~balance~~Crestmark LOC was based on certain inventory components (under a specific formula previously defined in prior periodic reports) and receivables. The maximum available under the Crestmark LOC was $~~277~~1,500,000. However on June 25, ~~and~~ 2018, the facility was amended to decrease the amounts available under the inventory component until availability under the inventory component was zero; making the Crestmark LOC a receivables-based only line of credit as of ~~December~~July 311, ~~2019~~2020. The facility was further amended on June 22, 2020 to decrease the ~~balance~~maximum onavailability (“Maximum Amount”) under the Crestmark LOC ~~was~~ to $~~337~~1,000,000.

~~EQUIPMENT~~The ~~LOAN~~Crestmark ~~WITH~~LOC ~~CRESTMARK~~has a minimum loan balance requirement of $500,000. At December 31, 2021, the Company did not meet the minimum loan balance requirement as our balance was $178,000. 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 Crestmark 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).

OnAs ~~May 1,~~part ~~2017, the Company entered into term loan with Crestmark in the amount~~ of ~~$38,000 related to~~ 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 toon ~~its~~June ~~LSA~~22, ~~and~~2020, ~~Promissory Note with Crestmark. The amendments addressed~~ the ~~inclusion~~minimum ofTangible ~~the~~Net ~~term~~Worth ~~loan into~~(“TNW”) ~~the~~covenant ~~LSA~~(previously ~~and~~defined ~~an extension of the Crestmark LOC. No terms of the Crestmark LOC were changed~~ in ~~the~~other ~~amendment.~~periodic ~~The~~reports) ~~interest rate on the term loan~~ was ~~the~~removed ~~WSJ~~effective ~~Prime~~with ~~Rate plus 3%; or 6.25%. The loan was satisfied in~~ the quarter ended ~~September~~June 30, 2020.

~~The Company~~In ~~incurred~~the ~~minimal~~event ~~interest~~of ~~expense~~a indefault of the ~~Fiscal~~LSA, ~~2020 related~~which includes but is not limited to, failure of the ~~Equipment~~Company ~~Loan~~to ~~and~~make ~~less~~any ~~than~~payment $1when due,~~000~~ inCrestmark ~~interest expense~~is inpermitted ~~Fiscal~~to ~~2019.~~charge ~~The~~an ~~balance~~Extra onRate. ~~the~~The ~~Equipment~~Extra ~~Loan~~Rate is $0the ~~at December~~Company’s ~~31,~~then ~~2020~~current ~~and~~interest ~~$7,000~~rate atplus ~~December~~12.75% ~~31,~~per ~~2019~~annum.

~~F-18~~Interest on the Crestmark LOC is at a variable rate based on the Prime Rate plus 3% with a floor of 5.25%. As of December 31, 2021 and as of the date of this report, the interest only rate on the Crestmark LOC is 6.50%. As of the date of this report, with all fees considered (the interest rate + an Annual Loan Fee of $7,500 + a monthly maintenance fee of 0.30% of the actual average monthly balance from the prior month), the interest rate on the Crestmark LOC is 11.95%.

~~2019~~The ~~TERM~~Company ~~LOAN~~incurred ~~WITH~~$50,000 ~~CHEROKEE~~and $41,000 in interest expense related to the Crestmark LOC in Fiscal 2021 and Fiscal 2020, respectively.

~~On February~~Given ~~25, 2019 (~~the ~~“Closing~~nature ~~Date”), the Company entered into an agreement dated (and effective) February 13, 2019 (the “Agreement”) with Cherokee under which Cherokee provided the Company with a loan in the amount~~ of ~~$200,000 (~~the ~~“2019~~ ~~Cherokee~~administration ~~Term Loan”). Gross proceeds~~ of the ~~2019 Cherokee~~Crestmark ~~Term Loan were $200~~LOC,~~000;~~ ~~$150,000~~at ofDecember ~~which was used to satisfy the 2018 Cherokee Term Loan~~31, ~~$48,000~~2021 ~~(which~~and ~~was~~December ~~used to pay a portion of the $75~~31,~~000~~ ~~principal reduction payment; with the remaining $27~~2020,~~000~~ ~~being paid with cash on hand) and $2,000 which was used to pay Cherokee’s legal fees in connection with~~ the ~~financing.~~ ~~In connection with the 2019 Cherokee Term Loan, the~~ Company ~~issued~~had ~~200,000~~$0 ~~restricted shares of common stock to Cherokee~~ in ~~the~~accrued ~~three months ended March 31, 2019~~interest.

~~The annual~~As ~~interest~~of ~~rate~~December ~~under~~31, ~~the~~2021 ~~2019~~and ~~Cherokee~~December ~~Term~~31, ~~Loan~~2020, isthe ~~18% (fixed)~~balance ~~paid~~on ~~quarterly in arrears with~~ the ~~first~~Crestmark ~~interest~~LOC ~~payment being~~was ~~made~~$178,000 onand ~~May 15~~$277,000, ~~2019~~respectively. ~~and~~There ~~the~~is ~~latest~~no ~~interest~~in ~~payment~~additional ~~being made~~availability inunder ~~September~~the ~~2020.~~Crestmark ~~The~~LOC ~~loan~~at ~~was~~December ~~required~~31, to2021 bebecause ~~paid~~we indraw ~~full~~any balance available on ~~February~~ ~~15,~~a ~~2020~~daily basis.

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 due date of the 2019 ~~Term~~TERM ~~Loan~~LOAN toWITH February 15, 2021. No terms of the facility were changed under the Extension Agreement. For consideration of the Extension Agreement, the Company issued 1.5% of the $200,000 principal, or $3,000, in 42,857 restricted shares of the Company’s common stock to Cherokee. The Company also incurred a penalty in the amount of $20,000 which was added to the principal balance of the Cherokee Term Loan.CHEROKEE

InOn ~~the event~~February of25, ~~default~~2019, ~~this~~the ~~includes,~~Company ~~but~~entered isinto ~~not~~an ~~limited~~agreement ~~to,~~dated ~~the Company’s~~(and ~~inability~~effective) toFebruary ~~make~~13, ~~any~~2019 ~~payments~~with ~~due~~Cherokee under ~~the Agreement,~~which Cherokee ~~has~~provided the ~~right~~Company towith ~~increase~~a loan in the ~~interest~~amount ~~rate~~of ~~on the~~$200,000. ~~financing~~The toannual ~~20%~~interest ~~and~~rate ~~Cherokee~~under ~~will~~the ~~automatically~~2019 ~~add~~Cherokee ~~a delinquent~~Term ~~payment~~Loan ~~penalty~~is of18% ~~$20,000~~(fixed) topaid ~~the~~quarterly ~~outstanding principal~~in arrears.

~~The Company~~F-18 ~~recognized~~Table ~~$40,000 in interest expense related to the 2019 Cherokee Term Loan in Fiscal 2020 (~~of ~~which $1,000 is debt issuance cost amortization recorded as interest expense) and $48,000 in interest expense (of which $15,000 was debt issuance costs recorded as interest expense) in Fiscal 2019.~~Contents

~~The Company~~AMERICAN ~~had~~BIO ~~$7,000~~MEDICA in accrued interest expense at December 31, 2020 related to the Cherokee Term Loan and $5,000 in accrued interest expense at December 31, 2019. The balance on the 2019 Term Loan is $220,000 at December 31, 2020 (including the $20,000 penalty referenced above). As of December 31, 2019, the balance on the Cherokee Term Loan was $200,000; however, the discounted balance was $199,000.CORPORATION

ANotes ~~final balloon~~to ~~payment~~financial was due on February 15, 2021; however the Company further extended the 2019 Cherokee Term Loan. See “Note K – Subsequent Events” for information regarding the extension of the Cherokee Term Loan.statements

~~SBA~~On ~~PAYCHECK~~February ~~PROTECTION~~24, ~~LOAN~~2020, the Company completed a transaction related to a one-year Extension Agreement dated February 14, 2020 (~~PPP~~the ~~LOAN~~“Extension Agreement”) with Cherokee under which Cherokee extended the due date of the 2019 Cherokee Term Loan to February 15, 2021. No terms of the facility were changed under the Extension Agreement. For consideration of the Extension Agreement, the Company issued 1.5% of the $200,000 principal, or $3,000, in 42,857 restricted shares of the Company’s common stock to Cherokee. The Company also incurred a penalty in the amount of $20,000 which was added to the principal balance of the 2019 Cherokee Term Loan.

~~On April~~The ~~22,~~final ~~2020,~~balloon wepayment ~~entered~~was ~~into~~due aon ~~Promissory~~February ~~Note (“PPP Note”) for $332~~15,~~000~~ ~~with~~2021; ~~Crestmark~~however ~~Bank, pursuant to~~ the ~~U.S. Small~~Company ~~Business~~further ~~Administration~~extended ~~Paycheck Protection Program under Title I of~~ the ~~Coronavirus~~2019 ~~Aid,~~Cherokee ~~Relief,~~Term ~~and~~Loan ~~Economic Security (“CARES”) Act passed by Congress and signed into law~~ on ~~March~~ ~~27,~~February ~~2020. The PPP Note is unsecured~~24, ~~bears~~2021 ~~interest~~to atFebruary ~~1.00% per annum~~15, ~~with principal and interest payments deferred for the first six months, and matures in two years~~2022. ~~The~~Under ~~principal is payable in equal monthly installments, with interest, beginning on~~ the ~~first~~terms ~~business~~of ~~day after~~ the ~~end~~extension, of the ~~deferment~~2019 ~~period.~~Cherokee ~~The PPP~~Term ~~Note~~Loan ~~may~~was beincreased ~~forgiven~~to ~~subject~~$240,000 to ~~the~~include ~~terms~~a of$20,000 ~~the~~penalty ~~Paycheck Protection~~that ~~Program.~~was ~~Additionally,~~due ~~certain~~as ~~acts~~a result of the Company~~, including~~ ~~but~~being ~~not~~unable ~~limited~~ to: ~~(i) the failure to~~ pay ~~any~~back ~~taxes when due, (ii) becoming~~ the ~~subject~~principal ofbalance ato ~~proceeding~~Cherokee ~~under~~on ~~any~~February ~~bankruptcy or insolvency law~~15, ~~(iii)~~2021. ~~making~~The anannual ~~assignment~~interest ~~for~~rate under the ~~benefit~~2019 ~~of creditors,~~Cherokee orTerm ~~(iv)~~Loan ~~reorganizing,~~remains ~~merging,~~fixed ~~consolidating~~at ~~or otherwise~~18% ~~changing~~paid ~~ownership~~quarterly orin ~~business~~arrears ~~structure~~with ~~without PPP Lender’s prior written consent, are considered events of default which grant Lender~~ the ~~right~~first tointerest ~~seek immediate~~ payment ~~of all~~being ~~amounts~~due ~~owing~~on ~~under~~May ~~the~~15, ~~PPP Note~~2021. ~~The~~If the Company ~~intends~~doesn’t topay ~~apply for~~off ~~forgiveness~~the ofprincipal ~~loan~~on inor ~~the~~before ~~amount~~February of15, ~~$332~~2022,~~000~~ ~~under~~Cherokee ~~PPP guidelines~~may ~~after~~impose 24an ~~weeks,~~8% ordelinquent ~~after October 2020~~fee. AsThis ofdelinquent ~~April~~fee ~~2021, the~~would ~~online~~only ~~application~~apply ~~with~~to ~~Crestmark~~the ~~has~~principal ~~been~~balance ~~started~~is ~~and~~on weFebruary ~~are reconciling~~15, ~~data with our payroll provider~~2022.

The Company recognized $243,000 in interest expense related to the ~~PPP loan~~2019 Cherokee Term Loan in Fiscal ~~2020~~2021. The Company recognized $240,000 ~~was~~in ~~accrued~~interest atexpense ~~December~~related ~~31,~~to ~~2020 and~~the is2019 ~~eligible~~Cherokee ~~for~~Term ~~forgiveness~~Loan ~~under~~in ~~PPP~~Fiscal ~~guidelines.~~2020 As (of ~~December~~ ~~31,~~which ~~2020, the balance on the PPP Note was~~ $~~332~~1,000 ~~and~~is ~~as of~~debt ~~December~~issuance ~~31,~~cost ~~2019,~~amortization ~~the~~recorded ~~balance on the PPP Note was $0 (~~as ~~the facility~~interest ~~was not in place at December 31, 2019~~expense).

~~F-19~~On August 18, 2021, we issued 270,000 restricted shares of common stock to Cherokee in lieu of paying the $11,000 August 2021 interest payment in cash. The closing price of the Company’s common shares on the date of the payment in lieu of cash was $0.04.

~~NOVEMBER~~The Company had $4,000 in accrued interest expense related to the 2019 Cherokee Term Loan at December 31, 2021 and $7,000 in accrued interest expense at December 31, 2020. ~~LOAN~~The ~~WITH~~balance ~~CHAIM~~on ~~DAVIS~~the 2019 Cherokee Term Loan is $240,000 at December 31, 2021 and $220,000 at December 31, 2020.

~~On November~~In ~~6, 2020,~~ the ~~Company~~event ~~entered into a loan agreement with our Chairman~~ of ~~the~~default, ~~Board~~this ~~Chaim Davis~~includes, ~~under~~but ~~which~~is ~~Davis~~not ~~provided the~~limited ~~Company the sum of $25~~to,~~000~~ (the ~~“November~~Company’s ~~2020 Loan”).~~inability ~~There~~to ~~were~~make noany ~~expenses~~payments ordue ~~interest~~under ~~related to~~ the ~~November~~ ~~2020~~Agreement; ~~loan.~~Cherokee ~~The~~has ~~Company~~the ~~incurred~~right $0to inincrease ~~interest~~the ~~expense in Fiscal 2020 and $0 in~~ interest ~~expense~~rate inon ~~Fiscal 2019 (as~~ the ~~facility~~ ~~was~~financing ~~not~~to ~~in place until November 2020)~~20%. ~~The~~A ~~balance~~final onballoon ~~the November~~payment ~~2020 Term Loan~~ was ~~$25,000~~due aton ~~December~~February 3115, ~~2020,~~2022. ~~and~~See $0Note ~~at December~~L ~~31,~~– ~~2019~~Subsequent ~~(as~~Events ~~the~~for ~~facility~~more ~~was~~information ~~not~~on ~~in place at December 31, 2019). The principal in~~ the ~~amount~~status of ~~$25,000 was paid on February 24, 2021 with proceeds from~~ the ~~Lincoln~~2019 ~~Park~~Cherokee ~~equity line~~Term Loan.

~~NOVEMBER~~SBA ~~2020~~PAYCHECK ~~TERM~~PROTECTION LOAN (PPP LOAN)

On ~~November~~ 4April 22, 2020, the Company entered into a ~~loan~~Promissory ~~agreement~~Note ~~with~~(“PPP ~~an individual~~Note”) infor ~~the amount of~~ $50332,000. ~~There~~with ~~were~~Crestmark noBank, ~~expenses~~pursuant ~~related~~ to the ~~term~~U.S. ~~loan~~Small ~~and~~Business ~~the~~Administration ~~interest~~Paycheck ~~rate~~Protection isProgram 7%under ~~(Prime~~Title +I ~~3.75%).~~of ~~The first~~the ~~interest~~Coronavirus ~~only~~Aid, ~~payment~~Relief, isand ~~due~~Economic onSecurity ~~February~~(“CARES”) 4,Act ~~2021~~passed ~~and~~by ~~the final~~Congress ~~interest payment~~ and ~~50,000~~signed ~~principal~~into islaw ~~due~~ on ~~May~~March 427, ~~2021~~2020. The ~~company~~PPP ~~recognized~~Note ~~and~~was ~~accrued~~unsecured, ~~less~~with ~~than~~an $interest rate of 1.00% per annum,~~000~~ ofwith ~~interest expense~~principal ~~related~~and tointerest ~~the~~payments ~~term~~deferred ~~loan~~for inthe ~~Fiscal~~first ~~2020~~six months, and $0would mature in ~~interest expense~~two inyears. ~~Fiscal~~On ~~2019~~June ~~(as~~15, 2021, the ~~loan~~Company ~~was~~applied ~~not~~for forgiveness of the PPP loan in ~~place~~the atamount ~~December 31~~of $332,000 ~~2019)~~under PPP guidelines. ~~The~~Our ~~balance~~forgiveness onapplication was reviewed by the ~~2020~~SBA ~~Term~~and ~~Loan~~on ~~was~~August ~~$50~~3,~~000~~ ~~at December 31~~2021, ~~2020~~the ~~and~~Small $0Business atAdministration ~~December~~remitted ~~31,~~payment ~~2019~~to ~~(as~~Crestmark Bank for the ~~loan~~balance ~~was~~of ~~not in~~the ~~place~~PPP atLoan ~~December~~principal ~~31,~~and ~~2019)~~all interest due on the PPP Loan.

~~OTHER~~Interest ~~DEBT~~in ~~INFORMATION~~the amount of $3,000 was forgiven along with the principal. Since the loan was paid in full, there was $0 in accrued interest at December 31, 2021. The Company had $2,000 in accrued interest expense related to the PPP loan in Fiscal 2020; however as indicated previously, all interest was forgiven in August 2021.

~~In addition~~The tobalance on the ~~debt~~PPP ~~indicated~~Loan ~~previously,~~was ~~previous~~$0 ~~debt~~at ~~facilities (paid~~December in31, ~~full~~2021 ~~via~~and ~~refinance~~$332,000 orat ~~conversion~~December ~~into~~31, ~~equity) had financial impact on Fiscal~~ 2020 ~~and/or Fiscal 2019~~. ~~More specifically:~~

~~2018~~NOVEMBER ~~TERM~~2020 LOAN ~~WITH CHEROKEE~~

On ~~March~~ 2November 6, ~~2018~~2020, the Company entered into a ~~one-year~~loan ~~Loan~~agreement ~~Agreement made~~with asour of(then) ~~February~~Chairman ~~15,~~of ~~2018 (~~the ~~“Closing~~Board ~~Date”)~~Chaim ~~with Cherokee~~Davis, under which ~~Cherokee~~Davis provided the Company ~~with~~the sum of $~~150~~25,000 (the “~~2018~~November ~~Cherokee~~2020 ~~Term~~ Loan”). ~~The~~There ~~proceeds from the 2018 Cherokee Term Loan~~ were ~~used~~no byexpenses ~~the~~or ~~Company~~interest torelated ~~pay a $75,000 principal reduction payment~~ to ~~Cherokee~~the ~~that~~November ~~was~~2020 ~~due~~loan. onThe ~~February 15,~~Company ~~2018~~incurred ~~and~~ $~~1,000~~0 in ~~legal~~interest ~~fees~~expense ~~incurred~~in byboth ~~Cherokee.~~Fiscal ~~Net proceeds~~2021 ~~(to be used for working capital~~ and ~~general~~Fiscal ~~business purposes) were $74,000~~2020. The ~~annual~~balance ~~interest~~on ~~rate for~~ the ~~2018 Cherokee~~November 2020 Term Loan was ~~12%~~$0 toat beDecember ~~paid quarterly in arrears with the first interest payment being made on May 15~~31, ~~2018.~~2021 Inas ~~connection with~~ the ~~2018~~principal ~~Cherokee~~amount ~~Term~~of ~~Loan~~$25, ~~the Company issued 150,~~000 ~~restricted~~ ~~shares of common stock to Cherokee on March 8, 2018. The 2018 Cherokee Term Loan~~ was ~~required to be~~ paid in full on February 15 24, ~~2019 and was paid in full via refinance into the 2019 Term Loan with Cherokee~~2021.

~~The Company~~F-19 ~~recognized~~Table ~~$3,000 in interest expense related to the 2018 Cherokee Term Loan in Fiscal 2019 (~~of which $2,000 was debt issuance costs recorded as interest expense). As of December 31, 2020 and December 31, 2019, the balance on the 2018 Cherokee Term Loan was $0 as the Company paid the facility in full with proceeds from the 2019 Term Loan with Cherokee.Contents

~~JULY~~AMERICAN ~~2019~~BIO ~~TERM~~MEDICA ~~LOAN WITH CHAIM DAVIS, ET AL~~CORPORATION

OnNotes ~~July 31, 2019, the Company entered into loan agreements with two (2) individuals, under which each individual provided the Company the sum of $7,000 (for a total of $14,000)~~ to befinancial used in connection with certain fees and/or expenses related legal matters of the Company (the “July 2019 Term Loan”). One of the individuals was our Chairman of the Board Chaim Davis. There were no expenses related to the July 2019 Term Loan. The first payment of principal and interest was due on September 1, 2019 and the last payment of principal and interest was due on October 1, 2020. The annual interest rate of the July 2019 Term Loan was fixed at 7.5% (which represented the WSJ Prime Rate when the loan agreements were executed) +2.0%.statements

~~The balance~~NOVEMBER ~~on the 2019 Term Loan was $10,000 at December 31, 2019. In February~~ 2020, ~~all~~SHAREHOLDER ~~amounts~~TERM loaned under the July 2019 Term Loan were converted into equity as part of the February 2020 Private Placement. . Any interest that was incurred under the facility in 2019 and up to the conversion in February 2020 was forgiven by the holders. The balance on the July 2019 Term Loan was $0 at December 31, 2020.LOAN

~~F-20~~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 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 until November 4, 2021. The interest rate and all other terms of the note remained unchanged under the Extension.

~~DECEMBER~~On ~~2019~~November ~~CONVERTIBLE~~4, ~~NOTE~~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.

~~On December~~The ~~31, 2019, the~~ Company ~~entered~~recognized ~~into a Convertible Note with one individual in the amount of~~ $253,000 ~~(“2019~~in ~~Convertible Note”).~~interest ~~Under~~expense ~~the~~related ~~terms~~to ofthis ~~the~~loan ~~2019~~in ~~Convertible~~Fiscal ~~Note,~~2021 ~~the principal~~and ~~amount~~less ~~would~~than ~~convert~~$1,000 ~~into~~in ~~equity~~interest ~~within~~expense ~~120 days of the origination of the note or upon the close of a contemplated private placement~~ in ~~early~~Fiscal 2020~~, whichever was sooner~~. The ~~2019~~Company ~~Convertible Note~~had ~~did~~accrued ~~not~~less ~~bear~~than ~~any~~$1,000 ~~interest and was ultimately converted into equity as part of a private placement closed~~ in ~~February~~interest ~~2020.~~expense ~~The balance~~related onto ~~the~~this ~~2019~~loan ~~Convertible Note was $0~~ at December 31, ~~2020~~ 2021 and less than $251,000 at December 31, ~~2019~~2020.

~~NOTE F~~DECEMBER –2021 ~~INCOME~~SHAREHOLDER ~~TAXES~~LOANS

~~The Company~~On ~~follows~~December ~~ASC~~14, ~~740~~2021, ~~“Income Taxes” (“ASC 740”) which prescribes~~ the ~~asset~~Company ~~and~~entered ~~liability~~into ~~method~~Loan ~~whereby deferred~~Agreements ~~tax~~with ~~assets~~two ~~and~~non-affiliated ~~liabilities~~investors ~~are~~resulting ~~determined~~in ~~based~~gross ~~on differences between financial reporting~~ (and ~~tax~~net) ~~bases~~proceeds of ~~assets and liabilities~~$75,000 ~~and~~as ~~are~~there ~~measured~~were ~~using~~no ~~the~~costs ~~enacted~~associated ~~laws~~with ~~and tax rates that will be in effect when~~ the ~~differences are expected to reverse~~loans. The ~~measurement~~loans ofbear ~~deferred~~interest ~~tax~~of ~~assets~~7% isper ~~reduced,~~annum ~~if necessary,~~until byprincipal aand ~~valuation~~interest ~~allowance~~are ~~for~~both ~~any~~due ~~tax~~in ~~benefits~~full, ~~that~~or ~~are not~~until ~~expected~~June to15, ~~be realized~~2022. The ~~effect~~first oninterest ~~deferred~~payments ~~tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes~~ are ~~enacted.~~due ~~Under~~on ~~ASC~~March ~~740~~15, ~~tax~~2022 ~~benefits are~~and ~~recorded~~payment ~~only~~of ~~for~~final ~~tax~~interest ~~positions~~and ~~that~~principal are ~~more~~due ~~likely~~June ~~than~~15, ~~not to~~2022, beor ~~sustained~~earlier ~~upon examination by tax authorities. The amount recognized is measured~~ as ~~the~~we ~~largest~~receive ~~amount~~further ofERC ~~benefit that is greater than 50 percent likely to be realized upon ultimate settlement~~refunds. ~~Unrecognized tax benefits are tax benefits claimed in the Company’s tax returns that do not meet these recognition and measurement standards.~~

~~On March~~OTHER ~~27,~~DEBT 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. In addition, the CARES Act allows NOLs incurred in tax years 2018, 2019, and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The CARES Act also contains modifications on the limitation of business interest for tax years beginning in 2019 and 2020. The modifications to Section 163(j) increase the allowable interest expense deduction. Any tax benefit as a result of the CARES Act is primarily due to the carryback of net operating losses to prior years and increased interest expense deductions.INFORMATION

~~A reconciliation~~In ofaddition to the ~~U.S.~~debt ~~Federal~~indicated ~~statutory~~previously, ~~income~~previous ~~tax~~debt ~~rate~~facilities to(paid ~~the effective~~in ~~income~~full ~~tax~~via ~~rate~~refinance isor conversion into equity) are as follows:

	Year Ended December 31, 2020	Year Ended December 31, 2019
Tax expense at federal statutory rate	(21%)	(21%)
State tax expense, net of federal tax effect	0%	0%
Expired NOL	42%	46%
Deferred income tax asset valuation allowance	(21%)	(26%)
Effective income tax rate	(0%)	(1%)

JULY 2019 TERM LOAN WITH CHAIM DAVIS, ET AL

~~F-21~~On July 31, 2019, the Company entered into loan agreements with two (2) individuals, under which each individual provided the Company the sum of $7,000 (for a total of $14,000) to be used in connection with certain fees and/or expenses related legal matters of the Company (the “July 2019 Term Loan”). One of the individuals was our (then) Chairman of the Board, Chaim Davis. There were no expenses related to the July 2019 Term Loan. The first payment of principal and interest was due on September 1, 2019 and the last payment of principal and interest was due on October 1, 2020. The annual interest rate of the July 2019 Term Loan was fixed at 7.5% (which represented the WSJ Prime Rate when the loan agreements were executed) +2.0%.

~~AMERICAN~~The ~~BIO~~balance ~~MEDICA~~on ~~CORPORATION~~the 2019 Term Loan was $10,000 at December 31, 2019. In February 2020, all amounts loaned under the July 2019 Term Loan were converted into equity as part of the February 2020 Private Placement. Any interest that was incurred under the facility in 2019 and up to the conversion in February 2020 was forgiven by the holders. The balance on the July 2019 Term Loan was $0 at December 31, 2020.

~~Notes to~~DECEMBER ~~financials~~2019 CONVERTIBLE NOTE

~~Significant components~~On ofDecember 31, 2019, the Company’s ~~deferred~~entered ~~income~~into ~~tax~~a ~~assets~~Convertible ~~are~~Note with one individual in the amount of $25,000 (“2019 Convertible Note”). Under the terms of the 2019 Convertible Note, the principal amount would convert into equity within 120 days of the origination of the note or upon the close of a contemplated private placement in early 2020, whichever was sooner. The 2019 Convertible Note did not bear any interest and was ultimately converted into equity as ~~follows:~~ part of a private placement closed in February 2020. The balance on the 2019 Convertible Note was $0 at December 31, 2020.

	December 31, 2020	December 31, 2019
Inventory capitalization	$8,000	$8,000
Inventory allowance	73,000	76,000
Allowance for doubtful accounts	6,000	9,000
Accrued compensation	18,000	18,000
Stock based compensation	162,000	168,000
Deferred wages payable	36,000	50,000
Depreciation – Property, Plant & Equipment	(5,000)	(1,000)
Research and development credits	22,000	0
Net operating loss carry-forward	3,123,000	3,339,000
Total gross deferred income tax assets	3,443,000	3,667,000
Less deferred income tax assets valuation allowance	(3,443,000)	(3,667,000)
Net deferred income tax assets	$0	$0

F-20

Table of Contents

~~The valuation~~AMERICAN ~~allowance~~BIO ~~for~~MEDICA deferred income tax assets as of December 31, 2020 and December 31, 2019 was $3,443,000 and $3,667,000, respectively. The net change in the deferred income tax assets valuation allowance was $224,000 for Fiscal 2020 and $217,000 for Fiscal 2019. The Company believes that it is more likely than not that the deferred tax assets will not be realized.CORPORATION

AsNotes ~~of December~~to ~~31,~~financial ~~2020, the prior three years remain open for examination by the federal or state regulatory agencies for purposes of an audit for tax purposes.~~statements

~~At December~~NOTE ~~31,~~F ~~2020,~~– ~~the~~INCOME Company had Federal net operating loss carry-forwards for income tax purposes of approximately $3,123,000 and research and development credits of $22,000. The Company’s net operating loss carry-forwards began to expire in 2019 and continue to expire through 2035. In assessing the realizability of deferred income tax assets, management considers whether or not it is more likely than not that some portion or all deferred income tax assets will be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the projected future taxable income and tax planning strategies in making this assessment.TAXES

The Company’s ~~ability~~follows toASC ~~utilize~~740 “Income Taxes” (“ASC 740”) which prescribes the ~~operating~~asset ~~loss carry-forwards~~and ~~may~~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 ~~subject~~in effect when the differences are expected to anreverse. ~~annual~~The ~~limitation~~measurement inof ~~future periods~~deferred ~~pursuant~~tax assets is reduced, if necessary, by a valuation allowance for any tax benefits that are not expected to ~~Section~~be ~~382~~realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the ~~Internal~~period ~~Revenue~~that ~~Code~~such ~~of 1986~~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 ~~amended,~~the iflargest ~~future~~amount ~~changes~~of benefit that is greater than 50 percent likely to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in ~~ownership occur~~the Company’s tax returns that do not meet these recognition and measurement standards.

~~The Company~~On ~~recognizes~~March ~~potential~~27, ~~interest~~2020, the Coronavirus Aid, Relief, and ~~penalties~~Economic ~~related~~Security Act (CARES Act) was enacted in response to ~~income~~ ~~tax~~the ~~positions~~COVID-19 aspandemic. aThe ~~component~~CARES Act, among other things, permits Net Operating Loss (“NOL”) carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. With regards to the ~~provision~~use of net losses incurred for 2018 and later, such net operating losses have no expiration, while taxable income ~~taxes~~ oncan ~~operations.~~only ~~The~~be ~~Company~~offset ~~does~~up ~~not~~to ~~anticipate~~80% ~~that~~of ~~total unrecognized~~taxable ~~tax~~income. ~~benefits~~Net ~~will~~operating ~~materially~~losses ~~change~~incurred inprior ~~the~~to ~~next~~2018 ~~twelve months~~may be fully utilized to offset taxable income.

~~NOTE~~A Greconciliation –of ~~OTHER~~the ~~INCOME~~U.S. /Federal ~~EXPENSE~~statutory income tax rate to the effective income tax rate is as follows:

Other expense in Fiscal 2020 consisted of interest expense associated with our credit facilities, offset by non-refundable deposits for cancelled Covid test orders. Other expense in Fiscal 2019 consisted of interest expense associated with our credit facilities, offset by other income from proceeds for an insurance claim related to our New Jersey facility (a claim that resulted from actions of a service vendor) and a gain on an accrual for a contingent liability.

	Year Ended December 31, 2021			Year Ended December 31, 2020
Tax expense at federal statutory rate	(21		%)	(21		%)
State tax expense, net of federal tax effect		0	%		0	%
Permanent differences	(12		%)		-
Expired NOL		119	%		42	%
Deferred income tax asset valuation allowance	(86		%)	(21		%)
Effective income tax rate	(0		%)	(0		%)

~~F-22~~Significant components of the Company’s deferred income tax assets are as follows:

AMERICAN BIO MEDICA CORPORATION

	December 31, 2021			December 31, 2020

Inventory capitalization	$	8,000		$	8,000
Inventory allowance		72,000			73,000
Allowance for doubtful accounts		1,000			6,000
Accrued compensation		18,000			18,000
Stock based compensation		160,000			162,000
Deferred wages payable		21,000			36,000
Depreciation – property, plant and equipment		(24,000	)		(5,000	)
Research and development credits		24,000			22,000
Net operating loss carry-forward		2,631,000			3,123,000
Total gross deferred income tax assets		2,911,000			3,443,000
Less deferred income tax assets valuation allowance		(2,911,000	)		(3,443,000	)
Net deferred income tax assets	$	0		$	0

~~Notes to~~The ~~financials~~valuation allowance for net deferred income tax assets as of December 31, 2021 and December 31, 2020 was $2,911,000 and $3,443,000, respectively. The net change in the valuation allowance was $532,000 for Fiscal 2021 and $224,000 for Fiscal 2020. The Company believes that it is more likely than not that the net deferred tax assets will not be realized.

~~NOTE~~F-21 HTable –of ~~STOCKHOLDERS’ EQUITY~~Contents

~~[1]~~AMERICAN ~~Stock~~BIO ~~option~~MEDICA plans: 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.CORPORATION

~~[2]~~Notes ~~Stock options: During Fiscal 2020, the Company issued 0 options~~ to ~~purchase~~financial shares of common stock. During Fiscal 2019, the Company issued four stock option grants to non-employee members of our board of directors (under the Fiscal 2001 Plan) to purchase 20,000 shares of common stock (each); for a total of 80,000 common shares.statements

As of December 31, ~~2020~~2021, ~~there were 1,987,000 options issued and outstanding under~~ the ~~2001~~prior ~~Plan.~~three ~~There~~years ~~were~~remain noopen ~~options~~for ~~issued~~examination ~~under the~~by ~~2013 Plan, making~~ the ~~total~~federal ~~issued~~or ~~and~~state ~~outstanding~~regulatory ~~options 1,987,000~~agencies asfor ofpurposes ~~December 31, 2020. Of the total options issued and outstanding, 1,987,000 were fully vested as~~ of ~~December~~an ~~31,~~audit ~~2020. As of December 31, 2020, there were 1,730,000 options available~~ for ~~issuance~~ ~~under~~tax ~~the 2001 Plan and 4,000,000 options available under the 2013 Plan~~purposes.

~~Stock option~~At ~~activity~~December 31, 2021, the Company had Federal net operating loss carry-forwards for ~~Fiscal~~income ~~2020~~tax purposes of approximately $2,631,000 and ~~Fiscal~~research ~~2019~~and development credits of $24,000. The Company’s net operating loss carry-forwards begin to expire in 2022 and continue to expire through 2037. Net operating losses incurred from 2018 to date have no expiration date. In assessing the realizability of net deferred income tax assets, management considers whether or not it is ~~summarized~~more ~~as follows:~~likely (than not that some portion or all of the ~~figures~~net ~~contained~~deferred ~~within~~income tax assets will be realized. The ultimate realization of net deferred income tax assets is dependent upon the ~~tables~~generation ~~below~~of ~~have~~future ~~been rounded~~taxable toincome during the ~~nearest~~periods ~~thousand)~~in which those temporary differences become deductible. Management considers the projected future taxable income and tax planning strategies in making this assessment.

	Year ended December 31, 2020			Year ended December 31, 2019
	Shares	Weighted Average Exercise Price	Aggregate Intrinsic Value as of December 31, 2020	Shares	Weighted Average Exercise Price	Aggregate Intrinsic Value as of December 31, 2019
Options outstanding at beginning of year	2,252,000	$0.13		2,222,000	$0.13
Granted	0	NA		80,000	$0.07
Exercised	0	NA		0	NA
Cancelled/expired	(265,000)	$0.10		(50,000)	$0.20
Options outstanding at end of year	1,987,000	$0.13	$291,324	2,252,000	$0.13	$1,000
Options exercisable at end of year	1,987,000	$0.13		2,172,000	$0.13

The Company’s ability to utilize the operating loss carry-forwards may be subject to an annual limitation in future periods pursuant to Section 382 of the Internal Revenue Code of 1986, as amended, if future changes in ownership occur.

~~F-23~~The Company recognizes potential interest and penalties related to income tax positions as a component of the provision for income taxes on operations. The Company does not anticipate that total unrecognized tax benefits will materially change in the next twelve months.

~~The following~~NOTE ~~table~~G ~~presents~~– ~~information~~OTHER ~~relating~~INCOME to/ ~~stock~~EXPENSE ~~options outstanding as of December 31, 2020:~~

	Options Outstanding			Options Exercisable
			Weighted Average Remaining		Weighted Average
	Shares	Weighted Average Exercise Price	Life in Years	Shares	Exercise Price
$0.07 - $0.11	910,000	$0.11	5.59	910,000	$0.11
$0.12 - $0.16	780,000	$0.13	3.68	780,000	$0.13
$0.18 - $0.26	297,000	$0.19	1.68	297,000	$0.19
TOTAL	1,987,000	$0.13	4.26	1,987,000	$0.13

Other income of $718,000 in Fiscal 2021 consisted of income related to the forgiveness of our PPP loan in the amount of $335,000, other income of $58,000; which is $50,000 related to certain non-refundable prepayments (customer deposits) that were forfeited when the customer did not remit the remaining amounts due on the order and $8,000 in income related to gains on certain liabilities, $619,000 in income from the Employee Retention Credit recognized in Fiscal 2021 (which is $44,000 in credits taken in Q3 2021, $38,000 in credit taken in Q4 2021 and $537,000 in refunds filed for credits in the first three quarters of 2021). This income was offset by interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and a shareholder loan) and a $100,000 write off related to impairment of the Company’s patent asset.

~~The following~~Other ~~table~~expense ~~summarizes~~of ~~weighted-average~~$173,000 ~~assumptions~~in ~~using~~Fiscal ~~the Black-Scholes~~2020 ~~option-pricing~~consisted ~~model~~of ~~used~~interest onexpense ~~the~~associated ~~date~~with our credit facilities (our line of ~~the~~credit, ~~grants issued~~equipment ~~during~~loan ~~Fiscal~~with ~~2020~~Crestmark Bank and ~~Fiscal~~our ~~2019:~~two loans with Cherokee Financial, LLC) nominally offset by $2,000 in other income.

	Year Ended December 31
	2020	2019
Volatility	NA	85%
Expected term (years)	NA	10 years
Risk-free interest rate	NA	2.01%
Dividend yield	NA	0%

NOTE H – STOCKHOLDERS’ EQUITY

[1] Stock option plans: The Company ~~recognized~~currently $2has two non-statutory stock option plans,~~000~~ inthe ~~share~~Fiscal ~~based~~2001 ~~payment~~Non-statutory ~~expense~~Stock ~~related~~Option ~~to stock~~Plan ~~options~~(the in“2001 ~~Fiscal~~Plan”) ~~2020,~~and the 2013 Equity Compensation Plan (the “2013 Plan”). Both plans have been adopted by our Board of Directors and ~~$5,000~~approved inby ~~share~~our ~~based~~shareholders. ~~payment expense~~Both ~~related~~the to2001 ~~stock~~Plan and the 2013 Plan have options inavailable ~~Fiscal~~for ~~2019~~future issuance. AsAny ofcommon ~~December~~shares ~~31, 2020,~~issued ~~there~~as ~~was~~a $0result of ~~total~~the ~~unrecognized~~exercise ~~share~~of ~~based~~stock ~~payment expense~~options ~~related~~would tobe ~~stock~~new ~~options~~common shares issued from our authorized issued shares.

[32] Stock options: During Fiscal 2021 and Fiscal 2020, the Company issued 0 options to purchase shares of common stock.

~~Warrants:~~As of December 31, 2021, there were 1,937,000 options issued and outstanding under the 2001 Plan. There were no options issued under the 2013 Plan, making the total issued and outstanding options 1,937,000 as of December 31, 2021. Of the total options issued and outstanding, 1,937,000 were fully vested as of December 31, 2021. As of December 31, 2021, there were 1,780,000 options available for issuance under the 2001 Plan and 4,000,000 options available under the 2013 Plan.

~~Warrant activity~~F-22 ~~for~~Table ~~Fiscal 2020 and Fiscal 2019 is summarized as follows. Any common shares issued as a result~~ of ~~the exercise of warrants would be new common shares issued from our authorized issued shares.~~Contents

	Year Ended December 31, 2020			Year Ended December 31, 2019
	Shares	Weighted Average Exercise Price	Aggregate Intrinsic Value	Shares	Weighted Average Exercise Price	Aggregate Intrinsic Value
Warrants outstanding at beginning of year	2,000,000	$0.18		2,000,000	$0.18
Granted	0	NA		0	NA
Exercised	0	NA		0	NA
Cancelled/expired	(2,000,000)	NA		(0)	NA
Warrants outstanding at end of year	0	NA	None	2,000,000	$0.18	None
Warrants exercisable at end of year	0	NA		2,000,000	$0.18

AMERICAN BIO MEDICA CORPORATION

~~The Company~~Notes ~~recognized $0 in debt issuance and deferred finance costs related~~ to ~~the~~financial ~~issuance of these warrants outstanding in Fiscal 2020 and Fiscal 2019. As of December 31, 2020, there was $0 of total unrecognized expense.~~statements

~~F-24~~Stock option activity for Fiscal 2021 and Fiscal 2020 is summarized as follows: (the figures contained within the tables below have been rounded to the nearest thousand)

NOTE I – COMMITMENTS, CONTINGENCIES AND OTHER MATTERS

	Year Ended December 31,2021							Year Ended December 31, 2020
	Shares			Weighted Average Exercise Price		Aggregate Intrinsic Value		Shares			Weighted Average Exercise Price		Aggregate Intrinsic Value
Options outstanding-beginning of year		1,987,000		$	0.13				2,252,000		$	0.13
Granted		0		NA					0		NA
Exercised		0		NA					0		NA
Cancelled/expired		(50,000	)	$	0.13				(265,000	)	$	0.10
Options outstanding-end of year		1,937,000		$	0.13	$	1,000		1,987,000		$	0.13	$	291,324
Options exercisable-end of year		1,937,000		$	0.13				1,987,000		$	0.13

~~[1] Operating leases:~~ The ~~Company~~following ~~leases office~~table ~~and~~presents ~~R&D/production~~information ~~facilities~~relating into ~~New~~stock ~~Jersey~~options ~~under~~outstanding ~~a, non-cancellable~~as ~~operating~~of ~~lease through~~ December 31, 2019. In December 2019, the Company extended the lease for the New Jersey facility through December 31, 2022. The Company also leases office support equipment through July 2022 and December 2025. At December 31, 2019, the future minimum rental payments under these operating leases are as follows2021:

2021	39,000
		Options Outstanding						Options Exercisable
2022	38,000
				Weighted		Weighted				Weighted
2023	1,000
				Average		Average				Average
2024	1,000
Range of Exercise				Exercise		Remaining				Exercise
Thereafter	1,000
Price		Shares		Price		Life in Years		Shares		Price
	$80,000
$0.07 - $0.11			910,000	$	0.11		4.59		910,000	$	0.11
$0.12 - $0.16			730,000	$	0.13		2.90		730,000	$	0.13
$0.18 - $0.26			297,000	$	0.19		0.68		297,000	$	0.19
TOTAL			1,937,000	$	0.13		3.35		1,937,000	$	0.13

~~Rent Expense~~The ~~was~~Company recognized $460 in share based payment expense related to stock options in Fiscal 2021 and $2,000 in share based payment expense in Fiscal 2020. ~~and~~As ~~Fiscal~~of ~~2019~~December 31, 2021, there was $0 of total unrecognized share based payment expense related to stock options.

[23] ~~Employment agreements~~Warrants: The Company has an employment agreement in place with its Chief Executive Officer/Principal Financial Officer, Melissa Waterhouse. The employment agreement with Ms. Waterhouse provides for a $160,000 annual salary (although the salary of Ms. Waterhouse was deferred by 10% through the June 2020; resulting in deferred compensation due to Waterhouse in the amount of $106,000 through December 31, 2020). The employment agreement contains severance provisions; in the event the Company terminates Ms. Waterhouse’s employment for any reason other than cause (which is defined under the employment agreement), Ms. Waterhouse would receive severance pay equal to 12 months of her base salary at the time of termination, with continuation of all medical benefits during the twelve-month period at the Company’s expense. In addition, Ms. Waterhouse may tender her resignation and elect to exercise the severance provision if she is required to relocate more than 50 miles from the Company’s New York facility as a continued condition of employment, if there is a substantial change in the responsibilities normally assumed by her position, or if she is asked to commit or conceal an illegal act by an officer or member of the board of directors of the Company. In the case of a change in control of the Company, Ms. Waterhouse would be entitled to severance pay equal to two times her base salary under certain circumstances.

~~[3] Legal~~Warrant activity for Fiscal 2021 and Fiscal 2020 is summarized as follows:

ABMC v. Todd Bailey

Year Ended December 31, 2021

Year Ended December 31, 2020

Shares

Weighted Average Exercise Price

Aggregate

Intrinsic Value

Shares

Weighted Average Exercise Price

Aggregate Intrinsic Value

Warrants outstanding at beginning of year

2,000,000

0.18

Granted

Exercised

Cancelled/expired

(2,000,000

)

Warrants outstanding at end of year

None

Warrants exercisable at end of year

~~On August 5, 2019, we settled litigation with Todd Bailey; a former Vice President, Sales & Marketing and sales consultant of the Company until December~~ F-23, ~~2016;~~Table ~~hereinafter referred to as “Bailey”). The litigation was filed by the Company in the Northern District~~ of New York in February 2017. Our complaint sought damages related to profits and revenues that resulted from actions taken by Bailey related to our customers. The settlement also addressed a counter-claim filed by Bailey in October 2017 (filed originally in Minnesota but, transferred to the Norther District of New York in January 2019). Bailey was seeking deferred commissions in the amount of $164,000 that he alleged were owed to him by the Company. These amounts were originally deferred under a deferred compensation program initiated in 2013; a program in which Bailey was one of the participants. We believed the amount sought was not due to Bailey given the actions indicated in our litigation.Contents

~~Under the~~AMERICAN ~~settlement,~~BIO ~~both~~MEDICA parties elected to resolve the litigation and settle any and all claims made within the litigation. Neither party admitted to any of the allegations contained within the ABMC v. Baily litigation (including any allegations made by Bailey in his counterclaim). Both parties also agreed to dismiss all claims made against each other.CORPORATION

~~Other~~Notes to financial statements

~~From time~~NOTE toI ~~time,~~– ~~the Company may be named in legal proceedings in connection with matters that arose during the normal course of business. While the ultimate outcome of any such litigation cannot be predicted~~COMMITMENTS, ifCONTINGENCIES ~~the~~AND ~~Company~~OTHER is unsuccessful in defending any such litigation, the resulting financial losses are not expected to have a material adverse effect on the financial position, results of operations and cash flows of our company.MATTERS

F[1] Operating leases: The Company leases office and R&D/production facilities in New Jersey under a, non-25cancellable operating lease through December 31, 2022. The Company also leases office support equipment through July 2022 and December 2025. At December 31, 2021, the future minimum rental payments under these operating leases are as follows:

NOTE J – LINCOLN PARK EQUITY LINE OF CREDIT

2022		38,000
2023		1,000
2024		1,000
2025		1,000
2026		0
	$	41,000

~~On December~~Rent 9,Expense ~~2020,~~was ~~the Company 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~~ $1047,~~250,~~000 ~~of our shares of common stock, par value $0.01 per share, subject to certain limitations set forth~~ in ~~the Purchase~~Fiscal ~~Agreement,~~2021 ~~during the term of the Purchase Agreement (two years). Pursuant to the terms of the Registration Rights Agreement, the Company was required to file with the U.S. Securities~~ and ~~Exchange~~ ~~Commission (the “SEC”) a registration statement on Form S-1 (the “Registration Statement”) to register for resale under the Securities Act of 1933~~$46,000 ~~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~~Fiscal ~~future to issue and sell to Lincoln Park from time to time under the Purchase Agreement~~2020.

~~On December~~[2] 9,Employment ~~2020,~~agreements: ~~the~~The Company ~~sold~~has ~~500~~an employment agreement in place with its Chief Executive Officer/Principal Financial Officer, Melissa Waterhouse. The employment agreement with Ms. Waterhouse provides for a $160,000 ~~shares~~annual salary (although the salary of ~~common~~Ms. ~~stock to~~Waterhouse ~~Lincoln~~was ~~Park~~deferred inby an10% ~~initial~~through ~~purchase~~June ~~under~~2020; ~~the~~resulting ~~Purchase~~in ~~Agreement for~~deferred acompensation ~~purchase~~due ~~price~~to Waterhouse in the amount of $~~125~~73,000 through December 31, 2021). AsThe ~~consideration~~employment ~~for~~agreement ~~Lincoln Park~~contains severance provisions; in the event the Company terminates Ms. Waterhouse’s ~~irrevocable~~employment ~~commitment~~for toany ~~purchase~~reason ~~common~~other ~~shares~~than ~~upon~~ cause (which is defined under the ~~terms~~employment ofagreement), ~~and~~Ms. ~~subject~~Waterhouse would receive severance pay equal to ~~satisfaction~~12 months of ~~the~~her ~~conditions~~base ~~set forth~~salary inat the ~~Purchase~~time ~~Agreement~~of termination, onwith ~~December~~continuation 9,of ~~2020,~~all medical benefits during the twelve-month period at the Company ~~also~~’s ~~issued~~expense. 1In addition,~~250,000~~ ~~shares~~Ms. ofWaterhouse ~~common~~may ~~stock~~tender toher ~~Lincoln~~resignation ~~Park~~and ~~as commitment~~elect ~~shares.~~to ~~The~~exercise ~~commitment~~the ~~shares~~severance ~~were~~provision ~~valued~~if atshe ~~$138,000 and~~is ~~recorded~~required asto anrelocate ~~addition~~more tothan ~~equity~~50 ~~for~~miles from the ~~issuance~~Company’s ofNew ~~common stock~~York ~~and~~facility ~~treated~~ as a ~~reduction~~continued tocondition ~~equity~~of asemployment, aif ~~cost~~there ofis ~~capital~~a to

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