Aspira Women's Health Inc. [AWH] Filings

10-Q 1 awh-20230930x10q.htm 10-Q awh-20230930x10q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

o 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: 001-34810

Aspira Women’s Health Inc.

(Exact name of registrant as specified in its charter)


Delaware		33-0595156
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
12117 Bee Caves Road, Building III, Suite 100, Austin, Texas		78738
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (512) 519-0400

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


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	AWH	The Nasdaq Capital Market

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes þ 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 þ

Smaller reporting company þ

Emerging growth company ¨

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

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

As of November 9, 2023, the registrant had 10,336,834 shares of common stock, par value $0.001 per share, outstanding.

ASPIRA WOMEN’S HEALTH INC.

FORM 10-Q

For the Quarter Ended September 30, 2023

Table of Contents




		Page
PART I	Financial Information	3
Item 1	Financial Statements (unaudited)	3
	Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022	3
	Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2023 and 2022	4
	Condensed Consolidated Statements of Changes in Stockholders’ (Deficit)Equity for the three and nine months ended September 30, 2023 and 2022	5
	Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022	7
	Notes to Condensed Consolidated Financial Statements	9
Item 2	Management's Discussion and Analysis of Financial Condition and Results of Operations	32
Item 3	Quantitative and Qualitative Disclosures About Market Risk	49
Item 4	Controls and Procedures	49
PART II	Other Information	52
Item 1	Legal Proceedings	52
Item 1A	Risk Factors	52
Item 2	Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities	53
Item 3	Defaults Upon Senior Securities	53
Item 4	Mine Safety Disclosures	54
Item 5	Other Information	54
Item 6	Exhibits	55
SIGNATURES		57

The following are registered and unregistered trademarks and service marks of Aspira Women’s HealthInc.: VERMILLION^SM, Aspira Women’s Health®, OVA1®, OVERA®, ASPiRA LABS^SM, OvaCalc®, OVASUITE^SM, ASPiRA GenetiX^SM, OVA1PLUS®, OVAWATCH^SM, EndoCheck^SM, OVAInherit^SM, Aspira Synergy^SM,, OVA360^SM, ASPIRA IVD® , and YOUR HEALTH, OUR PASSION®.

PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Aspira Women’s Health Inc.

Condensed Consolidated Balance Sheets (unaudited)

(Amounts in Thousands, Except Share and Par Value Amounts)


	September 30,		December 31,
	2023		2022
Assets
Current assets:
Cash and cash equivalents	$	5,100	$	13,306
Accounts receivable, net of reserves of $35 and $9, at September 30, 2023 and December 31, 2022, respectively		1,590		1,245
Prepaid expenses and other current assets		581		1,442
Inventories		301		316
Total current assets		7,572		16,309
Property and equipment, net		221		368
Right-of-use assets		600		282
Restricted cash		256		251
Other assets		13		163
Total assets	$	8,662	$	17,373
Liabilities and Stockholders’ (Deficit) Equity
Current liabilities:
Accounts payable	$	1,382	$	881
Accrued liabilities		3,089		3,402
Current portion of long-term debt		378		403
Short-term debt		77		764
Current maturities of lease liabilities		236		77
Total current liabilities		5,162		5,527
Non-current liabilities:
Long-term debt		1,217		2,315
Non-current maturities of lease liabilities		429		272
Warrant liabilities		2,513		2,280
Total liabilities		9,321		10,394
Commitments and contingencies (Note 4)
Stockholders’ (deficit) equity:
Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 10,287,182 and 8,306,326 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		11		8
Additional paid-in capital		514,544		508,584
Accumulated deficit		(515,214)		(501,613)
Total stockholders’ (deficit) equity		(659)		6,979
Total liabilities and stockholders’ (deficit) equity	$	8,662	$	17,373

See accompanying notes to the unaudited condensed consolidated financial statements.
‎

Aspira Women’s Health Inc.

Condensed Consolidated Statements of Operations (unaudited)

(Amounts in Thousands, Except Share and Per Share Amounts)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
			(as restated)				(as restated)
Revenue:
Product	$	2,217	$	2,037	$	7,023	$	5,890
Genetics		-		35		1		141
Total revenue		2,217		2,072		7,024		6,031
Cost of revenue⁽¹⁾:
Product		910		875		2,981		2,768
Genetics		-		41		-		180
Total cost of revenue		910		916		2,981		2,948
Gross profit		1,307		1,156		4,043		3,083
Operating expenses:
Research and development⁽²⁾		998		2,157		2,958		4,915
Sales and marketing⁽³⁾		1,702		3,950		6,069		12,027
General and administrative⁽⁴⁾		2,723		3,629		9,733		12,188
Total operating expenses		5,423		9,736		18,760		29,130
Loss from operations		(4,116)		(8,580)		(14,717)		(26,047)
Change in fair value of warrant liabilities		(1,201)		1,236		(233)		1,236
Interest income, net		12		18		46		(10)
Other income (expense), net		599		(457)		1,303		(473)
Net loss	$	(4,706)	$	(7,783)	$	(13,601)	$	(25,294)
Net loss per share - basic and diluted	$	(0.48)	$	(1.00)	$	(1.54)	$	(3.33)
Weighted average common shares used to compute basic and diluted net loss per common share		9,776,436		7,807,876		8,838,342		7,590,872
Non-cash stock-based compensation expense included in cost of revenue and operating expenses:
(1) Cost of revenue	$	7	$	(23)	$	26	$	64
(2) Research and development		65		65		224		114
(3) Sales and marketing		(105)		76		19		281
(4) General and administrative		451		428		1,033		1,535

See accompanying notes to the unaudited condensed consolidated financial statements.

Aspira Women’s Health Inc.

Condensed Consolidated Statements of Changes in Stockholders’ (Deficit) Equity (unaudited)

(Amounts in Thousands, Except Share Amounts)


	Common Stock
	Shares	Amount		Additional Paid-In Capital		Accumulated Deficit		Total Stockholders’ (Deficit) Equity
Balance at December 31, 2022	8,306,326	$	8	$	508,584	$	(501,613)	$	6,979
Net loss	-		-		-		(6,578)		(6,578)
Common stock issued under an at the market offering agreement, net of issuance costs	23,217		-		30		-		30
Stock-based compensation expense	-		-		396		-		396
Balance at March 31, 2023	8,329,543	$	8	$	509,010	$	(508,191)	$	827
Net loss	-		-		-		(2,317)		(2,317)
Common stock issued under an at the market offering agreement, net of issuance costs	12,335		-		38		-		38
Common stock issued under an equity line of credit agreement, net of issuance costs	53,335		-		178		-		178
Common stock issued for entering into equity line of credit with Lincoln Park	47,733				258				258
Common stock issued for vested restricted stock awards	30,441		1		263		-		264
Stock-based compensation expense	-		-		224		-		224
Fractional shares adjustment related to reverse stock split	(24)		-		-		-		-
Balance at June 30, 2023	8,473,363	$	9	$	509,971	$	(510,508)	$	(528)
Net loss	-		-		-		(4,706)		(4,706)
Common stock issued under a registered direct offering, net of issuance costs	1,694,820		2		4,155		-		4,157
Common stock issued for vested restricted stock awards	118,999		-		421		-		421
Stock-based compensation expense	-		-		(3)		-		(3)
Balance at September 30, 2023	10,287,182	$	11	$	514,544	$	(515,214)	$	(659)

‎

Aspira Women’s Health Inc.

Condensed Consolidated Statements of Changes in Stockholders’ (Deficit) Equity (unaudited) (continued)

(Amounts in Thousands, Except Share Amounts)


	Common Stock
	Shares	Amount		Additional Paid-In Capital		Accumulated Deficit		Total Stockholders’ (Deficit) Equity
Balance at December 31, 2021	7,475,916	$	7	$	501,893	$	(471,728)	$	30,172
Net loss	-		-		-		(9,268)		(9,268)
Common stock issued in conjunction with exercise of stock options	200		-		2		-		2
Stock-based compensation expense	-		-		838		-		838
Balance at March 31, 2022	7,476,116	$	7	$	502,733	$	(480,996)	$	21,744
Net loss	-		-		-		(8,243)		(8,243)
Common stock issued in conjunction with exercise of stock options	1,333		-		11		-		11
Common stock issued for vested restricted stock awards	8,977		-		140		-		140
Stock-based compensation expense	-		-		470		-		470
Balance at June 30, 2022	7,486,426	$	7	$	503,354	$	(489,239)	$	14,122
Net loss (as restated)	-		-		-		(7,783)		(7,783)
Common stock and warrants issued in conjunction with follow-on public offering, net of issuance costs (as restated)	800,000		1		4,292		-		4,293
Common stock issued for vested restricted stock awards	9,950		-		95		-		95
Stock-based compensation expense	-		-		451		-		451
Balance at September 30, 2022 (as restated)	8,296,376	$	8	$	508,192	$	(497,022)	$	11,178

Aspira Women's Health Inc. [AWH] Filings
10-Q	[2023-11-13]
10-Q	[2023-08-14]
10-Q	[2023-05-15]
10-K	[2023-03-30]
10-Q	[2022-11-10]
10-Q	[2022-08-10]
10-Q	[2022-05-11]
10-K	[2022-03-31]
10-Q	[2021-11-10]
10-Q	[2021-08-12]
10-Q	[2021-05-14]
10-K	[2021-03-31]
10-Q	[2020-11-12]
10-Q	[2020-08-14]
10-Q	[2020-05-14]
10-K	[2020-04-07]
10-Q	[2019-11-12]
10-Q	[2019-08-08]
10-Q	[2019-05-14]
10-K	[2019-03-28]
10-Q	[2018-11-08]
10-Q	[2018-08-09]
10-Q	[2018-05-14]
10-K	[2018-03-13]
10-Q	[2017-11-08]
10-Q	[2017-08-11]
10-Q	[2017-05-11]
10-K	[2017-03-31]
10-Q	[2016-11-10]
10-Q	[2016-08-10]
10-Q	[2016-05-16]
10-K	[2016-03-30]
10-Q	[2015-11-12]
10-Q	[2015-08-13]
10-Q	[2015-05-12]
10-K	[2015-03-31]
10-Q	[2014-11-13]
10-Q	[2014-08-14]
10-Q	[2014-05-15]
10-K	[2014-03-31]
10-Q	[2013-11-14]
10-Q	[2013-08-14]
10-Q	[2013-05-15]
10-K	[2013-03-01]
10-Q	[2012-11-13]
10-Q	[2012-08-14]
10-Q	[2012-05-15]
10-K	[2012-03-27]