XBRL Financials

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 04, 2022
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
Document Transition Report	false
Current Fiscal Year End Date	--12-31
Entity File Number	001-34810
Entity Registrant Name	Aspira Women’s Health Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	33-0595156
Entity Address, Address Line One	12117 Bee Caves Road
Entity Address, Address Line Two	Building Three
Entity Address, Address Line Three	Suite 100
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78738
City Area Code	512
Local Phone Number	519-0400
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	AWH
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		124,445,639
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Central Index Key	0000926617
Amendment Flag	false

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 20,551	$ 37,180
Accounts receivable, net of allowance of $6 and $23, respectively	1,201	1,027
Prepaid expenses and other current assets	944	1,624
Inventories	280	174
Total current assets	22,976	40,005
Property and equipment, net	417	464
Right-of-use assets	299	346
Restricted cash	250	250
Other assets		14
Total assets	23,942	41,079
Current liabilities:
Accounts payable	1,893	1,501
Accrued liabilities	4,988	5,299
Current portion of long-term debt	343	201
Short-term debt		779
Lease liability	73	60
Total current liabilities	7,297	7,840
Non-current liabilities:
Long-term debt	2,426	2,718
Lease liability	293	349
Warrant liabilities	2,748
Total liabilities	12,764	10,907
Commitments and contingencies (Note 2)
Stockholders' equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2022 and December 31, 2021; 124,445,639 and 112,138,741 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	124	112
Additional paid-in capital	504,851	501,788
Accumulated deficit	(493,797)	(471,728)
Total stockholders' equity	11,178	30,172
Total liabilities and stockholders' equity	$ 23,942	$ 41,079

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Condensed Consolidated Balance Sheets [Abstract]
Accounts receivable, allowance	$ 6	$ 23
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	124,445,639	112,138,741
Common stock, shares outstanding	124,445,639	112,138,741

Condensed Consolidated Statements Of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Revenue:
Revenue	$ 2,072	$ 1,666	$ 6,031	$ 4,961
Cost of revenue:
Cost of revenue	916	917	2,948	2,913
Gross profit	1,156	749	3,083	2,048
Operating expenses:
Research and development	2,157	1,518	4,915	3,861
Sales and marketing	3,950	5,083	12,027	12,209
General and administrative	4,746	3,839	13,305	9,627
Total operating expenses	10,853	10,440	30,247	25,697
Loss from operations	(9,697)	(9,691)	(27,164)	(23,649)
Change in fair value of warrant liabilities	5,004		5,004
Interest income (expense), net	18	(14)	(10)	(35)
Other income (expense), net	117	(2)	101	983
Net loss	$ (4,558)	$ (9,707)	$ (22,069)	$ (22,701)
Net loss per share - basic	$ (0.04)	$ (0.09)	$ (0.19)	$ (0.20)
Net loss per share - diluted	$ (0.04)	$ (0.09)	$ (0.19)	$ (0.20)
Weighted average number of common shares used to compute basic net loss per common share	117,118,136	112,077,133	113,863,079	110,904,824
Weighted average number of common shares used to compute diluted net loss per common share	117,118,136	112,077,133	113,863,079	110,904,824
Product [Member]
Revenue:
Revenue	$ 2,037	$ 1,617	$ 5,890	$ 4,753
Cost of revenue:
Cost of revenue	875	715	2,768	2,209
Genetics [Member]
Revenue:
Revenue	35	49	141	208
Cost of revenue:
Cost of revenue	41	202	180	704
Cost Of Revenue [Member]
Operating expenses:
Stock-based compensation expense	(23)	49	64	137
Research And Development [Member]
Operating expenses:
Stock-based compensation expense	65	115	114	236
Sales And Marketing [Member]
Operating expenses:
Stock-based compensation expense	76	368	281	843
General And Administrative [Member]
Operating expenses:
Stock-based compensation expense	$ 428	$ 646	$ 1,535	$ 1,733

Consolidated Statements Of Changes In Stockholders' Equity - USD ($)	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Total
Balance (in shares) at Dec. 31, 2020	104,619,876
Balance at Dec. 31, 2020	$ 105,000	$ 449,680,000	$ (440,066,000)	$ 9,719,000
Net loss			(5,920,000)	$ (5,920,000)
Common stock issued in conjunction with exercise of stock options (in shares)		317,000		317,000
Common stock issued in conjunction with exercise of stock options	$ 196,976
Common stock issued in conjunction with public offering, net of issuance costs (in shares)	6,900,000
Common stock issued in conjunction with public offering, net of issuance costs	$ 7,000	$ 47,713,000		$ 47,720,000
Stock-based compensation expense		489,000		489,000
Balance (in shares) at Mar. 31, 2021	111,716,852
Balance at Mar. 31, 2021	$ 112,000	498,199,000	(445,986,000)	52,325,000
Balance (in shares) at Dec. 31, 2020	104,619,876
Balance at Dec. 31, 2020	$ 105,000	449,680,000	(440,066,000)	9,719,000
Net loss				(22,701,000)
Balance (in shares) at Sep. 30, 2021	112,100,049
Balance at Sep. 30, 2021	$ 112,000	501,159,000	(462,767,000)	38,504,000
Balance (in shares) at Mar. 31, 2021	111,716,852
Balance at Mar. 31, 2021	$ 112,000	498,199,000	(445,986,000)	52,325,000
Net loss			(7,074,000)	(7,074,000)
Common stock issued in conjunction with exercise of stock options (in shares)	305,090
Common stock issued in conjunction with exercise of stock options		304,000		304,000
Common stock issued for restricted stock awards (in shares)	36,092
Common stock issued for restricted stock awards		267,000		267,000
Common stock issued in conjunction with public offering, net of issuance costs		1,000		1,000
Stock-based compensation expense		1,015,000		1,015,000
Balance (in shares) at Jun. 30, 2021	112,058,034
Balance at Jun. 30, 2021	$ 112,000	499,786,000	(453,060,000)	46,838,000
Net loss			(9,707,000)	(9,707,000)
Common stock issued in conjunction with exercise of stock options (in shares)	27,500
Common stock issued in conjunction with exercise of stock options		58,000		58,000
Common stock issued for restricted stock awards (in shares)	14,515
Common stock issued for restricted stock awards		108,000		108,000
Common stock issued in conjunction with public offering, net of issuance costs		137,000		137,000
Stock-based compensation expense		1,070,000		1,070,000
Balance (in shares) at Sep. 30, 2021	112,100,049
Balance at Sep. 30, 2021	$ 112,000	501,159,000	(462,767,000)	38,504,000
Balance (in shares) at Dec. 31, 2021	112,138,741
Balance at Dec. 31, 2021	$ 112,000	501,788,000	(471,728,000)	30,172,000
Net loss			(9,268,000)	(9,268,000)
Common stock issued in conjunction with exercise of stock options (in shares)	3,000
Common stock issued in conjunction with exercise of stock options		2,000		2,000
Stock-based compensation expense		838,000		838,000
Balance (in shares) at Mar. 31, 2022	112,141,741
Balance at Mar. 31, 2022	$ 112,000	502,628,000	(480,996,000)	21,744,000
Balance (in shares) at Dec. 31, 2021	112,138,741
Balance at Dec. 31, 2021	$ 112,000	501,788,000	(471,728,000)	30,172,000
Net loss				(22,069,000)
Balance (in shares) at Sep. 30, 2022	124,445,639
Balance at Sep. 30, 2022	$ 124,000	504,851,000	(493,797,000)	11,178,000
Balance (in shares) at Mar. 31, 2022	112,141,741
Balance at Mar. 31, 2022	$ 112,000	502,628,000	(480,996,000)	21,744,000
Net loss			(8,243,000)	(8,243,000)
Common stock issued in conjunction with exercise of stock options (in shares)	20,000
Common stock issued in conjunction with exercise of stock options		11,000		11,000
Common stock issued for restricted stock awards (in shares)	134,647
Common stock issued for restricted stock awards		140,000		140,000
Stock-based compensation expense		470,000		470,000
Balance (in shares) at Jun. 30, 2022	112,296,388
Balance at Jun. 30, 2022	$ 112,000	503,249,000	(489,239,000)	14,122,000
Net loss			(4,558,000)	(4,558,000)
Common stock issued for restricted stock awards (in shares)	149,251
Common stock issued for restricted stock awards		95,000		95,000
Common stock and warrants issued in conjunction with follow-on public offering, net of issuance costs (in shares)	12,000,000
Common stock and warrants issued in conjunction with follow-on public offering, net of issuance costs	$ 12,000	1,056,000		1,068,000
Stock-based compensation expense		451,000		451,000
Balance (in shares) at Sep. 30, 2022	124,445,639
Balance at Sep. 30, 2022	$ 124,000	$ 504,851,000	$ (493,797,000)	$ 11,178,000

Condensed Consolidated Statements Of Cash Flows $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2022 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)
Cash flows from operating activities:
Net loss	$ (4,558)	$ (22,069)	$ (22,701)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash lease expense		4	35
Depreciation and amortization		195	238
Stock-based compensation expense		1,994	2,949
Change in fair value of warrant liabilities	(5,004)	(5,004)
Loss on sale and disposal of property and equipment		10	1
Forgiveness of PPP loan			(1,006)
Changes in operating assets and liabilities:
Accounts receivable		(174)	(238)
Prepaid expenses and other assets		694	262
Inventories		(106)	(107)
Accounts payable, accrued liabilities and other liabilities		(653)	821
Net cash used in operating activities		(25,109)	(19,746)
Cash flows from investing activities:
Purchase of property and equipment		(158)	(154)
Net cash used in investing activities		(158)	(154)
Cash flows from financing activities:
Principal repayment of DECD loan		(196)	(148)
Proceeds from issuance of common stock from exercise of stock options		13	679
Proceeds from public offering		9,000	48,236
Payment of offering costs for public offering	(179)	(179)	(378)
Net cash (used in) provided by financing activities		8,638	48,389
Net (decrease) increase in cash, cash equivalents and restricted cash		(16,629)	28,489
Cash, cash equivalents and restricted cash, beginning of period		37,430	16,631
Cash, cash equivalents and restricted cash, end of period	20,801	20,801	45,120
Reconciliation to Condensed Consolidated Balance Sheet:
Cash and cash equivalents	20,551	20,551	44,870
Restricted cash	250	250	250
Unrestricted and restricted cash and cash equivalents	$ 20,801	20,801	45,120
Supplemental disclosure of cash flow information:
Cash paid during the period for interest		57	57
Supplemental disclosure of noncash investing and financing activities:
Net decrease in right-of-use assets		(47)	(45)
Forgiveness of PPP loan			$ (1,006)
Fair value of warrants issued in conjunction with common stock offering		$ 7,752

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

9 Months Ended

Sep. 30, 2022

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Aspira Women’s Health Inc., formerly known as Vermillion, Inc. (“Aspira” and its wholly-owned subsidiaries are collectively referred to as the “Company”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company currently markets and sells the following products and related services: (1) Ova1, a blood test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation does not indicate malignancy; (2) Overa, a second-generation biomarker reflex intended to maintain Ova1’s high sensitivity while improving specificity; (3) Ova1Plus, a reflex offering which uses Ova1 as the primary test and Overa as a confirmation for Ova1 intermediate range results; and (4) Aspira Synergy, the Company’s decentralized testing platform and cloud service for decentralized global access of protein biomarker testing. The Company continues to make Ova1, Overa, and Ova1Plus, and plans to make future technology available through Aspira Synergy. The Company’s Ova1 test received FDA de novo classification in September 2009. Ova1 comprises instruments, assays, reagents, and the OvaCalc software, which includes a proprietary algorithm that produces a risk score. The Company’s Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1 and Overa each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources (in addition to revenue from Aspira GenetiX) is included in total revenue in the results of operations for the nine months ended September 30, 2022.

Liquidity

As of September 30, 2022, the Company had $20,551,000 of cash and cash equivalents (excluding restricted cash of $250,000), an accumulated deficit of approximately ($493,797,000), and working capital of $15,679,000. For the nine months ended September 30, 2022, the Company incurred a net loss of ($22,069,000) and used cash in operations of ($25,109,000). The Company has incurred significant net losses and negative cash flows from operations since inception and the Company also expects to continue to incur a net loss and negative cash flows from operations for 2022. There can be no assurance that the Company will achieve or sustain profitability or positive cash flow from operations. Given the above conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

The Company expects to raise capital through sources that may include public or private equity offerings, debt financings, the exercise of common stock warrants, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity, and that could have a material adverse effect on the Company’s business, results of operations and financial condition.

On June 1, 2022, the Company received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying the Company that, for the preceding 30 consecutive business days, the closing bid price for the Company’s common stock was below the minimum $1.00 per share requirement for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). As provided in the Nasdaq rules, the Company has 180 calendar days, or until November 28, 2022, to regain compliance with the Minimum Bid Price Rule. The Company may achieve compliance during this period if the closing bid price of Aspira common stock is at least $1.00 per share for a minimum of 10 consecutive business

days. If the Company fails to regain compliance on or prior to November 28, 2022, the Company may be eligible for an additional 180-calendar day compliance period, which would extend the deadline until May 27, 2023. There is no assurance that the Company will be able to regain compliance by the November 28, 2022 deadline or the additional 180-calendar day extended deadline, and there is no assurance that the Company will otherwise maintain compliance with this or any of the other Nasdaq continued listing requirements.

The COVID-19 pandemic has severely impacted global economic activity, and many countries and many states in the United States reacted to it by instituting quarantines, mandating business and school closures and restricting travel periodically throughout the pandemic. Patient enrollment for the Company’s planned clinical research studies of serial draws of the Company’s OvaNex study has been slower than originally planned due to the impact of clinic closures and patients not seeking medical care in some states, which has led to delays in the completion of such studies. Given the uncertainties associated with potential resurgences of the COVID-19 pandemic, the Company is unable to estimate the extent of the impact of the COVID-19 pandemic on its operations or liquidity.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2021 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and notes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in Aspira’s Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 31, 2022.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.

Significant Accounting Policies

Revenue Recognition

Product Revenue – Ova1, Overa and Ova1Plus: The Company recognizes product revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is recognized upon completion of the Ova1, Overa or Ova1Plus test and delivery of results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, the Company considers factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and the Company, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management as the collection cycle on some accounts can be as long as one year. The effect of any change made to an estimated input component and, therefore revenue recognized, would be recorded as a change in estimate at the time of the change.

The Company also reviews its patient account population and determines an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar

collection experience. The Company has elected this practical expedient that, when evaluated for collectability, results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis. During the period ended September 30, 2022, there were no adjustments to estimates of variable consideration to derecognize revenue for services provided in a prior period. There were no impairment losses on accounts receivable recorded during the periods ended September 30, 2022 and 2021.

Genetics Revenue – Aspira GenetiX: Under ASC 606, the Company’s genetics revenue is recognized upon completion of the Aspira GenetiX test and delivery of results to the physician based on estimates of amounts that will ultimately be realized. In determining the amount of revenue to be recognized for a delivered test result, the Company considers factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and the Company, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management.

In September 2022, the Company received a notice of cancellation from its only Aspira Synergy genetics carrier screening customer, Axia Women’s Health. As a result of this cancellation, along with the general deterioration of commercial opportunities in the genetics carrier screening market, has led the Company to cease providing Aspira GenetiX, including genetics carrier screening, on our Aspira Synergy platform, effective as of September 30, 2022. The Company did not incur any termination penalties nor did the Company accrue any expenses as a result of the cancellation. This is not expected to have a material impact on the Company’s revenues in 2022 or in any future periods.

Recent Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board issued Accounting Standard Update No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This update changes the impairment model from the currently used incurred loss methodology to an expected loss methodology, which will result in the more timely recognition of losses. This ASU 2016-13 is scheduled to be effective in 2023 for smaller reporting companies. While the Company is evaluating the effect of adopting this new accounting guidance, its effect will largely depend on the composition and credit quality of the Company’s portfolio of financial assets and the economic conditions at the time of adoption.

In August 2020, the Financial Accounting Standards Board issued Accounting Standard Update No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). This update was issued to assist in simplifying the accounting for convertible instruments. This ASU 2020-06 is scheduled to be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is in the process of evaluating the impact of this standard on its condensed consolidated financial statements.

Commitments And Contingencies

9 Months Ended

Sep. 30, 2022

Commitments And Contingencies [Abstract]

Commitments And Contingencies

2. COMMITMENTS AND CONTINGENCIES

Coronavirus Aid, Relief, and Economic Security (CARES) Act and Paycheck Protection Program Loan

On May 1, 2020, the Company obtained the Paycheck Protection Program loan (the “PPP Loan”) from BBVA USA in the aggregate amount of approximately $1,006,000. The Company applied for forgiveness of the PPP Loan in March 2021, and, effective May 27, 2021, the U.S. Small Business Administration confirmed the waiver of the Company’s repayment of the PPP Loan which was recognized as a gain in other income in 2021. The Company remains subject to an audit of the PPP loan. There is no assurance that the Company will not be required to repay all or a portion of the PPP Loan, as a result of any such audit.

Loan Agreement

On March 22, 2016, the Company entered into a loan agreement (as amended, the “DECD Loan Agreement”) with the State of Connecticut Department of Economic and Community Development (the “DECD”), pursuant to which the Company may borrow up to $4,000,000 from the DECD. The loan bears interest

at a fixed rate of 2.0% per annum and requires equal monthly payments of principal and interest until maturity, which occurs on April 15, 2026. As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender.

The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, the Company received a disbursement of the remaining $2,000,000 under the DECD Loan Agreement, as the Company had achieved the target employment milestone necessary to receive an additional $1,000,000 under the DECD Loan Agreement and the DECD determined to fund the remaining $1,000,000 under the DECD Loan Agreement after concluding that the required revenue target would likely have been achieved in the first quarter of 2020 in the absence of the impacts of COVID-19.

Under the terms of the DECD Loan Agreement, the Company may be eligible for forgiveness of up to $1,500,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by December 31, 2022. Conversely, if the Company is either unable to retain 25 full-time employees with a specified average annual salary for a consecutive two-year period or does not maintain the Company’s Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the loan plus a penalty of 5% of the total funded loan. The carrying value approximates fair value, as the interest represents market prices for similar types of borrowing arrangements.

Long-term debt consisted of the following:


	September 30,		December 31,
	2022		2021
(in thousands)
DECD loan, net of issuance costs	$	2,769	$	2,919
Less: Current portion, net of issuance costs		(343)		(201)
Total long-term debt, net of issuance costs	$	2,426	$	2,718

As of September 30, 2022, the annual amounts of future minimum principal payments due under the Company’s contractual obligation are shown in the table below. Unamortized debt issuance costs for the DECD loan were $12,000.


		Payments Due by Period
(in thousands)		Total		2022		2023		2024		2025		2026		Thereafter
DECD Loan	$	2,781	$	52	$	406	$	452	$	461	$	341	$	1,069
Total	$	2,781	$	52	$	406	$	452	$	461	$	341	$	1,069

‎

Accrued Liabilities

The following table describes the principal components of accrued liabilities on the Company’s condensed consolidated balance sheet as of:


	September 30,		December 31,
(in thousands)	2022		2021
Payroll and benefits related expenses	$	3,405	$	2,652
Collaboration and research agreements expenses		349		382
Professional services		764		1,992
Other accrued liabilities		470		273
Total accrued liabilities	$	4,988	$	5,299

Insurance Notes

During 2021, the Company entered into an insurance promissory note for the payment of insurance premiums at an interest rate of 3.74%, with an aggregate principal amount outstanding of approximately $0 and $779,000 as of September 30, 2022 and December 31, 2021, respectively. This note was payable in ten monthly installments with a maturity date of October 1, 2022 and has no financial or operational covenants.

Operating Leases

The Company leases facilities to support its business. The Company’s principal facility, including the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) laboratory used by Aspira Labs, Inc., is located in Austin, Texas, and the CLIA laboratory and administrative offices are located in Trumbull, Connecticut. The Company’s Austin, Texas lease, which expires on January 31, 2023, has no automatic renewal or renewal option. The Company’s Texas lease has a term of 12 months. The Company recognizes the lease payments in profit and loss on a straight-line basis over the term of the lease, and variable lease payments in the period in which the obligation for the payments was incurred.

In October 2015, the Company entered into a lease agreement for the facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $596,000. In September 2020, the Company exercised the renewal option for its Trumbull, Connecticut lease. The Company’s renewed lease expires on June 30, 2026, with a five-year renewal option. The Company is not reasonably certain that it will exercise the five-year renewal option beginning on July 1, 2026.

The expense associated with these operating leases for the three and nine months ended September 30, 2022 and 2021 is shown in the table below (in thousands).


		Three Months Ended September 30,
Lease Cost	Classification	2022		2021
Operating rent expense
	Cost of revenue	$	20	$	14
	Research and development		6		13
	Sales and marketing		9		8
	General and administrative		16		16
Variable rent expense
	Cost of revenue	$	10	$	8
	Research and development		5		12
	Sales and marketing		8		11
	General and administrative		16		16

		Nine Months Ended September 30,
Lease Cost	Classification	2022		2021
Operating rent expense
	Cost of revenue	$	59	$	42
	Research and development		20		35
	Sales and marketing		28		25
	General and administrative		49		51
Variable rent expense
	Cost of revenue	$	30	$	23
	Research and development		16		25
	Sales and marketing		26		30
	General and administrative		51		46

Based on the Company’s leases as of September 30, 2022, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).


2022	$	25
2023		106
2024		116
2025		124
2026		64
Total Operating Lease Payments		435
Less: Interest		(69)
Present Value of Lease Liabilities	$	366

Weighted-average lease term and discount rate were as follows:


Weighted-average remaining lease term (in years)		3.7
Weighted-average discount rate		9.31%

Non-cancellable Royalty Obligations

The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine under which the Company licenses certain of its intellectual property directed at the discovery and validation of biomarkers in human subjects, including but not limited to clinical application of biomarkers in the understanding, diagnosis and management of human disease. Under the terms of the amended research collaboration agreement, Aspira is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500. Royalty expense for the three months ended September 30, 2022 and 2021 totaled $82,000 and $65,000, respectively, and royalty expense for the nine months ended September 30, 2022 and 2021 totaled $236,000 and $190,000, respectively, as recorded in cost of revenue in the condensed consolidated statements of operations.

Commercial Reorganization

During the three months ended March 31, 2022, the Company executed a commercial reorganization resulting in the separation of a number of employees. The organizational changes resulted in the recording within the condensed consolidated statement of operations in sales and marketing, research and development and general and administrative expenses of one-time severance, separation, and settlement charges of approximately $1,284,000. These amounts have been partially offset by insurance reimbursement of $523,000. All charges have been settled as of September 30, 2022.

Business Agreements

On August 8, 2022, the Company entered into a sponsored research agreement with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz for the generation of a multi-omic, non-invasive diagnostic aid to identify endometriosis based on circulating microRNAs and proteins. This collaboration is expected to accelerate the Company’s development and commercialization of future endometriosis products, such as EndoCheck. Under the terms of and as further described in the agreement, payments of approximately $1,252,000 have or will become due from the Company to the counterparties upon successful completion of certain deliverables in 2022 and 2023 as follows: 68% was paid in August 2022, 15% will become payable upon completion of certain deliverables estimated to occur in the fourth quarter of 2022, and 17% will become payable upon completion of certain deliverables estimated to occur in the second quarter of 2023. As of September 30, 2022 approximately $852,000 has been recorded as expense for the project.

Contingent Liabilities

From time to time, the Company is involved in legal proceedings and regulatory proceedings arising from operations. The Company establishes reserves for specific liabilities in connection with legal actions that management deems to be probable and estimable. The Company is not currently a party to any proceeding, the adverse outcome of which would have a material adverse effect on the Company’s financial position or results of operations.

Stockholders' Equity

9 Months Ended

Sep. 30, 2022

Stockholders' Equity [Abstract]

Stockholders' Equity

3. STOCKHOLDERS’ EQUITY

2022 Public Offering

On August 22, 2022, the Company, entered into an underwriting agreement (the “2022 Underwriting Agreement”) with William Blair & Company, L.L.C., as the sole underwriter (the “2022 Underwriter”). Pursuant to the 2022 Underwriting Agreement, the Company agreed to issue and sell, in an underwritten public offering (the “2022 Offering”), 12,000,000 shares of the Company’s common stock, par value $0.001 per share (“Common Stock”) and warrants to purchase up to 12,000,000 shares of Common Stock (the “Warrants”). Each share of Common Stock was sold together with one Warrant to purchase one share of Common Stock, at a price to the public of $0.75 per share and related Warrant.

The Warrants were issued pursuant to a common stock purchase warrant (the “Form of Warrant”). Each Warrant has an initial exercise price equal to $0.88 per share of Common Stock and are exercisable for five years

from the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of the Warrants are subject to adjustment in the event of certain subdivisions and combinations, including by any stock split or reverse stock split, stock dividend, recapitalization or otherwise. The exercise of the Warrants may be limited in certain circumstances if, after giving effect to such exercise, the holder or any of its affiliates would beneficially own (as determined in accordance with the terms of the Warrants) more than 4.99% (or, at the election of the holder, 9.99%) of the outstanding Common Stock immediately after giving effect to the exercise. There is no established trading market available for the Warrants on any securities exchange or nationally recognized trading system.

The Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and applicable authoritative guidance in Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815-40, Contracts in Entity’s Own Equity (“ASC 815-40”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and meet all of the requirements for equity classification under ASC 815-40, including whether the warrants are indexed to the Company’s own stock and whether the events where holders of the warrants could potentially require net cash settlement are within the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. As further described in the Form of Warrant, if the Company consummates any merger, consolidation, sale or other reorganization event, including the sale of all or substantially all of the Company’s assets, in which its common stock is converted into or exchanged for securities, cash or other property (“Fundamental Transaction”), then the Company shall pay at the holder’s option, exercisable at any time commencing on the occurrence or the consummation of the Fundamental Transaction (or, if later, the date of public announcement) and continuing up to 30 days, an amount of cash equal to the value of the remaining unexercised portion of the Warrant as determined in accordance with the Black-Scholes option pricing model on the date of such Fundamental Transaction provided; however, that if the Fundamental Transaction is not within the Company’s control, including not approved by the Board of Directors, the holder of the Warrant shall only be entitled to receive the same type or form of consideration (and in the same proportion), at the Black Scholes Value of the unexercised portion of the Warrant, that is being offered and paid to the holder of the Common Stock of the Company in connection with the Fundamental Transaction. The Black-Scholes option pricing model, as defined in the Form of Warrant, includes as an input, the highest volume weighted average price (“VWAP”) for a period of one trading day preceding the consummation or announcement of a Fundamental Transaction up to 30 days after a Fundamental Transaction. The Company has determined that an adjustment based on this input is not limited to the effect that is attributable to the Fundamental Transaction and therefore causes the Warrants to fail the indexation guidance under ASC 815-40. As a result, the Company has determined that the Warrants must be recorded as derivative liabilities upon issuance and marked to market on a quarterly basis in the Company’s condensed consolidated statement of operations until their exercise or expiration.

The fair values of the Warrants as of August 22, 2022, the issuance date, and September 30, 2022 were $7,752,000 and $2,748,000, respectively. The fair value of the Warrants was estimated using Black-Scholes pricing model based on the following assumptions:



	September 30, 2022			August 22, 2022
Dividend yield		-	%		-	%
Volatility		97.5	%		95.0	%
Risk-free interest rate		4.06	%		3.17	%
Expected lives (years)		4.89			5.00
Weighted average fair value	$	0.229		$	0.646

The fair value of the Warrants was deemed to be derivative instruments due to certain contingent put feature, was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the Warrants issued, including a fixed term and exercise price.

The fair value of Warrants was affected by changes in inputs to the Black-Scholes option pricing model including the Company’s stock price, expected stock price volatility, the contractual term, and the risk-free interest rate. This model uses Level 2 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement. At September 30, 2022, the fair value of all Warrants was $2,748,000, which are classified as a long-term Warrant liability on the Company’s balance sheet.

The 2022 Offering resulted in net proceeds to the Company of approximately $7,704,000, after deducting underwriting discounts and offering expenses of $1,296,000. Offering costs were allocated between liability expense and equity based on the fair value of the Warrants of $7,752,000 and the total gross proceeds of $9,000,000. $1,117,000 of offering costs were allocated to the Warrants and were expensed immediately and recorded as selling, general and administrative expense in the condensed unaudited consolidated statement of operations for the three months ended September 30, 2022, resulting in a net impact to the Company’s equity of $179,000.

2021 Public Offering

On February 4, 2021, the Company entered into an underwriting agreement (the “2021 Underwriting Agreement”) with William Blair & Company, L.L.C. and Truist Securities, Inc., as representatives of several underwriters (the “2021 Underwriters”), in connection with the underwritten public offering of 6,000,000 shares of Aspira common stock at a price to the public of $7.50 per share. The 2021 Underwriters purchased these 6,000,000 shares at the public offering price per share, less the underwriting discount of $0.4875 per share.

Under the 2021 Underwriting Agreement, the Company granted the 2021 Underwriters an option to purchase up to an additional 900,000 shares of Aspira common stock at the public offering price, less the underwriting discount of $0.4875 per share. On February 5, 2021, the 2021 Underwriters notified the Company that they were exercising this option in connection with the closing of the 2021 Offering. The 2021 Offering, including the additional 900,000 shares of Aspira common stock, closed on February 8, 2021 and resulted in net proceeds to the Company of approximately $47,858,000, after deducting underwriting discounts and offering expenses of $378,000. There was a change in estimate in the third quarter of 2021 in the amount of $138,000 relating to an expense reversal of offering costs.

2019 Stock Incentive Plan

At the Company’s 2019 annual meeting of stockholders, the Company’s stockholders approved the Vermillion, Inc. 2019 Stock Incentive Plan, the name of which was subsequently changed to the Aspira Women’s Health Inc. 2019 Stock Incentive Plan (the “2019 Plan”). The purposes of the 2019 Plan are (i) to align the interests of the Company’s stockholders and recipients of awards under the 2019 Plan by increasing the proprietary interest of such recipients in the Company’s growth and success; (ii) to advance the interests of the Company by attracting and retaining non-employee directors, officers, other employees, consultants, independent contractors and agents; and (iii) to motivate such persons to act in the long-term best interests of the Company and its stockholders. The 2019 Plan allows the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units and performance awards to participants.

Subject to the terms and conditions of the 2019 Plan, the initial number of shares authorized for grants under the 2019 Plan is 10,492,283. To the extent an equity award granted under the 2019 Plan expires or otherwise terminates without having been exercised or paid in full, or is settled in cash, the shares of common stock subject to such award will become available for future grant under the 2019 Plan. As of September 30, 2022, 9,873,424 shares of Aspira common stock were subject to outstanding stock options, and 149,249 shares of Aspira common stock were subject to unvested restricted stock awards and a total of 3,531,486 shares of Aspira common stock were reserved for issuance under the 2019 Plan.

‎

Stock-Based Compensation

During the three months ended March 31, 2022, the Company granted the following awards under the 2019 Plan. In addition, assumptions included in the fair value per share calculations were expected terms of one to four years, one- to five-year treasury interest rates of 1.38% to 3.28% and market close prices ranging from $1.04 to $1.08. The Company recorded $334,000 in forfeitures for the three months ended March 31, 2022.


Grant Date	Number of Shares	Type of Award	Exercise Price / Share	Fair Value / Share
1/28/2022	222,000	Options	$ 1.08	$ 0.70
3/1/2022	5,000	Options	$ 1.05	$ 0.31
3/31/2022	1,706,282	Options	$ 1.04	$ 0.51
3/31/2022	269,297	Restricted Stock Units	$ -	$ -
	2,202,579

During the three months ended June 30, 2022, the Company granted the following awards under the 2019 Plan. In addition, assumptions included in the fair value per share calculations were expected terms of one to two years, one- to five-year treasury interest rates of 1.72% to 3.13% and market close prices ranging from $0.52 to $1.05. The Company recorded $109,000 in forfeitures for the three months ended June 30, 2022.


Grant Date	Number of Shares	Type of Award	Exercise Price	Fair Value / Share
4/1/2022	5,000	Options	$ 1.05	$ 0.33
5/2/2022	5,000	Options	$ 0.70	$ 0.22
5/19/2022	60,000	Options	$ 0.55	$ 0.28
6/1/2022	5,000	Options	$ 0.56	$ 0.22
6/23/2022	15,000	Options	$ 0.52	$ 0.21
6/23/2022	78,000	Options	$ 0.52	$ 0.27
6/23/2022	83,799	Options	$ 0.52	$ 0.36
6/23/2022	169,043	Restricted Stock Units	$ -	$ -
	420,842

During the three months ended September 30, 2022, the Company granted the following awards under the 2019 Plan. In addition, assumptions included in the fair value per share calculations were expected terms of one to two years, five-year treasury interest rates of 2.79% to 3.50% and market close prices ranging from $0.25 to $0.48. The Company recorded $119,000 in forfeitures for the three months ended September 30, 2022.


Grant Date	Number of Shares	Type of Award	Exercise Price	Fair Value / Share
7/1/2022	5,000	Options	$ 0.73	$ 0.32
7/5/2022	200,000	Options	$ 0.77	$ 0.40
8/1/2022	5,000	Options	$ 0.80	$ 0.35
8/18/2022	122,000	Options	$ 0.92	$ 0.48
9/1/2022	5,000	Options	$ 0.53	$ 0.25
	337,000

The allocation of employee stock-based compensation expense, including expense reversals due to forfeitures, by functional area for the three and nine months ended September 30, 2022 and 2021 was as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
(in thousands)	2022		2021		2022		2021
Cost of revenue	$	(27)	$	44	$	52	$	123
Research and development		31		113		21		231
Sales and marketing		76		350		281		814
General and administrative		428		445		1,445		1,236
Total	$	508	$	952	$	1,799	$	2,404

Loss Per Share	9 Months Ended
Loss Per Share	Sep. 30, 2022
Loss Per Share [Abstract]
Loss Per Share	4. LOSS PER SHAREThe Company calculates basic loss per share using the weighted average number of shares of Aspira common stock outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of Aspira common stock outstanding and excludes the anti-dilutive effects of 10,022,672 and 10,529,341 potential shares of Aspira common stock as of September 30, 2022 and 2021, respectively, in addition to 12,000,000 shares of Aspira common stock issuable upon the exercise of the Warrants outstanding as of September 30, 2022. Potential shares of Aspira common stock and warrants include incremental shares of Aspira common stock issuable upon the exercise of stock options and warrants and the vesting of unvested restricted stock units.

Organization, Basis Of Presentation And Summary Of Significant Accounting And Reporting Policies (Policy)	9 Months Ended
	Sep. 30, 2022
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]
Organization	Organization Aspira Women’s Health Inc., formerly known as Vermillion, Inc. (“Aspira” and its wholly-owned subsidiaries are collectively referred to as the “Company”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company currently markets and sells the following products and related services: (1) Ova1, a blood test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation does not indicate malignancy; (2) Overa, a second-generation biomarker reflex intended to maintain Ova1’s high sensitivity while improving specificity; (3) Ova1Plus, a reflex offering which uses Ova1 as the primary test and Overa as a confirmation for Ova1 intermediate range results; and (4) Aspira Synergy, the Company’s decentralized testing platform and cloud service for decentralized global access of protein biomarker testing. The Company continues to make Ova1, Overa, and Ova1Plus, and plans to make future technology available through Aspira Synergy. The Company’s Ova1 test received FDA de novo classification in September 2009. Ova1 comprises instruments, assays, reagents, and the OvaCalc software, which includes a proprietary algorithm that produces a risk score. The Company’s Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1 and Overa each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources (in addition to revenue from Aspira GenetiX) is included in total revenue in the results of operations for the nine months ended September 30, 2022.
Liquidity	Liquidity As of September 30, 2022, the Company had $20,551,000 of cash and cash equivalents (excluding restricted cash of $250,000), an accumulated deficit of approximately ($493,797,000), and working capital of $15,679,000. For the nine months ended September 30, 2022, the Company incurred a net loss of ($22,069,000) and used cash in operations of ($25,109,000). The Company has incurred significant net losses and negative cash flows from operations since inception and the Company also expects to continue to incur a net loss and negative cash flows from operations for 2022. There can be no assurance that the Company will achieve or sustain profitability or positive cash flow from operations. Given the above conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties. The Company expects to raise capital through sources that may include public or private equity offerings, debt financings, the exercise of common stock warrants, collaborations, licensing arrangements, grants and government funding and strategic alliances. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity, and that could have a material adverse effect on the Company’s business, results of operations and financial condition. On June 1, 2022, the Company received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying the Company that, for the preceding 30 consecutive business days, the closing bid price for the Company’s common stock was below the minimum $1.00 per share requirement for continued inclusion on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). As provided in the Nasdaq rules, the Company has 180 calendar days, or until November 28, 2022, to regain compliance with the Minimum Bid Price Rule. The Company may achieve compliance during this period if the closing bid price of Aspira common stock is at least $1.00 per share for a minimum of 10 consecutive business days. If the Company fails to regain compliance on or prior to November 28, 2022, the Company may be eligible for an additional 180-calendar day compliance period, which would extend the deadline until May 27, 2023. There is no assurance that the Company will be able to regain compliance by the November 28, 2022 deadline or the additional 180-calendar day extended deadline, and there is no assurance that the Company will otherwise maintain compliance with this or any of the other Nasdaq continued listing requirements.