UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended: September 30, ~~2020~~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: 001-32288

NEPHROS, INC.

(Exact name of registrant as specified in its charter)

~~DELAWARE~~delaware		13-3971809
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

380 Lackawanna Place South Orange, NJ		07079
(Address of principal executive offices)		(Zip Code)

(201)343-5202

Registrant’s telephone number, including area code

N/A

(Former name, former address and former fiscal year, if changed since last report)

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

Title of each class		Trading symbol		Name of exchange on which registered
Common stock, par value $0.001 per share		NEPH		The Nasdaq Stock Market LLC

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ~~[X]~~ ☒ YES ~~[ ]~~ ☐ NO

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

Large accelerated filer ~~[ ]~~☐	Accelerated filer ~~[ ]~~☐
Non-accelerated filer ~~[X]~~ ☒	Smaller reporting company ~~[X]~~☒
	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 ~~[X]~~☒ NO

As of November ~~3, 2020, 9,864,673~~1, 2021, 10,233,083 shares of the registrant’s common stock, $0.001 par value per share, were outstanding.

NEPHROS, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION	3
Item 1. Financial Statements (unaudited).	3
CONDENSED CONSOLIDATED BALANCE SHEETS – September 30, ~~2020~~2021 and December 31, ~~2019~~2020	3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS – Three and nine months ended September 30, ~~2020~~2021 and ~~2019~~2020	4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY – Three and nine months ended September 30, ~~2020~~2021 and ~~2019~~2020	5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS – Nine months ended September 30, ~~2020~~2021 and ~~2019~~2020	7
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS	8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.	2322
Item 3. Quantitative and Qualitative Disclosures About Market Risk.	3834
Item 4. Controls and Procedures.	3834
PART II - OTHER INFORMATION	3935
Item 1A. Risk Factors	3935
Item 5. Other Information	35
Item 6. Exhibits	4035
SIGNATURES	4136

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

	September 30, 2020			December 31, 2019			September 30, 2021			December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	5,155		$	4,166		$	7,350		$	8,249
Accounts receivable, net		901			1,045			1,555			1,364
Inventory, net		5,385			2,562
Inventory								4,649			5,304
Prepaid expenses and other current assets		314			526			67			237
Total current assets		11,755			8,299			13,621			15,154
Property and equipment, net		302			81			382			295
Lease right-of-use assets		1,117			1,106			814			1,037
Intangible assets, net		517			548			1,573			506
Goodwill		759			759			759			759
License and supply agreement, net		703			804			569			670
Other assets		89			32			102			89
TOTAL ASSETS	$	15,242		$	11,629		$	17,820		$	18,510

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Secured revolving credit facility	$	-		$	560
Current portion of secured note payable		224			211		$	243		$	229
Current portion of paycheck protection program loan		340			-
Accounts payable		887			959			641			423
Accrued expenses		596			136			573			341
Contingent consideration		6			300
Current portion of lease liabilities		326			262			366			332
Total current liabilities		2,379			2,428			1,823			1,325
Secured note payable, net of current portion		428			613			164			364
Paycheck protection program loan, net of current portion		141			-
PPP loan								-			482
Equipment financing, net of current portion		8			10			5			7
Lease liabilities, net of current portion		846			889			498			759
TOTAL LIABILITIES		3,802			3,940			2,490			2,937

COMMITMENTS AND CONTINGENCIES (Note 15)

STOCKHOLDERS’ EQUITY

Preferred stock, $.001 par value; 5,000,000 shares authorized at September 30, 2020 and December 31, 2019; no shares issued and outstanding at September 30, 2020 and December 31, 2019.		-			-
Common stock, $.001 par value; 40,000,000 shares authorized at September 30, 2020 and December 31, 2019; 9,039,673 and 8,058,850 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively.		9			8
Preferred stock, $.001 par value; 5,000,000 shares authorized at September 30, 2021 and December 31, 2020; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020.											-
Common stock, $.001 par value; 40,000,000 shares authorized at September 30, 2021 and December 31, 2020; 10,233,083 and 9,873,006 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively.								10			10
Additional paid-in capital		139,410			131,934			146,883			144,296
Accumulated other comprehensive income		69			65			66			74
Accumulated deficit		(131,100	)		(127,332	)		(134,683	)		(131,858	)
Subtotal		8,388			4,675			12,276			12,522
Noncontrolling interest		3,052			3,014			3,054			3,051
TOTAL STOCKHOLDERS’ EQUITY		11,440			7,689			15,330			15,573
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	15,242		$	11,629		$	17,820		$	18,510

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,						2021			2020			2021			2020
	2020			2019			2020			2019			Three Months Ended September 30,						Nine Months Ended September 30,
Net revenues:
													2021			2020			2021			2020
Net revenue:
Product revenues	$	2,094		$	3,054		$	6,133		$	7,067		$	2,595		$	2,094		$	7,503		$	6,133
Royalty and other revenues		27			41			94			106			42			27			136			94
Total net revenues		2,121			3,095			6,227			7,173			2,637			2,121			7,639			6,227
Cost of goods sold		896			1,276			2,616			2,989			1,225			896			3,365			2,616
Gross margin		1,225			1,819			3,611			4,184			1,412			1,225			4,274			3,611
Operating expenses:
Research and development		751			777			2,150			2,326			632			751			1,675			2,150
Depreciation and amortization		49			44			142			142			50			49			151			142
Selling, general and administrative		1,544			1,787			5,104			4,693			1,892			1,544			5,745			5,104
Change in fair value of contingent consideration		(187	)		(94	)		(229	)		(113	)		-			(187	)		-			(229	)
Total operating expenses		2,157			2,514			7,167			7,048			2,574			2,157			7,571			7,167
Loss from operations		(932	)		(695	)		(3,556	)		(2,864	)		(1,162	)		(932	)		(3,297	)		(3,556	)
Other (expense) income:
Interest expense		(22	)		(48	)		(95	)		(140	)		(10	)		(22	)		(34	)		(95	)
Interest income		3			-			8			-			2			3			8			8
Other expense, net		(61	)		(1	)		(124	)		(31	)
Extinguishment of PPP loan														-			-			482			-
Other income (expense), net														8			(61	)		16			(124	)
Total other (expense) income:														-			(80	)		472			(211	)
Net loss		(1,012	)		(744	)		(3,767	)		(3,035	)		(1,162	)		(1,012	)		(2,825	)		(3,767	)
Less: Undeclared deemed dividend attributable to noncontrolling interest		(60	)		(60	)		(179	)		(180	)		(60	)		(60	)		(179	)		(179	)
Net loss attributable to Nephros, Inc. shareholders	$	(1,072	)	$	(804	)	$	(3,946	)	$	(3,215	)		(1,222	)		(1,072	)		(3,004	)		(3,946	)

Net loss per common share, basic and diluted	$	(0.12	)	$	(0.10	)	$	(0.44	)	$	(0.43	)	$	(0.12	)	$	(0.12	)	$	(0.30	)	$	(0.44	)
Weighted average common shares outstanding, basic and diluted		9,039,673			7,703,033			8,872,624			7,408,569			10,044,745			9,039,673			9,957,528			8,872,624

Comprehensive loss:
Net loss	$	(1,012	)	$	(744	)	$	(3,767	)	$	(3,035	)	$	(1,162	)	$	(1,012	)	$	(2,825	)	$	(3,767	)
Other comprehensive income (loss), foreign currency translation adjustments, net of tax		4			(7	)		4			(8	)		(4	)		4			(8	)		4
Comprehensive loss		(1,008	)		(751	)		(3,763	)		(3,043	)		(1,166	)		(1,008	)		(2,833	)		(3,763	)
Comprehensive loss attributable to noncontrolling interest		(60	)		(60	)		(179	)		(180	)		(60	)		(60	)		(179	)		(179	)
Comprehensive loss attributable to Nephros, Inc. shareholders	$	(1,068	)	$	(811	)	$	(3,942	)	$	(3,223	)	$	(1,226	)	$	(1,068	)	$	(3,012	)	$	(3,942	)

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

(Unaudited)

	Shares		Amount		Capital		Income			Deficit			Subtotal			Interest		Equity
	Three and nine months ended September 30, 2021
	Common Stock				Additional Paid-in		Accumulated Other Comprehensive			Accumulated						Noncontrolling		Total Stockholders’
	Shares		Amount		Capital		Income			Deficit			Subtotal			Interest		Equity
Balance, December 31, 2020		9,873,006	$	10	$	144,296	$	74		$	(131,858	)	$	12,522		$	3,051	$	15,573
Net loss				-		-		-			(537	)		(537	)		-		(537	)
Net unrealized losses on foreign currency translation, net of tax				-		-		(6	)		-			(6	)		-		(6	)
Exercise of options		14,754		-		62		-			-			62			-		62
Cashless exercise of options		131		-		-		-			-			-			-		-
Exercise of warrants
Exercise of warrants, shares
Cashless exercise of warrants
Cashless exercise of warrants, shares
Issuance of vested restricted stock
Issuance of vested restricted stock, shares
Issuance of common stock, net of equity
Issuance of common stock, net of equity issuance costs, shares
Stock-based compensation				-		443		-			-			443			2		445
Balance, March 31, 2021		9,887,891	$	10	$	144,801	$	68		$	(132,395	)	$	12,484		$	3,053	$	15,537

Net loss			$	-	$	-	$	-		$	(1,126	)	$	(1,126	)	$	-	$	(1,126	)
Net unrealized gains on foreign currency translation, net of tax				-		-		2			-			2			-		2
Cashless exercise of options		14,616		-		-		-			-			-			-		-
Exercise of warrants		110,003		-		297		-			-			297			-		297
Cashless exercise of warrants		10,963		-		-		-			-			-			-		-
Stock-based compensation				-		280		-			-			280			1		281
Balance, June 30, 2021		10,023,473	$	10	$	145,378	$	70		$	(133,521	)	$	11,937		$	3,054	$	14,991

Net loss			$	-	$	-	$	-		$	(1,162	)	$	(1,162	)	$	-	$	(1,162	)
Net unrealized losses on foreign currency translation, net of tax				-		-		(4	)		-			(4	)		-		(4	)
Issuance of common stock for asset acquisition (see Note 3)		123,981		-		1,124		-			-			1,124			-		1,124
Exercise of options		21,291		-		114		-			-			114			-		114
Issuance of vested restricted stock		23,781		-		-		-			-			-			-		-
Stock-based compensation				-		267		-			-			267					267
Balance, September 30, 2021		10,192,526	$	10	$	146,883	$	66		$	(134,683	)	$	12,276		$	3,054	$	15,330

	Three and nine months ended September 30, 2020																				Three and nine months ended September 30, 2020
	Common Stock				Additional Paid-in		Accumulated Other Comprehensive			Accumulated						Noncontrolling		Total Stockholders’			Common Stock				Additional Paid-in		Accumulated Other Comprehensive			Accumulated						Noncontrolling		Total Stockholders’
	Shares		Amount		Capital		Income			Deficit			Subtotal			Interest		Equity			Shares		Amount		Capital		Income			Deficit			Subtotal			Interest		Equity
Balance, December 31, 2019		8,003,739	$	8	$	131,934	$	65		$	(127,332	)	$	4,675		$	3,014	$	7,689			8,003,739	$	8	$	131,934	$	65		$	(127,332	)	$	4,675		$	3,014	$	7,689
Net loss											(1,098	)		(1,098	)				(1,098	)				-		-		-			(1,098	)		(1,098	)		-		(1,098	)
Net unrealized losses on foreign currency translation, net of tax								(1	)					(1	)				(1	)				-		-		(1	)		-			(1	)		-		(1	)
Issuance of common stock, net of equity issuance costs of $729		937,500		1		6,770								6,771					6,771
Issuance of common stock, net of equity issuance costs of $729																						937,500		1		6,770		-			-			6,771			-		6,771
Issuance of common stock																						937,500		1		6,770		-			-			6,771			-		6,771
Exercise of warrants		18,889				51								51					51			18,889		-		51		-			-			51					51
Exercise of options		556				2								2					2			556		-		2		-			-			2			-		2
Cashless exercise of options		755																				755		-		-		-			-			-			-		-
Noncash stock-based compensation						196								196			26		222
Stock-based compensation																								-		196		-			-			196			26		222
Balance, March 31, 2020		8,961,439	$	9	$	138,953	$	64		$	(128,430	)	$	10,596		$	3,040	$	13,636			8,961,439	$	9	$	138,953	$	64		$	(128,430	)	$	10,596		$	3,040	$	13,636

Net loss											(1,657	)		(1,657	)				(1,657	)			$	-	$	-	$	-		$	(1,657	)	$	(1,657	)	$	-	$	(1,657	)
Net unrealized gains on foreign currency translation, net of tax								1						1					1					-		-		1			-			1			-		1
Exercise of warrants		21,123				112								112					112			21,123		-		112		-			-			112			-		112
Exercise of options		2,000				5								5					5			2,000		-		5		-			-			5			-		5
Issuance of vested restricted stock		55,111																				55,111		-		-		-			-			-			-		-
Noncash stock-based compensation						173								173			6		179
Stock-based compensation																								-		173		-			-			173			6		179
Balance, June 30, 2020		9,039,673	$	9	$	139,243	$	65		$	(130,087	)	$	9,230		$	3,046	$	12,276			9,039,673	$	9	$	139,243	$	65		$	(130,087	)	$	9,230		$	3,046	$	12,276

Net loss											(1,012	)		(1,012	)				(1,012	)			$	-	$	-	$	-		$	(1,012	)	$	(1,012	)	$	-	$	(1,012	)
Net unrealized gains on foreign currency translation, net of tax								4						4					4					-		-		4						4			-		4
Noncash stock-based compensation						166								166			6		172
Stock-based compensation																								-		166		-			-			166			6		172
Balance, September 30, 2020		9,039,673	$	9	$	139,409	$	69		$	(131,099	)	$	8,388		$	3,052	$	11,440			9,039,673	$	9	$	139,409	$	69		$	(131,099	)	$	8,388		$	3,052	$	11,440

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

Three and nine months ended September 30, 2019
Common Stock Additional Paid-in
Accumulated Other
Comprehensive
Accumulated Noncontrolling Total Stockholders’
Shares Amount Capital Income Deficit Subtotal Interest Equity
Balance, December 31, 2018 7,134,719 $ 7 $ 127,873 $ 71 $ (124,153 ) $ 3,798 $ 3,000 $ 6,798
Net loss (1,349 ) (1,349 ) (1,349 )
Net unrealized losses on foreign currency translation, net of tax (3 ) (3 ) (3 )
Noncash stock-based compensation 158 158 158
Balance, March 31, 2019 7,134,719 $ 7 $ 128,031 $ 68 $ (125,502 ) $ 2,604 $ 3,000 $ 5,604
Net loss (942 ) (942 ) (942 )
Net unrealized gains on foreign currency translation, net of tax 2 2 2
Issuance of common stock, net of equity issuance costs of $8 493,827 1 1,991 1,992 1,992
Issuance of vested restricted stock 44,270
Noncash stock-based compensation 147 147 3 150
Balance, June 30, 2019 7,672,816 $ 8 $ 130,169 $ 70 $ (126,444 ) $ 3,803 $ 3,003 $ 6,806
Net loss (744 ) (744 ) (744 )
Net unrealized losses on foreign currency translation, net of tax (7 ) (7 ) (7 )
Exercise of warrants 108,147 292 292 292
Exercise of stock options 4,166 21 21 21
Aggregate fractional shares cancelled due to reverse stock split (594 )
Noncash stock-based compensation 348 348 6 354
Balance, September 30, 2019 7,784,535 $ 8 $ 130,830 $ 63 $ (127,188 ) $ 3,713 $ 3,009 $ 6,722

NEPHROS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

	2021			2020
	Nine Months Ended September 30,
	2021			2020
OPERATING ACTIVITIES:
Net loss	$	(2,825	)	$	(3,767	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment		22			18
Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset		140			136
Stock-based compensation, including stock options and restricted stock		825			573
Inventory obsolescence charge		123			4
Extinguishment of PPP loan		(482	)		-
Change in fair value of contingent consideration		-			(229	)
Accretion of contingent consideration		-			14
(Gain) loss on foreign currency transactions		(4	)		7
Change in lease right-of-use assets		237			233
Increase (decrease) in operating assets:
Accounts receivable		(191	)		144
Inventory		532			(2,827	)
Prepaid expenses and other current assets		170			207
Other assets		(14	)		(57	)
Decrease (increase) in operating liabilities:
Accounts payable		223			(79	)
Accrued expenses		402			464
Lease liabilities		(240	)		(218	)
Net cash used in operating activities		(1,082	)		(5,377	)

INVESTING ACTIVITIES:
Purchase of property and equipment		(36	)		(239	)
Payment of direct transaction costs for asset acquisition		(49	)		-
Net cash used in investing activities		(85	)		(239	)

FINANCING ACTIVITES:
Proceeds from issuance of common stock		-			6,771
Proceeds from Paycheck Protection Program Loan		-			479
Net payments from secured revolving credit facility		-			(560	)
Payments on secured note payable		(186	)		(172	)
Principal payments on finance lease liability		(11	)		(6	)
Principal payments on equipment financing		(2	)		(2	)
Proceeds from exercise of warrants		297			163
Proceeds from exercise of options		176			7
Payment of contingent consideration		-			(79	)
Net cash provided by financing activities		274			6,601
Effect of foreign exchange rates on cash		(6	)		4
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS		(899	)		989
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		8,249			4,166
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	7,350		$	5,155

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid for interest expense	$	33		$	80
Cash paid for income taxes	$	42		$	21

SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING INFORMATION
Right-of-use asset obtained in exchange for operating lease liability	$	21		$	201
Right-of-use asset obtained in exchange for finance lease liability	$	-		$	17
Issuance of common shares for asset acquisition	$	1,124		$	-

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

NEPHROS, INC. AND SUBSIDIARIES

~~CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS~~

~~(In thousands)~~

~~(Unaudited)~~

Nine months ended September 30,
2020 2019
OPERATING ACTIVITIES:
Net loss $ (3,767 ) $ (3,035 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment 18 20
Amortization of intangible assets, license and supply agreement and finance lease right-of-use asset 136 132
Non-cash stock-based compensation, including stock options and restricted stock 573 662
Inventory reserve 4 37
Change in fair value of contingent consideration (229 ) (113 )
Accretion of contingent consideration 14 41
Loss (gain) on foreign currency transactions 7 (2 )
(Increase) decrease in operating assets:
Accounts receivable 144 (461 )
Inventory (2,827 ) (301 )
Allowance for doubtful accounts reserve - 19
Prepaid expenses and other current assets 207 21
Operating right-of-use assets and operating lease liabilities 15 49
Other assets (57 ) (21 )
Increase (decrease) in operating liabilities:
Accounts payable (79 ) (144 )
Accrued expenses 464 456
Net cash used in operating activities (5,377 ) (2,640 )

INVESTING ACTIVITIES:
Purchase of equipment (239 ) (14 )
Acquisition of the Aether business - (137 )
Net cash used in investing activities (239 ) (151 )

FINANCING ACTIVITES:
Proceeds from issuance of common stock 6,771 1,992
Proceeds from Paycheck Protection Program Loan 479 -
Net payments on secured revolving credit facility (560 ) (9 )
Payments on secured note payable (172 ) (159 )
Principal payments on finance lease liability (6 ) -
Principal payments on equipment financing (2 ) (1 )
Proceeds from equipment financing - 14
Proceeds from exercise of warrants 163 292
Proceeds from exercise of options 7 21
Payment of contingent consideration (79 ) (78 )
Net cash provided by financing activities 6,601 2,072
Effect of foreign exchange rates on cash 4 (7 )
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 989 (726 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 4,166 4,581
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 5,155 $ 3,855

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid for interest expense $ 80 $ 98
Cash paid for income taxes $ 21 $ 4

SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING INFORMATION
Right-of-use asset obtained in exchange for operating lease liability $ 201 $ 800
Right-of-use asset obtained in exchange for finance lease liability $ 17 $ -

~~The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.~~

~~NEPHROS, INC. AND SUBSIDIARIES~~

NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (unaudited)

Note 1 – Organization and Nature of Operations

Nephros, Inc. (“Nephros” or the “Company”) was incorporated under the laws of the State of Delaware on April 3, 1997. The Company was founded by health professionals, scientists and engineers affiliated with Columbia University to develop advanced end stage renal disease (“ESRD”) therapy technology and products.

Beginning in 2009, Nephros introduced high performance liquid purification filters to meet the demand for water purification in certain medical markets. The Company’s filters, generally classified as ultrafilters, are primarily used in hospitals for the prevention of infection from waterborne pathogens, such as legionella and pseudomonas, and in dialysis centers for the removal of biological contaminants from water and bicarbonate concentrate. The Company also develops and sells water filtration products for commercial applications, focusing on the hospitality and food service markets. The water filtration business is a reportable segment, referred to as the Water Filtration segment.

The Company’s pathogen detection systems are portable, near real-time systems designed to provide actionable data for infection control teams and other organizations. The pathogen detection systems business is a reportable segment, referred to as the Pathogen Detection segment.

In July 2018, the Company formed a new subsidiary, Specialty Renal Products, Inc. (“SRP”), to drive the development of its second-generation hemodiafiltration system and other products focused on improving therapies for patients with renal disease. The Company transferred three patents to SRP, which were carried at zero book value. SRP is a reportable segment, referred to as the Renal Products segment.

The Company’s primary U.S. facilities are located at 380 Lackawanna Place, South Orange, New Jersey 07079, 3221 Polaris Avenue, Las Vegas, Nevada 89102 and 1015 Telegraph Street, Unit B, Reno, Nevada 89502. These locations house the Company’s corporate headquarters, research, manufacturing, and distribution facilities. In addition, the Company maintains small administrative offices in various locations in the United States and Ireland.

Note 2 – Basis of Presentation and Liquidity

Interim Financial Information

The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of December 31, ~~2019~~2020 was derived from the Company’s audited financial statements. Accordingly, ~~these interim financial statements~~they do not include all of the information and footnotes required by GAAP for annual financial statements. Results as of and for the three and nine months ended September 30, ~~2020~~2021 are not necessarily indicative of the results that may be expected for the year ending December 31, ~~2020.~~2021.

The condensed consolidated interim financial statements and notes thereto should be read in conjunction with the consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, ~~2019.~~2020.

Consolidation

The accompanying condensed consolidated financial statements include the accounts of Nephros, Inc. and its subsidiaries, including SRP, in which a controlling interest is maintained by the Company. Outside ~~shareholders’~~stockholders’ interest in SRP of ~~37.5%~~37.5% is shown on the condensed consolidated balance sheet as noncontrolling interest. All intercompany accounts and transactions were eliminated in the preparation of the accompanying condensed consolidated financial statements.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amount of revenues and expenses, during the reporting period. Actual results could differ materially from those estimates. Included in these estimates are assumptions about the collection of accounts receivable, value of inventories, useful life of fixed assets and intangible assets, the assessment of expected cash flows used in evaluating goodwill and other long-lived assets, value of contingent consideration, the assessment of the ability to continue as a going concern and assumptions used in determining stock compensation such as expected volatility and risk-free interest rate.

~~Liquidity~~

Reclassifications

Certain reclassifications were made to the prior year’s amounts related to the gross up of the changes in lease right-of-use assets and lease liabilities on the condensed consolidated statement of cash flows to conform to the 2021 presentation.

Liquidity

The Company has sustained operating losses and expects such losses to continue over the next several quarters. In addition, net cash from operations has been negative since inception, generating an accumulated deficit of ~~$131.1~~$134.7 million as of September 30, ~~2020.~~2021.

On February 4, 2020, the Company completed a confidentially marketed underwritten public offering whereby the Company sold 937,500 shares of its common stock for aggregate net proceeds of $6.8 million. Additionally, the Company received $0.5 million from the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”) on April 24, 2020. The PPP was established by the Coronavirus Aid, Relief and Economic Security Act (CARES Act), enacted on March 27, 2020, in response to the Coronavirus Disease 2019 (COVID-19) pandemic. Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying expenses during the first 24 weeks of the loan. The Company intends to use the entire loan amount for such qualifying expenses.

On May 26, 2020, the Company terminated its secured asset-based revolving credit facility, which had allowed the Company to borrow up to $2.5 million. As of September 30, 2020, there was no outstanding amount due under the secured asset-based revolving credit facility.

On September 5, 2018, SRP completed a private placement transaction whereby SRP sold preferred shares equivalent to ~~37.5%~~37.5% of its outstanding equity interests for aggregate proceeds of ~~$3.0~~$3.0 million. As of approximately July 1, 2020, SRP had fully spent the proceeds from this private placement. ~~During the three months ended September 30, 2020, SRP borrowed $0.8 million in operating funds from Nephros.~~ On October 9, 2020, Nephros and SRP entered into a ~~formal~~ loan agreement inunder which Nephros agreed to lend up to ~~$1.3~~$1.3 million ~~of operating funds~~ to SRP, including the ~~$0.8~~$1.0 million borrowed during the ~~three months~~year ended ~~September 30,~~December 31, 2020. These funds are to be used to fund SRP’s operating activities and are expected to be sufficient to fund SRP through the planned FDA 510(k) clearance process of SRP’s second-generation hemodiafiltration system, which ~~is expected to be~~was initially submitted to the FDA ~~near~~for “Special 510(k)” clearance in February 2021 and resubmitted for “Traditional 510(k)” clearance in June 2021. As of September 30, 2021, the ~~end of 2020.~~outstanding balance, including accrued interest, was $1.3 million.

~~On October 20, 2020, the Company completed a registered direct offering of 833,333 shares of its common stock at a price of $6.00 per share with net proceeds of $4.7 million.~~

Based on cash that is available for the Company’s operations and projections of future Company operations, the Company believes that its cash balances will be sufficient to fund its current operating plan – including ~~the potential~~any remaining negative impact of the COVID-19 pandemic – through at least the next 12 months from the date of issuance of the accompanying condensed consolidated financial statements. Additionally, the Company’s operating plans are designed to help control operating costs and to increase revenue until such time as the Company generates sufficient cash flows from operations. ~~However, there is~~

While significant progress has been made against the COVID-19 pandemic, some uncertainty remains with respect to the Company’s projections regarding the availability of sufficient cash resources, ~~as a result of~~due to the possibility that COVID-19 infections could increase again and cause further disruption to economic conditions. During the pandemic, ~~and the economic conditions it has caused. In recent months,~~particularly during calendar year 2020, the Company ~~has seen~~saw decreased demand for its hospital filtration products, ~~both with respect~~particularly in emergency pathogen outbreak response. In addition, sales to new ~~hospital~~ customers – including water filtration and ~~its existing hospital, restaurant~~pathogen detection products – were hindered by pandemic-related travel restrictions. Also, the Company’s commercial filtration products, which are primarily targeted at the hospitality and ~~hospitality customers, which have been significantly impacted by the COVID-19 pandemic.~~

~~If this~~food service markets, saw a decrease in demand, ~~continues beyond~~due to the ~~third quarter~~closure of ~~fiscal year 2021~~many hotels and restaurants. The Company believes that broad vaccine distribution has reduced the probability of further significant negative COVID-19 impacts, but if these decreases in demand return and the Company is unable to achieve its revenue plan, the Company may ~~be forced~~need to ~~cut costs~~reduce budgeted expenditures as appropriate to preserve its available capital ~~resources. If~~resources, which could slow its revenue growth plans.

On April 24, 2020, the Company ~~is unable to sufficiently decrease its spending to match any future decreased demands~~obtained a loan from the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”) in the amount of $0.5 million (“PPP loan”). Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for ~~its products,~~qualifying expenses during the first 24 weeks of the loan. On January 14, 2021, the U.S Small Business Administration notified the Company ~~may exhaust its capital resources sooner than it currently anticipates. Further,~~that, in accordance with the PPP terms, the PPP loan was forgiven in full, including all principal and interest outstanding as ~~a result~~ of the ~~recent volatility~~date of the capital markets and economic conditions generally, it may be difficult for the Company to raise additional capital at times when it may need it, and even if the Company were able to raise additional capital, it may be on terms than are detrimental to the Company. Accordingly, the current economic conditions caused by the COVID-19 pandemic place uncertaintyforgiveness. As such, $0.5 million has been recognized as an extinguishment of debt on the Company’s ~~ability to maintain adequate levels~~condensed consolidated statement of ~~liquidity.~~operations and comprehensive loss.

Recently Adopted Accounting Pronouncements

In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2017-04, “Simplifying the Test for Goodwill Impairment,” which simplifies the test for goodwill impairment. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. Early adoption is permitted for interim or annual goodwill impairments tests after January 1, 2017. The Company adopted this guidance as of January 1, 2020 and the guidance did not have an impact on its consolidated financial statements.

In August 2018, the FASB issued ASU 2018-13, “Disclosure Framework-Changes to the Disclosure Requirements for the Fair Value Measurement,” which modifies the disclosure requirements on fair value measurements. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. The Company adopted this guidance as of January 1, 2020 and the guidance did not have an impact on its consolidated financial statements.

In August 2018, the FASB issued ASU 2018-15, “Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract,” which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. The Company adopted this guidance as of January 1, 2020 and the guidance did not have an impact on its consolidated financial statements.

In November 2018, the FASB issued ASU 2018-18, “Collaborative Arrangements: Clarifying the Interaction Between Topic 808 and Topic 606.” This guidance clarifies that, when the collaborative arrangement participant is a customer in the context of a unit-of-account, revenue from contracts with customers guidance should be applied, adds unit-of-account guidance to collaborative arrangements guidance, and precludes, in a transaction with a collaborative arrangement participant who is not a customer, presenting the transaction together with revenue recognized under contracts with customers. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. The Company adopted this guidance as of January 1, 2020 and the guidance did not have an impact on its consolidated financial statements.

In November 2019, the FASB issued ASU 2019-08, “Codification Improvements – Share-Based Consideration Payable to a Customer,” which requires that an entity measure and classify share-based payment awards granted to a customer by applying the guidance in Topic 718. The guidance is effective for the Company beginning in the first quarter of fiscal year 2020. The Company adopted this guidance as of January 1, 2020 and the guidance did not have an impact on its consolidated financial statements.

~~Recent Accounting Pronouncements, Not Yet Effective~~

In December 2019, the FASB issued ~~ASU~~Accounting Standards Update ("ASU") 2019-12, “Simplifying the Accounting for Income Taxes,” which removes certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The Company adopted this guidance as of January 1, 2021 and the guidance did not have an impact on its condensed consolidated financial statements.

Recent Accounting Pronouncements, Not Yet Effective

In May 2021, the FASB issued ASU 2021-04, “Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options,” which clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The guidance is effective for the Company beginning in the first quarter of fiscal year ~~2021.~~2022. Early adoption is permitted. The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

In October 2021, the FASB issued ASU 2021-08, “Accounting for Contract Assets and Contract Liabilities from Contracts with Customers,” which requires that an entity recognize contract assets and contract liabilities acquired in a business combination in accordance with Accounting Standards Codification (“ASC”) 606. The guidance is effective for the Company beginning in the first quarter of fiscal year 2023 and should be applied prospectively. Early adoption is permitted. The Company will assess the impact, if any, of adopting this guidance on its consolidated financial statements.

Concentration of Credit Risk

The Company deposits its cash in financial institutions. At times, such deposits may be in excess of insured limits. To date, the Company has not experienced any impairment losses on its cash. The Company also limits its credit risk with respect to accounts receivable by performing credit evaluations when deemed necessary.

Major Customers

For the three months ended September 30, ~~2020~~2021 and ~~2019,~~2020, the following customers, all of which are in the Water Filtration segment, accounted for the following percentages of the Company’s revenues, respectively:

Schedule of Revenues and Receivable Major Customers

Customer	2020			2019			2021			2020
A		17	%		19	%		26	%		17	%
B		16	%		7	%
C		8	%		31	%		9	%		16	%
E								11	%		6	%
Total		41	%		57	%		46	%		39	%

For the nine months ended September 30, ~~2020~~2021 and ~~2019,~~2020, the following customers, all of which are in the Water Filtration segment, accounted for the following percentages of the Company’s revenues, respectively:

Customer	2020			2019			2021			2020
C		18	%		18	%
A		15	%		16	%		19	%		15	%
B		11	%		10	%		10	%		3	%
C								9	%		11	%
D								7	%		18	%
Total		44	%		44	%		45	%		47	%

As of September 30, ~~2020~~2021 and December 31, ~~2019,~~2020, the following customers ~~all of which are in the Water Filtration segment,~~ accounted for the following percentages of the Company’s accounts receivable, respectively:

Customer	2020			2019			2021			2020
D		14	%		2	%
B		10	%		-%
A		5	%		26	%		16	%		18	%
C		9	%		11	%		15	%		6	%
F								11	%		1	%
E								10	%		6	%
G								2	%		12	%
Total		38	%		39	%		54	%		43	%

~~Cash and Cash Equivalents~~

The Company considers all highly liquid money market instruments with an original maturity of three months or less when purchased to be cash equivalents. At September 30, 2020 and December 31, 2019, cash and cash equivalents were deposited in financial institutions and consisted entirely of immediately available fund balances. The Company maintains its cash deposits and cash equivalents with financial institutions it believes to be well-known and stable.

Accounts Receivable

The Company provides credit terms to customers in connection with purchases of the Company’s products. Management periodically reviews customer account activity in order to assess the adequacy of the allowances provided for potential collection issues and returns. Factors considered include economic conditions, each customer’s payment and return history and credit worthiness. Adjustments, if any, are made to reserve balances following the completion of these reviews to reflect management’s best estimate of potential losses. ~~There was no allowance for doubtful accounts as of September 30, 2020.~~ The allowance for doubtful accounts was approximately ~~$25,000~~$4,000 and $11,000 as of September 30, 2021 and December 31, ~~2019. For~~2020, respectively. There were 0 write-offs of accounts receivable for the three and nine months ended September 30, ~~2020, there was no provision for bad debt expense. For the three and nine months ended September 30, 2019, the provision for bad debt expense was approximately $19,000.~~2021. Write-offs of accounts receivable were approximately ~~$25,000~~$25,000 for the ~~three and~~ nine months ended September 30, 2020 which were reserved for in a prior period. Write-offs of accounts receivable were approximately $5,000 for the nine months ended September 30, 2019 which were reserved for in a prior period. There were no write-offs of accounts receivable for the three months ended September 30, 2019. There was no allowance for sales returns at September 30, 2020 or December 31, 2019.

Depreciation Expense

Depreciation related to equipment utilized in the manufacturing process is recognized in cost of goods sold on the condensed consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2021, depreciation expense was approximately $7,000 and $22,000, respectively. Approximately $3,000 of the approximately $7,000 and approximately $11,000 of the $22,000 of depreciation expense for the three and nine months ended September 30, 2021, respectively, has been recognized in the cost of goods sold. For the three and nine months ended September 30, 2020, depreciation expense was approximately ~~$8,000~~$8,000 and ~~$18,000,~~$18,000, respectively. Approximately ~~$4,000~~$4,000 of the approximately ~~$8,000~~$8,000 and approximately ~~$12,000~~$12,000 of the approximately ~~$18,000~~ $18,000 of depreciation expense for the three and nine months ended September 30, 2020, respectively, has been recognized in the cost of goods sold. ~~For~~

Note 3 – Asset Acquisition

On July 9, 2021, the Company acquired 100% of GenArraytion, Inc. (“GenArraytion”). The acquisition did not qualify as a business combination and, as a result, was accounted for as an asset acquisition as the fair value of the gross assets acquired was primarily related to a single asset. The Company issued 123,981 shares of the Company’s common stock to GenArraytion, reflecting an aggregate purchase price of $1.2 million. The purchase price, including direct acquisition costs of approximately $49,000, was allocated among the acquired assets which include intellectual property and equipment, based upon their relative fair values at the date of acquisition.

Fifty percent of the 123,981 common shares issued were subject to a risk of forfeiture which lapsed during the three months ended September 30, ~~2019, depreciation expense~~2021. The Company will also make royalty payments to GenArraytion equal to 5% of net sales of certain products over the next five years.

The total consideration of $1.2 million was ~~approximately $4,000 and was recognized in cost~~allocated as follows to the acquired assets:

Schedule of ~~goods sold. Approximately $10,000~~Assets Acquired

	Total Consideration
	(in thousands)
Intellectual property	$	1,098
Equipment		75
Total consideration	$	1,173

The acquired intellectual property is being amortized over its estimated useful life of ~~the approximately $20,000 of depreciation expense recognized for the nine months ended September 30, 2019 has been recognized in cost of goods sold.~~10 years.

Note 34 – Revenue Recognition

The Company recognizes revenue related to product sales when product is shipped via external logistics ~~provider~~providers and the other criteria of ASC 606 ~~“Revenue from Contracts with Customers” (“ASC 606”),~~ are met. Product revenue is recorded net of returns and allowances. There was no allowance for sales returns for the three and nine months ended September 30, 2021 or 2020. In addition to product revenue, the Company recognizes revenue related to royalty and other agreements in accordance with the five-step model in ASC 606. Royalty and other ~~revenue~~revenues recognized for the three and nine months ended September 30, 2021 and 2020 ~~and 2019 is~~are comprised of:

Schedule of License, Royal and Other Revenue

Three Months Ended
September 30,

Nine Months Ended
September 30,

2020 2019 2020 2019
Royalty revenue under the License Agreement with Bellco $ 20 $ 10 $ 49 $ 50
Other revenue 7 31 45 56
Total license, royalty and other revenue $ 27 $ 41 $ 94 $ 106

	2021		2020		2021		2020
	Three Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020
	(in thousands)				(in thousands)
Royalty revenue under the Bellco License Agreement	$	15	$	20	$	44	$	49
Royalty revenue under the Sublicense Agreement with Camelbak ⁽¹⁾		-		-		20		-
Other revenue		27		7		72		45
Total royalty and other revenues	$	42	$	27	$	136	$	94
Revenue	$	42	$	27	$	136	$	94

⁽¹⁾

In May 2015, the Company entered into a Sublicense Agreement (the “Sublicense Agreement”) with CamelBak Products, LLC (“CamelBak”). Under this Sublicense Agreement, the Company granted CamelBak an exclusive, non-transferable, worldwide (with the exception of Italy) sublicense and license, in each case solely to market, sell, distribute, import and export the IWTD. In exchange for the rights granted to CamelBak, CamelBak agreed, through December 31, 2022, to pay the Company a percentage of the gross profit on any sales made to a branch of the U.S. military, subject to certain exceptions, and to pay a fixed per-unit fee for any other sales made. CamelBak was also required to meet or exceed certain minimum annual fees payable to the Company, and, if such fees are not met or exceeded, the Company was able to convert the exclusive sublicense to a non-exclusive sublicense with respect to non-U.S. military sales. In the first quarter of 2019, the Sublicense Agreement was amended to eliminate the minimum fee obligations starting May 6, 2018 and, as such, CamelBak has no further minimum fee obligations.

Bellco License Agreement

With regard to the OLpūr MD190 and MD220, on June 27, 2011, the Company entered into a License Agreement (the “License Agreement”), effective July 1, 2011, with Bellco S.r.l. (“Bellco”), an Italy-based supplier of hemodialysis and intensive care products, for the manufacturing, marketing and sale of the Company’s patented mid-dilution dialysis filters (the “Products”). Under the License Agreement, as amended, the Company granted Bellco a license to manufacture, market and sell the Products under its own name, label, and CE mark in certain countries on an exclusive basis, and to do the same on a non-exclusive basis in certain other countries. Under the License Agreement, ~~with Bellco,~~ the Company received upfront payments which were previously deferred and subsequently recognized as license revenue over the term of the License Agreement.

The License Agreement, as amended, also provides minimum sales targets which, if not satisfied, will, at the discretion of the Company, result in conversion of the license to non-exclusive status. Beginning on January 1, 2015 through and including December 31, 2021, Bellco will pay the Company a royalty based on the number of units of Products sold per year in the covered territory as follows: for the first 125,000 units sold in total, ~~€1.75~~€1.75 (approximately ~~$1.90)~~$2.10) per unit; thereafter, ~~€1.25~~€1.25 (approximately ~~$1.40)~~$1.50) per unit. The License Agreement also provides for a fixed royalty payment payable to the Company for the period beginning on January 1, 2015 through and including December 31, 2021 if the minimum sales targets are not met.

The Company recognized royalty income from Bellco pursuant to the License Agreement of approximately $20,000 and $10,000 for the three months ended September 30, 2020 and 2019, respectively. The Company recognized royalty income from Bellco pursuant to the License Agreement of approximately $49,000 and $50,000 for the nine months ended September 30, 2020 and 2019, respectively.

Note 45 – Fair Value Measurements

The Company measures certain financial instruments and other items at fair value.

To determine the fair value, the Company uses the fair value hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs based on assumptions about the factors market participants would use to value an asset or liability.

To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable:

Level 1 – Quoted prices in active markets for identical assets or liabilities.

Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means.

Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and also includes instruments for which the determination of fair value requires significant judgment or estimation.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level of classification for each reporting period.

~~The following table sets forth~~At September 30, 2021 and December 31, 2020, the Company’s ~~financial~~cash equivalents consisted of money market funds. The Company values its cash equivalents using observable inputs that reflect quoted prices for securities with identical characteristics and classify the valuation techniques that use these inputs as Level 1.

At September 30, 2021 and December 31, 2020, the fair value measurements of the Company’s assets and liabilities ~~that were~~ measured ~~at fair value~~ on a recurring basis were as follows:

Schedule of ~~September 30, 2020:~~Assets and Liabilities Measured at Fair Value on Recurring Basis

	Fair Value Measurements at Reporting Date Using
	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
	(in thousands)
September 30, 2021
Cash equivalents:
Money market funds	$	4,019	$	-	$	-

December 31, 2020
Cash equivalents:
Money market funds	$	4,011	$	-	$	-

Quoted prices in
active markets for
identical assets
(Level 1)

Significant other
observable
inputs
(Level 2)

Significant
unobservable
inputs
(Level 3)
Total
(in thousands)
At September 30, 2020:
Total contingent consideration liability $ - $ - $ 6 $ 6

~~The following table sets forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of December 31, 2019:~~

Quoted prices in active markets for identical assets
(Level 1)

Significant other observable
inputs
(Level 2)

Significant unobservable
inputs
(Level 3)
Total
(in thousands)
At December 31, 2019:
Total contingent consideration liability $ - $ - $ 300 $ 300

The following table summarizes the change in fair value, as determined by Level 3 inputs, for the contingent consideration liability using unobservable Level 3 inputs for the nine months ended September 30, 2020:

Contingent Consideration
(in thousands)
Balance as of December 31, 2019 $ 300
Payments against contingent consideration (79 )
Change in fair value of contingent consideration liability (229 )
Accretion of contingent consideration liability 14
Balance as of September 30, 2020 $ 6

During the three and nine months ended September 30, 2020, the Company recognized a change in the fair value of contingent consideration of ~~$0.2~~approximately $0.2 million on its condensed consolidated statement of operations and comprehensive loss. This was due to the settlement of the contingent consideration liability. In October 2020, the Company entered into a Second Amendment to the Membership Interest Purchase Agreement dated December 31, 2018 ~~(the “Amended Agreement”)~~ related to the acquisition of the Aether business, in which the Company agreed to pay a lump sum of ~~$0.1~~$0.1 million in full consideration for the Company’s obligation to make payments of contingent consideration under the Membership Interest Purchase ~~Agreement (see Note 17 – Subsequent Events). Approximately $94,000 of~~Agreement. As such, there were no outstanding amounts related to contingent consideration on the ~~remaining obligation will be paid out of amounts remaining in escrow~~Company’s consolidated balance sheets as of September 30, 2021 or December 31, 2020.

~~During each of the three and nine months ended September 30, 2019, a change in fair value of contingent consideration of $0.1 million was recorded due to lower than planned performance.~~

Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain levels of earnings in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. Fair value as of the date of acquisition is estimated based on projections of expected future cash flows of the acquired business. The Company estimated the contingent consideration liability using the income approach (discounted cash flow method), which requires the Company to make estimates and assumptions regarding the future cash flows and profits. Changes in these estimates and assumptions could have a significant impact on the amounts recognized.

~~There were no transfers between levels in the fair value hierarchy during the three and nine months ended September 30, 2020.~~

Assets and Liabilities Not Measured at Fair Value on a Recurring Basis

The carrying amounts of ~~cash and cash equivalents,~~ accounts receivable, ~~secured revolving credit facility,~~ accounts payable and accrued expenses approximate fair value due to the short-term maturity of these instruments.

The carrying amounts of the secured long-term note payable, lease liabilities and equipment financing approximate fair value as of September 30, ~~2020~~2021 and December 31, ~~2019~~2020 because those financial instruments bear interest at rates that approximate current market rates for similar agreements with similar maturities and credit.

~~The carrying amount of the PPP loan does not include interest imputed at a market rate as the PPP loan is a transaction whereby the interest rate is prescribed by a government agency~~.Note 6 – Inventory

~~Note 5 – Inventory, net~~

Inventory is stated at the lower of cost or net realizable value using the first-in, first-out method and consists of raw materials and finished goods. The Company’s inventory components as of September 30, ~~2020~~2021 and December 31, ~~2019~~2020 were as follows:

Schedule of Inventory, Net

	September 30, 2020			December 31, 2019			September 30, 2021		December 31, 2020
	(in thousands)						(in thousands)
Finished goods	$	4,645		$	2,248		$	3,644	$	4,340
Raw materials		781			359			1,005		964
Less: inventory reserve		(41	)		(45	)
Total inventory, net	$	5,385		$	2,562
Total inventory							$	4,649	$	5,304

Note 67 – Intangible Assets and Goodwill

Intangible Assets, net

Intangible assets ~~as of~~at September 30, ~~2020~~2021 and December 31, ~~2019~~2020 are set forth in the table below. Gross carrying values and accumulated amortization of the Company’s intangible assets by type are as follows:

September 30, 2020 December 31, 2019
Cost Accumulated Amortization Net Cost Accumulated Amortization Net
(in thousands)
Tradenames, service marks and domain names $ 50 $ (17 ) $ 33 $ 50 $ (10 ) $ 40
Customer relationships 540 (56 ) 484 540 (32 ) 508
Total intangible assets $ 590 $ (73 ) $ 517 $ 590 $ (42 ) $ 548

Schedule of Intangible Assets

	September 30, 2021							December 31, 2020
	Cost		Accumulated Amortization			Net		Cost		Accumulated Amortization			Net
	(in thousands)
Tradenames, service marks and domain names	$	50	$	(28	)	$	22	$	50	$	(20	)	$	30
Intellectual property		1,098		-			1,098		-		-			-
Customer relationships		540		(87	)		453		540		(64	)		476
Total intangible assets	$	1,688		(115	)	$	1,573	$	590		(84	)		506

The Company recognized amortization expense of approximately ~~$10,000~~$11,000 for each of the three months ended September 30, ~~2020~~2021 and ~~2019~~2020 and such amounts are included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss. The Company recognized amortization expense of approximately ~~$31,000~~$21,000 for each of the nine months ended September 30, ~~2020~~2021 and ~~2019~~2020 and such amounts are included in selling, general and administrative expenses on the accompanying condensed ~~consolidated~~ statement of operations and comprehensive loss.

As of September 30, ~~2020,~~2021, future amortization expense for each of the next five years is (in thousands):

Schedule of Future Amortization Expense

Fiscal Years
2021 (excluding the nine months ended September 30, 2021)	$	11
2022		42
2023		42
2024		32
2025		32

Fiscal Years
2020 (excluding the nine months ended September 30, 2020) $ 11
2021 42
2022 42
2023 42
2024 32

The Company did ~~not~~0t recognize any intangible asset impairment charges during the three and nine months ended September 30, ~~2020~~2021 or ~~2019.~~2020.

Goodwill

Goodwill ~~had~~has a carrying value on the Company’s condensed consolidated balance sheets of ~~$0.8~~$0.8 million at ~~each of~~ September 30, ~~2020~~2021 and December 31, ~~2019.~~2020. Goodwill has been allocated to the Water Filtration segment. The Company concluded the carrying value of goodwill was not impaired as of September 30, 2021 or December 31, 2020 as the Company determined that it was not more likely than not that the fair value of goodwill was less than its carrying value.

Note 78 – License and Supply Agreement, net

On April 23, 2012, the Company entered into a License and Supply Agreement (the “License and Supply Agreement”) with Medica S.p.A. (“Medica”), an Italy-based medical product manufacturing company, for the marketing and sale of certain filtration products based upon Medica’s proprietary Medisulfone ultrafiltration technology in conjunction with the Company’s filtration products, and for an exclusive supply arrangement for the filtration products. Under the License and Supply Agreement, as amended, Medica granted to the Company an exclusive license, with right of sublicense, to market, promote, distribute, offer for sale and sell the filtration products worldwide, with certain limitations on territory, during the term of the License and Supply Agreement. In addition, the Company granted to Medica an exclusive license under the Company’s intellectual property to make the filtration products during the term of the License and Supply Agreement. The filtration products covered under the License and Supply Agreement includes both certain products based on Medica’s proprietary Versatile microfiber technology and certain filtration products based on Medica’s proprietary Medisulfone ultrafiltration technology. The term of the License Agreement with Medica expires on December 31, 2025, unless earlier terminated by either party in accordance with the terms of the License and Supply Agreement.

In exchange for the license, the gross value of the intangible asset capitalized was ~~$2.3~~$2.3 million. License and supply agreement, net, on the condensed consolidated balance sheet is ~~$0.7~~$0.6 million and ~~$0.8~~$0.7 million as of September 30, ~~2020~~2021 and December 31, ~~2019,~~2020, respectively. Accumulated amortization is ~~$1.6~~$1.7 million and ~~$1.5~~$1.6 million, respectively, as of September 30, ~~2020~~2021 and December 31, ~~2019, respectively.~~2020. The intangible asset is being amortized as an expense over the life of the License and Supply Agreement. Amortization expense of approximately ~~$34,000~~$33,000 was recognized in each of the three months ended September 30, ~~2020~~2021 and ~~2019~~2020 on the condensed consolidated statement of operations and comprehensive loss. Amortization expense of ~~$0.1 million~~approximately $100,000 was recognized in each of the nine months ended September 30, ~~2020~~2021 and ~~2019~~2020 on the condensed consolidated statement of operations and comprehensive loss.

As of September 2013, the Company has an understanding with Medica whereby the Company has agreed to pay interest to Medica at a ~~12%~~12% annual rate calculated on the principal amount of any outstanding invoices that are not paid pursuant to the original payment terms. There was no0 interest recognized for the three or nine months ended September 30, ~~2020~~2021 or ~~2019.~~September 30, 2020.

In addition, for the period beginning April 23, 2014 through December 31, 2025, the Company will pay Medica a royalty rate of 3%3% of net sales of the filtration products sold, subject to reduction as a result of a supply interruption pursuant to the terms of the License and Supply Agreement. Approximately ~~$60,000~~$70,000 and ~~$82,000~~$60,000 for the three months ended September 30, ~~2020~~2021 and ~~2019,~~2020, respectively, was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations and comprehensive loss. Approximately ~~$173,000~~$198,000 and ~~$190,000~~$173,000 for the nine months ended September 30, ~~2020~~2021 and ~~2019,~~2020, respectively, was recognized as royalty expense and is included in cost of goods sold on the condensed consolidated statement of operations and comprehensive loss. Approximately ~~$60,000~~$70,000 in royalties are included in accrued expenses as of September 30, ~~2020.~~2021. Approximately ~~$83,000~~$68,000 in royalties are included in accounts payable as of December 31, ~~2019.~~2020.

Note 89 – Secured Revolving Credit Facility

On August 17, 2017, the Company entered into the Loan ~~Agreement~~ and Security Agreement, subsequently amended on December 20, 2019 (the “Loan Agreement”) with Tech Capital, LLC (“Tech Capital”). The Loan Agreement ~~initially~~ provided for a secured asset-based revolving credit facility (the “Revolver”) of up to ~~$1.0~~$2.5 million, which the Company drew upon and repaid from time to time during the term of the Loan Agreement. On December 20, 2019, the Company and Tech Capital entered into a First Modification to the Loan Agreement (“the Amendment”). The Amendment increased the Revolver from $1.0 million to $2.5 million. The outstanding principal balance of the Loan Agreement was $0.6 million as of December 31, 2019. The Company used these proceeds for working capital and general corporate purposes.

On May 26, 2020, the Company terminated the Revolver and, as a result, recognized fees of approximately ~~$7,000,~~$7,000, which are included in interest expense on the ~~condensed~~ consolidated statement of operations and comprehensive loss for the ~~nine months~~year ended ~~September 30,~~December 31, 2020. Although the Revolver was terminated, the Loan Agreement, as amended on May 26, 2020 to reflect this termination, remains in place for purposes of specifying obligations related to the Secured Note ~~Payable~~ (see Note 910 – Secured Note Payable).

For the nine months ended September 30, 2020, excluding approximately $7,000 related to the termination of the Revolver, approximately $25,000 was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss. For the three and nine months ended September 30, ~~2019,~~2020, excluding approximately ~~$17,000~~$7,000 related to the termination of the Revolver, approximately $17,000 and ~~$40,000,~~$40,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss.

Note 910 – Secured Note Payable

On March 27, 2018, the Company entered into a Secured Promissory Note Agreement (the “Secured Note”) with Tech Capital for a principal amount of ~~$1.2~~$1.2 million. The Secured Note was amended and restated on May 26, 2020 to reflect the then-current balance on the Secured Note. There were no other changes to the terms and conditions of the Secured Note. As of September 30, ~~2020,~~2021, the principal balance of the Secured Note was ~~$0.7~~$0.4 million.

The Secured Note has a maturity date of April 1, ~~2023.~~2023. The unpaid principal balance accrues interest at a rate of 8%8% per annum. Principal and interest payments ~~commenced on May 1, 2018 and~~ are due on the first day of each ~~month.~~

month commencing on May 1, 2018. The Secured Note is subject to the terms and conditions of and is secured by security interests granted by the Company in favor of Tech Capital under the Loan Agreement ~~and all of the riders and amendments thereto~~ (see Note 89 – Secured Revolving Credit Facility). An event of default under such Loan Agreement is an event of default under the Secured Note and vice versa. In addition, the ~~event the principal balance under the Loan Agreement is due, all amounts due under the Secured Note also become due.~~

~~In addition,~~accounts receivable, inventory, and other assets of Nephros International Limited, a wholly-owned subsidiary of the Company, ~~unconditionally guaranteed~~are available collateral in meeting the Company’s obligations under the Loan Agreement.

During each of the three months ended September 30, ~~2020~~2021 and ~~2019,~~2020, the Company made payments under the Secured Note of approximately ~~$73,000.~~$72,000 and $73,000, respectively. Included in the total payments made, approximately ~~$14,000~~$9,000 and ~~$18,000~~$14,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss for the three months ended September 30, ~~2020~~2021 and ~~2019, respectively.~~2020. During each of the nine months ended September 30, ~~2020~~2021 and ~~2019,~~2020, the Company made payments under the Secured Note of approximately ~~$217,000.~~$216,000 and $217,000, respectively. Included in the total payments made, approximately ~~$45,000~~$30,000 and ~~$58,000~~$45,000 was recognized as interest expense on the condensed consolidated ~~statement~~statements of operations and comprehensive loss for the nine months ended September 30, 2021 and 2020, ~~and 2019,~~ respectively.

As of September 30, ~~2020,~~2021, future principal maturities are as follows (in thousands):

Schedule of Future Debt Principal Maturities

Fiscal Years
2020 (excluding the nine months ended September 30, 2020)	$	39
2021		249
2021 (excluding the nine months ended September 30, 2021)			$	43
2022		269		269
2023		95		95
Total	$	652	$	407

~~Note 10 – Paycheck Protection Program Loan~~

On April 24, 2020, the Company was granted a PPP loan in the amount of $0.5 million. The PPP, established as part of the CARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. In connection with the PPP loan, the Company issued a promissory note dated April 24, 2020, in the principal amount of $0.5 million. The loan matures on April 24, 2022 and bears interest at a rate of 1.0% per annum, payable monthly commencing November 24, 2020. The note may be prepaid at any time prior to maturity with no prepayment penalties. Funds from the loan may only be used for payroll costs, benefits, rent, utilities and interest on other debt obligations incurred prior to February 15, 2020. The Company intends to use the entire amount for such qualifying expenses. Under the terms of the PPP, certain amounts of the loan may be forgiven if they are used for qualifying expenses during the first 24 weeks of the loan. For the three and nine months ended September 30, 2020, approximately $1,000 and $2,000, respectively, was recognized as interest expense on the condensed consolidated statement of operations and comprehensive loss.

Note 11 – Leases

The Company has operating leases for corporate offices, an automobile and office equipment. The leases have remaining lease terms of 1 year to 4 years.

The Company entered into an operating lease in March 2020 for 1015 Telegraph Street, Unit B, Reno, Nevada 89502. The rental agreement commenced in March 2020 and expires in February 2022 with an option to extend for two additional years that the Company is reasonably certain to exercise. The monthly cost is approximately $5,000. Approximately $5,000 related to a security deposit for this office facility is classified as other assets on the condensed consolidated balance sheet as of September 30, 2020.

~~The Company entered into a finance lease in February 2020 for office equipment. The rental agreement commenced in February 2020 and expires in January 2023 with a monthly cost of approximately $1,000.~~

The Company entered into an operating lease in June 2020 for 923 Incline Way, #37, Incline Village, Nevada 89451. The rental agreement commenced in March 2020 and expires in January 2021. The monthly cost is approximately $2,000. The Company adopted the short-term lease practical expedient and, as such, will recognize the lease payments on a straight-lease basis over the lease term.

~~Operating lease~~Lease cost, as presented below, includes costs associated with leases for which ~~right of use~~right-of-use (“ROU”) assets have been recognized as well as short-term leases.

The components of total lease costs were as follows:

Schedule of Components of Lease Cost

	Three months ended September 30, 2021		Three months ended September 30, 2020
	(in thousands)
Operating lease cost	$	98	$	105
Finance lease cost:
Amortization of right-of-use assets		3		3
Interest on lease liabilities		1		-
Total finance lease cost		4		3
Variable lease cost		17		7
Total lease cost	$	119	$	115

Three months ended
September 30, 2020

Three months ended
September 30, 2019

(in thousands)
Operating lease cost $ 105 $ 98
Finance lease cost:
Amortization of right-of-use assets 3 -
Interest on lease liabilities - -
Total finance lease cost 3 -
Variable lease cost 7 -
Total lease cost $ 115 $ 98

	Nine months ended September 30, 2020		Nine months ended September 30, 2019		Nine months ended September 30, 2021		Nine months ended September 30, 2020
	(in thousands)				(in thousands)
Operating lease cost	$	300	$	214	$	294	$	300
Finance lease cost:
Amortization of right-of-use assets		4		-		9		4
Interest on lease liabilities		1		-		2		1
Total finance lease cost		5		-		11		5
Variable lease cost		30		-		36		30
Total lease cost	$	335	$	214	$	341	$	335

Supplemental cash flow information related to leases was as follows:

Schedule of Supplemental Cash Flow Information Related to Leases

	Nine months ended September 30, 2020		Nine months ended September 30, 2019		Nine months ended September 30, 2021		Nine months ended September 30, 2020
		(in thousands)			(in thousands)
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	293	$	165	$	316	$	293
Financing cash flows from finance leases		5		-	$	9	$	5

ROU assets obtained in exchange for lease obligations:
Operating leases	$	201	$	800
Finance leases	$	17		-

Supplemental balance sheet information related to leases was as follows:

Schedule of Supplemental Balance Sheet Information Related to Leases

	September 30, 2020			December 31, 2019			September 30, 2021			December 31, 2020
		(in thousands)					(in thousands)
Operating lease right-of-use assets	$	1,079		$	1,106		$	787		$	1,002
Finance lease right-of-use assets	$	38		$	-		$	27		$	35

Current portion of operating lease liabilities	$	315		$	262		$	354		$	321
Operating lease liabilities, net of current portion		819			889			483			735
Total operating lease liabilities	$	1,134		$	1,151		$	837		$	1,056

Current portion of finance lease liabilities	$	11		$	-		$	12		$	11
Finance lease liabilities, net of current portion		27			-			15			24
Total finance lease liabilities	$	38		$	-		$	27		$	35

Weighted average remaining lease term
Operating leases		3.4 years			4 years			2.5 years			3.1 years
Finance leases		3.3 years			-			2.4 years			3.3 years

Weighted average discount rate
Operating leases		8.0	%		8.0	%		8.0	%		8.0	%
Finance leases		8.0	%		-			8.0	%		8.0	%

As of September 30, ~~2020,~~2021, maturities of lease liabilities were as follows:

Schedule of Maturities of Lease Liabilities

	Operating Leases			Finance Leases
	(in thousands)
2021 (excluding the nine months ended September 30, 2021)	$	100		$	3
2022		395			14
2023		269			8
2024		156			7
2025		-			4
Total future minimum lease payments		920			36
Less imputed interest		(83	)		(9	)
Total	$	837		$	27

Operating Leases Finance Leases
(in thousands)
2020 (excluding the nine months ended September 30, 2020) $ 98 $ 3
2021 389 14
2022 388 14
2023 261 8
2024 153 4
Total future minimum lease payments 1,289 43
Less imputed interest (155 ) (5 )
Total $ 1,134 $ 38

Note 12 – Stock Plans and Share-Based Payments

The fair value of stock options and restricted stock is recognized as stock-based compensation expense in the Company’s condensed consolidated statement of operations and comprehensive loss. The Company calculates stock-based compensation expense in accordance with ASC 718. The fair value of stock-based awards is amortized over the vesting period of the award.

Stock Options

~~During~~The Company granted stock options to purchase 59,868 and 232,296 shares of common stock, respectively, to employees during the three and nine months ended September 30, ~~2020, the Company granted stock options to purchase 157,064 and 170,675 shares, respectively, of common stock to employees.~~2021. These stock options are being expensed over the respective vesting period, which is based on a service condition. The fair value of the stock options granted during the three and nine months ended September 30, ~~2020~~2021, respectively, was ~~approximately $704,000~~$0.3 million and ~~$783,000, respectively.~~$1.2 million.

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model. The below assumptions for the risk-free interest rates, expected dividend yield, expected lives and expected stock price volatility were utilized for the stock options granted during the ~~three and~~ nine months ended September 30, ~~2020.~~2021.

Schedule of Fair Value Assumptions

Assumptions for Option Grants
Stock Price Volatility	~~71.96~~71.60	%
Risk-Free Interest ~~Rates~~Rate	~~0.37~~0.81	%
Expected Life (in years)	~~6.25~~6.18
Expected Dividend Yield	-	%

Stock-based compensation expense related to stock options was ~~$166,000~~$212,000 and ~~$348,000~~$166,000 for the three months ended September 30, ~~2020~~2021 and ~~2019,~~2020, respectively. For the three months ended September 30, ~~2020,~~2021, approximately ~~$150,000~~$203,000 and ~~approximately $16,000~~$12,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the three months ended September 30, ~~2019,~~2020, approximately ~~$335,000~~$150,000 and ~~approximately $13,000~~$16,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

Stock-based compensation expense related to stock options was ~~$483,000~~$661,000 and ~~$623,000~~$483,000 for the nine months ended September 30, ~~2020~~2021 and ~~2019,~~2020, respectively. For the nine months ended September 30, ~~2020,~~2021, approximately ~~$435,000~~$626,000 and ~~approximately $48,000~~$35,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the nine months ended September 30, ~~2019,~~2020, approximately ~~$577,000~~$435,000 and ~~approximately $46,000~~$48,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

There were no stock options exercised during the three months ended September 30, 2020. During the nine months ended September 30, 2020, stock options to purchase 2,556 shares of the Company’s common stock were exercised in a cash exercise for proceeds of approximately $7,000, resulting in the issuance of 2,556 shares of the Company’s common stock. During the nine months ended September 30, 2020, stock options to purchase 1,112 shares of the Company’s common stock were exercised in a cashless exercise, resulting in the issuance of 755 shares of the Company’s common stock. There were no stock options exercised during the three or nine months ended September 30, 2019.

There was no0 tax benefit related to expense recognized in the three or nine months ended September 30, ~~2020~~2021 and ~~2019,~~2020, as the Company is in a net operating loss position. As of September 30, ~~2020,~~2021, there was ~~$1.1~~$2.0 million of total unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of ~~2.5~~4.5 years. ~~Such amount does not include the effect of future grants of equity compensation, if any.~~

Restricted Stock

Total stock-based compensation expense for restricted stock on the Company’s condensed consolidated statement of operations and comprehensive loss was approximately $55,000 for the three months ended September 30, 2021 and is included in selling, general and administrative expenses. There was no0 stock-based compensation expense for restricted stock recognized during the three months ended September 30, ~~2020 or 2019.~~2020.

Total stock-based compensation expense for restricted stock was approximately ~~$52,000~~$161,000 and ~~$30,000~~$52,000 for the nine months ended September 30, 2021 and 2020, respectively. For the nine months ended September 30, 2021, approximately $161,000 is included in selling, general and ~~2019, respectively.~~administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss. For the nine months ended September 30, 2020, approximately ~~$42,000~~$42,000 and ~~$10,000~~$10,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidation statement of operations and comprehensive loss.

Approximately $168,000 of restricted stock was granted to employees during the three and nine months ended September 30, 2021 for services rendered during the year ended December 31, 2020.

As of September 30, 2021, there was approximately $213,000 of unrecognized compensation expense related to unvested stock-based awards granted under the equity compensation plans, which will be amortized over the weighted average remaining requisite service period of 2.4 years.

The aggregate shares of common stock legally issued and outstanding as of September 30, 2021 is greater than the aggregate shares of common stock outstanding for accounting purposes by the amount of unvested restricted shares.

SRP Equity Incentive Plan

SRP’s 2019 Equity Incentive Plan was approved on May 7, 2019 under which 150,000 shares of SRP’s common stock are reserved for the issuance of options and other awards.

There were 0SRP stock options granted during the three or nine months ended September 30, 2021. There was no stock-based compensation expense related to the SRP stock options for the three months ended September 30, 2021. There was approximately $3,000 recognized for stock-based compensation expense for the nine months ended September 30, 2021 which was included in selling, general and administrative expenses on the accompanying condensed consolidated statement of operations and comprehensive loss.

Stock-based compensation expense related to the SRP stock options was approximately $6,000 and $38,000, respectively, for the three and nine months ended September 30, 2020. For the three months ended September 30, 2020, approximately $2,000 and $4,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the nine months ended September 30, ~~2019,~~2020, approximately ~~$28,000~~$16,000 and ~~$2,000~~$22,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

~~There were no unvested shares of restricted stock as~~As of September 30, ~~2020.~~

~~SRP Equity Incentive Plan~~

~~SRP’s 2019 Equity Incentive Plan was approved on May 7, 2019 under which 150,000 shares of SRP’s common stock are reserved for the issuance of options and other awards.~~

~~There were no~~2021, all outstanding SRP stock options ~~granted during the three or nine months ended September 30, 2020. Stock-based compensation expense related to the~~were vested. SRP stock options were expensed over the respective vesting period, which was approximately $6,000 and $38,000 for the three and nine months ended September 30, 2020, respectively. For the three months ended September 30, 2020, approximately $2,000 and $4,000 are included in selling, general and administrative expenses and research and development expenses, respectively,based on the accompanying consolidated statement of operations and comprehensive loss. For the nine months ended September 30, 2020, approximately $16,000 and $22,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying consolidated statement of operations and comprehensive loss.

Stock-based compensation expense related to the SRP stock options was approximately $6,000 and $9,000 for the three and nine months ended September 30, 2019. For the three months ended September 30, 2019, approximately $2,000 and $4,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss. For the nine months ended September 30, 2019, approximately $3,000 and $6,000 are included in selling, general and administrative expenses and research and development expenses, respectively, on the accompanying condensed consolidated statement of operations and comprehensive loss.

a service condition. Stock-based compensation expense related to the SRP stock options is presented by the Company as noncontrolling interest on the consolidated balance ~~sheet~~sheets as of September 30, 2021 and December 30, 2020.

Note 13 – Stockholders’ Equity

July 2021 Common Stock Issuance

On July 9, 2021, the Company issued 123,981 shares of common stock to acquire 100% of GenArraytion. The purchase price was $1.2 million, including transaction costs of approximately $49,000, and was allocated among the acquired assets based upon their relative fair values at the date of acquisition. Fifty percent of the 123,981 common shares issued were subject to a risk of forfeiture which lapsed during the three months ended September 30, 2021.

February 2020 Common Stock Issuance

On February 4, 2020, the Company issued 937,500 shares of common stock through a ~~confidentially marketed underwritten~~ public offering resulting in gross proceeds to the Company of ~~$7.5~~$7.5 million. The purchase price for each share was ~~$8.00.~~$8.00. Proceeds, net of equity issuance costs of ~~$0.7~~$0.7 million, recorded as a result of the offering were ~~$6.8~~$6.8 million.

Noncontrolling Interest

On September 5, 2018, SRP entered into a Series A Preferred Stock Purchase Agreement with certain purchasers pursuant to which SRP sold 600,000 shares of its Series A Preferred Stock (“Series A Preferred”) for ~~$5.00~~$5.00 per share. The aggregate purchase price was ~~$3.0~~$3.0 million. SRP incurred transaction-related expenses of approximately ~~$30,000,~~$30,000, which were included in selling, general and administrative expenses on the ~~accompanying~~Company’s consolidated statement of operations and comprehensive loss for the ~~three and nine months~~year ended ~~September 30,~~December 31, 2018. The net proceeds from the issuance of the Series A Preferred ~~are~~were restricted to SRP expenses and may not be used for the benefit of the Company or other affiliated entities, except to reimburse for expenses directly attributable to SRP. Following the Series A Preferred transaction, the Company retained a ~~62.5%~~62.5% ownership interest in SRP, holding ~~100%~~100% of the outstanding common shares, and holders of Series A Preferred retained a ~~37.5%~~37.5% interest in SRP on a fully diluted basis, holding ~~100%~~100% of the outstanding preferred shares. Of the 600,000 shares of Series A Preferred issued, the shares purchased by related parties comprised of persons controlled by members of management and by the Company’s largest ~~shareholder~~stockholder amounted to 18,000 and 400,000 shares, respectively.

Each share of Series A Preferred is initially convertible into one share of SRP common stock, subject to adjustment for stock splits and recapitalization events. Subject to customary exempt issuances, in the event SRP issues additional shares of its common stock or securities convertible into common stock at a per share price that is less than the original Series A Preferred price, the conversion price of the Series A Preferred will automatically be reduced to such lower price.

In the event of any voluntary or involuntary liquidation, dissolution or winding up of SRP, the holders of the Series A Preferred are entitled to be paid out of the assets of SRP available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders in such deemed liquidation event or the available proceeds, before any payment shall be made to the holders of SRP common stock by reason of their ownership thereof, an amount per share equal to one times (1x) the Series A Preferred original issue price, plus any accruing dividends accrued but unpaid thereon, whether or not declared, together with any other dividends declared but unpaid thereon (the “Series A Liquidation Preference”). If upon any such liquidation, dissolution or winding up of SRP or deemed liquidation event, the assets of SRP available for distribution to its stockholders shall be insufficient to pay the Series A Liquidation Preference in full, the holders of Series A Preferred shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. After the full payment of the Series A Liquidation Preference, the holders of the Series A Preferred and the holders of common stock will share ratably in any remaining proceeds available for distribution on an as-converted to common stock basis.

Each share of Series A Preferred accrues dividends at the rate per annum of ~~$0.40~~$0.40 per share. The accruing dividends shall accrue from day to day, whether or not declared, and shall be cumulative and shall be payable only when, as, and if declared by the Board.

Holders of Series A Preferred shall be entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series A Preferred held by such holder are convertible as of the record date for determining stockholders entitled to vote. Except as provided by law or by the other provisions, the holders of Series A Preferred vote together with the holders of common stock as a single class. Notwithstanding the foregoing, for as long as at least 150,000 shares of Series A Preferred are outstanding, SRP is required to obtain the affirmative vote or written consent of a majority of the Series A Preferred in order to effect certain corporate transactions, including without limitation, the issuance of any securities senior to or on parity with the Series A Preferred, a liquidation or deemed liquidation of SRP, amendments to SRP’s charter documents, the issuance of indebtedness in excess of ~~$250,000,~~$250,000, any annual budget for the Company’s operations, and the hiring or firing of any executive officers of SRP. In addition, the holders of the Series A Preferred are entitled to elect two members of SRP’s board of directors.

The noncontrolling interest in SRP held by holders of the Series A Preferred has been classified as equity on the accompanying consolidated interim balance sheet, as the noncontrolling interest is redeemable only upon the occurrence of events that are within the control of the Company.

Warrants

There were no0 warrants exercised during the three months ended September 30, ~~2020.~~2021. During the nine months ended September 30, 2021, the Company issued an aggregate of 120,966 shares of its common stock upon the exercise of outstanding warrants relating to an aggregate of 126,008 shares of common stock. Of such 120,966 shares issued, 110,003 were issued in cash exercises resulting in gross proceeds to the Company of $0.3 million (the “Cash Exercises”) and 10,963 shares were issued in connection with cashless (net) exercises of outstanding warrant relating to 16,005 shares of common stock (the “Cashless Exercises”). Among the shares issued in connection with the Cash Exercises, 66,667 shares were issued to the Company’s largest stockholder, which resulted in proceeds to the Company of $0.2 million. Among the Cashless Exercises, 4,570 shares of common stock were issued to persons affiliated with members of the Company’s management upon the exercise of warrants relating to 6,669 shares.

During the three months ended September 30, 2020, there were 0 warrants exercised. During the nine months ended September 30, 2020, warrants to purchase 40,012 shares of the Company’s common stock were exercised, resulting in proceeds of ~~$0.2~~$0.2 million and the issuance of 40,012 shares of the Company’s common stock.

During the three and nine months ended September 30, 2019, warrants to purchase 108,149 shares of the Company’s common stock were exercised, resulting in proceeds of $0.3 million and the issuance of 108,147 shares of the Company’s common stock. Of the warrants exercised during the three and nine months ended September 30, 2019, warrants to purchase 4,444 shares of the Company’s common stock were exercised by members of management, resulting in proceeds of approximately $12,000.

~~There were no warrants issued during the three or nine months ended September 30, 2020 or 2019.~~

Note 14 – Net Loss per Common Share

Basic loss per common share is calculated by dividing net loss available to common shareholders by the number of weighted average common shares issued and outstanding. Diluted loss per common share is calculated by dividing net loss available to common shareholders by the weighted average number of common shares issued and outstanding for the period, plus amounts representing the dilutive effect from the exercise of stock options and warrants and unvested restricted stock, as applicable. The Company calculates dilutive potential common shares using the treasury stock method, which assumes the Company will use the proceeds from the exercise of stock options and warrants to repurchase shares of common stock to hold in its treasury stock reserves.

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as they would be antidilutive:

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

	September 30,				September 30,
	2020		2019		2021		2020
Shares underlying warrants outstanding		270,597		629,921		123,476		270,597
Shares underlying options outstanding		1,159,655		887,782		1,298,172		1,159,655
Unvested restricted stock						40,557		-

Note 15 – Commitments and Contingencies

Purchase Commitments

In exchange for the rights granted under the License and Supply Agreement with Medica (see Note 78 – License and Supply Agreement, net), the Company agreed to make certain minimum annual aggregate purchases from Medica over the term of the License and Supply Agreement. For the year ended December 31, ~~2020,~~2021, the Company has agreed to make minimum annual aggregate purchases from Medica of ~~€3.2~~€3.3 million (approximately ~~$3.5~~$4.0 million). As of September 30, ~~2020,~~2021, the Company’s aggregate purchase commitments totaled ~~€4.5~~€2.8 million (approximately ~~$5.0~~$3.3 million).

Contractual Obligations

See Note 11 – Leases for a discussion of the Company’s contractual obligations.

Note 16 – Segment Reporting

On January 1, 2020, the Company began reporting the results of its Pathogen Detection Systems business as a new segment, known as the Pathogen Detection segment. Prior to the additional reporting of Pathogen Detection as a reporting segment, the Company had two operating segments, Water Filtration and Renal Products. The Company reflected the new segment measures beginning in the three months ended March 31, 2020, and prior periods have been restated for comparability.

The Company has defined three reportable segments: Water Filtration, Pathogen Detection and Renal Products. The Water Filtration segment primarily develops and sells high performance water purification filters. The Pathogen Detection segment develops and sells portable, real-time water testing systems designed to provide actionable data on waterborne pathogens in approximately one hour. The Renal Products segment is focused on the development of medical device products for patients with renal disease, including a 2^ndgeneration hemodiafiltration system for the treatment of patients with ESRD.

The Company’s chief operating decision maker evaluates the financial performance of the Company’s segments based upon segment revenues, gross margin and operating expenses which include research and development and selling, general and administrative expenses. Items below loss from operations are not reported by segment, since they are excluded from the measure of segment profitability reviewed by the Company’s chief operating decision maker. The Company does not report balance sheet information by segment since itsuch information is not reviewed by the Company’s chief operating decision maker.

The accounting policies for the Company’s segments are the same as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, ~~2019.~~2020.

The tables below present segment information reconciled to total Company loss from operations, with segment operating loss including gross profit less direct research and development expenses and direct selling, general and administrative expenses to the extent specifically identified by segment:

Schedule of Segment Information

	Three Months Ended September 30, 2020
	(in thousands)													Three Months Ended September 30, 2021 (in thousands)
		Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated				Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues		$	2,121		$	-		$	-		$	2,121		$	2,578		$	59		$	-		$	2,637
Gross margin			1,227			(2	)		-			1,225			1,360			52			-			1,412
Research and development expenses			359			49			343			751			363			237			32			632
Depreciation and amortization expense			49			-			-			49			49			1			-			50
Selling, general and administrative expenses			1,317			116			111			1,544			1,703			175			14			1,892
Change in fair value of contingent consideration			(187	)		-			-			(187	)
Total operating expenses			1,538			165			454			2,157			2,115			413			46			2,574
Loss from operations		$	(311	)	$	(167	)	$	(454	)	$	(932	)	$	(755	)	$	(361	)	$	(46	)	$	(1,162	)

	Nine Months Ended September 30, 2021 (in thousands)
		Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues	$	7,504		$	135		$	-		$	7,639
Gross margin		4,162			112			-			4,274
Research and development expenses		961			505			209			1,675
Depreciation and amortization expense		150			1			-			151
Selling, general and administrative expenses		5,314			372			59			5,745
Total operating expenses		6,425			878			268			7,571
Loss from operations	$	(2,263	)	$	(766	)	$	(268	)	$	(3,297	)

	Three Months Ended September 30, 2020 (in thousands)
		Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues	$	2,121		$	-		$	-		$	2,121
Gross margin		1,227			(2	)		-			1,225
Research and development expenses		359			49			343			751
Depreciation and amortization expense		49			-			-			49
Selling, general and administrative expenses		1,317			116			111			1,544
Change in fair value of contingent consideration		(187	)		-			-			(187	)
Total operating expenses		1,538			165			454			2,157
Loss from operations	$	(311	)	$	(167	)	$	(454	)	$	(932	)

	Nine Months Ended September 30, 2020 (in thousands)
		Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues	$	6,199		$	28		$	-		$	6,227
Gross margin		3,597			14			-			3,611
Research and development expenses		1,014			206			930			2,150
Depreciation and amortization expense		142			-			-			142
Selling, general and administrative expenses		4,381			377			346			5,104
Change in fair value of contingent consideration		(229	)		-			-			(229	)
Total operating expenses		5,308			583			1,276			7,167
Loss from operations	$	(1,711	)	$	(569	)	$	(1,276	)	$	(3,556	)

Nine Months Ended September 30, 2020
(in thousands)
Water Filtration Pathogen Detection Renal Products Nephros, Inc. Consolidated
Total net revenues $ 6.199 $ 28 $ - $ 6,227
Gross margin 3,597 14 - 3,611
Research and development expenses 1,014 206 930 2,150
Depreciation and amortization expense 142 - - 142
Selling, general and administrative expenses 4,381 377 346 5,104
Change in fair value of contingent consideration (229 ) - - (229 )
Total operating expenses 5,308 583 1,276 7,167
Loss from operations $ (1,711 ) $ (569 ) $ (1,276 ) $ (3,556 )

Three Months Ended September 30, 2019
(in thousands)
Water Filtration Pathogen Detection
Renal
Products
Nephros, Inc. Consolidated
Total net revenues $ 3,095 $ - $ - $ 3,095
Gross margin 1,819 - - 1,819
Research and development expenses 231 180 366 777
Depreciation and amortization expense 44 - - 44
Selling, general and administrative expenses 1,756 - 31 1,787
Change in fair value of contingent consideration (94 ) - - (94 )
Total operating expenses 1.937 180 397 2,514
Loss from operations $ (118 ) $ (180 ) $ (397 ) $ (695 )

Nine Months Ended September 30, 2019
(in thousands)
Water Filtration Pathogen Detection Renal Products Nephros, Inc. Consolidated
Total net revenues $ 7,173 $ - $ - $ 7,173
Gross margin 4,184 - - 4,184
Research and development expenses 698 492 1,136 2,326
Depreciation and amortization expense 142 - - 142
Selling, general and administrative expenses 4,577 - 116 4,693
Change in fair value of contingent consideration (113 ) - - (113 )
Total operating expenses 5,304 492 1,252 7,048
Loss from operations $ (1,120 ) $ (492 ) $ (1,252 ) $ (2,864 )

~~Note 17 – Subsequent Events~~

On October 9, 2020, Nephros and SRP entered into a formal loan agreement, in which Nephros agreed to lend up to $1.3 million of operating funds to SRP, including the $0.8 million borrowed during the three months ended September 30, 2020. These funds are expected to be sufficient to fund SRP through the planned FDA 510(k) clearance process of SRP’s second-generation hemodiafiltration system, which is expected to be initially submitted to the FDA near the end of 2020.

On October 20, 2020, the Company issued 833,333 shares of the Company’s common stock in a registered direct offering, resulting in net proceeds to the Company of $4.7 million. The purchase price for each share was $6.00.

On October 15, 2020, the Company entered into the Amended Agreement related to the acquisition of the Aether business in which the Company agreed to pay a lump sum of $0.1 million in full consideration for the Company’s obligation to make payments of contingent consideration under the Membership Interest Purchase Agreement.

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

The following discussion should be read in conjunction with our condensed consolidated financial statements and notes thereto included in Item 1 of Part I of this Quarterly Report on Form 10-Q. This discussion includes forward-looking statements about our business, financial condition and results of operations including discussions about management’s expectations for our business. These statements represent projections, beliefs and expectations based on current circumstances and conditions and in light of recent events and trends, and these statements should not be construed either as assurances of performances or as promises of a given course of action. Instead, various known and unknown factors are likely to cause our actual performance and management’s actions to vary, and the results of these variances may be both material and adverse.

Business Overview

We are a commercial-stage company that develops and sells high performance water solutions to the medical and commercial markets.

In medical markets, we sell water filtration products and waterborne pathogen detection products. Our medical water filters, mostly classified as ultrafilters, are used primarily by hospitals for the prevention of infection from waterborne pathogens, such as legionella and pseudomonas, and in dialysis centers for the removal of biological contaminants from water and bicarbonate concentrate. Because our ultrafilters capture contaminants as small as 0.005 microns in size, they minimize exposure to a wide variety of bacteria, viruses, fungi, parasites, and endotoxins.

In commercial markets, we manufacture and sell water filters that improve the taste and odor of water and reduce biofilm, bacteria, and scale build-up in downstream equipment. Marketed under both the Nephros and AETHER brands, our products are marketed primarily to the food service, hospitality, convenience store, and health care markets.

Our pathogen detection systems are portable, near real-time systems designed to provide actionable data for infection control teams, biomedical engineers in dialysis clinics, and water quality teams in building management organizations.

We also have a subsidiary, Specialty Renal Products, Inc. (“SRP”), a development-stage medical device company, focused primarily on developing hemodiafiltration (“HDF”) technology. SRP is developing a second-generation of the Nephros OLpūr H2H ~~Hemodia-filtration~~Hemodiafiltration System, the FDA 510(k)-cleared medical device that enables nephrologists to provide HDF treatment to patients with end stage renal disease (“ESRD”).

We were founded in 1997 by healthcare professionals affiliated with Columbia University Medical Center/New York-Presbyterian Hospital to develop and commercialize an alternative method to hemodialysis. We have extended our filtration technologies to meet the demand for liquid purification in other areas, in particular, water purification.

COVID-19 Pandemic

~~The~~Most customers and prospects – including healthcare, hospitality, and food and beverage– have begun to re-open to our sales activity as the country has progressed through the COVID-19 pandemic. Furthermore, our filter emergency response business has begun to normalize. We expect the pandemic ~~has impacted nearly every business~~to continue its overall trend toward abatement in the ~~United States and around~~coming months, but recent infection increases from new viral variants such as the ~~world. To date,~~Delta variant may interrupt that abatement for a period of time.

During the pandemic, we ~~have fully~~ maintained full operations, ~~through the crisis,~~ supporting our customers and strategic partners. Our warehouse and laboratory teams have integrated disinfection procedures into their activities, while our office teams have worked primarily from home. Our manufacturing and sterilization facilities have been operational, ourpartners, with no significant interruptions in supply chain ~~has not been materially impacted, and our warehouses are shipping product on normal schedules.~~or service capabilities.

~~In recent months, the COVID-19 pandemic has negatively impacted our business in several ways, including:~~

	●	We have seen decreased demand for our hospital filtration products, particularly in emergency pathogen outbreak response. We believe this decreased demand is due primarily to our customers temporarily shifting their focus to matters related to the COVID-19 pandemic and de-prioritizing unrelated matters, including both proactive and reactive efforts to detect and reduce waterborne pathogens.
	●	~~Early in the COVID-19 pandemic, we experienced some delays in expected orders from existing customers. However, customer re-orders seem to have returned to prior levels.~~
	●	The inability of our sales personnel to meet with new potential customers due to policies implemented to address the spread of COVID-19 has also hindered demand for our products, especially our new PluraPath™ pathogen detection system, which launched less than two months before the onset of the COVID-19 pandemic in the United States.
	●	~~Our commercial filtration products, which are primarily targeted at the hospitality and food service markets, have seen a decrease in demand, due to the closure of many hotels and restaurants.~~
	●	We increased our cash and accounts payable usage in the first nine months of the year to purchase extra inventory from our Italian manufacturer as a hedge against the risk of COVID-19-related supply chain interruptions.

As we are unable to determine the duration of the COVID-19 pandemic, we are not able to predict when we will see an increase in demand for our products and a corresponding increase to our revenue. Due to this uncertainty, we applied for and received $0.5 million from the U.S. Small Business Administration’s Paycheck Protection Program (“PPP”) on April 24, 2020, which we believe will help us offset the adverse effect on our results of operations and financial condition that could result from a prolonged decrease in demand for our products.

We believe that, as the COVID-19 pandemic generally subsides, we may experience ~~over the medium-to-long-term~~ a net positive impact on demand for ~~all of~~ our products, due especially to increased global awareness of infectious pathogens and the serious problems they cause. Specifically, we expect that:

●

Purchase decisions for infection control filtration that had been deferred, both in new and existing customer organizations, may be re-prioritized.

●

Demand for our pathogen detection products may increase as unoccupied buildings, including office buildings and hotels, are readied for re-occupation. Extended periods of low, or no, water flow through building piping creates opportunities for biofilm propagation – a problem our strategic partners are trained to eradicate.

●

Demand for our commercial filtration products may increase as ~~and~~business returns to ~~the extent that~~ hotels, casinos, and ~~restaurants re-open.~~restaurants.

●22

~~Sales meetings at new potential customers may resume.~~

In summary, the COVID-19 pandemic adds uncertainty to our business plans in the short term, while we believe that our medium-to-long-term prospects remain strong. At this time, we cannot predict the specific extent or duration of the impact of the COVID-19 pandemic on our condition, resources and results.

Our Products

Water Filtration Products

We develop and sell water filtration products used in both medical and commercial applications. Our water filtration products employ multiple filtration technologies, as described below.

In medical markets, our primary filtration mechanism is to pass liquids through the pores of polysulfone hollow fiber. Our filters’ pores are significantly smaller than those of competing products, resulting in highly effective elimination of waterborne pathogens, including legionella bacteria (the cause of Legionnaires disease) and viruses, which are not eliminated by most other microbiological filters on the market. Additionally, the fiber structure and pore density in our hollow fiber enables significantly higher flow rates than in other polysulfone hollow fiber.

Our primary sales strategy in medical markets is to sell through value-added resellers (“VARs”). Leveraging VARs has enabled us to expand rapidly our access to target customers without significant sales staff expansion. In addition, while we are currently focused in medical markets, the VARs that support these customers also support a wide variety of commercial and industrial customers. We believe that our VAR relationships will facilitate growth in filter sales outside of the medical industry.

In commercial markets, we develop and sell our Nephros- and AETHER-branded filters, for which carbon-based absorption is the primary filtration mechanism. Aether products allow us to improve water’s odor and taste, to reduce scale and heavy metals, and to reduce other water contaminants for customers who are primarily in the food service, convenience store, and hospitality industries.

Our Aether filter offerings have the potential to generate accretive revenue growth in at least three ways. First, we expect the business to continue its organic growth. Second, cross-selling opportunities are generated by offering taste/odor-focused products to the medical markets, as well as pathogen-focused filtration to the commercial markets. Finally, as part of the more substantial Nephros organization, Aether may be able to compete for larger filtration contracts than may have been available to it as a smaller, independent firm. ~~Since~~In the year since we acquired the AETHER brand, we have seen some promising results in each of these strategies, but it is still too early to judge the likelihood or magnitude of their long-term success.

In commercial markets, our model combines both direct and indirect sales. Our sales staff have sold products directly to a number of convenience stores, hotels, casinos, and restaurants. We are also pursuing large corporate contracts through partnerships.

Target Markets

Our ultrafiltration products currently target the following markets:

●

Hospitals and Other Healthcare Facilities: Filtration of water for washing and drinking as an aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures, and washing of surgeons’ hands.

●

Dialysis Centers: Filtration of water or bicarbonate concentrate used in hemodialysis.

●

Commercial Facilities: Filtration and purification of water for consumption, including for use in ice machines and soft drink dispensers.

●

Military and Outdoor Recreation: Individual water purification devices used by soldiers and backpackers to produce drinking water in the field, as well as filters customized to remote water processing systems.

Hospitals and Other Healthcare Facilities. Nephros filters are a leading tool used to provide proactive protection to patients in high-risk areas (e.g., ice machines, surgical rooms, NICUs) and reactive protection to patients in broader areas during periods of water pathogen outbreaks. Our products are used in hundreds of medical facilities to aid in infection control, both proactively and reactively.

According to the American Hospital Association, approximately 6,200 hospitals, with approximately 931,000 beds, treated over 36 million patients in the United States in 2017. The U.S. Centers for Disease Control and Prevention estimates that healthcare associated infections (“HAI”) occurred in approximately 1 out of every 31 hospital patients, or about 687,000 patients in 2015. HAIs affect patients in hospitals or other healthcare facilities and are not present or incubating at the time of admission. They also include infections acquired by patients in the hospital or facility, but appearing after discharge, and occupational infections among staff. Many HAIs are caused by waterborne bacteria and viruses that can thrive in aging or complex plumbing systems often found in healthcare facilities.

In June 2017, the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (“CMS”) announced the addition of requirements for facilities to develop policies and procedures that inhibit the growth and spread of legionella and other opportunistic pathogens in building water systems. Going forward, CMS surveyors will review policies, procedures, and reports documenting water management implementation results to verify that facilities are compliant with these requirements. We believe that these CMS regulations may have a positive impact on the sale of our HAI-inhibiting ultrafilters.

We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the hospital setting to aid in infection control:

	●	The DSU-H and SSU-H are in-line, 0.005-micron ultrafilters that provide dual- and single-stage protection, respectively, from waterborne pathogens. They are primarily used to filter potable water feeding ice machines, sinks, and medical equipment, such as endoscope washers and surgical room humidifiers. The DSU-H has an up to 6-month product life in a typical hospital setting, while the SSU-H has an up to 3-month life.

	●	The S100 is a point-of-use, 0.01-micron microfilter that provides protection from waterborne pathogens. The S100 is primarily used to filter potable water feeding sinks and showers. The S100 has an up to 3-month product life when used in a hospital setting.

	●	The HydraGuard^TM and HydraGuard^TM - Flush are 0.005-micron cartridge ultrafilters that provide single-stage protection from waterborne pathogens. The HydraGuard ultrafilters are primarily used to filter potable water feeding ice machines and medical equipment, such as endoscope washers and surgical room humidifiers. The HydraGuard has an up to 6-month product life and the HydraGuard - Flush has an up to 12-month product life when used in a hospital setting.

Our complete hospital infection control product line, including in-line, point-of-use, and cartridge filters, can be viewed on our website at http://www.nephros.com/infection-control/. We are not including the information on our website as a part of, nor incorporating it by reference into, this Quarterly Report on Form 10-Q.

Dialysis Centers - Water/Bicarbonate. In the dialysis water market, Nephros ultrafiltration products are among the highest performing products on the market. The DSU-D, SSU-D and the SSUmini have become the standard endotoxin filter in many portable reverse osmosis systems. The EndoPur^®, our large-format ultrafilter targeted at dialysis clinic water systems, provides the smallest pore size available. Following a long pilot project at a major dialysis provider, we are now seeing growth in the use of this product. In addition, we aim to expand EndoPur’s usage into heat-disinfected water systems, which will further open the market for this product.

To perform hemodialysis, all dialysis clinics have dedicated water purification systems to produce water and bicarbonate concentrate, two essential ingredients for making dialysate, the liquid that removes waste material from the blood. According to the American Journal of Kidney Diseases, there are approximately 6,500 dialysis clinics in the United States servicing approximately 468,000 patients annually. We estimate that there are over 100,000 hemodialysis machines in operation in the United States.

Medicare is the main payer for dialysis treatment in the United States. To be eligible for Medicare reimbursement, dialysis centers must meet the minimum standards for water and bicarbonate concentrate quality set by the Association for the Advancement of Medical Instrumentation (“AAMI”), the American National Standards Institute (“ANSI”) and the International Standards Organization (“ISO”). We anticipate that the stricter standards approved by these organizations in 2009 will be adopted by Medicare in the near future.

We currently have FDA 510(k) clearance on the following portfolio of medical device products for use in the dialysis setting to aid in bacteria, virus, and endotoxin retention:

	●	The DSU-D, SSU-D and SSUmini are in-line, 0.005-micron ultrafilters that provide protection from bacteria, viruses, and endotoxins. All of these products have an up to 12-month product life in the dialysis setting and are used to filter water following treatment with a reverse osmosis (“RO”) system, and to filter bicarbonate concentrate. These ultrafilters are primarily used in the water lines and bicarbonate concentrate lines leading into dialysis machines, and as a polish filter for portable RO machines.

	●	The EndoPur is a 0.005-micron cartridge ultrafilter that provides single-stage protection from bacteria, viruses, and endotoxins. The EndoPur has an up to 12-month product life in the dialysis setting, and is used to filter water following treatment with an RO system. More specifically, the EndoPur is used primarily to filter water in large RO systems designed to provide ultrapure water to an entire dialysis clinic. The EndoPur is a cartridge-based, “plug and play” market entry that requires no plumbing at installation or replacement. The EndoPur is available in 10”, 20”, and 30” configurations. ~~We expect that the EndoPur will be validated for heat disinfection by the end of the third quarter of fiscal year 2020.~~

Commercial and Industrial Facilities. Our commercial NanoGuard^® product line accomplishes ultrafiltration via small pore size (0.005 micron) technology, filtering bacteria and viruses from water. In addition, the recently acquired AETHER brand expands our product line to include water filtration and purification technologies that are primarily focused on improving odor and taste and on reducing scale and heavy metals from filtered water.

We purchased the AETHER brand to expedite our access to commercial markets and to expand our filtration expertise and capabilities. Our commercial market focus is in the hotel, restaurant, and convenience store markets. In the first year post-acquisition, we upgraded Aether facilities to increase production and logistics capacity, integrated Aether products into the Nephros infection control product portfolio, and initiated sales efforts with a number of large commercial customers. We have recently added to our commercial sales team and, going forward, ~~hope~~expect to close on one or more large contracts that may result in step-change increases in commercial market revenue.

Over time, we believe that the same water safety management programs currently underway at medical facilities may migrate to commercial markets. As the epidemiology of waterborne pathogens expands, links to contamination sources will become more efficient and the data more readily available. In cases where those sources are linked to restaurants, hotels, office buildings and residential complexes, the corporate owners of those facilities will likely face increasing liability exposure. We expect that building owners will come to understand ASHRAE-188, which outlines risk factors for buildings and their occupants, and provides water safety management guidelines. We believe, in time, most commercial buildings will need to follow the basic requirements of ASHRAE-188: create a water management plan, perform routine testing, and establish a plan to treat the building in the event of a positive test.

As demand for water testing and microbiological filtration grows, we will be ready to deploy our expertise and solutions based on years of experience servicing the medical market. We believe that we have an opportunity to offer unique expertise and products to the commercial market, and that our future revenue from the commercial market could even surpass our infection control revenue.

We currently market the following portfolio of proprietary products for use in the commercial, industrial, and food service settings:

●

The NanoGuard set of products are in-line, 0.005-micron ~~ultrafilters~~ultrafilter that ~~provide~~provides dual-stage retention of any organic or inorganic particle larger than 15,000 Daltons. NanoGuard products are designed to fit a variety of existing plumbing configurations, including 10” and 20” standard housings, and AETHER and Everpure® manifolds. Included in the NanoGuard product line are both conventional and flushable filters.

	●
	●	The AETHER line of commercial filters, which are also sold under the Nephros brand, provide a variety of technology solutions that improve water quality in food service, convenience store, hospitality, and industrial applications. AETHER filters improve water taste and odor, and reduce sediment, dirt, rust particles and other solids, chlorine and heavy minerals, lime scale build-up, and both particulate lead and soluble lead.

AETHER products combine effectively with NanoGuard ultrafiltration technologies to offer full-featured solutions to the commercial water market, including to existing users of Everpure filter manifolds.

Military and Outdoor Recreation. We developed our individual water treatment device (“IWTD”) in both in-line and point-of-use configurations. Our IWTD allows a soldier in the field to derive drinking water from any freshwater source. This enables the soldier to remain hydrated, to help maintain mission effectiveness and unit readiness, and to extend mission reach. Our IWTD has been validated by the military to meet the NSF Protocol P248 standard. It has also been approved by the U.S. Army Public Health Command and the U.S. Army Test and Evaluation Command for deployment.

In May 2015, we entered into a Sublicense Agreement (the “Sublicense Agreement”) with CamelBak Products, LLC (“CamelBak”). Under this Sublicense Agreement, we granted CamelBak an exclusive, non-transferable, worldwide (with the exception of Italy) sublicense and license, in each case solely to market, sell, distribute, import and export the IWTD. In exchange for the rights granted to CamelBak, CamelBak agreed, through December 31, 2022, to pay us a percentage of the gross profit on any sales made to a branch of the U.S. military, subject to certain exceptions, and to pay us a fixed per-unit fee for any other sales made. CamelBak was also required to meet or exceed certain minimum annual fees payable to us, and, if such fees are not met or exceeded, we were able to convert the exclusive sublicense to a non-exclusive sublicense with respect to non-U.S. military sales. In the first quarter of 2019, the Sublicense Agreement was amended to eliminate the minimum fee obligations starting May 6, 2018 and, as such, CamelBak has no further minimum fee obligations. Related to this Sublicense Agreement, approximately $20,000 of revenue was recognized in the three and nine months ended September 30, 2021. There was no royalty revenue recognized during the three ~~and~~or nine months ended September 30, ~~2020 or 2019 related to this Sublicense Agreement.~~2020. CamelBak product sales have been slower than originally ~~hoped.~~expected. However, military contracts often take years to close, and we remain optimistic about these products and markets.

Pathogen Detection Systems

Pathogen Detection in Infection Control.We recently expanded our portfolio of solutions with the introduction of our PluraPath™~~, SequaPath™, and DialyPath™~~ pathogen detection ~~systems,~~system, which we believe ~~represent~~represents a significant growth ~~opportunities~~opportunity for Nephros.

~~PluraPath: Pathogen Detection in Infection Control.~~We developed the PluraPath pathogen detection system to provide real-time data to infection control teams executing their water management plans. We integrated our ultrafilter technology with emerging, quantitative polymerase chain reaction (qPCR) technology and real-time analytics. We chose a portable, open-source qPCR platform that allows us to parallel-processes up to 15 different bacteria and virus assays. We worked with industry experts to select and develop DNA- and RNA-based assays that could meet our goals of providing quantitative precision within one hour. We also developed a mobile application to extract and process the data real-time. Furthermore, we designed the system so that anyone can perform qPCR testing, not just someone with training in microbiological laboratory techniques.

With the PluraPath system, it iswill be possible to map and track the changes to levels of multiple bacterial and viral pathogens in a building’s water system on a real-time basis, at cost levels equivalent to assays that currently take 24-72 hours or more and typically provide data on only a single pathogen. Using PluraPath, we expect that infection control teams will be able to quickly assess approximate levels of a broad array of pathogens in their water systems, and optimally focus their secondary disinfection efforts and point-of-use filtration; services and products offered by our strategic partners.

The PluraPath system does not replace culture-based assays, which are the current regulatory requirements for confirmation in testing for waterborne pathogens. Rather, we believe PluraPath will become a valuable tool in the arsenal of defense, permitting faster decision making about a larger target population of pathogens. Our objective is to provide our customers and strategic partners with a user-friendly system that delivers dependable, actionable data to infection control teams in less than an hour.

~~SequaPath:~~ Pathogen Detection in Dialysis Facilities. We have also been investigating pathogen detection efforts in the dialysis space. The LAL (limulus amebocyte lysate) test is a dialysis industry standard assay that identifies the presence of potential endotoxins, agnostic to the source species. The source of endotoxins are gram-negative bacteria. LAL testing routinely takes 48-72 hours to provide results from the time of shipping the sample to a central laboratory. When dialysis clinics have urgent contamination or severely elevated endotoxin issues, they may have to shut down for extended periods of time creating enormous logistical issues for patients and increasing the cost of care.

To provide a real-time solution for this testing paradigm, we announced the DialyPath™ pathogen detection and endotoxin estimation system in October 2020. The DialyPath system mirrors our PluraPath but includes a gram-negative DNA marker test and test for six different gram-negative bacteria. The DialyPath system is designed to provide data on two test samples in one run in less than one hour. The system will provide an estimate of the overall endotoxin in the sample, as well as estimated levels of six specific endotoxin-generating bacteria known to be frequent invaders of dialysis clinic water systems.

Facility-Wide Pathogen Detection. Bacterial contaminants in water systems can originate from thousands of different bacterial families. The technology now exists to map the water system biome in real-time, on-site, using an enhanced form of the portable PluraPath system and a bioinformatics database. The SequaPath system provides the capability to screen water for over 20,000 different bacterial genera (families), including genera of the 40+ pathogenic bacteria listed by the Centers for Disease Control & Prevention (CDC) in their “Opportunistic Pathogens of Premise Plumbing.” The system incorporates our proprietary filtration technology and a DNA sequencing step that makes it possible to screen rapidly for genera of waterborne pathogens. Like PluraPath, the SequaPath platform is portable, allowing for same-day on-site analysis.

~~Due to re-opening concerns associated with buildings~~The SequaPath technology was used in ~~the COVID-19 environment, we have accelerated the market launch of SequaPath™ from late~~ 2020 to ~~the current quarter. The technology was also used to~~ perform ~~a recent~~an academic study that found far more bacteria in buildings unoccupied during the COVID-19 pandemic than in occupied buildings.

The potential for building biome mapping is enormous. We are developing the technology, processes, and procedures to perform as many as 96 tests in a single run. ~~Our plan~~SequaPath is ~~to first provide SequaPath~~currently available as a service ~~and then as a product that we can support with partners who have the in-house technical capabilities to manage this system.~~offering.

While this service could be of value to the management of any water system in any building in any part of the world, we will first focus on the hospital customers of our strategic partners. Once proven in the hospital space, we believe that SequaPath has the potential to shift the building water testing paradigm across multiple markets and geographies.

~~DialyPath: Endotoxin Detection in Dialysis Facilities.~~ ~~We have also been investigating pathogen detection efforts in~~On July 9, 2021, the ~~dialysis space.~~Company acquired 100% of GenArraytion, Inc. (“GenArraytion”). The ~~LAL (limulus amebocyte lysate) test is~~acquisition did not qualify as a ~~dialysis industry standard assay that identifies the presence of potential endotoxins, agnostic to the source species.~~business combination and, as a result, was accounted for as an asset acquisition. The source of endotoxins are gram-negative bacteria. LAL testing routinely takes 48-72 hours to provide results from the time of shipping the sample to a central laboratory. When dialysis clinics have urgent contamination or severely elevated endotoxin issues, they may have to shut down for extended periods of time creating enormous logistical issues for patients and increasing the cost of care.

To provide a real-time solution for this testing paradigm, we launched the DialyPath pathogen detection and endotoxin estimation system on October 13, 2020. The DialyPath system mirrors PluraPath, but includes a gram-negative DNA marker test and tests for six different gram-negative bacteria. The DialyPath system is designed to provide data on two test samples in one run in about an hour. The system provides an estimateCompany issued 123,981 shares of the ~~overall endotoxin in the sample, as well as estimated levels~~Company’s common stock to GenArraytion, reflecting an aggregate purchase price of ~~six specific endotoxin-generating bacteria known~~$1.2 million. This acquisition will give us access to GenArraytion’s many proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other microorganisms using Polymerase Chain Reaction technology. GenArraytion’s assets will be ~~frequent invaders of dialysis clinic water systems, and to cause inflammation in dialysis patients.~~integrated into our Pathogen Detection Systems segment.

Specialty Renal Products: HDF System

Introduction to HDF

The current standard of care in the United States for patients with chronic renal failure is hemodialysis (“HD”), a process in which toxins are cleared via diffusion. Patients typically receive HD treatments at least 3 times weekly for 3-4 hours per treatment. HD is most effective in removing smaller, easily diffusible toxins. For patients with acute renal failure, the current standard of care in the United States is hemofiltration (“HF”), a process where toxins are cleared via convection. HF offers a much better removal of larger sized toxins when compared to HD; however, HF treatment is more challenging for patients, as it is performed on a daily basis, and typically takes 12-24 hours per treatment.

Hemodiafiltration (“HDF”) is an alternative dialysis modality that combines the benefits of HD and HF into a single therapy by clearing toxins using both diffusion and convection. Though not widely used in the United States, HDF is prevalent in Europe and is performed for a growing number of patients. Clinical experience and literature show the following clinical and patient benefits of HDF:

	●	Enhanced clearance of middle and large molecular weight toxins
	●	Improved survival - up to a 35% reduction in mortality risk
	●	Reduction in the occurrence of dialysis-related amyloidosis
	●	Reduction in inflammation
	●	Reduction in medication such as EPO and phosphate binders
	●	Improved patient quality of life
	●	Reduction in number of hospitalizations and overall length of stay

However, like HD, HDF can be resource-intensive and can require a significant amount of time to deliver one course of treatment.

Nephros HDF Background

Over the course of our history, we originally developed a medical device that enabled a standard HD machine to perform HDF. We refer to our approach as an on-line mid-dilution hemodiafiltration (“mid-dilution HDF”) system. Our original solution included an OLpūr H2H Hemodiafiltration Module (“H2H Module”), an OLpūr MD 220 Hemodiafilter (“HDF Filter”) and an H2H Substitution Filter (“Dialysate Filter”).

Our H2H Module attaches to a standard HD machine to perform on-line HDF therapy. The HD machine controls and monitors the basic treatment functions, as it would normally when providing HD therapy. The H2H Module is a free-standing, movable device that is placed next to either side of an HD machine. The H2H Module connects to the clinic’s water supply, drain, and electricity.

The H2H Module utilizes the HDF Filter, and is very similar to a typical hollow fiber dialyzer assembled with a single hollow fiber bundle made with a high-flux (or high-permeability) membrane. The fiber bundle is separated into two discrete, but serially connected, blood paths. Dialysate flows in one direction that is counter-current to blood flow in Stage 1 and co-current to blood flow in Stage 2.

In addition to the HDF Filter, the H2H Module also utilizes a Dialysate Filter during patient treatment. The Dialysate Filter is a hollow fiber, ultrafilter device that consists of two sequential (redundant) ultrafiltration stages in a single housing. During on-line HDF with the H2H Module, fresh dialysate is redirected by the H2H Module’s hydraulic (substitution) pump and passed through this dual-stage ultrafilter before being infused as substitution fluid into the extracorporeal circuit. Providing ultrapure dialysate is crucial for the success of on-line HDF treatment.

Our original HDF system conformed with current ANSI/AAMI/ISO standards and was cleared by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with chronic renal failure in 2012. To date, our HDF System is the only HDF system cleared by the FDA.

Over the last four years, DaVita Healthcare Partners, the Renal Research Institute (a research division of Fresenius Medical Care), and Vanderbilt University conducted post-market evaluations of our hemodiafiltration system in their clinics. We gathered direct feedback from these evaluations to develop a better understanding of how our system best fits into the current clinical and economic ESRD treatment paradigm. The ultimate goal of the evaluations was to better understand the potential for HDF in the U.S. clinical setting in order to (a) improve the quality of life for the patient, (b) reduce overall expenditure compared to other dialysis modalities, (c) minimize the impact on nurse work flow at the clinic, and (d) demonstrate the pharmacoeconomic benefit of the HDF technology to the U.S. healthcare system, as has been done in Europe with other HDF systems. The last evaluation was concluded at Vanderbilt in the first quarter of 2018.

Specialty Renal Products, Inc.

Over the past two years, we have dramatically simplified and redesigned our HDF device. Our updates have made the system significantly easier to use. By shifting from a reusable substitution ultrafilter to a disposable substitution ultrafilter, we were able to simplify the set-up process and substantially reduce the time required between patient treatments – two of the key complaints from users of our first-generation system. We used real-time user feedback to aid in the fine-tuning of our changes to the system that impacted usability. We believe our ~~second generation~~second-generation HDF system will meet the needs of both clinicians and patients.

In 2018, we spun-off the development of the HDF device into SRP. We raised $3 million of outside capital directly into SRP to fund the second-generation development described above. ~~These funds were exhausted in early July 2020.~~ Nephros ~~which~~ maintains a 62.5% ownership stake in ~~SRP, loaned $0.8 million in operating funds to SRP during~~SRP.

We submitted the ~~three months ended September 30, 2020.~~

On October 9, 2020, Nephros and SRP entered into a formal loan agreement, in which Nephros agreed to lend up to $1.3 million of operating funds to SRP, including the $0.8 million borrowed by SRP during the three months ended September 30, 2020. These funds are expected to be sufficient to fund SRP through the planned FDA 510(k) clearance process of SRP’s second-generation ~~hemodiafiltration~~HDF system ~~which is expected to be initially submitted to the FDA near the end of 2020.~~

~~Once we have obtained~~for FDA clearance ~~for our second-generation device,~~in June 2021. Once it is cleared, we intend to launch it at 2-3 clinics with previous experience with our device. We plan to then expand our efforts, on a measured basis, to clinics that wish to provide HDF therapy to their patients. At this time, we do not believe making a rapid and broad push into the market would be optimal. Nephrologists in the United States are not trained on HDF therapy; however, many nephrologists want to explore the option and we believe that early adopters will want to perform studies to better understand the technology. We intend to support these investigator-initiated studies.

While a number of studies have been performed in Europe, the body of evidence for optimal use of HDF needs to be built in the U.S. treatment setting. According to European data from Fresenius, over 15% of dialysis treatments are HDF. That could translate to over 10 million individual treatments if HDF achieved that level of penetration in the United States. We do not believe that the United States will instantaneously mirror Europe. However, we do believe that HDF therapy has a place in the treatment landscape for patients with ESRD in the United States, and we look forward to enabling this pathway.

Critical Accounting Policies

For the ~~nine months~~nine-month period ended September 30, 2020, other than our cash and cash equivalents policy (see Note 2, “Basis of Presentation and Liquidity,” of the Notes to our Unaudited Condensed Consolidated Interim Financial Statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q),2021, there were no significant changes to our critical accounting policies as identified in our Annual Report on Form 10-K for the year ended December 31, ~~2019.~~2020.

Recent Accounting Pronouncements

We are subject to recently issued accounting standards, accounting guidance and disclosure requirements. For a description of these new accounting standards, see Note 2, “Basis of Presentation and Liquidity,” of the Notes to our Unaudited Condensed Consolidated Interim Financial Statements contained in Item 1 of Part I of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.

Results of Operations

Fluctuations in Operating Results

Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our annual results of operations will be impacted for the foreseeable future by several factors, including the progress and timing of expenditures related to our research and development efforts, marketing expenses related to product launches, timing of regulatory approval of our various products and market acceptance of our products. ~~Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication of our future performance.~~

Three Months Ended September 30, ~~2020~~2021 Compared to the Three Months Ended September 30, ~~2019~~2020

The following table sets forth our summarized, consolidated results of operations for the three months ended September 30, ~~2020~~2021 and ~~2019~~2020 (in thousands, except percentages):

	2021			2020			$ Increase (Decrease)			% Increase (Decrease)
Total net revenues	$	2,637		$	2,121		$	516			24	%
Cost of goods sold		1,225			896			329			37	%
Gross margin		1,412			1,225			187			15	%
Gross margin %		54	%		58	%		-			(4	)%
Research and development expenses		632			751			(119	)		(16	)%
Depreciation and amortization expense		50			49			1			2	%
Selling, general and administrative expenses		1,892			1,544			348			23	%
Change in fair value of contingent consideration		-			(187	)		(187	)		(100	)%
Loss from operations		(1,162	)		(932	)		230			25	%
Interest expense		(10	)		(22	)		(12	)		(55	)%
Interest income		2			3			(1	)		(33	)%
Other income (expense), net		8			(61	)		69			113	%
Net loss		(1,162	)		(1,012	)		150			15	%
Less: Undeclared deemed dividend attributable to noncontrolling interest		(60	)		(60	)		-			-
Net loss attributable to Nephros, Inc.	$	(1,222	)	$	(1,072	)	$	150			14	%

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Total net revenues $ 2,121 $ 3,095 $ (974 ) (31 )%
Cost of goods sold 896 1,276 (380 ) (30 )%
Gross margin 1,225 1,819 (594 ) (33 )%
Gross margin % 58 % 59 % - (1 )%
Research and development expenses 751 777 (26 ) (3 )%
Depreciation and amortization expense 49 44 5 11 %
Selling, general and administrative expenses 1,544 1,787 (243 ) (14 )%
Change in fair value of contingent consideration (187 ) (94 ) 93 99 %
Loss from operations (932 ) (695 ) 237 34 %
Interest expense (22 ) (48 ) (26 ) (54 )%
Interest income 3 - 3 100 %
Other expense (61 ) (1 ) 60 6000 %
Net loss (1,012 ) (744 ) 268 36 %
Less: Undeclared deemed dividend attributable to noncontrolling interest (60 ) (60 ) - -
Net loss attributable to Nephros, Inc. $ (1,072 ) $ (804 ) $ 268 33 %

Net ~~Revenues~~Revenues.

~~Total~~ Our business is reported in three reportable segments: Water Filtration, Pathogen Detection and Renal Products. Our net revenues in each of these segments for the three months ended September 30, 2021 and 2020 (in thousands, except percentages) were ~~$2.1 million compared~~as follows:

	2021		2020		$ Increase (Decrease)		% Increase (Decrease)
Water Filtration	$	2,578	$	2,121	$	457		22	%
Pathogen Detection		59		-		59		100	%
Renal Products		-		-		-		-
Total	$	2,637	$	2,121	$	516		24	%

Total net revenues in the Water Filtration segment increased 22% as a result of increased medical device filter sales.

Total net revenues in the Pathogen Detection segment increased 100% reflecting early receptivity of the market to ~~$3.1 million~~our pathogen detection products.

Gross Profit Margin

	2021			2020			% Increase (Decrease)
Water Filtration		53	%		58	%		(5	)%
Pathogen Detection		88	%		-	%		88	%
Renal Products		-	%		-	%		-%
Total		54	%		58	%		(4	)%

Consolidated gross margin was approximately 54% for the three months ended September 30, ~~2019. The decrease of $1.0 million, or 31%, was driven by reduced customer demand that appears to be related to decreased customer focus on waterborne pathogens during the COVID-19 pandemic.~~

~~Cost of Goods Sold~~

~~Cost of goods sold was $0.9 million for the three months ended September 30, 2020~~2021 compared to $1.3 million for the three months ended September 30, 2019. This decrease of $0.4 million, or 30%, was primarily due to $0.3 million in decreased direct product costs consistent with the decrease in revenue and lower product costs due to volume discounts, partially offset by an increase in expense related to inventory expiration and adjustments of $0.1 million during the three months ended September 30, 2020 compared to the three months ended September 30, 2019.

~~Gross Margin~~

~~Gross margin was~~ approximately 58% for the three months ended September 30, ~~2020 compared to~~2020. The decrease of approximately ~~59%~~4% was driven by the Water Filtration segment primarily as a result of increased shipping costs and inventory adjustments.

Research and Development Expenses

Research and development expenses by segment for the three months ended September 30, ~~2019. The decrease of approximately 1 percentage point is~~2021 and 2020 (in thousands, except percentages) were as follows:

	2021		2020		$ Increase (Decrease)			% Increase (Decrease)
Water Filtration	$	363	$	359	$	4			1	%
Pathogen Detection		237		49		188			384	%
Renal Products		32		343		(311	)		(91	)%
Total	$	632	$	751	$	(119	)		(16	)%

Consolidated research and development expenses decreased $0.1 million primarily due to ~~unfavorable inventory expiration~~decreasing investment in the second-generation HDF product in the Renal Products segment, partially offset by increased R&D investments in our Pathogen Detection products.

Selling, General and ~~adjustments of $0.1 million during~~Administrative Expenses

Selling, general and administrative expenses by segment for the three months ended September 30, ~~2020.~~2021 and 2020 (in thousands, except percentages) were as follows:

	2021		2020		$ Increase (Decrease)			% Increase (Decrease)
Water Filtration	$	1,703	$	1,317	$	386			29	%
Pathogen Detection		175		116		59			51	%
Renal Products		14		111		(97	)		(87	)%
Total	$	1,892	$	1,544	$	348			23	%

~~Research~~Consolidated selling, general and ~~Development Expenses~~administrative expenses increased $0.3 million primarily due to increased headcount related expenditures of $0.3 million in the Water Filtration segment.

~~Research and development expenses were $0.8 million~~Interest Expense

Interest expense was approximately $10,000 for ~~each of~~ the three months ended September 30, ~~2020 and 2019.~~2021 compared to $22,000 for the three months ended September 30, 2020. Both expenses included our secured note payable. The $12,000 reduction is primarily due to elimination of our contingent consideration accretion expense.

~~Depreciation and Amortization Expense~~Other Income (Expense), net

~~Depreciation and amortization expenses were~~Other income of approximately ~~$49,000 and $44,000~~$8,000 for the three months ended September 30, 2021 is related to foreign currency exchange gains. Other expense of approximately $61,000 for the three months ended September 30, 2020 ~~and 2019, respectively.~~

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $1.5 million for the three months ended September 30, 2020 compared to $1.8 million for the three months ended September 30, 2019, representing a decrease of $0.2 million, or 14%. The decrease was primarily due to a decrease in travel-related and marketing expenses of approximately $0.2 million as a result of the COVID-19 pandemic.

~~Change in Fair Value of Contingent Consideration~~

Change in fair value of contingent consideration of approximately $0.2 million for the three months ended September 30, 2020 was due to settlement of the contingent consideration liability. Change in fair value of contingent consideration of approximately $0.1 million for the three months ended September 30, 2019 was due to lower-than-planned revenue performance of commercial filtration products.

~~Interest Expense~~

~~Interest expense was approximately $22,000 for the three months ended September 30, 2020 and~~ is ~~primarily~~ related to interest on our secured note payable. Interest expense was approximately $48,000 for the three months ended September 30, 2019, which was comprised primarily of interest on our secured note payable and interest on our secured revolving credit facility, which was terminated on May 26, 2020.

~~Interest Income~~

~~Interest income was approximately $3,000 for the three months ended September 30, 2020. There was no interest income for the three months ended September 30, 2019.~~

~~Other Expense~~

~~Other expense was approximately $61,000 and $1,000 for the three months ended September 30, 2020 and 2019, respectively, and is a result of losses on~~ foreign currency ~~transactions.~~exchange losses.

~~Water Filtration~~

~~The following table sets forth results of operations for the Water Filtration segment for the three months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Total net revenues $ 2,121 $ 3,095 $ (974 ) (31 )%
Cost of goods sold 894 1,276 (382 ) (30 )%
Gross margin 1,227 1,819 (592 ) (33 )%
Gross margin % 58 % 59 % - (1 )%
Research and development expenses 359 231 128 55 %
Depreciation and amortization expense 49 44 5 11 %
Selling, general and administrative expenses 1,317 1,756 (439 ) (25 )%
Change in fair value of contingent consideration (187 ) (94 ) 93 99 %
Loss from operations $ (311 ) $ (118 ) $ 193 164 %

~~Net Revenues~~

Total net revenues for the three months ended September 30, 2020 were $2.1 million compared to $3.1 million for the three months ended September 30, 2019. The decrease of $1.0 million, or 31%, was driven by reduced customer demand that appears to be related to decreased customer focus on waterborne pathogens during the COVID-19 pandemic.

~~Cost of Goods Sold~~

Cost of goods sold was $0.9 million for the three months ended September 30, 2020 compared to $1.3 million for the three months ended September 30, 2019. This decrease of $0.4 million, or 30%, was primarily due to $0.3 million in decreased direct product costs consistent with the decrease in revenue and lower product costs due to volume discounts, partially offset by an increase in expense related to inventory expiration and adjustments of $0.1 million during the three months ended September 30, 2020 compared to the three months ended September 30, 2019.

~~Gross Margin~~

Gross margin was approximately 58% for the three months ended September 30, 2020 compared to approximately 59% for the three months ended September 30, 2019. The decrease of approximately 1 percentage point is primarily due to unfavorable inventory expiration and adjustments of $0.1 million during the three months ended September 30, 2020.

~~Research and Development Expenses~~

Research and development expenses were $0.3 million and $0.2 million for the three months ended September 30, 2020 and 2019, respectively. This increase of $0.1 million, or 55%, reflects increased headcount expenditures on product research and development.

~~Depreciation and Amortization Expense~~

~~Depreciation and amortization expenses were approximately $49,000 and $44,000 for the three months ended September 30, 2020 and 2019, respectively.~~

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $1.3 million and $1.8 million for the three months ended September 30, 2020 and 2019, respectively, representing a decrease of $0.4 million, or 25%. The decrease was primarily due to a decrease in stock based compensation expense of $0.2 million, primarily related to the vesting of options as a result of the performance condition met upon our Nasdaq listing during the three months ended September 30, 2019 and a decrease in travel-related and marketing expenses of $0.2 million as a result of the COVID-19 pandemic.

~~Change in Fair Value of Contingent Consideration~~

Change in fair value of contingent consideration of $0.2 million for the three months ended September 30, 2020 was due to settlement of the contingent consideration liability. Change in fair value of contingent consideration of $0.1 million for the three months ended September 30, 2019 was due to lower-than-planned revenue performance of commercial filtration products.

~~Pathogen Detection~~

~~The following table sets forth results of operations for the Pathogen Detection segment for the three months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Total net revenues $ - $ - $ - -
Cost of goods sold 2 - 2 100 %
Gross margin (2 ) - (2 ) (100 )%
Gross margin % 0 % 0 % - -
Research and development expenses 49 180 (131 ) (73 )%
Selling, general and administrative expenses 116 - 116 100 %
Loss from operations $ (167 ) $ (180 ) $ (13 ) (7 )%

~~Cost of Goods Sold~~

~~Cost of goods sold was approximately $2,000 for the three months ended September 30, 2020.~~

~~Research and Development Expenses~~

Research and development expenses were $49,000 and $0.2 million, respectively for each of the three months ended September 30, 2020 and 2019. This decrease of $0.1 million, or 73%, reflects this business segment’s transition from a purely research focus to a commercial phase.

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $0.1 million for the three months ended September 30, 2020 and were due to the sales efforts that began during the nine months ended September 30, 2020.

~~Renal Products~~

~~The following table sets forth results of operations for the Renal Products segment for the three months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Research and development expenses $ 343 366 $ (23 ) (6 )%
Selling, general and administrative expenses 111 31 80 258 %
Loss from operations $ (454 ) $ (397 ) $ 57 14 %

~~Research and Development Expenses~~

~~Research and development expenses were $0.4 million for each of the three months ended September 30, 2020 and 2019.~~

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $0.1 million and $31,000 for the three months ended September 30, 2020 and 2019, respectively, an increase of approximately $80,000 due to an increased investment in operational management.

Nine Months Ended September 30, ~~2020~~2021 Compared to the Nine Months Ended September 30, ~~2019~~2020

The following table sets forth our summarized, consolidated results of operations for the nine months ended September 30, ~~2020~~2021 and ~~2019~~2020 (in thousands, except percentages):

	2021			2020			$ Increase (Decrease)			% Increase (Decrease)
Total net revenues	$	7,639		$	6,227		$	1,412			23	%
Cost of goods sold		3,365			2,616			749			29	%
Gross margin		4,274			3,611			663			18	%
Gross margin %		56	%		58	%		-			(2	)%
Research and development expenses		1,675			2,150			(475	)		(22	)%
Depreciation and amortization expense		151			142			9			6	%
Selling, general and administrative expenses		5,745			5,104			641			13	%
Change in fair value of contingent consideration		-			(229	)		(229	)		(100	)%
Loss from operations		(3,297	)		(3,556	)		(259	)		(7	)%
Interest expense		(34	)		(95	)		(61	)		(64	)%
Interest income		8			8			-			-
Forgiveness of PPP Loan		482			-			482			100	%
Other income (expense), net		16			(124	)		140			113	%
Net loss		(2,825	)		(3,767	)		(942	)		(25	)%
Less: Undeclared deemed dividend attributable to noncontrolling interest		(179	)		(179	)		-			-
Net loss attributable to Nephros, Inc.	$	(3,004	)	$	(3,946	)	$	(942	)		(24	)%

2020 2019 $ Increase (Decrease) % Increase (Decrease)
Total net revenues $ 6,227 $ 7,173 $ (946 ) (13 )%
Cost of goods sold 2,616 2,989 (373 ) (12 )%
Gross margin 3,611 4,184 (573 ) (14 )%
Gross margin % 58 % 58 % - -
Research and development expenses 2,150 2,326 (176 ) (8 )%
Depreciation and amortization expense 142 142 - -
Selling, general and administrative expenses 5,104 4,693 411 9 %
Change in fair value of contingent consideration (229 ) (113 ) 116 103 %
Loss from operations (3,556 ) (2,864 ) 692 24 %
Interest expense (95 ) (140 ) (45 ) (32 )%
Interest income 8 - 8 100 %
Other expense (124 ) (31 ) 93 300 %
Net loss (3,767 ) (3,035 ) 732 24 %
Less: Undeclared deemed dividend attributable to noncontrolling interest (179 ) (180 ) (1 ) (1 )%
Net loss attributable to Nephros, Inc. $ (3,946 ) $ (3,215 ) $ 731 23 %

Net ~~Revenues~~Revenues.

~~Total~~ Our business is reported in three reportable segments: Water Filtration, Pathogen Detection and Renal Products. Our net revenues in each of these segments for the nine months ended September 30, 2021 and 2020 (in thousands, except percentages) were ~~$6.2 million compared~~as follows:

	2021		2020		$ Increase (Decrease)		% Increase (Decrease)
Water Filtration	$	7,504	$	6,199	$	1,305		21	%
Pathogen Detection		135		28		107		382	%
Renal Products		-		-		-		-
Total	$	7,639	$	6,227	$	1,412		23	%

Total net revenues in the Water Filtration segment increased 21% as a result of increased medical device filter sales.

The increase in total net revenues in the Pathogen Detection segment reflects early receptivity of the market to ~~$7.2 million~~our pathogen detection products.

Gross Profit Margin

	2021			2020			% Increase (Decrease)
Water Filtration		55	%		58	%		(3	)%
Pathogen Detection		83	%		51	%		33	%
Renal Products		-	%		-	%		%
Total		56	%		58	%		(2	)%

Consolidated gross margin was approximately 56% for the nine months ended September 30, ~~2019. The decrease of $0.9 million was driven by reduced customer demand of $1.7 million during the three months ended September 30, 2020 and June 30, 2020 – which appears~~2021 compared to ~~be related to decreased customer focus on waterborne pathogens during the COVID-19 pandemic – offset by increased customer demand of $0.8 million during the three months ended March 31, 2020.~~

~~Cost of Goods Sold~~

~~Cost of goods sold was $2.6 million~~approximately 58% for the nine months ended September 30, ~~2020 compared to $3.0 million~~2020. The decrease of approximately 2% was driven by inventory adjustments.

Research and Development Expenses

Research and development expenses by segment for the nine months ended September 30, ~~2019, consistent with the decrease in net revenues.~~2021 and 2020 (in thousands, except percentages) were as follows:

	2021		2020		$ Increase (Decrease)			% Increase (Decrease)
Water Filtration	$	961	$	1,014	$	(53	)		(5	)%
Pathogen Detection		505		206		299			145	%
Renal Products		209		930		(721	)		(78	)%
Total	$	1,675	$	2,150	$	(475	)		(22	)%

~~Gross Margin~~

~~Gross margin was approximately 58% for each of the nine months ended September 30, 2020 and 2019.~~

~~Research and Development Expenses~~

~~Research~~Consolidated research and development expenses ~~were $2.1~~decreased $0.5 million ~~and $2.3 million for the nine months ended September 30, 2020 and 2019, respectively. This decrease of $0.2 million, or 8%, is~~ primarily due to decreasing investment in the second-generation HDF product ~~as it nears submission for FDA clearance, and~~in the Renal Products segment, partially offset by increased R&D investments in our Pathogen Detection ~~Systems business segment’s transition from a purely research focus to a commercial phase.~~products.

~~Depreciation~~Selling, General and ~~Amortization Expense~~Administrative Expenses

~~Depreciation~~Selling, general and ~~amortization~~administrative expenses ~~were approximately $142,000~~by segment for ~~each of~~ the nine months ended September 30, 2021 and 2020 ~~and 2019.~~(in thousands, except percentages) were as follows:

	2021		2020		$ Increase (Decrease)			% Increase (Decrease)
Water Filtration	$	5,314	$	4,381	$	933			21	%
Pathogen Detection		372		377		(5	)		(1	)%
Renal Products		59		346		(287	)		(83	)%
Total	$	5,745	$	5,104	$	641			13	%

~~Selling, General and Administrative Expenses~~

~~Selling,~~Consolidated selling, general and administrative expenses increased $0.6 million primarily due to increased headcount related expenditures of $0.9 million in the Water Filtration segment, which were ~~$5.1~~partially offset by a decrease in headcount related expenditures of $0.3 million in the Renal Products segment as a result decreasing investment in the second-generation HDF product, which was submitted for 510(k) FDA clearance in June 2021.

Interest Expense

Interest expense was approximately $34,000 for the nine months ended September 30, 2021 compared to $95,000 for the nine months ended September 30, 2020. Both expenses included our secured note payable. The $61,000 reduction is primarily due to elimination of both our secured revolving credit facility and contingent consideration accretion expense.

Extinguishment of PPP loan

Our outstanding PPP loan was forgiven in January 2021 resulting in an extinguishment of approximately $482,000.

Other Income (Expense), net

Other income was approximately $16,000 for the nine months ended September 30, 2021 as a result of gains on foreign currency transactions. Other expense was approximately $124,000 for the nine months ended September 30, 2020 compared to $4.7 million for the nine months ended September 30, 2019, representing an increase of $0.4 million, or 9%. The increase was due to several factors, including increased headcount-related expenses of $0.7 million, driven by investments in pathogen detection, renal products, and logistics, and partially offset by a decrease in travel and marketing related expenses of $0.2 million as a result of ~~the COVID-19 pandemic.~~

~~Change in Fair Value of Contingent Consideration~~

Change in fair value of contingent consideration of $0.2 million for the nine months ended September 30, 2020 was due to settlement of the contingent consideration liability. Change in fair value of contingent consideration of $0.1 million for the nine months ended September 30, 2019 was due to lower-than-planned revenue performance of commercial filtration products.

~~Interest Expense~~

~~Interest expense was approximately $95,000 and $140,000 for the nine months ended September 30, 2020 and 2019, respectively, and is primarily related to interest~~losses on ~~our secured note payable, interest on our secured revolving credit facility that was terminated on May 26, 2020 and accretion of contingent consideration.~~

~~Interest Income~~

~~Interest income was approximately $8,000 for the nine months ended September 30, 2020. There was no interest income for the nine months ended September 30, 2019.~~

~~Other Expense~~

Other expense was approximately $124,000 and $31,000 for the nine months ended September 30, 2020 and 2019, respectively. Other expense for the nine months ended September 30, 2020 and 2019 is primarily related to foreign currency ~~exchange losses.~~transactions.

~~Water Filtration~~

~~The following table sets forth results of operations for the Water Filtration segment for the nine months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Total net revenues $ 6,199 $ 7,173 $ (974 ) (14 )%
Cost of goods sold 2,602 2,989 (387 ) (13 )%
Gross margin 3,597 4,184 (587 ) (14 )%
Gross margin % 58 % 58 % - -
Research and development expenses 1,014 698 316 45 %
Depreciation and amortization expense 142 142 - -
Selling, general and administrative expenses 4,381 4,577 (196 ) (4 )%
Change in fair value of contingent consideration (229 ) (113 ) 116 103 %
Loss from operations $ (1,711 ) $ (1,120 ) $ 591 53 %

~~Net Revenues~~

Total net revenues for the nine months ended September 30, 2020 were $6.2 million compared to $7.2 million for the nine months ended September 30, 2019. The decrease of $0.9 million was driven by reduced customer demand of $1.7 million during the three months ended September 30, 2020 and June 30, 2020 – which appears to be related to decreased customer focus on waterborne pathogens during the COVID-19 pandemic –offset by increased customer demand of $0.8 million during the three months ended March 31, 2020.

~~Cost of Goods Sold~~

~~Cost of goods sold was $2.6 million for the nine months ended September 30, 2020 compared to $3.0 million for the nine months ended September 30, 2019, consistent with the decrease in net revenues.~~

~~Gross Margin~~

~~Gross margin was approximately 58% for each of the nine months ended September 30, 2020 and 2019.~~

~~Research and Development Expenses~~

Research and development expenses were $1.0 million and $0.7 million for the nine months ended September 30, 2020 and 2019, respectively. This increase of $0.3 million, or 31%, reflects increased headcount expenditures on product research and development.

~~Depreciation and Amortization Expense~~

~~Depreciation and amortization expenses were approximately $142,000 for each of the nine months ended September 30, 2020 and 2019.~~

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $4.4 million for the nine months ended September 30, 2020 compared to $4.6 million for the nine months ended September 30, 2019, representing a decrease of $0.2 million, or 4%. The decrease was primarily due to a decrease in travel and marketing related expenses of $0.2 million as a result of the COVID-19 pandemic.

~~Change in Fair Value of Contingent Consideration~~

~~Pathogen Detection~~

~~The following table sets forth results of operations for the Pathogen Detection segment for the nine months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Total net revenues $ 28 $ - $ 28 100 %
Cost of goods sold 14 - 14 100 %
Gross margin 14 - 14 100 %
Gross margin % 51 % - % - 51 %
Research and development expenses 206 492 (286 ) (58 )%
Selling, general and administrative expenses 377 - 377 100 %
Loss from operations $ (569 ) $ (492 ) $ 77 16 %

~~Net Revenues~~

~~Total net revenues for the nine months ended September 30, 2020 were approximately $28,000. Our sales of the pathogen detection system began during the nine months ended September 30, 2020.~~

~~Cost of Goods Sold~~

~~Cost of goods sold was approximately $14,000 for the nine months ended September 30, 2020.~~

~~Gross Margin~~

~~Gross margin was approximately 51% for the nine months ended September 30, 2020.~~

~~Research and Development Expenses~~

Research and development expenses were $0.2 million and $0.5 million for the nine months ended September 30, 2020 and 2019, respectively. This decrease of $0.3 million, or 58%, reflects this business segment’s transition from a purely research focus to a commercial phase.

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $0.4 million for the nine months ended September 30, 2020 and were due to the sales effort which began during the nine months ended September 30, 2020.

~~Renal Products~~

~~The following table sets forth results of operations for the Renal Products segment for the nine months ended September 30, 2020 and 2019 (in thousands, except percentages):~~

2020 2019
$
Increase
(Decrease)

%
Increase
(Decrease)

Research and development expenses $ 930 1,136 $ (206 ) (18 )%
Selling, general and administrative expenses 346 116 230 198 %
Loss from operations $ (1,276 ) $ (1,252 ) $ 24 2 %

~~Research and Development Expenses~~

Research and development expenses were $1.0 and $1.2 million for the nine months ended September 30, 2020 and 2019, respectively, a decrease of $0.2 million due to decreasing investment in the second-generation HDF product as it nears submission for FDA clearance.

~~Selling, General and Administrative Expenses~~

Selling, general and administrative expenses were $0.3 and $0.1 million for the nine months ended September 30, 2020 and 2019, respectively, an increase of $0.2 million due to an increased investment in operational management.

Liquidity and Capital Resources

The following table summarizes our liquidity and capital resources as of September 30, ~~2020~~2021 and December 31, ~~2019~~2020 and is intended to supplement the more detailed discussion that follows. The amounts stated are expressed in thousands.

	September 30,		December 31,		September 30,		December 31,
Liquidity and Capital Resources	2020		2019		2021		2020
Cash and cash equivalents	$	5,155	$	4,166	$	7,350	$	8,249
Other current assets		6,600		4,133		6,271		6,905
Working capital		9,376		5,871		11,798		13,829
Stockholders’ equity		11,440		7,689		15,330		15,573

At September 30, ~~2020,~~2021, we had an accumulated deficit of ~~$131.1~~$134.7 million and we expect to incur additional operating losses from operations until such time, if ever, that we are able to increase product sales and/or licensing revenue to achieve profitability.

The CARES Act established the PPP, which authorizes the issuance of loans to small businesses. Loan amounts are forgivable to the extent that proceeds are used to cover certain costs, including payroll, over a 24-week period following loan funding. Loans have a maturity of 2 years with an interest rate of 1.0% and may be prepaid without penalty. We applied for and received a PPP loan in the amount of $0.5 million on April 24, 2020.

~~On October 20, 2020, we completed a registered direct offering of 833,333 shares of common stock at a price of $6.00 per share with net proceeds of $4.7 million.~~ Based on cash that is available for our operations and projections of our future operations, we believe that our cash ~~balances~~ resources will be sufficient to fund our current operating plan ~~– including the potential negative impact of the COVID-19 pandemic –~~ through at least the next 12 months from the date of issuance of the ~~accompanying~~ condensed consolidated financial ~~statements.~~statements in this Quarterly Report on Form 10-Q. Additionally, our operating plans are designed to help control operating costs, ~~and~~ to increase revenue and to raise additional capital until such time as we generate sufficient cash flows ~~from~~to fund operations. ~~However,~~If there ~~is uncertainty with respect to our projections regarding~~were a decrease in the ~~availability of sufficient cash resources as a result of the COVID-19 pandemic and the economic conditions it has caused. In recent months, we have seen decreased~~ demand for our products ~~both with respect~~due to ~~new hospital customers and our existing hospital, restaurant and hospitality customers, which have been significantly impacted by the COVID-19 pandemic.~~

~~If this decrease in demand continues beyond the third quarter of fiscal year 2021 and~~either economic or competitive conditions, or if we are otherwise unable to achieve our ~~revenue~~ plan, ~~we may~~there could be ~~forced~~a significant reduction in liquidity due to our possible inability to cut costs as appropriate to preserve our available capital resources. If we are unable to sufficiently decrease our spending to match any future decreased demands for our products, we may exhaust our capital resources sooner than we currently anticipate. Further, as a result of the recent volatility of the capital markets and economic conditions generally, it may be difficult for us to raise additional capital at times when we need it, and even if we were able to raise additional capital, it may be on terms than are detrimental to us. Accordingly, the current economic conditions caused by the COVID-19 pandemic place uncertainty on our ability to maintain adequate levels of liquidity.sufficiently.

~~In addition to the factors caused by the COVID-19 pandemic and the current economic conditions, our~~Our future liquidity sources and requirements will depend on many other factors, including:

	●	the market acceptance of our products, and our ability to effectively and efficiently produce and market our products;
	●	the continued progress in, and the costs of, clinical studies and other research and development programs;
	●	the costs involved in filing and enforcing patent claims and the status of competitive products; and
	●	the cost of litigation, including potential patent litigation and any other actual or threatened litigation.

We expect to put our current capital resources to the following uses:

	●	the development, marketing, and sales of our water-filtration and water diagnostics product; and
	●	~~the development of our second-generation HDF product; and~~
	●	working capital purposes.

At September 30, ~~2020,~~2021, we had cash and cash equivalents totaling ~~$5.2~~$7.4 million and total assets of ~~$14.5~~$17.2 million excluding the asset related to the License and Supply Agreement with Medica of ~~$0.7~~$0.6 million.

Net cash used in operating activities was $1.1 million for the nine months ended September 30, 2021 compared to $5.4 million for the nine months ended September 30, 2020, a decrease of $4.3 million due primarily to a decrease of $0.5 million in inventory for the nine months ended September 30, 2021, compared to ~~$2.6~~an increase in inventory of $2.8 million for the nine months ended September 30, ~~2019, an increase of $2.7 million, due primarily to an increase of $2.8 million in~~2020. Excess inventory was purchased during the nine months ended September 30, 2020 ~~which we executed~~ to reduce the risk of ~~a disruption of our Italy-based~~pandemic-related supply chain ~~during~~disruptions. Since no such disruption took place, the ~~COVID-19 pandemic. In addition, reduced revenues increased our use of cash, since less gross margin was available to cover expenses.~~excess inventory is being sold through in 2021, thus reducing inventory levels.

Net cash used in investing activities was approximately $0.1 million for the nine months ended September 30, 2021 compared to $0.2 million for the nine months ended September 30, ~~2020~~2021. The change is due primarily due to decreased purchases of property and equipment.

Net cash ~~used in investing~~provided by financing activities ~~was $0.1~~of $0.3 million for the nine months ended September 30, ~~2019 due to a working capital adjustment related to~~2021 resulted primarily from proceeds from the ~~acquisition~~exercise of ~~the Aether business.~~warrants and options of $0.5 million offset partially by payments of $0.2 million on our secured note.

Net cash provided by financing activities of $6.6 million for the nine months ended September 30, 2020 resulted ~~primarily~~ from net proceeds from the issuance of common stock of $6.8 million, proceeds from the PPP loan of $0.5 million and proceeds from the exercise of warrants and options of $0.2 million, offset partially by net payments on our secured revolving credit facility of $0.6 million, payments of $0.2 million on our secured note, and payment of approximately $79,000 ~~for~~on our contingent consideration.

Net cash provided by financing activities of $2.1 million for the nine months ended September 30, 2019 resulted primarily from net proceeds from the issuance of common stock of $2.0 million and proceeds from the exercise of warrants and options of $0.3 million partially offset by payments on our secured note payable of $0.2 million and payment of contingent consideration of approximately $78,000.

Off-Balance Sheet Arrangements

We did not have any off-balance sheet arrangements as of September 30, ~~2020.~~2021.

Forward-Looking Statements

~~The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements.~~ Certain statements in this Quarterly Report on Form 10-Q constitute “forward-looking statements”. Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such products to market, the timeline for regulatory review and approval of our products, the availability of funding sources for continued development of such products, and other statements that are not historical facts, including statements which may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guaranties of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include, but are not limited to, the risks that:

●

we face significant challenges in obtaining market acceptance of our products, which could adversely affect our potential sales and revenues;

●

product-related deaths or serious injuries or product malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products;

●

we face potential liability associated with the production, marketing and sale of our products, and the expense of defending against claims of product liability could materially deplete our assets and generate negative publicity, which could impair our reputation;

●

to the extent our products or marketing materials are found to violate any provisions of the U.S. Food, Drug and Cosmetic Act or any other statutes or regulations, we could be subject to enforcement actions by the FDA or other governmental agencies;

●

we may not be able to obtain funding if and when needed or on terms favorable to us in order to continue operations;

●

we may not have sufficient capital to successfully implement our business plan;

●

we may not be able to effectively market our products;

●

we may not be able to sell our water filtration products, pathogen detection systems or chronic renal failure therapy products at competitive prices or profitably;

●

we may encounter problems with our suppliers, manufacturers and distributors;

●

we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures;

●

we may not obtain appropriate or necessary regulatory approvals to achieve our business plan;

●

products that appeared promising to us in research or clinical trials may not demonstrate anticipated efficacy, safety or cost savings in subsequent pre-clinical or clinical trials;

●

we may not be able to secure or enforce adequate legal protection, including patent protection, for our products;

●

we may not be able to achieve sales growth in key geographic markets; and

●

the effects of the ~~COVID-19~~Covid-19 pandemic may be more severe than we currently anticipate.

More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Quarterly Report on Form 10-Q, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2019~~2020 and our other reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Not required for smaller reporting companies.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We maintain a system of disclosure controls and procedures, as defined in Rule 13a-15(e) or Rule 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is designed to provide reasonable assurance that information required to be disclosed in our reports filed pursuant to the Exchange Act is accumulated and communicated to management in a timely manner. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives. Because there are inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud have been or will be detected.

At the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II - OTHER INFORMATION

Item 1A. Risk Factors

As a smaller reporting company, we are not required to provide disclosure pursuant to this item. However, in addition to other information set forth in this Quarterly Report on Form 10-Q, including the important information in the section entitled “Forward Looking Statements,” you should carefully consider the “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, ~~2019~~2020 for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in this Quarterly Report on Form 10-Q. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition and/or operating results. ~~You should also consider the following risk factor:~~

~~The effects~~Item 5. Other Information.

On October 29, 2021, Daron Evans resigned from his position as President and Chief Executive Officer of Specialty Renal Products, Inc. (“SRP”), a majority-owned subsidiary of the ~~COVID-19 pandemic, including measures taken to contain~~Company. Mr. Evans will remain a member of the ~~pandemic, are highly uncertain~~board of directors of SRP and ~~cannot be predicted.~~

~~Our operations expose us to risks associated with public health crises~~was appointed chairman of the SRP board of directors upon his resignation as its president and ~~pandemics, such as the outbreak~~chief executive officer. Andrew Astor, our President, Chief Executive Officer and Chief Financial Officer, was also appointed President and Chief Executive Officer of COVID-19. The COVID-19 pandemic has caused a general reduction in economic activity as businesses and consumers reduce activity to slow the spread of COVID-19 on a voluntary basis and in response to government orders. These reductions in activity have impacted andSRP upon Mr. Evans’ resignation. Mr. Astor, who will continue ~~to impact our workforce and operations, the operations of our customers, and the operations of our vendors and suppliers.~~

We have operations, supply chain, and customers in North America and Europe, and each of these regions has been affected by the outbreak and taken measures in an attempt to contain it. If the COVID-19 pandemic continues and conditions worsen, we may experienceserving as a ~~decline in sales activities or greater effects on our supply chain, and it remains uncertain what impact these changes will have on future sales and production once conditions begin to improve.~~

~~COVID-19 mitigation efforts have had broad effects on the economy and financial markets. The extent~~member of the ~~scope and duration~~SRP board of ~~these economic effects cannot currently be predicted, although they are likely to be significant~~directors, will not receive any additional compensation from SRP or from us for the near future. We expect that the economic impact of COVID-19 will affect us in a variety of ways, including without limitation, reducing demand for our products, making our stock price more volatile, making it more difficult to raise additional capital through offerings of equity or debt securities, whether due to the overall availability of capital or restrictions on terms that may be available to us, and reducing the availability of bank loans.his role with SRP.

The extent to which the COVID-19 pandemic impacts our business, results of operations and financial condition will depend on future developments, which are highly uncertain and cannot be predicted, including, but not limited to, the duration and spread of the outbreak, the severity of the outbreak, the actions of governments and private actors to slow the spread of the outbreak, the effect of fiscal stimulus measures, and how quickly and to what extent normal economic and operating conditions can resume. We do not yet know the full extent of the impact on our business, our operations or the global economy as a whole. However, the effects could have a material impact on our results of operations, and we will continue to monitor the COVID-19 pandemic closely.

Item 6. Exhibits

~~EXHIBIT INDEX~~

Exhibit No.		Description of Exhibit

10.1		~~Employment~~Asset Purchase Agreement between ~~the Registrant~~Nephros, Inc. and ~~Andrew Astor,~~GenArraytion, Inc. dated ~~August 23, 2020.~~July 9, 2021. *

~~10.2~~		Consulting Agreement between the Registrant and Daron Evans, dated August 23, 2020. *

~~10.3~~		Consulting Agreement between Specialty Renal Products, Inc. and Daron Evans, dated August 26, 2020. *

~~10.4~~		Loan Agreement between the Registrant and Specialty Renal Products, dated October 7, 2020, incorporated by reference to Exhibit 10.1 to Nephros, Inc.’s Current Report on Form 8-K filed with the SEC on October 13, 2020.

~~10.5~~		8% Convertible Promissory Note, from Specialty Renal Products, Inc. to the Registrant, dated October 7, 2020, incorporated by reference to Exhibit 10.2 to Nephros, Inc.’s Current Report on Form 8-K, filed with the SEC on October 13, 2020.

~~10.6~~		Form of Securities Purchase Agreement dated October 15, 2020, between the Registrant and the Purchasers, incorporated by reference to Exhibit 10.1 to Nephros, Inc.’s Current Report on Form 8-K filed with the SEC on October 16, 2020.

~~10.7~~		Second Amendment to Membership Interest Purchase Agreement, between the Registrant and Gregory Lucas, dated October 15, 2020, incorporated by reference to Exhibit 10.1 to Nephros, Inc.’s Current Report on Form 8-K filed with the SEC on October 20, 2020.

31.1		Certification by the Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. *

32.1		Certification by the Chief Executive Officer and 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		Interactive Data File. *

*		Filed herewith
**		Furnished herewith.

~~SIGNATURES~~

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	NEPHROS, INC.

Date: November ~~5, 2020~~4, 2021	By:	/s/ Andrew Astor
	Name:	Andrew Astor
	Title:	President, Chief Executive Officer and Chief Financial Officer (Principal Executive and Financial ~~and Accounting~~ Officer)

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)		Total
	(in thousands)
At September 30, 2020:
Total contingent consideration liability	$	-	$	-	$	6	$	6

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)		Total
	(in thousands)
At December 31, 2019:
Total contingent consideration liability	$	-	$	-	$	300	$	300

	Contingent Consideration
		(in thousands)
Balance as of December 31, 2019	$	300
Payments against contingent consideration		(79	)
Change in fair value of contingent consideration liability		(229	)
Accretion of contingent consideration liability		14
Balance as of September 30, 2020	$	6

	Three months ended September 30, 2020		Three months ended September 30, 2019
		(in thousands)
Operating lease cost	$	105	$	98
Finance lease cost:
Amortization of right-of-use assets		3		-
Interest on lease liabilities		-		-
Total finance lease cost		3		-
Variable lease cost		7		-
Total lease cost	$	115	$	98

	Three Months Ended September 30, 2019
	(in thousands)
	Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues	$	3,095		$	-		$	-		$	3,095
Gross margin		1,819			-			-			1,819
Research and development expenses		231			180			366			777
Depreciation and amortization expense		44			-			-			44
Selling, general and administrative expenses		1,756			-			31			1,787
Change in fair value of contingent consideration		(94	)		-			-			(94	)
Total operating expenses		1.937			180			397			2,514
Loss from operations	$	(118	)	$	(180	)	$	(397	)	$	(695	)

	Nine Months Ended September 30, 2019
	(in thousands)
	Water Filtration			Pathogen Detection			Renal Products			Nephros, Inc. Consolidated
Total net revenues	$	7,173		$	-		$	-		$	7,173
Gross margin		4,184			-			-			4,184
Research and development expenses		698			492			1,136			2,326
Depreciation and amortization expense		142			-			-			142
Selling, general and administrative expenses		4,577			-			116			4,693
Change in fair value of contingent consideration		(113	)		-			-			(113	)
Total operating expenses		5,304			492			1,252			7,048
Loss from operations	$	(1,120	)	$	(492	)	$	(1,252	)	$	(2,864	)

	2020			2019			$ Increase (Decrease)			% Increase (Decrease)
Total net revenues	$	2,121		$	3,095		$	(974	)		(31	)%
Cost of goods sold		896			1,276			(380	)		(30	)%
Gross margin		1,225			1,819			(594	)		(33	)%
Gross margin %		58	%		59	%		-			(1	)%
Research and development expenses		751			777			(26	)		(3	)%
Depreciation and amortization expense		49			44			5			11	%
Selling, general and administrative expenses		1,544			1,787			(243	)		(14	)%
Change in fair value of contingent consideration		(187	)		(94	)		93			99	%
Loss from operations		(932	)		(695	)		237			34	%
Interest expense		(22	)		(48	)		(26	)		(54	)%
Interest income		3			-			3			100	%
Other expense		(61	)		(1	)		60			6000	%
Net loss		(1,012	)		(744	)		268			36	%
Less: Undeclared deemed dividend attributable to noncontrolling interest		(60	)		(60	)		-			-
Net loss attributable to Nephros, Inc.	$	(1,072	)	$	(804	)	$	268			33	%

	2020			2019			$ Increase (Decrease)			% Increase (Decrease)
Total net revenues	$	6,227		$	7,173		$	(946	)		(13	)%
Cost of goods sold		2,616			2,989			(373	)		(12	)%
Gross margin		3,611			4,184			(573	)		(14	)%
Gross margin %		58	%		58	%		-			-
Research and development expenses		2,150			2,326			(176	)		(8	)%
Depreciation and amortization expense		142			142			-			-
Selling, general and administrative expenses		5,104			4,693			411			9	%
Change in fair value of contingent consideration		(229	)		(113	)		116			103	%
Loss from operations		(3,556	)		(2,864	)		692			24	%
Interest expense		(95	)		(140	)		(45	)		(32	)%
Interest income		8			-			8			100	%
Other expense		(124	)		(31	)		93			300	%
Net loss		(3,767	)		(3,035	)		732			24	%
Less: Undeclared deemed dividend attributable to noncontrolling interest		(179	)		(180	)		(1	)		(1	)%
Net loss attributable to Nephros, Inc.	$	(3,946	)	$	(3,215	)	$	731			23	%