UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

FORM 10-Q

☒    Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the quarterly period ended September 30, 2020
☐    Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from ____ to _____

Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended June 30, 2021

Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from ___________ to ___________

Commission File Number: 0-28666

AMERICAN BIO MEDICA CORPORATION
 (Exact name of registrant as specified in its charter)

New York14-1702188

AMERICAN BIO MEDICA CORPORATION

(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)

518-758-8158

 (Registrant's

(Registrant’s telephone number, including area code)

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

OTC Markets Pink

OTCQB® Venture Market

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


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


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


Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act) ☐ Yes   ☒ No

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

35,953,476

43,803,476 Common Shares as of November 16, 2020



August 18, 2021

American Bio Medica Corporation

Index to Quarterly Report on Form 10-Q

For the quarter ended SeptemberJune 30, 2020

2021

PAGE

PART I – FINANCIAL INFORMATION

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Signatures

29

 
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2

Table of Contents

PART I - FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

American Bio Medica Corporation
Condensed Balance Sheets
 
 
September 30,
 
 
December 31,
 
 
 
 2020
 
 
2019
 
ASSETS
 
 (Unaudited)
 
 
 
 
Current assets
 
 
 
 
 
 
Cash and cash equivalents
 $61,000 
 $4,000 
Accounts receivable, net of allowance for doubtful accounts of $35,000 at September 30, 2020 and $34,000 at December 31, 2019
  364,000 
  370,000 
Inventory, net of allowance of $397,000 at September 30, 2020 and $291,000 at December 31, 2019
  602,000 
  810,000 
Prepaid expenses and other current assets
  85,000 
  6,000 
Right of use asset – operating leases
  35,000 
  34,000 
Total current assets
  1,147,000 
  1,224,000 
Property, plant and equipment, net
  594,000 
  644,000 
Patents, net
  110,000 
  116,000 
Right of use asset – operating leases
  49,000 
  73,000 
Other assets
  21,000 
  21,000 
Total assets
 $1,921,000 
 $2,078,000 
 
    
    
LIABILITIES AND STOCKHOLDERS’ DEFICIT
    
    
Current liabilities
    
    
Accounts payable
 $604,000 
 $652,000 
Accrued expenses and other current liabilities
  577,000 
  543,000 
Right of use liability – operating leases
  33,000 
  34,000 
Wages payable
  98,000 
  104,000 
Line of credit
  208,000 
  337,000 
PPP Loan
  332,000 
  0 
Current portion of long-term debt, net of deferred finance costs
  1,120,000 
  17,000 
Total current liabilities
  2,972,000 
  1,687,000 
Long-term debt/other liabilities , net of current portion and deferred finance costs
  0 
  1,108,000 
Right of use liability – operating leases
  49,000 
  73,000 
Total liabilities
  3,021,000 
  2,868,000 
COMMITMENTS AND CONTINGENCIES
    
    
Stockholders' deficit:
    
    
Preferred stock; par value $.01 per share; 5,000,000 shares authorized, none issued and outstanding at September 30, 2020 and December 31, 2019
  0 
  0 
Common stock; par value $.01 per share; 50,000,000 shares authorized; 35,953,476 issued and outstanding at September 30, 2020 and 32,680,984 issued and outstanding as of December 31, 2019
  359,000 
  327,000 
Additional paid-in capital
  21,658,000 
  21,437,000 
Accumulated deficit
  (23,117,000)
  (22,554,000)
Total stockholders’ deficit
  (1,100,000)
  (790,000)
Total liabilities and stockholders’ deficit
 $1,921,000 
 $2,078,000 

American Bio Medica Corporation

Condensed Balance Sheets

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

 2021

 

 

2020

 

ASSETS

 

 (Unaudited)

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$30,000

 

 

$98,000

 

Accounts receivable, net of allowance for doubtful accounts of $5,000 at June 30, 2021 and $22,000 at December 31, 2020

 

 

387,000

 

 

 

407,000

 

Inventory, net of allowance of $321,000 at June 30, 2021 and $279,000 at December 31, 2020

 

 

475,000

 

 

 

536,000

 

Prepaid expenses and other current assets

 

 

25,000

 

 

 

104,000

 

Right of use asset – operating leases

 

 

36,000

 

 

 

35,000

 

Total current assets

 

 

953,000

 

 

 

1,180,000

 

Property, plant and equipment, net

 

 

544,000

 

 

 

576,000

 

Patents, net

 

 

104,000

 

 

 

108,000

 

Right of use asset – operating leases

 

 

22,000

 

 

 

41,000

 

Other assets

 

 

21,000

 

 

 

21,000

 

Total assets

 

$1,644,000

 

 

$1,926,000

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$593,000

 

 

$577,000

 

Accrued expenses and other current liabilities

 

 

487,000

 

 

 

620,000

 

Right of use liability – operating leases

 

 

26,000

 

 

 

33,000

 

Wages payable

 

 

92,000

 

 

 

107,000

 

Line of credit

 

 

287,000

 

 

 

277,000

 

PPP Loan

 

 

332,000

 

 

 

332,000

 

Current portion of long-term debt, net of deferred finance costs

 

 

1,290,000

 

 

 

75,000

 

Total current liabilities

 

 

3,107,000

 

 

 

2,021,000

 

Long-term debt/other liabilities , net of current portion and deferred finance costs

 

 

0

 

 

 

1,120,000

 

Right of use liability – operating leases

 

 

30,000

 

 

 

41,000

 

Total liabilities

 

 

3,137,000

 

 

 

3,182,000

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock; par value $.01 per share; 5,000,000 shares authorized, none issued and outstanding at June 30, 2021 and December 31, 2020

 

 

0

 

 

 

0

 

Common stock; par value $.01 per share; 75,000,000 shares authorized; 42,603,476 issued and outstanding at June 30, 2021 and 37,703,476 issued and outstanding as of December 31, 2020

 

 

426,000

 

 

 

377,000

 

Additional paid-in capital

 

 

22,232,000

 

 

 

21,717,000

 

Accumulated deficit

 

 

(24,151,000)

 

 

(23,350,000)

Total stockholders’ deficit

 

 

(1,493,000)

 

 

(1,256,000)

Total liabilities and stockholders’ deficit

 

$1,644,000

 

 

$1,926,000

 

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


American Bio Medica Corporation
 Condensed Statements of Operations
(Unaudited)
 
 
For The Nine Months Ended
 
 
 
September 30,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
Net sales
 $3,370,000 
 $2,775,000 
 
    
    
Cost of goods sold
  2,362,000 
  1,805,000 
 
    
    
Gross profit
  1,008,000 
  970,000 
 
    
    
Operating expenses:
    
    
Research and development
  77,000 
  62,000 
Selling and marketing
  408,000 
  350,000 
General and administrative
  951,000 
  968,000 
 
  1,436,000 
  1,380,000 
 
    
    
Operating loss
  (428,000)
  (410,000)
 
    
    
Other (expense) / income :
    
    
Interest expense
  (133,000)
  (200,000)
Other income, net
  0 
  172,000 
 
  (133,000)
  (28,000)
 
    
    
Net loss before tax
  (561,000)
  (438,000)
��
    
    
Income tax expense
  (2,000)
  (2,000)
 
    
    
Net loss
 $(563,000)
 $(440,000)
 
    
    
Basic and diluted loss per common share
 $(0.02)
 $(0.01)
 
    
    
Weighted average number of shares outstanding – basic & diluted
  35,278,455 
  32,479,123 

3

Table of Contents

 

 

For The Six Months Ended

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Net sales

 

$1,095,000

 

 

$2,486,000

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

854,000

 

 

 

1,714,000

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

241,000

 

 

 

772,000

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

41,000

 

 

 

52,000

 

Selling and marketing

 

 

155,000

 

 

 

319,000

 

General and administrative

 

 

798,000

 

 

 

656,000

 

 Total Operating expenses

 

 

994,000

 

 

 

1,027,000

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(753,000)

 

 

(255,000)

 

 

 

 

 

 

 

 

 

Other (expense) / income :

 

 

 

 

 

 

 

 

Interest expense

 

 

(96,000)

 

 

(91,000)

Other income, net

 

 

50,000

 

 

 

0

 

Total Other (expense) / income

 

 

(46,000)

 

 

(91,000)

 

 

 

 

 

 

 

 

 

Net loss before tax

 

 

(799,000)

 

 

(346,000)

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

(2,000)

 

 

0

 

 

 

 

 

 

 

 

 

 

Net loss

 

$(801,000)

 

$(346,000)

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$(0.02)

 

$(0.01)

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding – basic & diluted

 

 

39,910,658

 

 

 

34,937,236

 

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


American Bio Medica Corporation
 Condensed Statements of Operations
(Unaudited)
 
 
For The Three Months Ended
 
 
 
September 30,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
Net sales
 $883,000 
 $895,000 
 
    
    
Cost of goods sold
  648,000 
  536,000 
 
    
    
Gross profit
  235,000 
  359,000 
 
    
    
Operating expenses:
    
    
Research and development
  24,000 
  23,000 
Selling and marketing
  89,000 
  131,000 
General and administrative
  294,000 
  286,000 
 
  407,000 
  440,000 
 
    
    
Operating loss
  (172,000)
  (81,000)
 
    
    
Other (expense) / income:
    
    
Interest expense
  (42,000)
  (66,000)
Other income, net
  0 
  3,000 
 
  (42,000)
  (63,000)
 
    
    
Net loss before tax
  (214,000)
  (144,000)
 
    
    
Income tax expense
  (2,000)
  (0)
 
    
    
Net loss
 $(216,000)
 $(144,000)
 
    
    
Basic and diluted loss per common share
 $(0.01)
 $(0.00)
 
    
    
Weighted average number of shares outstanding – basic & diluted
  35,953,476 
  32,545,776 

4

Table of Contents

 

 

 

 

 

 

For The Three Months Ended

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Net sales

 

$529,000

 

 

$1,758,000

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

393,000

 

 

 

1,176,000

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

136,000

 

 

 

582,000

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

21,000

 

 

 

19,000

 

Selling and marketing

 

 

72,000

 

 

 

230,000

 

General and administrative

 

 

287,000

 

 

 

317,000

 

 Total Operating expenses

 

 

380,000

 

 

 

566,000

 

 

 

 

 

 

 

 

 

 

Operating (loss) / income

 

 

(244,000)

 

 

16,000

 

 

 

 

 

 

 

 

 

 

Other income / (expense):

 

 

 

 

 

 

 

 

Interest expense

 

 

(49,000)

 

 

(37,000)

Other income, net

 

 

50,000

 

 

 

0

 

 Total Other (expense) / income

 

 

1,000

 

 

 

(37,000)

 

 

 

 

 

 

 

 

 

Net loss before tax

 

 

(243,000)

 

 

(21,000)

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

(2,000)

 

 

0

 

 

 

 

 

 

 

 

 

 

Net loss

 

$(245,000)

 

$(21,000)

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

 

$(0.01)

 

$(0.00)

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding – basic & diluted

 

 

40,950,729

 

 

 

35,905,948

 

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


American Bio Medica Corporation
 Condensed Statements of Cash Flows
(Unaudited)
 
 
For The Nine Months Ended
 
 
 
September 30,
 
 
 
2020
 
 
2019
 
Cash flows from operating activities:
 
 
 
 
 
 
 Net loss
 $(563,000)
 $(440,000)
  Adjustments to reconcile net loss to net cash provided by / (used in) operating activities:
    
    
     Depreciation and amortization
  60,000 
  61,000 
     Amortization of debt issuance costs
  37,000 
  82,000 
Allowance for doubtful accounts
  1,000 
  (2,000)
 Provision for slow moving and obsolete inventory
  114,000 
  63,000 
 Share-based payment expense
  2,000 
  4,000 
 Director fee paid with restricted stock
  31,000 
  5,000 
     Refinance fee paid with restricted stock
  21,000 
  0 
     Changes in:
    
    
       Accounts receivable
  5,000 
  (38,000)
       Inventory
  94,000 
  66,000 
       Prepaid expenses and other current assets
  (56,000)
  11,000 
       Accounts payable
  (48,000)
  247,000 
       Accrued expenses and other current liabilities
  9,000 
  78,000 
 Wages payable
  (6,000)
  (142,000)
Net cash used in operating activities
  (299,000)
  (5,000)
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
  332,000 
  62,000 
  Payments on debt financing
  (7,000)
  (85,000)
Proceeds from Private Placement
  164,000 
  0 
Proceeds from lines of credit
  3,449,000 
  2,876,000 
Payments on lines of credit
  (3,578,000)
  (2,946,000)
         Net cash provided by / (used in) financing activities
  360,000 
  (93,000)
 
    
    
Net change in cash and cash equivalents
  57,000 
  (98,000)
Cash and cash equivalents - beginning of period
  4,000 
  113,000 
 
    
    
Cash and cash equivalents - end of period
 $61,000 
 $15,000 
Supplemental disclosures of cash flow information
    
    
Non-Cash transactions:
    
    
Debt issuance cost paid with restricted stock
 $0 
 $14,000 
Loans converted to stock
 $39,000 
 $0 
Cash paid during period for interest
 $109,000 
 $117,000 
Cash paid during period for taxes
 $2,000 
 $2,000 

5

Table of Contents

 

 

 

 

 

 

For The Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$(801,000)

 

$(346,000)

Adjustments to reconcile net loss to net cash (used in) operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

36,000

 

 

 

41,000

 

Amortization of debt issuance costs

 

 

0

 

 

 

37,000

 

Penalty added to Cherokee loan balance

 

 

120,000

 

 

 

0

 

Allowance for doubtful accounts

 

 

(17,000)

 

 

0

 

Provision for slow moving and obsolete inventory

 

 

42,000

 

 

 

72,000

 

Share-based payment expense

 

 

0

 

 

 

2,000

 

Director fee paid with restricted stock

 

 

0

 

 

 

30,000

 

Refinance fee paid with restricted stock

 

 

0

 

 

 

21,000

 

Changes in:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

37,000

 

 

 

20,000

 

Inventory

 

 

19,000

 

 

 

(32,000)

Prepaid expenses and other current assets

 

 

97,000

 

 

 

(112,000)

Accounts payable

 

 

16,000

 

 

 

(25,000)

Accrued expenses and other current liabilities

 

 

(150,000)

 

 

103,000

 

Wages payable

 

 

(15,000)

 

 

31,000

 

Net cash (used in) operating activities

 

 

(616,000)

 

 

(158,000)

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from debt financing

 

 

0

 

 

 

332,000

 

Payments on debt financing

 

 

(25,000)

 

 

(6,000)

Proceeds from Private Placement

 

 

0

 

 

 

164,000

 

Proceeds from Lincoln Park financing

 

 

564,000

 

 

 

0

 

Proceeds from lines of credit

 

 

1,143,000

 

 

 

2,352,000

 

Payments on lines of credit

 

 

(1,134,000)

 

 

(2,463,000)

Net cash provided by financing activities

 

 

548,000

 

 

 

379,000

 

 

 

 

 

 

 

 

 

 

Net change in cash and cash equivalents

 

 

(68,000)

 

 

221,000

 

Cash and cash equivalents - beginning of period

 

 

98,000

 

 

 

4,000

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents - end of period

 

$30,000

 

 

$225,000

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information

 

 

 

 

 

 

 

 

Non-Cash transactions:

 

 

 

 

 

 

 

 

Loans converted to stock

 

$0

 

 

$39,000

 

Director fees paid with restricted stock

 

$0

 

 

$30,000

 

Cash paid during period for interest

 

$90,000

 

 

$73,000

 

Cash paid during period for taxes

 

$2,000

 

 

$0

 

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


Notes

6

Table of Contents

Notes to condensed financial statements (unaudited)

September

June 30, 2020

2021

Note A - Basis of Reporting

The accompanying unaudited interim condensed financial statements of American Bio Medica Corporation (the “Company”) have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Regulation S-X. Accordingly, these unaudited interim condensed financial statements do not include all information and footnotes required by U.S. GAAP for complete financial statement presentation. These unaudited interim condensed financial statements should be read in conjunction with audited financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.2020. In the opinion of management, the interim condensed financial statements include all normal, recurring adjustments which are considered necessary for a fair presentation of the financial position of the Company at SeptemberJune 30, 2020,2021, and the results of operations for the three and ninesix month periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 20192020 and cash flows for the ninesix month periods ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019.

2020.

Operating results for the ninesix months ended SeptemberJune 30, 20202021 are not necessarily indicative of results that may be expected for the year ending December 31, 2020.2021. Amounts at December 31, 20192020 are derived from audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.

2020.

During the ninesix months ended SeptemberJune 30, 2020,2021, there were no significant changes to the Company’s critical accounting policies, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.

2020. 

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


These unaudited interim condensed financial statements have been prepared assuming that the Company will continue as a going concern and, accordingly, do not include any adjustments that might result from the outcome of this uncertainty. The independent registered public accounting firm’s report on the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019,2020, contained an explanatory paragraph regarding the Company’s ability to continue as a going concern. As of the date of this report, the Company’s current cash balances, together with cash generated from future operations and amounts available under the Company’s credit facilities may not be sufficient to fund operations through November 2021.


ThroughoutAugust 2022.

Through the ninesix months ended SeptemberJune 30, 2020,2021, the Company had a line of credit with Crestmark Bank. The maximum availability on the Company’s line of credit was $1,000,000 beginning June 22, 2020 when the facility was amended and extended. However, because the amount available under the line of credit is based upon the Company’s accounts receivable and inventory, the amounts actually available under our line of credit (historically) have been significantly less than the maximum availability. As of SeptemberJune 30, 2020,2021, based on the Company’s availability calculation, there were no additional amounts available under the Company’s line of credit because the Company draws any balance available on a daily basis.


In February 2020,2021, our credit facilities with Cherokee Financial, LLC were extended for another 12 months, or until February 15, 2021 (which2022, which is less than 12 months from the date of this report).report. Our total debt at SeptemberJune 30, 20202021 with Cherokee Financial, LLC is $1,120,000.$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, 2021.2022. We are currently looking at alternatives to further extend or refinance these facilities.



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On December 9, 2020, we entered into a Purchase Agreement (the “Purchase Agreement”) and a Registration Rights Agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) under which Lincoln Park agreed to purchase from the Company, from time to time, up to $10,250,000 of our shares of common stock, par value $0.01 per share, subject to certain limitations set forth in the Purchase Agreement, during the term of the Purchase Agreement. Pursuant to the terms of the Registration Rights Agreement, we were required to file with the SEC, a registration statement on Form S-1 (the “Registration Statement”) to register for resale under the Securities Act of 1933, as amended (the “Securities Act”), the shares of common stock that we had already issued and sold to Lincoln Park (500,000 shares of common stock for a purchase price of $125,000 along with 1,250,000 shares of common stock issued to Lincoln Park’s for their irrevocable commitment to purchase common shares upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement), and shares of common stock we may in the future elect to issue and sell to Lincoln Park from time to time under the Purchase Agreement.

As discussed in more detail in “Cash Flow, Outlook/Risk”, if sales levels decline further, the Company will have reduced availability on its line of credit due to decreased accounts receivable balances. If availability under the Company’s line of credit isand the Lincoln Park Security Agreement are not sufficient to satisfy itsour working capital and capital expenditure requirements, the Companywe 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 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.

Recently Adopted Accounting Standards

ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement”, issued in August 2018, adds, modifies and removes several disclosure requirements relative to the three levels of inputs used to measure fair value in accordance with Topic 820, “Fair Value Measurement.” ASU 2018-13 is effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year. The Company adopted ASU 2018-13 in the First Quarter 2020 and the adoption did not have an impact on the Company’s financial condition or its results of operations.
ASU 2019-08, Compensation – Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606)”, issued in November 2019, clarifies that an entity must measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. ASU 2019-08 is effective for fiscal years beginning after December 15, 2019, including interim reporting periods within those fiscal years. The Company adopted ASU 2019-08 in the First Quarter 2020 and the adoption did not have an impact on the Company’s financial condition or its results of operations.
Accounting Standards Issued; Not Yet Adopted

ASU 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes”, issued in December 2019 reduces the complexity by removing exemptions and simplifying the accounting for franchise taxes, deferred taxes and taxes related to employee’s stock ownership plan. The requirements in ASU 2019-12 will beare effective for public companies for fiscal years beginning after December 15, 2020, including interim periods. The Company is evaluatingadopted ASU 2019-02 on January 1, 2021 and the adoption did not have an impact on the Company’s financial condition or results of ASU 2019-12.

operation.

ASU 2020-01, “Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)”, issued in January 2020, clarifies 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 accounts for an equity security under the measurement alternative or a forward contract or purchased option to purchase securities that, upon settlement of the 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 825, Financial Instruments. These amendments improve current GAAP by reducing diversity in practice and increasing comparability of the accounting for these interactions. The requirements in ASU 2019-12 will be2021-01 are effective for public companies for fiscal years beginning after December 15, 2020, including interim periods within the fiscal year. Early adoption is permitted. The Company is evaluatingadopted ASU 2020-01 on January 1, 2021 and the adoption did not have an impact on the Company’s financial condition or results of ASU 2020-01.

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 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.

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Accounting Standards Issued; Not Yet Adopted

ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40), issued in May 2021, addresses an issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This amendment is evaluatingeffective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The Company will evaluate the impact of ASU 2020-06.




the pronouncement closer to the effective date

Any 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 Company’s financial position or results of operations.

Reclassifications

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

Note B – Inventory

Inventory is comprised of the following:
 
September 30, 2020
 
 
December 31, 2019
 
 
 
 
 
 
 
 
Raw Materials
 $695,000 
 $670,000 
Work In Process
  113,000 
  141,000 
Finished Goods
  191,000 
  290,000 
Allowance for slow moving and obsolete inventory
  (397,000)
  (291,000)
 
 $602,000 
 $810,000 

Inventory is comprised of the following:

 

 

June 30,

2021

 

 

December 31,

2020

 

 

 

 

 

 

 

 

Raw Materials

 

$536,000

 

 

$534,000

 

Work In Process

 

 

122,000

 

 

 

127,000

 

Finished Goods

 

 

138,000

 

 

 

154,000

 

Allowance for slow moving and obsolete inventory

 

 

(321,000)

 

 

(279,000)

 

 

$475,000

 

 

$536,000

 

Note C – Net Loss Per Common Share

Basic net loss per common share is calculated by dividing the net loss by the weighted average number of outstanding common shares during the period. Diluted net loss per common share includes the weighted average dilutive effect of stock options and warrants. Potential common shares outstanding as of SeptemberJune 30, 20202021 and 2019:

 
 
September 30, 2020
 
 
September 30, 2019
 
 
 
 
 
 
 
 
Warrants
  0 
  2,000,000 
Options
  2,142,000 
  2,252,000 
 
  2,142,000 
  4,252,000 
2020:

 

 

June 30, 2021

 

 

June 30, 2020

 

 

 

 

 

 

 

 

Warrants

 

 

0

 

 

 

0

 

Options

 

 

1,987,000

 

 

 

2,192,000

 

 

 

 

1,987,000

 

 

 

2,192,000

 

The number of securities not included in the diluted net loss per share for the three and ninesix months ended SeptemberJune 30, 2021 and June 30, 2020 was 1,987,000 and the three and nine months ended September 30, 2019 was 2,142,000 and 4,252,000,2,192,000, respectively, as their effect would have been anti-dilutive due to the net loss in both of the three and ninesix month periods.

Note D – Litigation/Legal Matters

ABMC v. Todd Bailey
On August 5, 2019, we settled litigation with Todd Bailey; a former Vice President, Sales & Marketing and sales consultant of the Company until December 23, 2016; 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.
Under the settlement, both 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.

From time to 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, if the Company 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 the Company.



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Note E – Line of Credit and Debt

The Company’s Line of Credit and Debt consisted of the following as of SeptemberJune 30, 20202021 and December 31, 2019:

 
 
September 30, 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 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 12.94%.
  208,000 
  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 year (or 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.
  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.
  0 
  10,000 
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.
    0  
    25,000  
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.
  332,000  
   
 
 $1,660,000 
 $1,479,000 
Less debt discount & issuance costs (Cherokee Financial, LLC loans)
  0 
  (17,000)
Total debt, net
 $1,660,000 
 $1,462,000 
 
    
    
Current portion
 $1,660,000 
 $354,000 
Long-term portion, net of current portion
 $0 
 $1,125,000 

2020:

 

 

June 30, 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 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.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.

 

 

$1,000,000

 

 

 

$900,000

 

Crestmark Line of Credit: Line of credit maturing on June 22, 2022 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 11.99%.

 

 

 

287,000

 

 

 

 

277,000

 

2019 Term Loan with Cherokee Financial, LLC: 1 year note at an annual fixed interest rate of 18% paid quarterly in arrears with first interest payment being made on May 15, 2019 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.

 

 

 

240,000

 

 

 

 

220,000

 

April 2020 PPP Loan with Crestmark: 2 year SBA loan at 1% interest with first payment due October 2020. Company applied for forgiveness of loan under PPP guidelines in June 2021.

 

 

 

332,000

 

 

 

 

332,000

 

November 2020 Shareholder Note: with Chaim Davis; 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. Interest only payments made on February 4, 2021 and May 4, 2021. Final interest and $50,000 principal due on November 4, 2021.

 

 

 

50,000

 

 

 

 

50,000

 

Total Debt

 

 

$1,909,000

 

 

 

$1,804,000

 

Current portion

 

 

$1,909,000

 

 

 

$684,000

 

Long-term portion, net of current portion

 

 

$0

 

 

 

$1,120,000

 

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

On March 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%.; paid quarterly in arrears. In addition to the 8% interest, the Company is required to pay Cherokee a 1% annual fee for oversight and administration of the loan. This oversight fee is paid in cash and is paid contemporaneously with the quarterly interest payments. The Company 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 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).

On February 24, 2020, (the “Closing Date”), 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 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.

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

Under the terms of the Extension Agreement, the Cherokee LSA was increased to $1,000,000 to include a $100,000 penalty that was due as a result of the Company being unable to pay back the principal balance to Cherokee on February 15, 2021. Under the Second Extension Agreement, the annual interest rate on the Cherokee LSA was increased to a fixed rate of 10% (the prior fixed rate was 8%) plus a 1% annual oversight fee (that remained unchanged). Interest and the oversight fee are paid quarterly with the first payment being made on May 15, 2021. Under the terms of the Second Extension Agreement, if the Company doesn’t pay off the principal on or before February 15, 2022, there will be an 8% delinquent fee charged. This delinquent fee will only apply to whatever the principal balance is on February 15, 2022. If the Company pays any portion (or all) of the principal back, the 8% fee will not be due on the prepaid amounts. The Company can prepay all of part of the facility back prior to February 15, 2022 with no penalty.

Cantone Research, Inc. earned a 3% fee on the extended principal of $900,000 (or $27,000) for their services related to securing the second extension with Cherokee investors. This 3% service fee will be “rebated” when/if the Company prepays any, or a portion, of the loan. As an example, if the Company makes a principal reduction payment of $100,000, only $97,000 in cash will 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. No common stock was issued in connection with the extensions. The Company also paid Cherokee’s legal fees in the amount of $1,000.

In the event of default, this includes, but is not limited to; the Company’s inability to make any payments due under the Cherokee LSA (as amended) Cherokee has the right to increase the interest rate on the financing to 18%. If the amount due is not paid by the extended due date, Cherokee will automatically add a delinquent payment penalty of $100,000 to the outstanding principal.

The Company will continue to make interest only payments and administrative fees quarterly on the Cherokee LSA. In addition to the 8% interest, the Company pays Cherokee a 1% annual fee for oversight and administration of the loan. This oversight fee is paid in cash and is paid contemporaneously with the quarterly interest payments. The Company can pay off the Cherokee loan at any time with no penalty; except that a 1% administration fee would be required to be paid to Cherokee to close out all participations.

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The Company recognized $72,000$48,000 in interest expense related to the Cherokee LSA in the ninesix months ended SeptemberJune 30, 20202021 (of which $16,000$0 is debt issuance cost amortization recorded as interest expense), and $125,000$53,000 in interest expense related to the Cherokee LSA in the ninesix months ended SeptemberJune 30, 20192020 (of which $70,000$17,000 is debt issuance cost amortization recorded as interest expense). The Company recognized $20,000$25,000 in interest expense related to the Cherokee LSA in the three months ended SeptemberJune 30, 2021 (of which of which $0 is debt issuance cost amortization recorded as interest expense) and $18,000 in interest expense related to the Cherokee LSA in the three months ended June 30, 2020 (of which $0 is debt issuance cost amortization recorded as interest expense), and $42,000 in interest expense related to the Cherokee LSA in the three months ended September 30, 2019 (of which $23,000 is debt issuance cost amortization recorded as interest expense).

The Company had $12,000$17,000 in accrued interest expense at SeptemberJune 30, 2021 and $14,000 in accrued interest expense at June 30, 2020 related to the Cherokee LSA and $10,000 in accrued interest expense at September 30, 2019.

LSA.

As of SeptemberJune 30, 2021, the balance on the Cherokee LSA was $1,000,000 including the $100,000 penalty referenced above. As of December 31, 2020, the balance on the Cherokee LSA was $900,000. As of December 31, 2019, the balance on the Cherokee LSA was $900,000; however, the discounted balance was $884,000.

LINE OF CREDIT WITH CRESTMARK BANK (“CRESTMARK”)

On June 29, 2015 (the “Closing Date”), the Company entered into a Loan and Security Agreement (“LSA”) with Crestmark related to a revolving line of credit (the “Crestmark LOC”). The Crestmark LOC is used for working capital and general corporate purposes. The Company amendedUpon 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 is received by Crestmark not less than sixty (60) days prior to the end of the renewal term. The Company did not provide Crestmark with a notice of non-renewal and therefore, the Crestmark LOC automatically renewed on June 22, 2020 and as a result of this amendment,2021 for another one year term, or until June 22, 2022.

Originally, availability under the Crestmark LOC expireswas based on June 22, 2021.


Until the amendment on June 22, 2020,certain inventory components (under a specific formula previously defined in prior periodic reports) and receivables. The maximum available under the Crestmark LOC provided the Company with a revolving line of credit up to $1,500,000 (“Maximum Amount”). The Maximum Amount was subject to an Advance Formula comprised of: 1) 90% of Eligible Accounts Receivables (excluding, receivables remaining unpaid for more than 90 days from the date of invoice and sales made to entities outside of the United States), and 2) up to 40% of eligible inventory plus up to 10% of Eligible Generic Packaging Components not to exceed the lesser of $350,000, or 100% of Eligible Accounts Receivable.$1,500,000. However as a result of an amendment executed on June 25, 2018, the amountfacility was amended to decrease the amounts available under the inventory component ofuntil availability under the line of creditinventory component was changed to 40% of eligible inventory plus up to 10% of Eligible Generic Packaging Components not to exceed the lesser of $250,000 (“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, (makingzero; 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.
credit as of July 1, 2020. The facility was further amended on June 22, 2020 to decrease the maximum availability (“Maximum Amount”) under the Crestmark LOC to $1,000,000.

The Crestmark LOC has a minimum loan balance requirement of $500,000. At SeptemberJune 30, 2020,2021, the Company did not meet the minimum loan balance requirement as our balance was $208,000.$287,000. 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).

Prior to

As part of the amendment on June 22, 2020, the Crestmark LOC contained a minimum Tangible Net Worth (“TNW”) covenant (previously defined in other periodic reports). was removed effective with the quarter ended June 30, 2020. 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.

In the event of a default underof the LSA, which includes but is not limited to, failure 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.

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 June 30, 2021 and as of the date of this report, the interest only rate on the Crestmark LOC is 6.25%. 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 was 12.94%is 11.99%.

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The Company recognized $29,000$24,000 in interest expense related to the Crestmark LOC in the ninesix months ended SeptemberJune 30, 20202021 and $36,000$17,000 in interest expense related to the Crestmark LOC in the ninesix months ended SeptemberJune 30, 2019.2020. The Company recognized $10,000 in interest expense in the three months ended September 30, 2020 and $11,000 in interest expense in the three months ended SeptemberJune 30, 2019.

2021 and $9,000 in interest expense in the three months ended June 30, 2020. Given the nature of the administration of the Crestmark LOC, at SeptemberJune 30, 2020,2021, the Company had $0 in accrued interest expense related to the Crestmark LOC, and there is $0 in additional availability under the Crestmark LOC.

At SeptemberJune 30 2021, the balance on the Crestmark LOC was $287,000 and as of December 31, 2020, the balance on the Crestmark LOC was $208,000 and as of December 31, 2019, the balance on the Crestmark LOC was $337,000.

EQUIPMENT LOAN WITH CRESTMARK
On May 1, 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 to its LSA and Promissory Note with Crestmark. The amendments addressed the inclusion of the term loan into the LSA and an extension of the Crestmark LOC. No terms of the Crestmark LOC were changed in the amendment. The interest rate on the term loan was the WSJ Prime Rate plus 3%; or 6.25%. The loan was satisfied in the quarter ended September 30, 2020.


The Company incurred minimal interest expense in the nine months ended September 30, 2020 related to the Equipment Loan and less than $1,000 in interest expense in the nine months ended September 30, 2019. The Company incurred minimal interest expense in the three months ended September 30, 2020 and less than $1,000 in interest expense in the three months ended September 30, 2019. The balance on the Equipment Loan is $0 at September 30, 2020 and $7,000 at December 31, 2019.
$277,000.

2019 TERM LOAN WITH CHEROKEE

On February 25, 2019, (the “Closing 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 Term Loan”). Gross proceeds of the 2019 Cherokee Term Loan were $200,000; $150,000 of which was used to satisfy the 2018 Cherokee Term Loan, $48,000 (which was used to pay a portion of the $75,000 principal reduction payment; with the remaining $27,000 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 200,000 restricted shares of common stock to Cherokee in the three months ended March 31, 2019.

The annual interest rate under the 2019 Cherokee Term Loan is 18% (fixed) paid quarterly in arrears with the first interest payment being made on May 15, 2019 and the latest interest payment being made in September 2020. The loan was required to be paid in full on February 15, 2020.
2019.

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 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 Cherokee Term Loan.

A final balloon payment was due on February 15, 2021; however the Company further extended the 2019 Cherokee Term Loan on February 24, 2021 to February 15, 2022. Under the terms of the extension, the 2019 Cherokee Term Loan was increased to $240,000 to include a $20,000 penalty that was due as a result of the Company being unable to pay back the principal balance to Cherokee on February 15, 2021. The annual interest rate under the 2019 Cherokee Term Loan remains fixed at 18% paid quarterly in arrears with the first interest payment being due on May 15, 2021. If the Company doesn’t pay off the principal on or before February 15, 2022, there will be an 8% delinquent fee charged. This delinquent fee will only apply to whatever the principal balance is on February 15, 2022. If the Company pays any portion (or all) of the principal back, the 8% fee will not be due on the prepaid amounts. The Company can prepay all of part of the facility back prior to February 15, 2022 with no penalty.

In the event of default, this includes, but is not limited to, the Company’s inability to make any payments due under the Agreement,Agreement; Cherokee has the right to increase the interest rate on the financing to 20% and Cherokee will automatically add a delinquent payment penalty of $20,000 to the outstanding principal.

.

The Company recognized $30,000$21,000 in interest expense related to the 2019 Cherokee Term Loan in six months ended June 30, 2021 and $21,000 in interest expense related to the 2019 Cherokee Term Loan in the ninesix months ended SeptemberJune 30, 2020 (of which $1,000 is debt issuance cost amortization recorded as interest expense) and $35,0002020. The Company recognized $11,000 in interest expense (of which $11,000 was debt issuance costs recorded as interest expense)related to the 2019 Cherokee Term Loan in the ninethree months ended SeptemberJune 30, 2019. The Company recognized2021 and $10,000 in interest expense related to the 2019 Cherokee Term Loan in the three months ended SeptemberJune 30, 2020 (of which $0 is debt issuance cost amortization recorded as interest expense) and $13,000 in interest expense in the three months ended September 30, 2019, (of which $4,000 was debt issuance cost amortization recorded as interest expense).

2020. The Company had $6,000$7,000 in accrued interest expense at SeptemberJune 30, 2020 related to the Cherokee Term Loan2021 and $5,000$14,000 in accrued interest expense at SeptemberJune 30, 2019. 2020.

The balance on the 2019 Term Loan is $220,000 at September 30, 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.



$240,000 at June 30, 2021 and $220,000 at December 31, 2020.

SBA PAYCHECK PROTECTION LOAN (PPP LOAN)

On April 22, 2020, we entered into a Promissory Note (“PPP Note”) for $332,000 with Crestmark Bank, pursuant to the U.S. Small Business Administration Paycheck Protection Program under Title I of the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act passed by Congress and signed into law on March 27, 2020. The PPP Note is unsecured, bears interest at 1.00% per annum, with principal and interest payments deferred for the first six months, and matures in two years. The principal is payable in equal monthly installments, with interest, beginning on the first business day after the end of the deferment period. The PPP Note may be forgiven subject to the terms of the Paycheck Protection Program. Additionally, certain acts of the Company, including but not limited to: (i) the failure to pay any taxes when due, (ii) becoming the subject of a proceeding under any bankruptcy or insolvency law, (iii) making an assignment for the benefit of creditors, or (iv) reorganizing, merging, consolidating or otherwise changing ownership or business structure without PPP Lender’s prior written consent, are considered events of default which grant Lender the right to seek immediate payment of all amounts owing under the PPP Note. TheOn June 5, 2021, the Company intends to applyapplied for forgiveness of loan in the amount of $332,000 under PPP guidelines after 24 weeks, or after October 2020.

guidelines. As of the date of this report, our forgiveness application has been reviewed by the SBA and the final forgiveness amount has been set to $332,000; the total amount of the loan.

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The Company recognized $2,000$1,000 in interest expense in the six months ended June 30, 2021 and $0 in interest expense in the six months ended June 30, 2020 (as the PPP loan was not in place until April 2020). The Company recognized less than $1,000 in interest expense in the three months ended June 30, 2021 and $0 in interest expense in the three months ended June 30, 2020 (as the PPP loan was not in place until April 2020). The Company had less than $1,000 in accrued interest expense at June 30 2021 and $2,000 in accrued interest expense at December 31, 2020 related to the PPP loan in the nine and three months ended September 30, 2020. The $2,000 wasLoan. This accrued at September 30, 2020 andinterest is eligible for forgiveness under PPP loan guidelines.

The balance on the PPP Loan was $332,000 at June 30, 2021 and at December 31, 2020.

NOVEMBER 2020 TERM LOAN

On November 4, 2020, the Company entered into a loan agreement with an 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 remain unchanged under the Extension. The interest payment due to the shareholder on May 4, 2021 was paid as required with the next interest payment being due on August 4, 2021.

The company recognized $2,000 of interest expense related to the term loan in the six months ended June 30, 2021 and $0 in interest expense in the six months ended June 30, 2020 (as the loan was not in place until November 4, 2020). The Company had less than $1,000 in accrued interest expense related to this loan as of June 30, 2021.

The company recognized and accrued less than $1,000 of interest expense related to the term loan in the three months ended June 30, 2021 and $0 in interest expense in the three months ended June 30, 2020 (as the loan was not in place until November 4, 2020). The balance on the November 2020 Term Loan was $50,000 at June 30, 2021 and at December 31, 2020.

OTHER DEBT INFORMATION

In addition to the current debt indicated previously, previous debt facilities (paid in full via refinance or conversion into equity) had financial impact on the ninethree and/or six months ended June 30, 2020. More specifically:

EQUIPMENT LOAN WITH CRESTMARK

On May 1, 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 was collateralized by a first security interest in a specific piece of manufacturing equipment. The Company executed an amendment to its LSA and Promissory Note with Crestmark. The amendments addressed the inclusion of the term loan into the LSA and an extension of the Crestmark LOC. No terms of the Crestmark LOC were changed in the amendment. The interest rate on the term loan was the WSJ Prime Rate plus 3% throughout the term of the loan.

The Company did not incur any interest expense in the six months ended June 30, 2021 as the Equipment Loan was satisfied in full in the quarter ended September 30, 2020 and minimal interest expense in the six months ended June 30, 2020.

The Company did not incur any interest expense in the three months ended June 30, 2021 as the Equipment Loan was satisfied in full in the quarter ended September 30, 2020 and minimal interest expense in the three months ended June 30, 2020. More specifically:

2018 TERMThe balance on the Equipment Loan was $0 at June 30, 2021 and at December 31, 2020.

NOVEMBER 2020 LOAN WITH CHEROKEE

CHAIM DAVIS

On March 2, 2018,November 6, 2020, the Company entered into a one-year Loan Agreement made asloan agreement with our (now former) Chairman of February 15, 2018 (the “Closing Date”) with Cherokeethe Board Chaim Davis, under which Cherokee provided the Company with $150,000 (the “2018 Cherokee Term Loan”). The proceeds from the 2018 Cherokee Term Loan were used by the Company to pay a $75,000 principal reduction payment to Cherokee that was due on February 15, 2018 and $1,000 in legal fees incurred by Cherokee. Net proceeds (to be used for working capital and general business purposes) were $74,000. The annual interest rate for the 2018 Cherokee Term Loan was 12% to be paid quarterly in arrears with the first interest payment being made on May 15, 2018. In connection with the 2018 Cherokee Term Loan, 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, 2019 and was paid in full via refinance into the 2019 Term Loan with Cherokee.

The Company recognized $3,000 in interest expense related to the 2018 Cherokee Term Loan in the nine months ended September 30, 2019 (of which $2,000 was debt issuance costs recorded as interest expense). The company recognized $0 of interest expense in the 3 months ended September 30, 2019. As of September 30, 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.
JULY 2019 TERM LOAN WITH CHAIM DAVIS, ET AL
On July 31, 2019, the Company entered into loan agreements with two (2) individuals, under which each individualDavis 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$25,000 (the “July 2019 Term“November 2020 Loan”). One of the individuals was our Chairman of the Board Chaim Davis. There were no expenses or interest related to the July 2019 Term Loan.November 2020 loan. The first payment of principalCompany incurred $0 in interest expense in the three and interest was due on September 1, 2019six months ended June 30, 2021 and $0 in the last payment of principalthree 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%.
All amounts loaned under the July 2019 Term Loan were converted into equity as part of a private placement closed in February 2020. Any interest that was incurred undersix months ended June 30, 2020 (as the facility was not in 2019 and up to the conversion in February 2020 was forgiven by the holders.place until November 2020). The balance on the July 2019November 2020 Term Loan was $0 at SeptemberJune 30, 2020 and $10,000 at December 31, 2019.


DECEMBER 2019 CONVERTIBLE NOTE
On December 31, 2019,2021 (as the Company entered into a Convertible Notefacility was paid in full on February 24, 2021 with one individual inproceeds from the amount of $25,000 (“2019 Convertible Note”). Under the terms of the 2019 Convertible Note, the principal amount would convert intoLincoln Park 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 part of a private placement closed in February 2020. The balance on the 2019 Convertible Note was $0 at September 30, 2020line) and $25,000 at December 31, 2019.
2020.

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NOTE F – Stock Options and Warrants

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

During the three months ended SeptemberJune 30, 2021 and the three months ended June 30, 2020, the Company issued 0 options to purchase shares of common stock. During the three months ended September 30, 2019, the Company issued 0 options to purchase shares of stock to any of its non-employee board members.


Stock option activity for the ninesix months ended SeptemberJune 30, 20202021 and the ninesix months ended SeptemberJune 30, 20192020 is summarized as follows (the figures contained within the tables below have been rounded to the nearest thousand):

 
 
     Nine months ended September 30, 2020        
 
 
     Nine months ended September 30, 2019       
 
 
 
 
Shares
 
 
Weighted Average Exercise Price
 
 
Aggregate
Intrinsic Value as of
September 30, 2020
 
 
 
Shares
 
 
Weighted Average Exercise Price
 
 
Aggregate Intrinsic Value as of
September 30, 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
  (110,000)
 $0.10 
 
 
 
  (50,000)
 $0.20 
 
 
 
Options outstanding at end of period
  2,142,000 
 $0.13 
 $398,000 
  2,252,000 
 $0.13 
 $1,000 
Options exercisable at end of period
  2,142,000 
 $0.13 
    
  2,172,000 
 $0.13 
    

 

 

Six months ended June 30, 2021

 

 

Six months ended June 30, 2020

 

 

 

Shares

 

 

Weighted Average Exercise Price

 

 

Aggregate

Intrinsic Value as of

June 30, 2021

 

 

Shares

 

 

Weighted Average Exercise Price

 

 

Aggregate Intrinsic Value as of

June 30, 2020

 

Options outstanding at beginning of year

 

 

1,987,000

 

 

$0.13

 

 

 

 

 

 

2,252,000

 

 

$0.14

 

 

 

 

Granted

 

 

0

 

 

NA

 

 

 

 

 

 

0

 

 

NA

 

 

 

 

Exercised

 

 

0

 

 

NA

 

 

 

 

 

 

0

 

 

NA

 

 

 

 

Cancelled/expired

 

 

0

 

 

NA

 

 

 

 

 

 

(60,000)

 

$0.13

 

 

 

 

Options outstanding at end of quarter

 

 

1,987,000

 

 

$0.13

 

 

 

25,000

 

 

 

2,192,000

 

 

$0.12

 

 

$177,000

 

Options exercisable at end of quarter

 

 

1,987,000

 

 

$0.13

 

 

 

 

 

 

 

2,192,000

 

 

$0.12

 

 

 

 

 

The Company recognized $0 in share based payment expense in the six months ended June 30, 2021 and $2,000 in share based payment expense in the ninesix months ended SeptemberJune 30, 2020 and $4,000 in share based payment expense in the nine months ended September 30, 2019.2020. The Company recognized $0 in share based payment expense in the three months ended SeptemberJune 30, 20202021 and $1,000 in share based payment expense in the three months ended SeptemberJune 30, 2019.2020. At SeptemberJune 30, 2020,2021, there was $0 of total unrecognized share based payment expense related to stock options.




The following table summarizes weighted-average assumptions using the Black-Scholes option-pricing model used on the date of the grants issued during the nine months ended September 30, 2020 and September 30, 2019:
  Nine months ended
  2020 2019
Volatility NA 85%
Expected term (years) NA 10 years
Risk-free interest rate NA 2.01%
Dividend yield NA 0%

Warrants

Warrant activity for the ninesix months ended SeptemberJune 30, 2020 and the ninesix months ended SeptemberJune 30, 2019 is summarized as follows:


 
 
          Nine months ended September 30, 2020  
 
 
      Nine months ended September 30, 2019   
 
 
 
 
Shares
 
 
Weighted Average Exercise Price
 
 
Aggregate
Intrinsic Value as of
September 30, 2020
 
 
 
Shares
 
 
Weighted Average Exercise Price
 
Aggregate Intrinsic Value as of September 30, 2019
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)
 $0.18 
    
  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 
 

 

 

Six months ended June 30, 2021

 

Six months ended June 30, 2020

 

 

 

Shares

 

 

Weighted Average Exercise Price

 

Aggregate

Intrinsic Value as of

June 30, 2021

 

Shares

 

 

Weighted Average Exercise Price

 

 

Aggregate Intrinsic Value as of

June 30, 2020

 

Warrants outstanding at beginning of year

 

 

0

 

 

NA

 

 

 

 

2,000,000

 

 

$0.18

 

 

 

 

Granted

 

 

0

 

 

NA

 

 

 

 

0

 

 

NA

 

 

 

 

Exercised

 

 

0

 

 

NA

 

 

 

 

0

 

 

NA

 

 

 

 

Cancelled/expired

 

 

0

 

 

NA

 

 

 

 

(2,000,000)

 

$0.18

 

 

 

 

Warrants outstanding at end of quarter

 

 

0

 

 

NA

 

None

 

 

0

 

 

NA

 

 

None

 

Warrants exercisable at end of quarter

 

 

0

 

 

NA

 

 

 

 

0

 

 

NA

 

 

 

 

In the ninesix months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, the Company recognized $0 in debt issuance and deferred finance costs related to the issuance of warrants.the above warrants outstanding. In the three months ended SeptemberJune 30, 20202021 and SeptemberJune 30, 2019,2020, the Company recognized $0 in debt issuance and deferred finance costs related to the issuance of the above warrants. AsThe warrants expired in January 2021 and as of SeptemberJune 30, 2020,2021; there was $0 of total unrecognized expense.



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NOTE G – CHANGES IN STOCKHOLDERS’ DEFICIT

Changes in Stockholders’ Deficit

The following table summarizes the changes in stockholders’ deficit for the ninesix month periods ending June 30, 2021 and June 30, 2020:

 

 

Common Stock

 

 

Additional Paid in

 

 

Accumulated

 

 

 

 

 

Shares

 

 

Amount

 

 

 

Capital Deficit

Total

 

Balance January 1, 2021

 

 

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 purchases under the 2020 Lincoln Park Equity Line

 

 

4,400,000

 

 

 

44,000

 

 

 

395,000

 

 

 

 

 

 

 

439,000

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

801,000

 

 

 

801,000

 

Balance – June 30, 2021

 

 

42,603,476

 

 

$426,000

 

 

$22,232,000

 

 

$24,151,000

 

 

$1,493,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance – January 1, 2020

 

 

32,680,984

 

 

$327,000

 

 

$21,437,000

 

 

 

(22,554,000)

 

$(790,000)

Shares issued in connection with private placement*

 

 

2,842,856

 

 

 

28,000

 

 

 

171,000

 

 

 

 

 

 

 

199,000

 

Shares issued to Cherokee in connection with loan

 

 

300,000

 

 

 

3,000

 

 

 

18,000

 

 

 

 

 

 

 

21,000

 

Share based payment expense

 

 

 

 

 

 

 

 

 

 

2,000

 

 

 

 

 

 

 

2,000

 

Shares issued for board meeting attendance in lieu of cash

 

 

129,636

 

 

 

1,000

 

 

 

30,000

 

 

 

 

 

 

 

31,000

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(346,000)

 

 

(346,000)

Balance – June 30, 2020

 

 

35,953,476

 

 

$359,000

 

 

$21,658,000

 

 

$(22,900,000)

 

$(883,000)

LINCOLN PARK EQUITY LINE OF CREDIT – DECEMBER 2020

On December 9, 2020, the Company entered into a Purchase Agreement and a Registration Rights Agreement with Lincoln Park (together the “Agreements”) under which Lincoln Park agreed to purchase from the Company, from time to time, up to $10,250,000 of our shares of common stock, par value $0.01 per share, subject to certain limitations set forth in the Purchase Agreement, during the term of the Purchase Agreement (two years). Pursuant to the terms of the Registration Rights Agreement, 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, as amended (the “Securities Act”), the shares of common stock issued and sold as well as the shares of common stock that the Company may elect in the future to issue and sell to Lincoln Park from time to time under the Purchase Agreement.

On December 9, 2020, the Company sold 500,000 shares of common stock to Lincoln Park in an initial purchase under the Purchase Agreement for a purchase price of $125,000. As consideration for Lincoln Park’s irrevocable commitment to purchase common shares upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, on December 9, 2020, the Company also issued 1,250,000 shares of common stock to Lincoln Park as commitment shares. The commitment shares were valued at $138,000 and recorded as an addition to equity for the issuance of common stock and treated as a reduction to equity as a cost of capital to be raised under the Lincoln Park facility. While this commitment fee relates to the entire offering and the purchases of common shares that will occur over time, the Company has recorded the entire commitment fee as issuance costs in additional paid-in capital at the time the commitment fee was paid because the offering has been consummated, and there is no guaranteed future economic benefit from this payment.

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The Company did not have the right to commence any further sales to Lincoln Park under the Purchase Agreement until all of the conditions that are set forth in the Purchase Agreement had been satisfied, including, but not limited to, the Registration Statement being declared effective by the SEC (at which time all conditions are satisfied, the “Commencement”).

On January 4, 2021, the Company was notified by the SEC that they would not review the Registration Statement on Form S-1 filed by the Company on December 29, 2020. The Company was subsequently instructed by the SEC (through counsel) to amend the originally filed Form S-1 to include certain information for the fiscal year ended SeptemberDecember 31, 2020 in place of the information in the original filing that was for the fiscal year ended December 31, 2019. The Company filed a Form S-1/A on January 7, 2021 and requested (through counsel) that the SEC declare the Form S-1 effective on January 11, 2021. The SEC granted the Company’s request. On January 11, 2021, the Company sold the remaining 500,000 shares of common stock to Lincoln Park required as an initial purchase under the Purchase Agreement for a purchase price of $125,000.

From and after the Commencement, under the Purchase Agreement, on any business day selected by the Company on which the closing sale price of its common stock exceeds $0.05, the Company may direct Lincoln Park to purchase up to 200,000 common shares on the applicable purchase date (a “Regular Purchase”), which maximum number of shares may be increased to certain higher amounts up to a maximum of 250,000 common shares, if the market price of the Company’s common stock at the time of the Regular Purchase equals or exceeds $0.20 and which maximum number of shares may be further increased to certain higher amounts up to a maximum of 500,000 common shares, if the market price of the Company’s common stock at the time of the Regular Purchase equals or exceeds $0.50 (such share and dollar amounts subject to proportionate adjustments for stock splits, recapitalizations and other similar transactions as set forth in the Purchase Agreement), provided that Lincoln Park’s purchase obligation under any single Regular Purchase may not exceed $500,000. The purchase price of the shares of common stock the Company may elect to sell to Lincoln Park under the Purchase Agreement in a Regular Purchase, if any, will be based on 95% of the lower of: (i) the lowest sale price on the purchase date for such Regular Purchase and (ii) the arithmetic average of the three lowest closing sale prices for the Company’s common shares during the 15 consecutive business days ending on the business day immediately preceding the purchase date for a Regular Purchase (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction.) In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts of the Company’s common shares in “accelerated purchases” and in “additional accelerated purchases” under the terms set forth in the Purchase Agreement.

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

Actual sales of common stock to Lincoln Park under the Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Company’s common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds to the Company from sales of common stock to Lincoln Park under the Purchase Agreement, if any, will depend on the frequency and prices at which the Company sells common stock to Lincoln Park under the Purchase Agreement. Any proceeds that the Company receives from sales of common stock to Lincoln Park under the Purchase Agreement will be used at the sole discretion of Company management and will be used for general corporate purposes, capital expenditures and working capital.

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The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. During any “event of default” under the Purchase Agreement, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any Regular Purchase or any other purchase of common shares by Lincoln Park, until such event of default is cured. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. In addition, in the event of bankruptcy proceedings by or against the Company, the Purchase Agreement will automatically terminate. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

In the six months ended June 30, 2021, the Company sold 500,000 shares of common stock that represented the balance of the Initial Purchase and 4,400,000 shares of common stock to Lincoln Park as Regular Purchases. The Company received proceeds of $564,000 from these purchases. There were no purchases in the six months ended June 30, 2020 and September 30, 2019:

 
 
 
Common Stock 
 
 
   
 
 
   
 
 
   
 
 
 
Shares
 
 
Amount
 
 
Additional Paid
in Capital
 
 
Accumulated
Deficit
 
 
Total
 
Balance – December 31, 2019
  32,680,984 
 $327,000 
 $21,437,000 
  (22,554,000)
 $(790,000)
Shares issued in connection with private placement
  2,842,856 
  28,000 
  171,000 
    
  199,000 
Shares issued to Cherokee in connection with loan
  300,000 
  3,000 
  18,000 
    
  21,000 
Share based payment expense
    
    
  2,000 
    
  2,000 
Shares issued for board meeting attendance in lieu of cash
  129,636 
  1,000 
  30,000 
    
  31,000 
Net loss
    
    
    
  (563,000)
  (563,000)
Balance – September 30, 2020
  35,953,476 
 $359,000 
 $21,658,000 
 $(23,117,000)
 $(1,100,000)
 
    
    
    
    
    
Balance – December 31, 2018
  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
  66,408 
    
  5,000 
    
  5,000 
Share based payment expense
    
    
  4,000 
    
  4,000 
Net loss
    
    
    
  (440,000)
  (440,000)
Balance-September 30, 2019
  32,545,776 
 $325,000 
 $21,425,000 
 $(22,313,000)
 $(563,000)
as the Lincoln Park Agreements were not executed until December 2020.

PRIVATE PLACEMENT

– FEBRUARY 2020

On February 20, 2020, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Chaim Davis (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”), 2,842,857 Units (the “Units”).

Each Unit consistsconsisted 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 July 2019 Term Loan with Chaim Davis, Et Al and the December 2019 Convertible Note (See Note E); totaling $39,000, were both converted into equity as part of a private placement closed in February 2020. Any interest that was incurred under the July 2019 Term Loan with Chaim Davis, Et in 2019 and up to the conversion in February 2020 was forgiven by the holders and the December 2019 Convertible Note did not bear any interest.

We do 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.

The Purchase Agreement contains customary representations, warranties and covenants made solely for the benefit of the parties to the Purchase Agreement. Although our Chairman of the Board was an investor in the Private Placement, the pricing of the Units was determined by the non-affiliate investors.


Item 2. Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations

Operations

General

The following discussion and analysis provides information, which we believe is relevant to an assessment and understanding of our financial condition and results of operations. The discussion should be read in conjunction with the Interim Condensed Financial Statements contained herein and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. Certain statements contained in this Quarterly Report on Form 10-Q, including, without limitation, statements containing the words “believes”, “anticipates”, “estimates”, “expects”, “intends”, “projects”, and words of similar import, are forward-looking as that term is defined by the Private Securities Litigation Reform Act of 1995 (“1995 Act”), and in releases issued by the United State Securities and Exchange Commission (the “Commission”). These statements are being made pursuant to the provisions of the 1995 Act and with the intention of obtaining the benefits of the “Safe Harbor” provisions of the 1995 Act. We caution that any forward-looking statements made herein are not guarantees of future performance and that actual results may differ materially from those in such forward-looking statements as a result of various factors, including, but not limited to, any risks detailed herein, in our “Risk Factors” section of our Form 10-K for the year ended December 31, 2019,2020, in our most recent reports on Form 10-Q and Form 8-K and from time to time in our other filings with the Commission, and any amendments thereto. Any forward-looking statement speaks only as of the date on which such statement is made, and we are not undertaking any obligation to publicly update any forward-looking statements. Readers should not place undue reliance on these forward-looking statements.

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Overview/Plan of Operations

Sales in

In the ninesix months ended SeptemberJune 30, 2020 were positively impacted by the sales and marketing of a Rapid Test to detect Covid-19 antibodies in whole blood, serum or plasma (that we are selling via a distribution agreement with Healgen Scientific, LLC; hereinafter referred to as the Covid-19 rapid antibody test) while2021, sales of our drugs of abuse testing products continued to bedrug tests were still being negatively impacted by the price competitiveness in our core markets (government, employment and clinical) and by the Covid-19 pandemic, although it does appear that drug test sales are startingpandemic. Sales related to reboundCovid-19 testing also declined dramatically in the six months ended June 30, 2021 compared to earliersales in 2020.the six months ended June 30, 2021 (when we were nearing the height of the pandemic and prior to vaccine availability). In addition to the marketing of our drug tests, in the six months ended June 30, 2021 we continued to market the Covid-19 IgG/IgM Rapid Test Cassette to detect Covid-19 antibodies in whole blood, serum or plasma (via a distribution agreement with Healgen Scientific, LLC), and we continued to market (via distribution) the Co-Diagnostics Logix Smart Covid-19 test. In December 2020, we announced that we were distributing a Rapid Covid-19 Antigen Test Cassette. In the middle of the three months ended March 31, 2021, we were informed by the manufacturer that we could no longer offer the Covid-19 antigen test for sale in the United States. In the three months ended June 30, 2020, we were able to find alternative tests to offer via distribution given this lack of marketing ability with the Covid-19 antigen test. In late March 2020,April, 2021, we started to market a Covid-19-Influenza A/B combination test that is EUA issued and CLIA waived. In addition, in May 2021, we began marketingdistributing a new Covid-19 Antigen Rapid Test that is EUA issued and CLIA waived along with a new Covid-19 Antibody Rapid Test that is EUA issued and CLIA waived and which can also be performed with finger stick blood at the Point of Care (i.e. patient care settings). All of the Covid-19 rapid antibody test, manufactured by Healgen Scientific, LLC,tests we are offering are being marketed in full complianceaccordance with the March 16, 2020 Emergency Use Authorization (“EUA”) policy set forth by the United States Food and Drug Administration (FDA) and in accordance with an EUAthe individual EUAs issued by FDA on May 29, 2020. Duefor the products.

The three new additional Covid-19 products have greater market applications than the tests we have been offering as we can offer them to specific regulatory events that occurred from March 2020 until May 2020,a wider array of customers. Although the pandemic is no longer at its height, we did not record any sales ofbelieve the need for these Covid-19 diagnostic tests until later in May 2020, although we did take pre-orders (with payments) forand the Covid-19 antibody tests prior to shipping product.

In October 2020, we announced that we signed a distribution agreement with Co-Diagnostics, Inc. granting ABMC the right to market and sell the Logix Smart Covid-19 tests in the United States on a non-exclusive basis. The addition of the Co-Diagnostics single step RT-PCR to the ABMC Covid-19 product portfolio is part of our planstill exist; albeit at lower levels.

We continue to offer a wide range of testing options for Covid-19. We believe there are a number of additional applications for Covid-19 antibody testing, but diagnostic testing is still in high demand in the US. The Co-Diagnostic RT-PCR test is a great complement to the Covid-19 rapid antibody test we distribute. In addition to the Covid-19 rapid antibody tests and RT-PCR tests, additionalother products and services are being offered to diversify our revenue stream through third partyvia distribution relationships. We currently offer a lower-cost alternative for onsite drug testing, point of care products for certain infectious diseases and alternative drug testing sample methods. With the exception of the lower-cost drug test alternative, and Covid-19 rapid antibody tests, these offerings have yet to materially positively impact sales.

In the year ended December 31, 2019, we expanded our contract manufacturing operations with two (2) new customers. BeginningUnfortunately, the Covid-19 pandemic halted sales to these new customers in mid-2019,the year ended December 31, 2020. We have open purchase orders (from 2020) with both customers and we can sellstarted to ship against these purchase orders in the three months ended June 30, 2021. One of the customers also placed an additional (new) order in April 2021, however this new order is not expected to ship until the sometime in the third quarter 2021.

Due to the Covid-19 pandemic, we are not yet marketing our oral fluid drugsdrug tests (OralStat®) in the employment and insurance markets underin the United States (under a limited exemption set forth by the FDA. Prior to this point,FDA). We remain hopeful that we could only sellcan effectively market our oral fluid drug tests in the forensic marketOralStat in the United States markets given its superior sensitivity and toaccuracy. Initially we may re-introduce the product in markets outside the United States. We are hopeful 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 when/if in the year ended December 31, 2020 we will see significant sales oral fluid drug testing in the employment market given the current global health crises and Covid-19.




States via distribution relationships.

We are focusing our efforts on further penetration of our markets with both current and new products including, but not limited to, the(drug testing, Covid-19 rapid antibody and the RT PCR test for Covid-19 we are distributing as well as other infectious disease products we are offering.diagnostic tests). We are also looking for avenues to capitalize on our US manufacturing operations; especially during this time of high demand for diagnostic products for Covid-19. operations. To that end, we are still working with a firm that would provide services related to public relations/social media to effectively communicate our manufacturing capabilities.

Operating expenses increased $56,000declined $33,000 in the ninesix months ended SeptemberJune 30, 2020 versus2021 compared to the ninesix months ended SeptemberJune 30, 20192020. Declines in research and development and selling and marketing (as of result of lower commissions being paid due to commissions paid on salesmuch lower levels of Covid-19 test sales) were partially offset by increased general and administrative costs (most of which is associated with costs associated with the refinancing of the Covid-19 rapid antibody tests.Cherokee facilities in February 2021). We continuously make efforts to control operational expenses to ensure they are in line with sales. We have consolidatedcontinued to consolidate job responsibilities in certain areas of the Company as a result of employee retirement and other departures and this has enabled us to implementresulting in personnel reductions. Throughout most of the six months ended

From August 2013 until June 30, 2020, we also maintained a 10% salary deferral program for our sole executive officer, our Chief Executive Officer/Principal Financial Officer Melissa Waterhouse. The 10%salary deferral program ceased in early June 2020 considering the length of time the deferral was in place forinitiated by Ms. Waterhouse (almost 7 years) and the balance owed.voluntarily. Until his departure in November 2019, another member of senior management participated in the program. As of September 30, 2020, we had total deferred compensation owed to these two individuals in the amount of $154,000. We did not make any payments on deferred compensation to Melissa Waterhouse in the nine months ended September 30, 2020 or in the nine months ended September 30, 2019.program voluntarily. After the member of senior management retired in November 2019, we agreed to make payments foron the deferred comp owed to this individual. In the ninesix months ended SeptemberJune 30, 2021 and in the six months ended June 30, 2020, we made payments totaling $45,000 to this individual; we did not make any payment to this individual in the nine month ended September 30, 2019. We will continue to make payments to the former member of senior management throughout the year ending December 31, 2020totaling $22,000 and when/if cash flow from operations allows, we intend to repay/make payments on$29,000, respectively. As of June 30, 2021, the deferred compensation owed to Melissathis individual is paid in full. Once the deferred compensation was paid in full to this individual in late May 2021, we began to make payments at the same rate to Ms. Waterhouse given the length of time the amount has been owed (7 years) and that the last payment made to Ms. Waterhouse was in August 2017. In the six months ended June 30, 2021, we made payments totaling $5,000 to Ms. Waterhouse.

As of June 30, 2021, we had deferred compensation owed to Ms. Waterhouse in the amount of $101,000.

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Our continued existence is dependent upon several factors, including our ability to: 1) raise revenue levels even though the drug testing market continues to be infiltrated by product manufactured outside of the United States as well as being impacted by the global health crisis caused by Covid-19, 2) further penetrate the markets (in and outside of the United States) for Covid-19 rapid antibody tests, 3) secure new contract manufacturing customers, 4) control operational costs to generate positive cash flows, 5) maintain our current credit facilities or refinance our current credit facilities if necessary, and 6) if needed, obtain working capital by selling additional shares of our common stock.

stock either to Lincoln Park or through an alternative method if necessary.

Results of operations for the ninesix months ended SeptemberJune 30, 20202021 compared to the ninesix months ended SeptemberJune 30, 2019

2020

NET SALES:Net sales for ninesix months ended SeptemberJune 30, 2020 increased 21.4%2021 decreased by $1,391,000, or 56%, when compared to net sales in the ninesix months ended SeptemberJune 30, 2019. Sales2020. The primary reason for this decline is lower distribution sales in the amount of $1,141,000; most of which is lower sales of Covid-19 tests. In the six months ended June 30, 2020, we recorded sales of Covid-19 rapid antibody tests in the amount of $1,382,000 offset declines$1,105,000 while in the six months ended June 30, 2021, we recorded sales of Covid-19 tests in the amount of $38,000. Most of these Covid-19 test sales in 2021 were made in the early part of the first quarter ended March 31, 2021 and were rapid antigen tests (sales of rapid antibody tests were negligible). In the middle of the first quarter 2021, we were informed by the manufacturer that we could no longer offer the Covid-19 antigen test for sale in the United States.

In late April/early May 2021, we were able to find alternative Covid-19 tests to offer via distribution given this lack of marketing ability with the Covid-19 antigen test. More specifically, we started to market a Covid-19-Influenza A/B combination test that is EUA issued and CLIA waived, a new Covid-19 Antigen Rapid Test that is EUA issued and CLIA waived and a new Covid-19 Antibody Rapid Test that is EUA issued and CLIA waived and which can also be performed with finger stick blood at the Point of Care (i.e. patient care settings). All of the Covid-19 tests we are offering are being marketed in accordance with the March 2020 Emergency Use Authorization (“EUA”) policy set forth by the United States Food and Drug Administration (FDA) and in accordance with the individual EUAs issued for the products. We also saw a decline in sales of the lower cost drugs of abuse products we offer via distribution. This decline was due to product availability and overall lower need from our customers.

Drugs of abuse manufacturing sales also decreased by $276,000 in the six months ended June 30, 2021 when compared to the six months ended June 30, 2020. Sales of drug test product sales which weretests continue to be negatively impacted by the Covid-19 pandemic. Contract manufacturing sales remained relatively flat; salespandemic along with the price competitive nature of RSV tests increased in the nine months ended September 30, 2020 dueour markets. Our markets do appear to increased diagnostic testing for respiratory viruses during the pandemic, while salesbe returning to some sense of malaria tests decreased due to decreased demand as a result of a shift in focus to Covid-19 tests in areas outside the US.

We began selling the Covid-19 rapid antibody test in late March 2020;normalcy; however, there were a number of regulatory events that resulted in an inability to get supply of the product from the manufacturing plant in China until May 2020. Once those events were addressed, we were able to receive product and ship orders to customers. The Covid-19 rapid antibody test is not a diagnostic test. Recently there have been infection surges in and outside the United States. As these infection surges occur, there is a higher demand for diagnostic tests (i.e. PCR’s or antigen tests); although 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.
In order to provide our customers with a diagnostic option for Covid-19, in October 2020 we began distributing the Co-Diagnostic Logix Smart Covid-19 tests in the United States. This RT-PCR test enables us to offer customers a diagnostic tool that can be run on high-throughput machines in clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA).



We believe that the demand for Covid-19 rapid antibody tests will increase over time as the need for data increases; that is, when testing is used as a means to determine the full impact/extent of the virus, its mortality rate, the length of time antibodies remain in the body and the impact of the antibodies on the virus, as well as a means to monitor the efficacy of vaccines as they are released. Information to date suggests that a vaccine could be available in early 2021. It is our opinion that once a vaccine (or vaccines) is/are released, the antibody status of individuals will be monitored very closely and rapid antibody tests are appropriate for this application.
Our core markets for drug test sales are clinical, government and workplace; all of which requirestill requiring a lower amount of tests due to reduced workforce, telecommuting and reduced budgets (especially in the government market as financial resources are still being used for Covid-19 testing and vaccinations). Also contributing to the decline in drugs of abuse manufacturing sales is the loss of a government account in the middle of 2020 due to pricing and sales declines in the international market due to two orders received in 2020 that have not yet been received in 2021. The clinical market continues to show signs of improvement with sales staying relatively flat.

In the six months ended June 30, 2021, we also experienced supply chain issues; particularly with materials that are used in the manufacture of lateral flow Covid-19 tests and plastic materials. The lead times for these materials are increasing significantly and in most cases without notice. This has caused the Company to have an increased level of backorders at times. As of June 30, 2021, we had open sales orders for drug tests that we manufacture in the amount of $128,000.

Contract manufacturing sales increased by $21,000 in the six months ended June 30, 2021 comparted to the six months ended June 30, 2020. This is primarily a result of orders shipped in the second quarter 2021 from two customers whose orders halted in 2020 due to the pandemic. We are expecting to ship more orders to these customers in 2021 as we fill open PO’s totaling $126,000. Sales of RSV (Respiratory Syncytial Virus) diagnostic tests declined due to lower levels of testing due to stay at home orders, reduced workforce and reduced budgets. In the ninepandemic stage we are in (along with the seasonality of the test usage).

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Over the last several months, ended September 30, 2020, we have started to see some reboundbeen working toward finalizing an agreement that we signed in our drug testing markets, however, given2020 under which we would provide manufacturing services for another diagnostic company. Given certain regulatory events (affecting the uncertainty of the markets (as they related to the pandemic)diagnostic company), we are unsure atif we will be moving forward with this time whetheragreement. We did expect this rebound will continue.

In additionagreement to the negativehave a positive impact on our revenue in 2021; however, that is now uncertain.

From a sales impact from the customer side,perspective, we also experienced delays in materials from vendors due to decreased production levels resulting from stay at home orders and reduced workforce numbers. Whileare focusing our staff continues to work due to the essential natureefforts on further penetration of our manufacturing, delays in materials resulted in customer backordersmarkets with both current and new products (drug testing, Covid-19 and other diagnostic tests). We are also looking for specific products that required the materials in question.

We do expect the marketing of the Covid-19 rapid antibody test and the RT PCR test for Covid-19avenues to further positively impact our revenues in the year ending December 31, 2020, however we do not yet know the full extent of the impact of COVID-19 test salescapitalize on our business, our financial condition and/or results ofUS manufacturing operations. The extent to which sales of the COVID-19 test may impact our business, operating results, financial condition, or liquidity in the future will depend on future developments which are evolving and uncertain including the duration of the outbreak and the need for antibody and diagnostic testing in the future.
As the market for Covid-19 testing develops over time,To that end, we are also reviewing alternative productsstill working with a firm that would provide services related to offerpublic relations/social media to effectively communicate our customers; products such as antigen tests and tests that use new (alternative) samples (such as saliva or breath).
manufacturing capabilities.

GROSS PROFIT:Gross profit decreased to 29.9%22.0% of sales in the ninesix months ended SeptemberJune 30, 20202021 compared to 34.9%31.0% of net sales in the ninesix months ended SeptemberJune 30, 2019. Although net sales2020 due to greater manufacturing inefficiencies and increased material costs. In the latter part of the three months ended March 31, 2021, we began to utilize our New Jersey facility to supplement assembly production in New York to mitigate the inefficiencies. Personnel levels in our New York facility have declined recently and we have been unsuccessful with hiring new personnel although we have advertised for the positions. Supplementing NY production in this manner results in a wiser use of labor and overhead costs in our New Jersey facility and will help improve manufacturing inefficiencies. In addition, in the latter part of June 2021, we began implementing a price increase in response to the increased costs related to labor and materials. To date, our customers appear to accept and understand the increase given our position as a 100% made in salesthe United States manufacturer who is experiencing increased labor, material and site costs. Gross profit in the six months ended June 30, 2020 was a result ofalso positively impacted by higher profit margins on Covid-19 products we distribute. Sales of products that we manufactured (primarily drug tests) decreased and this resultedwere distributing (which almost entirely offset lower manufacturing margins in greater inefficiencies in manufacturing. Manufacturing inefficiencies typically occur when revenues decline (from manufacturing) because certain overhead costs are fixed and cannot be reduced; if fewer testing strips are produced and fewer products are assembled this results in higher costs being expensed through cost of goods. Lower product pricing2020.) We will continue 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.

Lower gross margins from drug test sales (due to the increased manufacturing inefficiencies) were partially offset by higher margins related to Covid-19 rapid antibody 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 availabilitytake actions to customers,adjust our production schedules and costs of materialsuse manufacturing resources as wisely as possible to manufacture the Covid-19 tests).



try to mitigate future inefficiencies.

Operating expenses increased 4.0%decreased 3.2% in the ninesix months ended SeptemberJune 30, 20202021 compared to the ninesix months ended SeptemberJune 30, 2019.2020. Research & Development and Selling and Marketing expenses increaseddecreased while General and Administrative expenses decreased.increased. More specifically:

Research and development (“R&D”)

R&D expense increased 24.2%decreased 21.2% when comparing the ninesix months ended SeptemberJune 30, 20202021 with the ninesix months ended SeptemberJune 30, 2019. Increased2020. Decreased FDA compliance costs (associated with timing of facility registration fees) and increased costs related to supplies and materials costs were the primary reasons for the increasedecrease in expenses. All other expenses remained relatively consistent when comparing the two nine-monthsix-month periods. In the ninesix months ended SeptemberJune 30, 2020,2021, our R&D department primarily focused their efforts on the enhancement of our current products and the validation of new materials for ourrequired validations related to drug testing products.

product components.

Selling and marketing

Selling and marketing expense in the ninesix months ended SeptemberJune 30, 2020 increased 16.6%2021 decreased 51.4% when compared to the ninesix months ended SeptemberJune 30, 2019.2020. The primary reason for the increasedecrease in selling and marketing expense is significantly lower commissions paid related to sales of the Covid-19 rapid antibody test.tests. In addition to commissions, employeereductions in sales salary expense and benefits costs contributed(due to the increase. These increasestermination of personnel) and car allowance expense (due to the same terminations), were partiallynominally offset by decreased sales travel (as a resultincreased promotional expense (i.e. the semi-annual fee to OTC Markets paid in the second quarter of the Covid-19 pandemic) and lower auto allowance costs.

2021).

In the ninesix months ended SeptemberJune 30, 2020,2021, we continued selling and marketing 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). The addition of theseWe also marketed and sold antibody tests and diagnostic tests related to Covid-19 via distribution relationships. These offerings did not result in increased selling and marketing expenses. In late Marchexpenses, apart from increased commission costs in the six months ended June 30, 2020). Although we decreased the size of our sales force in the year ended December 31, 2020, we also started selling a Covid-19 rapid antibody test from Healgen Scientific, LLC via a distribution relationship. As of result of this new product offering, we recorded increased sales commission rates.those reductions were made for performance reasons. We are also taking effortsstill seeking new personnel to increase the size of our sales team to further penetrate the Covid-19 market and drug testour markets. We will continue to take all steps necessary to ensure selling and marketing expenditures are in line with sales.

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General and administrative (“G&A”)

G&A expense decreased 1.8%increased 21.6% in the ninesix months ended SeptemberJune 30, 20202021 when compared to G&A expense in the ninesix months ended SeptemberJune 30, 2019. Decreased2020. Increased costs associated with administrativeinvestor relations (primarily due to costs associated with our proxy and quality assurance employeesannual meeting of shareholders which was not held in June 2020 due to the pandemic), accounting fees (due to fewer employees and/or the consolidationtiming of job responsibilities)invoices), administrative salaries (due to an additional employee in 2021), insurance costs, legaloutside service fees (due to settlementa higher cost of the ABMC v. Bailey litigation) were almost entirely offset by increased non-cash costs related to meetings of the Board of Directorsour ISO audit held in March 2021), and bank service fees (due to increased costs related tofees in the amount of $148,000 incurred in connection with the extension of credit facilities).

the Cherokee loans), were partially offset by reductions in directors fees and expenses (due to less meetings held so far in 2021), legal fees (due to completion of the Lincoln Park financing in the early part of 2021), and repairs and maintenance. There was $0 in share based payment expense in the six months ended June 30, 2021 as all previously issued options have been completely amortized. There was $2,000 of share based payment expense in the six months ended June 30, 2020.

Other Incomeincome and Expense:expense: Other expense of $133,000$46,000 in the ninesix months ended SeptemberJune 30, 2021 consisted of interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and a shareholder loan) which was offset by other income of $50,000 related to certain non-refundable prepayments (customer deposits) that were forfeited when the customer did not remit the remaining amounts due on the order. Other expense of $91,000 in the six months ended June 30, 2020 consisted of interest expense associated with our credit facilities (our line of credit, equipment loan with Crestmark Bank and our two loans with Cherokee Financial, LLC). Other expense of $28,000 in the nine months ended September 30, 2019 consisted of 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 by other income related to gains on certain liabilities.




Results of operations for the three months ended SeptemberJune 30, 20202021 compared to the three months ended SeptemberJune 30, 2019

2020

NET SALES:Net sales for the three months ended SeptemberJune 30, 20202021 decreased 1.3%69.9%, when compared to net sales in the three months ended SeptemberJune 30, 2019. Sales2020. The primary reason for this decline is lower distribution sales in the amount of $1,126,000; most of which is lower sales of Covid-19 tests. In the three months ended June 30, 2020, we recorded sales of Covid-19 rapid antibody tests in the amount of $277,000 offset declines$1,105,000 while in the three months ended June 30, 2021, we recorded sales of Covid-19 tests in the amount of $2,000. This even further decline from sales in the first three months of 2021 is due to the manufacturer informing the Company that we could no longer offer their Covid-19 antigen test for sale in the United States. We were able to source alternative tests to distribute but, not until late April/early May 2021 when we started to offer new Covid-19 tests via distribution. More specifically, we started to market a Covid-19-Influenza A/B combination test that is EUA issued and CLIA waived, a new Covid-19 Antigen Rapid Test that is EUA issued and CLIA waived and a new Covid-19 Antibody Rapid Test that is EUA issued and CLIA waived and which can also be performed with finger stick blood at the Point of Care (i.e. patient care settings). All of the Covid-19 tests we are offering are being marketed in accordance with the March 2020 Emergency Use Authorization (“EUA”) policy set forth by the United States Food and Drug Administration (FDA) and in accordance with the individual EUAs issued for the products. We also saw a decline in sales of the lower cost drugs of abuse products we offer via distribution. This decline was due to product availability and overall lower need from our customers.

Drugs of abuse manufacturing sales also decreased by $112,000 in the three months ended June 30, 2021 when compared to the three months ended June 30, 2020. Sales of drug test product sales which weretests continue to be negatively impacted by the Covid-19 pandemic. pandemic along with the price competitive nature of our markets. Our markets do appear to be returning to some sense of normalcy; however, they are still requiring a lower amount of tests due to reduced workforce, telecommuting and reduced budgets (especially in the government market as financial resources are still being used for Covid-19 testing and vaccinations). Also contributing to the decline in drugs of abuse manufacturing sales is the loss of a government account in the middle of 2020 due to pricing and sales declines in the international market due to two orders received in 2020 that have not yet been received in 2021. The clinical market continues to show signs of improvement with sales staying relatively flat.

In the six months ended June 30, 2021, we also experienced supply chain issues; particularly with materials that are used in the manufacture of lateral flow Covid-19 tests and plastic materials. The lead times for these materials are increasing significantly and in most cases without notice. This has caused the Company to have an increased level of backorders at times. As of June 30, 2021, we had open sales orders for drug tests that we manufacture in the amount of $128,000. The majority of this amount was for orders received within the three months ended June 30, 2021.

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Contract manufacturing sales increased by $5,000 in the three months ended SeptemberJune 30, 2020 due2021 compared to increased sales of RSV tests as a result of increased diagnostic testing for respiratory viruses during the pandemic and increased sales of malaria tests due to the fact that we secured the malaria manufacturing customer in mid-2019.

We began selling the Covid-19 rapid antibody test in late March 2020; however there were a number of regulatory events that resulted in an inability to get supply of the product from the manufacturing plant in China until May 2020. Once those events were addressed, we were able to receive product and ship orders to customers. The Covid-19 rapid antibody test is not a diagnostic test. Recently there have been infection surges in and outside the United States. As these infection surges occur, there is a higher demand for diagnostic tests (i.e. PCR’s or antigen tests); although 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. The limited amount of Covid-19 rapid antibody tests in the three months ended SeptemberJune 30, 2020. This is primarily a result of orders shipped in the amount of $36,000 in the second quarter 2021 from two customers whose orders halted in 2020 is evidencedue to the pandemic. We are expecting to ship more orders to these customers in 2021 as we fill open PO’s totaling $126,000. The increased orders shipped to these tow customers was mostly offset by decreased sales of the impact of the surges and the need forRSV (Respiratory Syncytial Virus) diagnostic tests over antibody testing.
In orderdue to provide our customers with a diagnostic option for Covid-19, in October 2020 we began distributing the Co-Diagnostic Logix Smart Covid-19 tests in the United States. This RT-PCR test enables us to offer customers a diagnostic tool that can be run on high-throughput machines in clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA).
We believe that the demand for Covid-19 rapid antibody tests will increase over time as the need for data increases; that is, when testing is used as a means to determine the full impact/extent of the virus, its mortality rate, the length of time antibodies remain in the body and the impact of the antibodies on the virus, as well as a means to monitor the efficacy of vaccines as they are released. Information to date suggests that a vaccine could be available in early 2021. It is our opinion that once a vaccine (or vaccines) is/are released, the antibody status of individuals will be monitored very closely and rapid antibody tests are appropriate for this application.
Our core markets for drug test sales are clinical, government and workplace; all of which require a lower amountlevels of testing due to stay at home orders, reduced workforce and reduced budgets. In the three months ended September 30, 2020,pandemic stage we have started to see some reboundare in our drug testing markets, however, given(along with the uncertaintyseasonality of the test usage).

From a sales perspective, we are focusing our efforts on further penetration of our markets (as theywith both current and new products (drug testing, Covid-19 and other diagnostic tests). We are also looking for avenues to capitalize on our US manufacturing operations. To that end, we are still working with a firm that would provide services related to the pandemic), we are unsure at this time whether this rebound will continue.

In additionpublic relations/social media to the negative sales impact from the customer side, we also continued to experience delays in materials from vendors due to decreased production levels resulting from stay at home orders and reduced workforce numbers. While our staff continues to work due to the essential nature ofeffectively communicate our manufacturing delays in materials resulted in customer backorders for specific products that required the materials in question.
We do expect the marketing of the rapid antibody test and the RT PCR test for Covid-19 to further positively impact our revenues in the year ending December 31, 2020, however we do not yet know the full extent of the impact of COVID-19 test sales on our business, our financial condition and/or results of operations. The extent to which sales of the COVID-19 test may impact our business, operating results, financial condition, or liquidity in the future will depend on future developments which are evolving and uncertain including the duration of the outbreak and the need for antibody and diagnostic testing in the future.



As the market for Covid-19 testing develops over time, we are also reviewing alternative products to offer our customers; products such as antigen tests and tests that use new (alternative) samples (such as saliva or breath).
capabilities.

GROSS PROFIT:Gross profit decreased to 26.6%25.7% of net sales in the three months ended SeptemberJune 30, 2020 from 40.0%2021 compared to 33.1% of net sales in the three months ended SeptemberJune 30, 2019. Although sales were relatively flat when comparing2020 due to manufacturing inefficiencies and increased material costs. In three months ended June 30, 2021, we utilized our New Jersey facility to supplement assembly production in New York. Personnel levels in our New York facility have declined recently and we have been unsuccessful with hiring new personnel although we have advertised for the two periods, drug test sales declinedpositions. Supplementing NY production in this manner results in a wiser use of labor and those declines were partially offsetoverhead costs in our New Jersey facility and improves manufacturing inefficiencies. In addition, in the latter part of June 2021, we began implementing a price increase in response to the increased costs related to labor and materials. To date, our customers appear to accept and understand the increase given our position as a 100% made in the United States manufacturer who is experiencing increased labor, material and site costs. Gross profit in the three months ended June 30, 2020 was also positively impacted by increased sales ofhigher profit margins on Covid-19 products we distribute (primarily Covid-19 related). This means that sales of products that we manufactured (primarily drug tests) decreased and this resultedwere distributing (which almost entirely offset lower manufacturing margins in greater inefficiencies in our drug test manufacturing. Manufacturing inefficiencies typically occur when revenues decline (from manufacturing) because certain overhead costs are fixed and cannot be reduced; if fewer testing strips are produced and fewer products are assembled this results in higher costs being expensed through cost of goods. Lower product pricing2020.) We will continue 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.

Lower gross margins (due to the increased manufacturing inefficiencies) from drug test sales were partially offset by higher margins related to Covid-19 rapid antibody 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 availabilitytake actions to customers,adjust our production schedules and costs of materialsuse manufacturing resources as wisely as possible to manufacture the Covid-19 tests).
try to mitigate future inefficiencies.

OPERATING EXPENSES: Operating expenses decreased 7.5%32.9% in the three months ended SeptemberJune 30, 20202021 compared to the three months ended SeptemberJune 30, 2019.2020. Selling and Marketing and General and Administrative expense decreased while research and development remained relatively unchanged and general and administrative expense increased.increased slightly. More specifically:

Research and development (“R&D”)

R&D expense was relatively unchangedincreased 10.5% when comparing the three months ended SeptemberJune 30, 20202021 with the three months ended SeptemberJune 30, 2019 as all expenses remained consistent with2020. The reason for the prior year.slight increase (from a $ perspective) was FDA compliance costs (as a result of timing of facility registration fees and the fact that the fees did increase slightly). In the three months ended SeptemberJune 30, 2020,2021, our R&D department primarily focused their efforts on the enhancement of our current products and the validation of new materials for ourrequired validations related to drug testing products.

product components.

Selling and marketing

Selling and marketing expense in the three months ended SeptemberJune 30, 20202021 decreased 32.1%68.7% when compared to the three months ended SeptemberJune 30, 2019.2020. The primary reason for the decrease in selling and marketing expense is reduced employee expenses (salaries, benefits and auto expense) due to turnover and reduced net shipping/freight costs. These decreases were offset by increasedsignificantly lower commissions paid related to sales of the Covid-19 rapid antibody test.

tests. In addition to commissions, reductions in sales salary expense and benefits (due to the termination of personnel) and car allowance expense (due to the same terminations), were nominally offset by increased promotional expense (i.e. the semi-annual fee to OTC Markets paid in the second quarter of 2021).

In the three months ended SeptemberJune 30, 2020,2021, we continued selling and marketing efforts related to our drug tests and we continued to take actions to secure new contract manufacturing customers. We also secured distribution opportunities for additional Covid-19 tests and began marketing these new tests. In addition, we promoted lower cost alternatives for onsite drug testing and point of care products for infectious disease (through relationships with third parties). The addition of theseThese offerings did not result in increased selling and marketing expenses. In late March 2020,expenses, apart from increased commission costs in the six months ended June 30, 2020). Although we also started selling a Covid-19 rapid antibody test from Healgen Scientific, LLC via a distribution relationship. Asdecreased the size of result of this new product offering, we recorded increasedour sales commission rates.force, those reductions were made for performance reasons. We are also taking effortsstill seeking new personnel to increase the size of our sales team to further penetrate the Covid-19 market and drug testour markets. We will continue to take all steps necessary to ensure selling and marketing expenditures are in line with sales.



General and administrative (“G&A”)

G&A expense increased 2.8%decreased 9.5% in the three months ended SeptemberJune 30, 20202021 when compared to G&A expense in the three months ended SeptemberJune 30, 2019.2020. Decreased annual meeting costs (as we have not yet had our annual meeting of shareholders due to the pandemic), decreased costs related to insurance, fees associated with our ISO auditdirectors’ fees and expenses (due to less meetings held so far in 2021), accounting fees (due to timing of audit) and lowerinvoicing), legal fees, (as a result of the settlement of the ABMC v. Bailey litigation)repairs and maintenance and bank service fees were partially offset by increased bank service feesinvestor relations costs (primarily due to costs associated with our proxy and annual meeting of shareholders which was not held in June 2020 due to the pandemic), administrative salaries (due to increased costs related to extension of credit facilities).

Other incomean additional employee in 2021), and expense:
Otherinsurance costs. There was $0 in share based payment expense of $42,000 in the three months ended SeptemberJune 30, 2021 as all previously issued options have been completely amortized. There was $1,000 of share based payment expense in the three months ended June 30, 2020.

Other income and expense:

Other income of $1,000 in the three months ended June 30, 2021 consisted of other income of $50,000 related to certain non-refundable prepayments (customer deposits) that were forfeited when the customer did not remit the remaining amounts due on the order which was almost entirely offset by interest expense associated with our credit facilities (our line of credit, our two loans with Cherokee Financial, LLC and a shareholder loan). Other expense of $37,000 in the three months ended June 30, 2020 consisted of interest expense associated with our credit facilities (our line of credit, equipment loan with Crestmark Bank and our two loans with Cherokee Financial, LLC). Other expense of $63,000 in the three months ended September 30, 2019 consisted of 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 by other income related to gains on certain liabilities.

Liquidity and Capital Resources as of SeptemberJune 30, 2020

2021

Our cash requirements depend on numerous factors, including but not limited to manufacturing costs (such as raw materials, labor, equipment, etc.), selling and marketing initiatives, product development activities, regulatory costs, legal costs, 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.

On February 20,December 9, 2020, we entered into a Securities Purchase Agreement (the “Purchase Agreement”)and a Registration Rights Agreement with Chaim Davis (the Chairman of our Board of Directors) and certain other accredited investors (the “Investors”), pursuant toLincoln Park under which weLincoln Park agreed to issue and sellpurchase from the Company, from time to the Investors in a private placement (the “Private Placement”), 2,842,856 Units (the “Units”). Each Unit consistedtime, up to $10,250,000 of one (1) shareshares of our common stock, par value $0.01 per share, (“Common Share”subject to certain limitations set forth in the Purchase Agreement, during the term of the Purchase Agreement (two years). Pursuant to the terms of the Registration Rights Agreement, we were 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, as amended (the “Securities Act”), atshares of common stock issued and sold as well as the shares of common stock that we may elect in the future to issue and sell to Lincoln Park from time to time under the Purchase Agreement.

On January 4, 2021, we were notified by the SEC that they would not review the Registration Statement on Form S-1 filed on December 29, 2020. We were subsequently instructed by the SEC (through counsel) to amend the originally filed Form S-1 to include certain information for the fiscal year ended December 31, 2020 in place of the information in the original filing that was for the fiscal year ended December 31, 2019. We filed a price per UnitForm S-1/A on January 7, 2021 and requested (through counsel) that the SEC declare the Form S-1 effective on January 11, 2021. The SEC granted our request. In the six months ended June 30, 2021, the Company sold 4,900,000 shares of $0.07 (the “Purchase Price”) for aggregate grosscommon stock to Lincoln Park (including 500,000 shares required as an initial purchase under the Purchase Agreement) as Regular Purchases and received 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.

$564,000.

Our financial statements for the year ended December 31, 20192020 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 facility) may not be sufficient to fund operations through November 2021.August 2022. At SeptemberJune 30, 2020,2021, we have Stockholders’ Deficit of $1,100,000.

$1,493,000.

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Our loan and security agreement and 2019 Term Note with Cherokee for $900,000 and $200,000,$220,000, respectively, expired on February 15, 2020;2021; however, on February 24, 2021, the creditCompany 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 for another 12 months, or untilin February 15, 2021 (which is less than 12 months from2020). Under the dateterms of this report)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 on 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 SeptemberJune 30, 20202021 with Cherokee Financial, LLC is $1,120,000.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 is due in full on February 15, 2021.2022. We are currently looking at alternativesmay be able to further extend or refinance these facilities.




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 and given the current closing sales prices of our shares of common stock, that is not a certainty.

Throughout the ninesix months ended SeptemberJune 30, 2020,2021, we had a line of credit with Crestmark Bank. The maximum availability on the line of credit through most of the nine months ended September 30, 2020 was $1,500,000 but, it was reduced on June 22, 2020 to $1,000,000 under the amendment and extension of 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 SeptemberJune 30, 2020,2021, 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. The Company 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.

If availability under our line of credit and cash received from prepaid orders of Covid-19 rapid antibody testequity sales isunder the Lincoln Park Purchase Agreement are not 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.

As of SeptemberJune 30, 2020,2021, we had the following debt/credit facilities:

Facility
Debtor
Balance as of September 30, 2020
Loan and Security Agreement
Cherokee Financial, LLC
$900,000
Revolving Line of Credit
Crestmark Bank
$208,000
Term Loan
Cherokee Financial, LLC
$220,000
PPP Loan
Crestmark Bank, SBA
$332,000
Total Debt
$1,660,000

Facility

 

Debtor

 

Balance as of

June 30, 2021

 

 

Due Date

 

Loan and Security Agreement

 

Cherokee Financial, LLC

 

$1,000,000

 

 

February 15, 2022

 

Revolving Line of Credit

 

Crestmark Bank

 

 

287,000

 

 

June 22, 2022

 

Term Loan

 

Cherokee Financial, LLC

 

 

240,000

 

 

February 15, 2022

 

PPP Loan

 

Crestmark Bank, SBA

 

 

332,000

 

 

April 22, 2022

 

Term Loan

 

Individual

 

 

50,000

 

 

November 4, 2021

 

Total Debt

 

 

 

$1,909,000

 

 

 

 

Working Capital Deficit


At SeptemberJune 30, 2020,2021, we were operating at a working capital deficit of $1,825,000.$2,154,000. This compares to a working capital deficit of $1,365,000$1,624,000 at SeptemberJune 30, 2019.2020 and a working capital deficit of $841,000 at December 31, 2020. This increase in our working capital deficit wasis primarily a result of additional financing, including the $332,000 PPP Loan,decreased sales and, from December 31, 2020 to June 30, 2021, a decreasechange in accounts receivables (dueclassification of our debt with Cherokee from long-term to lower drug test sales), and a decrease in inventory (due to less purchasing of materials used in our drug test manufacturing).short-term. We have historically satisfied working capital requirements through cash from operations, bank debt and bank debt.


equity financings.

Dividends


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


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Cash Flow, Outlook/Risk


In the ninesix months ended, September 30, 2020, we had a net loss of $563,000$801,000 and net cash used byin operating activities of $299,000.$616,000. Our cash position increaseddecreased from $15,000$225,000 at September 30, 2019 to $61,000 at SeptemberJune 30, 2020 as a resultto $30,000 at June 30, 2021. This decrease stems from prepayments received from presales of prepayments for Covid-19 rapid antibody tests the private placement in the amount ofand $199,000 closed infrom the February 2020 and proceeds from the PPP loan.


In other efforts to reduce cash requirements, we have issued shares of restricted stock in lieu of cash. More specifically, we issued 300,000 restricted shares of common stock to Cherokee in connection with a February 2020 debt extension and 129,636 restricted shares of common stock to board members in connection with their attendance at meetings of our Board of Directorsequity private placement in the six months ended June 30, 2020, (there were no formal board meetings heldwhich did not recur in the threesix months ended SeptemberJune 30, 2020). We expect to issue additional restricted shares of common stock for attendance at meetings of the Board of Directors.



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, 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.

On June 22, 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.

In March 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 York where our headquarters are located, and in the State of New Jersey where our strip manufacturing facility is located. In response to the outbreak, we have followed the guidelines of the 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 todid not materially disrupt our business. While we have not seen a disruption in ourdaily business operations to date, our drug testing sales have been negatively impacted by the pandemic.


While the Covid-19 pandemic continues to rapidly evolve and as surges continue to occur, we continue to assessis seemingly winding down, the impact of the Covid-19 pandemic to best mitigate risk and continue the operations of our business. The extent to which the outbreak impactspandemic may continue to impact 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 new strains of Covid-19 (such as the Delta variant that has been dominating the headlines recently), 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.


On December 9, 2020, we entered into a Purchase Agreement (the “Purchase Agreement”) and a Registration Rights Agreement (the “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 our shares of common stock, par value $0.01 per share, subject to certain limitations set forth in the Purchase Agreement, during the term of the Purchase Agreement. We registered 9,750,000 shares of common stock under a Registration Statement on Form S-1 (as amended). The Form S-1 was declared effective by the SEC on January 11, 2021 and going forward we are able to utilize the Lincoln Park equity facility to fund operations (if necessary), pay down other debt (whenever possible) and fund our growth initiatives. In the six months ended June 30, 2021, we sold 4,900,000 shares of common stock to Lincoln Park as Regular Purchases and received proceeds of $564,000.

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.

We 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 stream, including anew Covid-19 rapid antibody test and a RT PCR test to detect Covid-19. We also secured the business of two (2) new contract manufacturing customers in the year ended December 31, 2019. As the market for Covid-19 testing continues to develop over time, we are also reviewing alternative products to offer our customers; products such as antigen tests and tests that use new (alternative) samples (such as saliva or breath).


tests.

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

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




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Item 3. QuantitativeQuantitative and Qualitative Disclosures About Market Risk

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

Item 4. ControlsControls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

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

(b) Changes in Internal Control Over Financial Reporting

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

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PART II – OTHEROTHER INFORMATION

Item 1. LegalLegal Proceedings

See Part I, Item 1, Note D in the Notes to interim condensed Financial Statements included in this report for a description of pending legal proceedings in which we may be a party.

Item 1A. RiskRisk Factors

There have been no material changes to our risk factors set forth in Part I, Item 1A, in our Annual Report on Form 10-K for the year ended December 31, 2019.

2020.

Item 2. UnregisteredUnregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. DefaultsDefaults Upon Senior Securities

None.

Item 4. MineMine Safety Disclosures

Not applicable.

Item 5. OtherOther Information

None.

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Item 6. Exhibits


Exhibits

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer/Chief Financial Officer

32.1/32.2

Certification of the Chief Executive Officer/Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101

101

The following materials from our Quarterly Report on Form 10-Q for the quarter ended SeptemberJune 30, 2020,2021, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Balance Sheet, (ii) Condensed Statements of Income (iii) Condensed Statements of Cash Flows, and (iv) Notes to Condensed Financial Statements.

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SIGNATURES

SIGNATURES

In accordance with the requirements of the Exchange Act, the registrant has caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

AMERICAN BIO MEDICA CORPORATION

(Registrant)

 
By:/s/ Melissa A. Waterhouse

Melissa A. Waterhouse

 
 
By: /s/   Melissa A. Waterhouse 
 
Melissa A. Waterhouse

Chief Executive Officer (Principal Executive Officer)

Principal Financial Officer

Principal Accounting Officer

Dated: August 18, 2021

Dated: November 16, 2020

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