Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

    (Mark One)

   


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

For the quarterly period ended March 31, 2024


	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  No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes  No 

Indicate by check mark whether the registrant 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  

    Smaller reporting company 
Emerging growth company 

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

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

As of May 10, 2024, the registrant had 12,449,512 shares of common stock, par value $0.001 per share, outstanding.

ASPIRA WOMEN’S HEALTH INC.

FORM 10-Q

For the Quarter Ended March 31, 2024

Table of Contents





		Page
PART I	Financial Information	1
Item 1	Financial Statements (unaudited)	1
	Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023	1
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2024 and 2023	2
	Condensed Consolidated Statements of Changes in Stockholders’ (Deficit) Equity for the three months ended March 31, 2024 and 2023	3
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2	Management's Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3	Quantitative and Qualitative Disclosures About Market Risk	27
Item 4	Controls and Procedures	27
PART II	Other Information	29
Item 1	Legal Proceedings	29
Item 1A	Risk Factors	29
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3	Defaults Upon Senior Securities	30
Item 4	Mine Safety Disclosures	30
Item 5	Other Information	30
Item 6	Exhibits	31
SIGNATURES		32

The following are registered and unregistered trademarks and service marks of Aspira Women’s Health Inc.: VERMILLION SM, Aspira Women’s Health®, OVA1®, OVERA®, ASPiRA LABS ®, OvaCalc®, OVASUITESM, ASPiRA GenetiXSM, OVA1PLUS®, OVAWATCH®, EndoCheckSM, OVAInheritSM, Aspira Synergy®,, OVA360SM, ASPIRA IVDSM, 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)


	March 31,			December 31,
	2024			2023
Assets
Current assets:
Cash and cash equivalents	$	3,413		$	2,597
Accounts receivable, net of reserves of $2 and $15, as of March 31, 2024 and December 31, 2023, respectively		1,531			1,459
Prepaid expenses and other current assets		942			997
Inventories		236			227
Total current assets		6,122			5,280
Property and equipment, net		131			165
Right-of-use assets		620			528
Restricted cash		260			258
Other assets		31			31
Total assets	$	7,164		$	6,262
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	1,643		$	1,261
Accrued liabilities		2,797			2,863
Current portion of long-term debt		249			166
Short-term debt		416			670
Current maturities of lease liabilities		188			159
Total current liabilities		5,293			5,119
Non-current liabilities:
Long-term debt		1,347			1,430
Non-current maturities of lease liabilities		487			427
Warrant liabilities		1,400			1,651
Total liabilities		8,527			8,627
Commitments and contingencies (Note 4)
Stockholders’ deficit:
Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively; 12,344,104 and 10,645,049 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively		12			11
Additional paid-in capital		521,557			515,927
Accumulated deficit		(522,932	)		(518,303	)
Total stockholders’ deficit		(1,363	)		(2,365	)
Total liabilities and stockholders’ deficit	$	7,164		$	6,262

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
	March 31,
	2024			2023
Revenue:
Product	$	2,153		$	2,315
Genetics		—			1
Total revenue		2,153			2,316
Cost of revenue:
Product		939			1,130
Total cost of revenue		939			1,130
Gross profit		1,214			1,186
Operating expenses:
Research and development		906			1,267
Sales and marketing		1,889			2,595
General and administrative		3,129			3,604
Total operating expenses		5,924			7,466
Loss from operations		(4,710	)		(6,280	)
Other income (expense), net:
Change in fair value of warrant liabilities		251			(24	)
Interest (expense) income, net		(5	)		26
Other expense, net		(165	)		(300	)
Total other income (expense), net		81			(298	)
Net loss	$	(4,629	)	$	(6,578	)
Net loss per share - basic and diluted	$	(0.39	)	$	(0.79	)
Weighted average common shares used to compute basic and diluted net loss per common share		11,846,075			8,313,091

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
Balance at December 31, 2023		10,645,049	$	11	$	515,927	$	(518,303	)	$	(2,365	)
Net loss		—		—		—		(4,629	)		(4,629	)
Common stock issued under an equity line of credit agreement		111,369		—		400		—			400
Common stock issued under a registered direct offering, net of issuance costs		1,371,000		1		4,868		—			4,869
Warrant Exercise		200,000		—		—		—			—
Common stock issued for vested restricted stock awards		16,686		—		—		—			—
Stock-based compensation expense		—		—		362		—			362
Balance at March 31, 2024		12,344,104	$	12	$	521,557	$	(522,932	)	$	(1,363	)

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
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

See accompanying notes to the unaudited condensed consolidated financial statements.

Aspira Women’s Health Inc.

Condensed Consolidated Statements of Cash Flows (unaudited)

(Amounts in Thousands)


	Three Months Ended
	March 31,
	2024			2023
Cash flows from operating activities:
Net loss	$	(4,629	)	$	(6,578	)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash lease expense		(3	)		1
Depreciation and amortization		29			70
Stock-based compensation expense		362			396
Change in fair value of warrant liabilities		(251	)		24
Loss on impairment and disposal of property and equipment		25			1
Changes in operating assets and liabilities:
Accounts receivable		(72	)		(309	)
Prepaid expenses and other assets		55			323
Inventories		(9	)		14
Accounts payable		382			(14	)
Accrued liabilities		(66	)		582
Other liabilities		(254	)		(216	)
Net cash used in operating activities		(4,431	)		(5,706	)
Cash flows from investing activities:
Purchase of property and equipment		(20	)		(8	)
Net cash used in investing activities		(20	)		(8	)
Cash flows from financing activities:
Principal repayment of DECD loan		—			(85	)
Proceeds from at the market offering		—			162
Payment of issuance costs for at the market offering		—			(132	)
Proceeds from equity line of credit		400			—
Proceeds from registered direct offering		5,563			—
Payment of issuance costs for registered direct offering		(694	)		—
Net cash provided by (used in) financing activities		5,269			(55	)
Net increase (decrease) in cash, cash equivalents and restricted cash		818			(5,769	)
Cash, cash equivalents and restricted cash, beginning of the period		2,855			13,557
Cash, cash equivalents and restricted cash, end of the period	$	3,673		$	7,788
Reconciliation to Consolidated Balance Sheet:
Cash and cash equivalents	$	3,413		$	7,535
Restricted cash		260			253
Unrestricted and restricted cash and cash equivalents	$	3,673		$	7,788
Supplemental disclosure of cash flow information:
Cash paid for interest	$	6		$	18
Supplemental disclosure of noncash investing and financing activities:
Net increase in right-of-use assets	$	169		$	—

See accompanying notes to the unaudited condensed consolidated financial statements.

Aspira Women’s Health Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

Aspira Women’s Health 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) the Ova1Plus workflow, which uses Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Ova1 is a qualitative serum 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. Overa is a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity. The Ova1 workflow leverages the strengths of Ova1’s (MIA) sensitivity and Overa’s (MIAG2G) specificity to reduce incorrectly elevated results; and

(2) OvaWatch, a Laboratory Developed Test (“LDT”) intended in the clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.

Collectively, these tests are referred to and marketed as OvaSuite.

For the three months ended March 31, 2024 and 2023, the Company’s product and related revenue was limited to the products described above, as well as residual revenue from Aspira GenetiX, which was discontinued in the third quarter of 2022. The Company’s products are distributed through its own national sales force, including field sales, inside sales and a contracted sales team, through its proprietary decentralized testing platform and cloud service marketed as Aspira Synergy, and through marketing and distribution agreements with BioReference Health, LLC and ARUP Laboratories.

Overa is currently not offered commercially except as a reflex test performed as part of the Ova1Plus workflow.

Going Concern and Liquidity

As of March 31, 2024, the Company had approximately $3,413,000 of cash and cash equivalents (excluding restricted cash of $260,000), an accumulated deficit of approximately $522,932,000, and working capital of approximately $829,000. For the three months ended March 31, 2024, the Company incurred a net loss of $4,629,000, and used cash in operations of $4,431,000. The Company has incurred significant net losses and negative cash flows from operations since inception. The Company also expects to continue to incur a net loss and negative cash flows from operations for the remainder of 2024. In order to fund operations, meet its capital requirements or satisfy the anticipated obligations as they become due, the Company expects to take further action to protect its liquidity position, which include, but are not limited to:

•

Raising capital through equity or debt offerings either in the public markets or via private placement offering, to the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. However, no assurance can be given that capital will be available on acceptable terms, or at all;

•

Securing debt, however, no assurance can be given that debt will be available on acceptable terms or at all;

•

Reducing executive bonuses or replacing cash compensation with equity grants;

•

Reducing professional services and consulting fees and eliminating non-critical projects;

•

Reducing travel and entertainment expenses; and

•

Reducing eliminating or deferring discretionary marketing programs.

The Company also has outstanding warrants to purchase shares of its common stock that may be exercised although there can be no assurance that the warrants will be exercised.

There can be no assurance that the Company will achieve or sustain profitability or positive cash flow from operations. Management expects cash from product sales and licensing to be the Company’s only material, recurring source of cash in 2024. Given the above conditions, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed. The unaudited condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.

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 unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The consolidated balance sheet at December 31, 2023 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, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on April 1, 2024.

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 – OvaSuite: The Company recognizes product revenue in accordance with the provisions of Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is recognized upon completion of the OvaSuite 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 March 31, 2024, there were $8,000 of 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 three months ended March 31, 2024.

The Company has discontinued providing Aspira GenetiX, including genetics carrier screening, on the Aspira Synergy platform, effective September 30, 2022.

Accounts Receivable: Virtually all accounts receivable are derived from sales made to customers located in North America. The Company grants credit to customers in the normal course of business and the resulting trade receivables are stated at their net realizable value. The Company maintains an allowance for credit losses based upon the expected collectability of accounts receivable, including the historical collection cycle. Amounts are written off against the allowances for credit losses when the Company determines that a customer account is not collectable. The Company believes its exposure to concentrations of credit risk is limited due to the diversity of its payer base.

Warrants: 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. Warrants that meet all of the criteria for equity classification are recorded as a component of additional paid-in capital at the time of issuance and are not remeasured. Warrants that do not meet the required criteria for equity classification are classified as liabilities. The Company adjusts such warrants to fair value at each reporting period until the warrants are exercised or expire. Any change in fair value is recognized in the Company’s statement of operations.

Recent Accounting Pronouncements

In August 2020, the FASB issued ASU 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 is scheduled to be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company adopted the new standard on January 1, 2024. The adoption of this standard did not have a material impact on its consolidated results of operations, financial position, or cash flows.

In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”) to clarify guidance in Topic 820 on the fair value measurement of an equity security that is subject to a contractual sale restriction and also requires specific disclosures related to an equity security. ASU 2022-03 is scheduled to be effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect a material impact as a result of this standard on its results of operations, financial position, or cash flows.

In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (“ASU 2023-06”). The amendments in this ASU are expected to clarify or improve disclosure and presentation requirements of a variety of ASC topics by aligning them with the SEC’s regulations. ASU 2023-06 will become effective for each amendment on the effective date of the SEC's corresponding disclosure rule changes. The Company does not expect ASU 2023-06 will have a material impact on its results of operations, financial position, or cash flows.

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. This ASU requires disclosure of significant segment expenses that are regularly provided to the Company’s Chief Operating Decision Maker (“CODM”) and included within the reported measure of a segment’s profit or loss, requires interim disclosures about a reportable segment’s profit or loss and assets that are currently required annually, requires disclosure of the position and title of the CODM, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. ASU 2023-07 is scheduled to be effective for fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024. The adoption of this standard is not expected to have a material impact on its consolidated results of operations, financial position, or cash flows.

FAIR VALUE MEASUREMENTS

Fair Value of Financial Instruments

Financial instruments of the Company consist primarily of cash and cash equivalents, restricted cash accounts, receivable, and accounts payable, and warrant liability. These items are considered Level 1 due to their short-term nature and their market interest rates. Warrant liability is considered Level 2 and is recorded at fair value at the end of each reporting period. Debt is considered Level 3, which the Company does not record at fair value.

The Company records warrants in connection with a public offering in 2022 (the “2022 Warrants”) as a liability. As discussed in Note 6 to the unaudited condensed consolidated financial statements, in connection with a registered direct offering in 2024, the Company amended certain of the 2022 Warrants to purchase up to an aggregate of 366,664 shares (the “Modified Warrants”). The terms of the remaining 433,321 of the 2022 Warrants were unchanged (the “Unmodified Warrants”).

The fair values of the Warrants as of March 31, 2024 and December 31, 2023 were approximately $1,400,000 and $1,651,000, respectively. The fair value of the 2022 Warrants was estimated using Black-Scholes pricing model based on the following assumptions:


	March 31, 2024						December 31, 2023
	Unmodified Warrants			Modified Warrants
Dividend yield		—	%		—	%		—	%
Volatility		104.9	%		101.7	%		105.1	%
Risk-free interest rate		4.31	%		4.21	%		3.93	%
Expected lives (years)		3.39			4.83			3.64
Weighted average fair value	$	1.329		$	2.247		$	2.064

The 2022 Warrants were deemed to be derivative instruments due to certain contingent put features. The fair value of the 2022 Warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the 2022 Warrants issued, including a fixed term and exercise price.

The fair value of the 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. The 2022 Warrants are classified as a long-term liability on the Company’s balance sheet.

The carrying value of the Company’s insurance promissory note approximates fair value as of March 31, 2024 and December 31, 2023, due to the short-term nature of the insurance note and is classified as Level 2 within the fair value hierarchy.

The DECD loan is classified within Level 3 of the fair value hierarchy. The following table presents the carrying value and fair value of the DECD loan. The fair value of the DECD loan is estimated based on discounted cash flows using the prevailing market interest rates.


		March 31,				December 31,
		2024				2023
(in thousands)	Fair Value Hierarchy	Carrying Value		Fair Value		Carrying Value		Fair Value
DECD loan	Level 3	$	1,604	$	1,287	$	1,604	$	1,255

PREPAID AND OTHER CURRENT ASSETS

Prepaid and other current assets at March 31, 2024 and December 31, 2023 consist of the following:


	March 31,		December 31,
(in thousands)	2024		2023
Prepaid insurance	$	479	$	684
Software licenses		173		103
Subscriptions		128		26
Other		162		184
Total prepaid and other current assets	$	942	$	997

COMMITMENTS AND CONTINGENCIES

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 January 1, 2032. 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 was eligible for forgiveness of up to $1,500,000 of the principal amount of the loan if it was able to achieve certain job creation and retention milestones by December 31, 2022. On June 26, 2023, the Company was notified by the DECD that the Company satisfied all job creation and retention requirements under the loan agreement to receive forgiveness of $1,000,000. During the year ended December 31, 2023, the Company recorded the $1,000,000 as other income in the statement of operations. If the Company fails to maintain its Connecticut operations through March 22, 2026, the DECD may require early repayment of a portion or all of the remaining amount of the loan plus a penalty of 5% of the total funded loan.

On June 6, 2023, the Company was granted a deferral of interest and principal payments on a portion of the remaining outstanding balances through December 1, 2023. On January 30, 2024, the Company was granted an additional deferral of interest and principal payments on a portion of the remaining outstanding balances through June 1, 2024. The Company determined the loan deferrals met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors, as the Company was experiencing financial difficulties and the lenders granted a concession. The future undiscounted cash flows of the DECD loan after the loan deferrals exceeded the carrying value of the DECD loan prior to the loan deferrals. As such no gain was recognized as a result of the deferrals.

Long-term debt consisted of the following:


	March 31,			December 31,
	2024			2023
(in thousands)
DECD loan, net of issuance costs	$	1,596		$	1,596
Less: Current portion, net of issuance costs		(249	)		(166	)
Total long-term debt, net of issuance costs	$	1,347		$	1,430

As of March 31, 2024, 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 $8,000 for both the three months ended March 31, 2024 and December 31, 2023, respectively.


	Payments Due by Period
(in thousands)	Total		2024		2025		2026		2027		2028		Thereafter
DECD Loan	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413
Total	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413

Insurance Notes

During 2023, the Company entered into an insurance promissory note for the payment of insurance premiums at an interest rate of 7.79%, with an aggregate principal amount outstanding of approximately $416,000 and $670,000 as of March 31, 2024 and December 31, 2023, respectively. Interest paid for the promissory note was $6,000 for each of the quarters ended March 31, 2024 and 2023. The amount outstanding in 2024 could be substantially offset by the cancellation of the related insurance coverage which is classified in prepaid insurance. This note is payable in nine monthly installments with a maturity date of October 1, 2024 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 administrative offices are located in Trumbull, Connecticut and Palo Alto, California.

In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut, which was renewed in September 2020. In May 2023, the Company entered into an agreement with the owner of its Trumbull, Connecticut offices to move to a more economical location in Shelton, Connecticut and replacing the Trumbull, Connecticut office lease. The new lease term is for five years, and its commencement date was October 1, 2023. Beginning on October 1, 2023, the fixed lease payment was reduced from approximately $8,900 per month to $5,000 per month for the first year, and to $5,383 per month for years two through four and $5,768 per month for the fifth year. Continuation of the lease would be on a month-to-month basis.

In January 2023, the Company entered into a new sublease agreement for an administrative facility in Palo Alto, California. The Company’s sublease term commenced in April 2023 and terminates on May 31, 2024, with no option for renewal with the sublessor. The fixed lease payment was initially approximately $9,000 per month and increased to approximately $10,000 per month beginning in January 2024.

In July 2023, the Company extended the Austin, Texas lease for an additional 37 months. The Company’s renewed lease expires on February 28, 2027, with the option to extend the lease for an additional three years. Prior to the renewal, the Company’s Texas lease had a term of 12 months, and the Company has elected the policy of not recording leases on the balance sheet when the leases have terms of 12 months or less. Through June 30, 2023, the Company recognized 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. Variable lease costs represent the Company’s share of the landlord’s operating expenses. Beginning in the third quarter of 2023, the Company added the extended Austin, Texas lease to its balance sheet as a right-of-use asset. Beginning February 1, 2024, the fixed lease payment were reduced from approximately $9,490 per month to approximately $7,100 per month for the first year (except for August 2024, which will be $0), and will be approximately $8,600 per month for the second year, approximately $8,900 per month for the third year and approximately $9,100 for the final month. The Company is not reasonably certain that it will exercise the three-year renewal option beginning on March 1, 2027.

Effective October 31, 2023, the Company entered into a new lease agreement for freezer storage for its samples. The lease term is for 36 months with a twelve-month automatic renewal provision. The company leases 6 freezers at a total of $5,200 per month. The Company added the lease to its balance sheet as a right-of-use asset in the first quarter of 2024.

The expense associated with these operating leases for the three months ended March 31, 2024 and 2023 is shown in the table below (in thousands).


		Three Months Ended March 31,
Lease Cost	Classification		2024		2023
Operating rent expense
	Cost of revenue		$	41	$	24
	Research and development			17		6
	Sales and marketing			1		2
	General and administrative			10		21
Variable rent expense
	Cost of revenue			5		15
	Research and development			-		3
	Sales and marketing			2		2
	General and administrative			9		21

Based on the Company’s leases as of March 31, 2024, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).


Year	Payments
2024	$	172
2025		229
2026		223
2027		84
2028		52
Total Operating Lease Payments		760
Less: Imputed Interest		(85	)
Present Value of Lease Liabilities		675
Less: Operating Lease Liability, current portion		(188	)
Operating Lease Liability, non-current portion	$	487

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


	Three Months Ended March 31,
	2024			2023
Cash paid for amounts included in measurement of lease liabilities:
Operating cash outflows relating to operating leases	$	117		$	111
Weighted-average remaining lease term (in years)		3.3			3.2
Weighted-average discount rate		7.28	%		9.29	%

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 March 31, 2024 and 2023 totaled $72,000 and $90,000, respectively, and are recorded in cost of revenue in the unaudited condensed consolidated statements of operations.

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 (the “Dana-Farber, Brigham, Lodz Research Agreement”), for the

generation of a multi-omic, non-invasive diagnostic aid to identify endometriosis based on circulating microRNAs and proteins. The Dana-Farber, Brigham, Lodz Research Agreement requires payments to be made upon the achievement of certain milestones. Under the terms of and as further described in the Dana-Farber, Brigham, Lodz Research Agreement, payments of approximately $1,252,000 have or will become due from the Company to the counterparties upon successful completion of certain deliverables as follows: 68% was paid in 2022, 15% was paid in 2023, and the remaining 17% will become payable upon completion of certain deliverables estimated to occur in the first half of 2024. During the three months ended March 31, 2024 and 2023, approximately $34,000 and $23,000 has been recorded, respectively, as research and development expense in the unaudited condensed consolidated financial statement of operations for the project. From the inception of the Dana-Farber, Brigham, Lodz Research Agreement through March 31, 2024, research and development expenses in the cumulative amount of $1,117,000 have been recorded.

On March 20, 2023, the Company entered into a licensing agreement (“Dana-Farber, Brigham, Lodz License Agreement”) with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz under which the Company will license certain of its intellectual property to be used in the Company’s OvaSuite product portfolio. Under the Dana-Farber, Brigham, Lodz License Agreement, the Company paid an initial license fee of $75,000 and pays an annual license maintenance fee of $50,000 on each anniversary of the date of the Dana-Farber, Brigham, Lodz License Agreement. The Company recorded $50,000 in annual license maintenance fees over the twelve month period ended March 20, 2024. The Dana-Farber, Brigham, Lodz License Agreement also requires non-refundable royalty payments of up to $1,350,000 based on certain regulatory approvals and commercialization milestones and further royalty payments based on the net sales of the Company’s products included under the Dana-Farber, Brigham, Lodz License Agreement. No milestones have been reached as of March 31, 2024.

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.

ACCRUED LIABILITIES

The following table describes the principal components of accrued liabilities on the Company’s unaudited condensed consolidated balance sheet as of March 31, 2024 and December 31, 2023.


	March 31,		December 31,
(in thousands)	2024		2023
Payroll and benefits related expenses	$	1,328	$	1,189
Collaboration and research agreements expenses		99		217
Professional services		911		951
Other accrued liabilities		459		506
Total accrued liabilities	$	2,797	$	2,863

STOCKHOLDERS’ DEFICIT

2024 Registered Direct Offering

On January 24, 2024, the Company entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of Common Stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of Common Stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”).

Pursuant to the 2024 Direct Offering Agreement, the Company issued 1,368,600 shares of common stock to certain investors at an offering price of $3.50 per share, and 2,400 shares of common stock to its Chief Executive Officer, Nicole Sandford, at an offering price of $4.2555 per share, which was the consolidated closing bid price of the Company’s common stock on The Nasdaq Capital Market on January 24, 2024 of $4.13 per share plus $0.125 per Purchase Warrant. The purchase price of each Pre-Funded Warrant is equal to the combined purchase price at which a share of Common Stock and the accompanying Purchase Warrant is sold in this 2024 Direct Offering, minus $0.0001. The gross proceeds to the Company from the 2024 Direct Offering were approximately $5,563,000, before deducting placement agent fees and other estimated expenses of $694,000 payable by the Company. The 2024 Direct Offering closed on January 26, 2024.

The Pre-Funded Warrants were exercisable at any time after the date of issuance and had an exercise price of $0.0001 per share. A holder of Pre-Funded Warrants could not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage to a percentage not in excess of 9.99% by providing at least 61 days’ prior notice to the Company. All of the Pre-Funded Warrants were exercised on February 6, 2024 for gross proceeds of $20.

The Purchase Warrants have an exercise price of $4.13 per share and will be exercisable beginning six months after issuance and will expire 5 years from the initial exercise date.

The Company engaged AGP to act as sole placement agent in the 2024 Direct Offering. The Company paid the placement agent a cash fee equal to 7.0% of the aggregate gross proceeds generated from the 2024 Direct Offering, except that, with respect to proceeds raised in this 2024 Direct Offering from certain designated persons, AGP’s cash fee is reduced to 3.5% of such proceeds, and to reimburse certain fees and expenses of the placement agent in connection with the 2024 Direct Offering. The Company also reimbursed the placement agent for its accountable offering-related legal expenses of $75,000 and a non-accountable expense allowance of $30,000. Costs related to the 2024 Direct Offering were recorded as an offset to additional paid-in capital on the Company's balance sheet as of March 31, 2024.

The Company evaluated the Pre-Funded Warrants and the Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

The Pre-Funded Warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) are immediately exercisable, (3) do not embody an obligation for the Company to repurchase its shares, (4) permit the holder to receive a fixed number of shares of common stock upon exercise, (5) are indexed to the Company's common stock and (6) meet the equity classification criteria.

The Purchase Warrants are equity classified because they (1) are freestanding financial instruments that are legally detachable and separately exercisable from the common stock, (2) do not embody an obligation for the Company to repurchase its shares, (3) permit the holder to receive a fixed number of shares of common stock upon exercise, (4) are indexed to the Company's common stock and (5) meet the equity classification criteria.

Effective upon the closing of the 2024 Direct Offering, the Company also amended certain existing warrants (the “2022 Warrants”), see Note 7 in our Annual Report on Form 10-K for the fiscal year-ended December 31, 2023, to purchase up to an aggregate of 366,664 shares at an exercise price of $13.20 per share and a termination date of August 25, 2027, so that the amended 2022 Warrants have a reduced exercise price of $4.13 per share and a new termination date of January 26, 2029. The other terms of the amended 2022 Warrants remain unchanged. The Company performed an analysis of the fair value of the 2022 Warrants immediately before and after the modification and the increase in fair value of the 2022 Warrants of $490 thousand was recorded as a change in fair value of warrant liabilities in the unaudited condensed statement of operations.

Approximately $106,000 of the costs related to the 2024 Direct Offering were allocated to the 2022 Warrants and were recorded as other expense in the unaudited condensed statement of operations.

2023 Registered Direct Offering

On July 20, 2023, the Company entered into a securities purchase agreement (the “Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,694,820 shares of its common stock, par value $0.001 per share (the “Direct Offering”).

Pursuant to the Direct Offering Agreement, the Company issued 1,650,473 shares of common stock to certain investors at an offering price of $2.75 per share, and 44,347 shares of common stock to its directors and executive officers at an offering price of $3.98 per share, which was the consolidated closing bid price of the Company’s common stock on The Nasdaq Capital Market on July 19, 2023. The aggregate gross proceeds to the Company from the Direct Offering were approximately $4.7 million, before deducting placement agent fees and other estimated expenses of $597,000 payable by the Company.

The Company engaged Alliance Global Partners to act as sole placement agent in the Direct Offering. The Company paid the placement agent a cash fee equal to 7.0% of the aggregate gross proceeds generated from the Direct Offering, except that, with respect to proceeds from the sale of 182,447 shares of common stock to certain investors, including directors and executive officers of the Company, the placement agent’s cash fee was 3.5%. The Company also reimbursed the placement agent for its accountable offering-related legal expenses of $75,000 and a non-accountable expense allowance of $30,000.

2023 At the Market Offering

On February 10, 2023, the Company entered into a Controlled Equity Offering Sales Agreement, (the “Cantor Sales Agreement”), with Cantor Fitzgerald & Co., (“Cantor”), as agent, pursuant to which it may offer and sell, from time to time, through Cantor, shares of the Company’s common stock, par value $0.001 per share, having an aggregate offering price of up to $12.5 million, (the “Placement Shares”). The Placement Shares were issued and sold pursuant to the Company’s effective registration statement on

Form S-3 (Registration Statement No. 333-252267), as previously filed with, and declared effective by, the SEC. The Company filed a prospectus supplement, dated February 10, 2023, with the SEC in connection with the offer and sale of the Placement Shares.

In connection with the Direct Offering on July 24, 2023, the Company delivered written notice to Cantor on July 19, 2023 that it was suspending the prospectus supplement, dated February 10, 2023, related to the Company’s common stock issuable under the Cantor Sales Agreement. The Company will not make any sales of common stock pursuant to the Cantor Sales Agreement unless and until a new prospectus supplement is filed with the SEC. The Cantor Sales Agreement remains in full force and effect during the suspension.

During the three months ended March 31, 2024, the Company sold 0 Placement Shares and recorded no transaction related offering costs. Over the life of the Cantor Sales Agreement, the Company sold 35,552 shares of the Placement Shares for gross proceeds of approximately $211,000. The Company has recorded $134,000 as an offset to additional paid-in capital representing transaction-related offering costs of the Placement Shares over the life of the Cantor Sales Agreement.

2023 Equity Line of Credit

On March 28, 2023, the Company entered into a purchase agreement (the “LPC Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and a registration rights agreement (the “LPC Registration Rights Agreement”), pursuant to which the Company has the right, in its sole discretion, to sell to Lincoln Park shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), having an aggregate value of up to $10,000,000 (the “Purchase Shares”), subject to certain limitations and conditions set forth in the LPC Purchase Agreement. The Company will control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the LPC Purchase Agreement.

Under the LPC Purchase Agreement, on any business day after March 28, 2023 selected by the Company over the 36-month term of the LPC Purchase Agreement (each, a “Purchase Date”), the Company may direct Lincoln Park to purchase up to 6,667 shares of Common Stock on such Purchase Date (a “Regular Purchase”); provided, however, that (i) a Regular Purchase may be increased to up to 13,333 shares, if the closing sale price per share of the Common Stock on The Nasdaq Capital Market is not below $7.50 on the applicable Purchase Date; (ii) a Regular Purchase may be increased to up to 16,666 shares, if the closing sale price per share of the Common Stock on The Nasdaq Capital Market is not below $11.25 on the applicable Purchase Date; and (iii) a Regular Purchase may be increased to up to 20,000 shares, if the closing sale price per share of the Common Stock on The Nasdaq Capital Market is not below $15.00 on the applicable Purchase Date. In any case, Lincoln Park’s maximum obligation under any single Regular Purchase will not exceed $1,000,000. The above-referenced share amount limitations and closing sale price thresholds are subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the LPC Purchase Agreement. The purchase price per share for each such Regular Purchase will be equal to the lesser of:

the lowest sale price for the Common Stock on The Nasdaq Capital Market on the date of sale; and

the average of the three lowest closing sale prices for the Common Stock on The Nasdaq Capital Market during the 10 consecutive business days ending on the business day immediately preceding the purchase date.

The Company also has the right to direct Lincoln Park, on any business day on which the Company has properly submitted a Regular Purchase notice for the maximum amount the Company is then permitted to sell to Lincoln Park in such Regular Purchase, to purchase an additional amount of the Common Stock (an “Accelerated Purchase”) of additional shares based on criteria established in the LPC Purchase Agreement. An Accelerated Purchase, which is at the Company’s sole discretion, may be subject to additional requirements and discounts if certain conditions are met as defined in the LPC Purchase Agreement.

The issuance of the Purchase Shares had been previously registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-252267) (the “Old Registration Statement”), and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement filed on March 28, 2023, that has expired. On April 22, 2024, the Company has filed a registration statement on Form S-3 (File No. 333-278867) (the “Registration Statement”), and the related base prospectus included in the Registration Statement, that was declared effective by the SEC on April 25, 2024.

The Company sold 472,312 shares of Common Stock under the LPC Purchase Agreement for gross proceeds of approximately $1,578,000 under the Old Registration Statement. In addition, 47,733 shares of Common Stock were issued to Lincoln Park as consideration for entering into the LPC Purchase Agreement. As of April 25, 2024, up to $8,422,000 of shares of Common Stock could be sold to Lincoln Park under the LPC Purchase Agreement, subject to the terms of the LPC Purchase Agreement.

During the three months ended March 31, 2024, the Company sold 111,369 shares under the LPC Purchase Agreement for gross proceeds of approximately $400,000. Over the life of the LPC Purchase Agreement through March 31, 2024, the Company sold 472,312 shares for gross proceeds of approximately $1,578,000. The Company incurred approximately $326,000 of costs related to the execution of the LPC Purchase Agreement, all of which are reflected in the unaudited condensed consolidated financial statements. Of the total costs incurred, approximately $258,000 was paid in common stock to Lincoln Park for a commitment fee and $30,000 was accrued for Lincoln Park expenses. These transaction costs were included in other expense in the statement of operations for the year ended December 31, 2023. Approximately $38,000 was incurred for legal fees during the year ended December 31, 2023, and were included in general and administrative expenses on the statement of operations. During the three months ended March 31, 2024 and 2023, the Company paid legal fees of $40,000 and none, respectively.

Subsequent to March 31, 2024, the Company sold 100,408 shares under the LPC Purchase Agreement for gross proceeds of approximately $300,000, as of May 10, 2024.

2010 Stock Incentive Plan

The Company’s employees, directors, and consultants were eligible to receive awards under the Vermillion, Inc. Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”), which was replaced by the 2019 Plan (as defined below) with respect to future equity grants. As of March 31, 2024, there were no shares of the Company’s common stock available for future grants under the 2010 Plan.

The following table summarizes stock option activity for the 2010 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	245,154
Options forfeited or expired	(33,965	)
Options outstanding at March 31, 2024	211,189

The weighted average exercise price of outstanding options under the 2010 Plan was $24.05 and the weighted average remaining life was 0.70 years.

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 699,485. On May 9, 2023, the Company’s stockholders approved an increase of 333,333 shares to the number of shares available for issuance under the 2019 Plan. On May 13, 2024, the Company’s stockholders approved an increase of 1,000,000 shares in the number of shares available for issuance under the 2019 Plan for a total of 2,032,818 shares. 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 March 31, 2024, 614,087 shares of Aspira common stock were subject to outstanding stock options, and 42,777 shares of Aspira common stock were subject to unreleased restricted stock awards and a total of 66,542 shares of Aspira common stock were reserved for future issuance under the 2019 Plan.

The following table summarizes stock option activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	514,768
Options granted	140,124
Options forfeited or expired	(40,805	)
Options outstanding at March 31, 2024	614,087

The weighted average exercise price of outstanding options under the 2019 Plan was $11.77 and the weighted average remaining life was 1.92 years.

The following table summarizes RSU activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	59,463
RSUs vested and issued	(16,686	)
Options outstanding at March 31, 2024	42,777

RSUs vested and unissued at March 31, 2024	22,777

Stock-Based Compensation

During the three months ended March 31, 2024, the Company granted option awards under the 2019 Plan with a weighted average grant date fair value of $2.97 and a weighted average exercise price of $4.77.

Assumptions included in the fair value per share calculations were (i) expected terms of two to three years, (ii) two- to three-year treasury interest rates of 4.33% to 4.56% and (iii) market close prices ranging from $4.00 to $4.87. The Company recorded $12,000 in forfeitures for the three months ended March 31, 2024.

The allocation of non-cash stock-based compensation expense by functional area for the three months ended March 31, 2024 and 2023 was as follows.


	Three Months Ended
	March 31,
(in thousands)	2024		2023
Cost of revenue	$	18	$	17
Research and development		66		103
Sales and marketing		25		(15	)
General and administrative		253		291
Total	$	362	$	396

As of March 31,2024, total unrecognized compensation cost related to unvested stock option awards was approximately $696,000, and the related weighted average period over which it is expected to be recognized was 1.92 years. As of March 31,2024, there was $52,000 in unrecognized compensation costs related to restricted stock units, and the related weighted average period over which it is expected to be recognized is 0.25 years.

LOSS PER SHARE

The 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 3,239,038 potential shares of Aspira common stock for the three months ended March 31, 2024 and 1,583,982 potential shares of Aspira common stock for the three months ended March 31, 2023, inclusive of 2,370,985 and 799,985 shares of Aspira common stock issuable upon the exercise of the warrants outstanding as of March 31, 2024 and 2023, respectively. 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.


	Three Months Ended
	March 31,
	2024			2023
Numerator:
Net Loss	$	(4,629	)	$	(6,578	)
Denominator:
Shares used in computing net loss per share, basic and diluted		11,846,075			8,313,091
Net loss per share, basic and diluted	$	(0.39	)	$	(0.79	)

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.

These statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “targeted,” “projects,” “aim” and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which this Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (the “SEC”), and, except as required by law, Aspira Women’s Health Inc. (“Aspira” and, together with its subsidiaries, the “Company,” “we,” “our,” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.

Examples of forward-looking statements include, without limitation:

•

projections or expectations regarding our future test volumes, revenue, price, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition;

•

the ability to maintain the listing of our common stock and public warrants on the Nasdaq Capital Market;

•

our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecological diseases, including additional pelvic disease conditions such as endometriosis, adenomyosis fibroids and benign pelvic mass monitoring;

•

our planned business strategy and the anticipated effects thereof, including partnerships such as those based on our Aspira Synergy platform, specimen or research collaborations, licensing arrangements and distribution agreements;

•

plans to expand our current or future products to markets outside of the United States;

•

plans to develop new algorithms, molecular diagnostic tests, products and tools and otherwise expand our product offerings;

•

plans to develop, launch and establish payer coverage and secure contracts for current and new products, including EndoCheck, EndoMDx and OvaMDx;

•

expectations regarding local and/or national coverage under Novitas, our Medicare Administrative Carrier;

•

anticipated efficacy of our products, product development activities and product innovations, including our ability to improve sensitivity and specificity over traditional diagnostics;

•

expected competition in the markets in which we operate;

•

plans with respect to Aspira Labs, Inc. (“Aspira Labs”), including plans to expand or consolidate Aspira Labs’ testing capabilities, specifically molecular lab capabilities;

•

expectations regarding continuing future services provided by Quest Diagnostics Incorporated;

•

expectations regarding continuing future services provided by BioReference Health, LLC;

•

plans to develop informatics products as laboratory developed tests (“LDTs”) and potential Food and Drug Administration (“FDA”) oversight changes of LDTs;

•

expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy platform and to provide and expand access to our risk assessment tests;

•

plans regarding future publications and presentations;

•

expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to enhance awareness and drive policies to provide broader access to our tests;

•

our ability to continue to comply with applicable governmental regulations, including regulations applicable to the operation of our clinical lab, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable;

•

our continued ability to expand and protect our intellectual property portfolio;

•

anticipated liquidity and capital requirements;

•

anticipated future losses and our ability to continue as a going concern;

•

expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations;

•

expectation regarding attrition and recruitment of top talent;

•

expectations regarding the results of our clinical research studies and our ability to recruit patients to participate in such studies;

•

our ability to use our net operating loss carryforwards and anticipated future tax liability under U.S. federal and state income tax legislation;

•

expected market adoption of our current and prospective diagnostic tests, including Ova1, Overa, Ova1Plus, OvaWatch, EndoCheck, EndoMDx and OvaMDx, as well as our Aspira Synergy platform;

•

expectations regarding our ability to launch new products we develop, license, co-market or acquire;

•

expectations regarding the size of the markets for our products;

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expectations regarding reimbursement for our products, and our ability to obtain such reimbursement, from third-party payers such as private insurance companies and government insurance plans;

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potential plans to pursue clearance designation with the FDA with respect to OvaWatch, EndoMDx and OvaMDx;

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expected potential target launch timing for future products;

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expectations regarding compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with laboratories;

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plans to advocate for legislation and professional society guidelines to broaden access to our products and services;

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ability to protect and safeguard against cybersecurity risks and breaches; and

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expectations regarding the results of our academic research agreements.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I Item 1A, “Risk Factors,” of our Annual Report on Form 10-K for the year ended December 31, 2023, as filed on April 1, 2024, as supplemented by the section titled “Risk Factors” in this Quarterly Report on Form 10-Q, that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform LDTs; our ability to comply with FDA regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions or force majeure of acts of God; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations.

Other sections of this Quarterly Report on Form 10-Q may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ from those contained in, or implied by, any forward-looking statements.

Company Overview

Corporate Vision

We are dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases, starting with ovarian cancer.

We plan to broaden our focus to the differential diagnosis of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures. We expect to continue commercializing our existing and new technology and to distribute our tests through our decentralized technology transfer service platform, Aspira Synergy. We also intend to continue to raise public awareness regarding the diagnostic superiority of Ova1Plus as compared to cancer antigen 125 (“CA-125”) on its own for all women with adnexal masses, as well as the superior performance of our machine learning algorithms in detecting ovarian cancer in different racial and ethnic populations. We plan to continue to expand access to our tests among Medicaid patients as part of our corporate mission to make the best care available to all women, and we plan to advocate for legislation and the adoption of our technology in professional society guidelines to provide broad access to our products and services.

We continue to focus on three key initiatives: growth, innovation, and operational excellence.

Growth. As a revenue-generating diagnostics company focused exclusively on gynecologic disease, our commercial capabilities are one of our most important differentiators. We expect our extensive experience with gynecologists and healthcare providers, along with the historical adoption of our OvaSuite tests, to drive growth as we introduce new products.

During 2023, we conducted a comprehensive review of our commercial programs to identify people, processes, and technology enhancements. As a result of the findings of that review, we implemented a revised commercial strategy (the “Commercial Refresh”) in the second half of 2023. In the first quarter of 2024, we completed the successful implementation of the Commercial Refresh and expect to leverage these enhancements as we continue to focus on growth through improving the profitability, efficiency, and effectiveness of the sales and marketing teams.

The average number of full-time representatives in the first quarter of 2024 was 16, compared with 21 representatives in the first quarter of 2023. The average OvaSuite volume per full-time sales representative increased from 298 tests per representative in the first quarter of 2023 to 364 tests per representative in the first quarter of 2024.

Innovation. We believe our ability to successfully develop novel AI-powered assays is superior to others based on our know-how and extensive experience in designing and successfully launching FDA-cleared and laboratory developed blood tests to aid in the diagnosis of ovarian cancer. We own and operate Aspira Labs, Inc., a research and commercial CLIA laboratory in Texas, and have accumulated more than 110,000 patient samples in our research biobank. Moreover, our history of successfully collaborating with world-class research and academic institutions allows us to innovate and provide outstanding patient care.

Our product pipeline is focused on two areas: ovarian cancer and endometriosis.

In ovarian cancer, we have developed clinical data to support the repeated use of our OvaWatch test for the monitoring of an adnexal mass. In the second quarter of 2024, we expanded the features of our commercially available OvaWatch test for monitoring of adnexal masses through periodic testing at physician prescribed intervals. As a result, we believe the addressable market for the test to be two to three times that of the single use test when applied to the more than 1.2 million women in the United States diagnosed with an adnexal mass each year.

We also made significant progress in the development of OvaMDx, a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for assessing the risk of ovarian cancer in women with an adnexal mass. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz.

In endometriosis, we are developing and intend to introduce a new noninvasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. We completed the design of EndoCheck, a protein-based blood test to aid the detection of endometrioma, one of the most common forms of endometriosis. EndoCheck is the first ever noninvasive test of its kind, a significant achievement. The algorithm was confirmed with three independent cohorts and is an important input for our EndoMDx test, a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis which is also in development.

Our endometriosis portfolio addresses an even larger addressable market. According to the U.S. Department of Health and Human Services, endometriosis affects more than 6.5 million women in the United States. We believe the proliferation of commercially available and in-development therapeutics for the treatment of endometriosis will create a significant demand for a non-invasive diagnostic.

Operational Excellence. During the first quarter of 2024, we decreased our operating expenses by $1.3 million, while also achieving our cash utilization goals for the quarter by continuing to focus on spending that fuels innovation and growth. We raised gross proceeds of $5.6 million in January 2024 in a follow-on offering.

Our Business and Products

We currently commercialize the following products and related services:

(1) the Ova1Plus workflow, which uses Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Ova1 is a qualitative serum 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. Overa is a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity. The Ova1Plus workflow leverages the strengths of Ova1’s MIA sensitivity and Overa’s (MIA2G) specificity to reduce incorrectly elevated results; and

(2) OvaWatch, an LDT intended to assist in the initial clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.

Our products are distributed through our own national sales force, including field sales, inside sales and a contracted sales team, through our proprietary decentralized testing platform and cloud service, marketed as Aspira Synergy, and through marketing and distribution agreements with BioReference Health, LLC and ARUP Laboratories.

Our 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. Our Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1, Overa and OvaWatch each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources is included in the results of operations in total revenue for the three months ended March 31, 2024.

In 2021, we began entering into decentralized arrangements with large healthcare networks and physician practices for our Aspira Synergy platform, our decentralized testing platform and cloud service for decentralized global access of protein biomarker testing. Ova1, Overa, and the Ova1Plus workflow continue to be available through the Aspira Synergy platform. As of March 31, 2024, we had one active Aspira Synergy contract.

OvaWatch has been developed and is validated for use in Aspira’s CLIA-certified lab as a non-invasive blood-based risk assessment test for use in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. The commercialization plan for OvaWatch has two phases. Phase I, which was launched during the fourth quarter of 2022, is a single use, point-in-time risk assessment test, and Phase II, which was launched during the second quarter of 2024 allows for longitudinal testing. We believe OvaWatch has the potential to significantly expand the addressable market compared to the Ova1Plus workflow.

Outside of the United States, we have sponsored studies in both the Philippines and Israel, which were intended to validate Overa and Ova1 in specific populations. In February 2024, we signed an exclusive license agreement with Hi-Precision Laboratories in the Philippines.

We own and operate Aspira Labs, based in Austin, Texas, a Clinical Chemistry and Endocrinology Laboratory accredited by the College of American Pathologists, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. Aspira Labs provides expert diagnostic services using a state-of-the-art biomarker-based risk assessment to aid in clinical decision making and to advance personalized treatment plans. The lab currently performs our Ova1Plus workflow and OvaWatch testing, and we plan to expand the testing to other gynecologic conditions with high unmet need. Aspira’s Labs holds a CLIA Certificate of Accreditation and a state laboratory license in California, Maryland, New York, Pennsylvania and Rhode Island. The Centers for Medicare & Medicaid Services (“CMS”) issued a supplier number to Aspira Labs in 2015. Aspira Labs also holds a current ISO 13485 certification which is the most accepted standard worldwide for medical devices.

In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and Medicaid, client bill accounts and patients. Novitas Solutions, a Medicare Administrative Carrier, covers and reimburses for Ova1 tests performed in certain states, including Texas. Due to our billed Ova1 tests being performed exclusively at Aspira Labs in Texas, the Local Coverage Determination (“LCD”) from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. We have applied for an LCD for OvaWatch, which is currently under review.

In November 2016, the American College of Obstetricians and Gynecologists (“ACOG”) issued Practice Bulletin Number 174 which included Ova1, defined as the “Multivariate Index Assay,” outlining ACOG’s clinical management guidelines for adnexal mass management. Practice Bulletin Number 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low-risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk-assessment tools such as existing CA-125 technology or Ova1 (“Multivariate Index Assay”) as listed in the bulletin. Based on this, Ova1 achieved parity with CA-125 as a Level B clinical recommendation for the management of adnexal masses.

Practice Bulletins summarize current information on techniques and clinical management issues for the practice of obstetrics and gynecology. Practice Bulletins are evidence-based documents, and recommendations are based on the evidence. This is also the

only clinical management tool used for adnexal masses. Although there are Practice Bulletins, guidelines do not exist for adnexal masses. ACOG guidelines do exist, however, for ovarian cancer management.

Product Pipeline

We aim to introduce new gynecologic diagnostic products and to expand our product offerings to additional women’s gynecologic health diseases by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, clinical risk factors and patient data to aid diagnosis and risk stratification. Future product expansions will be accelerated by the development of lab developed testing in a CLIA environment, relationships with strategic research and development partners, and access to specimens in our biobank.

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OvaWatch is the only commercially available blood test to assess the risk of ovarian cancer in women diagnosed with an adnexal mass considered indeterminate or benign by initial clinical assessment. In January 2023, we published a manuscript entitled: “Validation of deep neural network-based algorithm supporting the clinical management of adnexal mass,” in Frontiers in Medicine, a peer-reviewed journal to support the clinical adoption of OvaWatch as a single-use test. We collected additional clinical data to support the utility of OvaWatch to aid in surgical referral and as a longitudinal monitoring test. Two manuscripts were published in peer review journals in May 2024. OvaWatch was commercially launched as a longitudinal monitoring tool in the second quarter of 2024.

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OvaMDx is a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for assessing the risk of ovarian cancer in women with an adnexal mass. The test is being developed in collaboration with Harvard’s Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Medical University of Lodz. We are currently in the process of completing final test design, including conducting verification experiments to transfer the test to the FDA approved PCR system.

The miRNAs used in the OvaMDx test were the subject of a 2017 paper, “Diagnostic potential for a serum miRNA neural network for detection of ovarian cancer” published in the peer-reviewed journal Cancer Biology. In October 2023, a poster entitled “Improving the diagnostic accuracy of an ovarian cancer triage test using a joint miRNA-protein model,” was presented at the AACR Special Conference in Cancer Research: Ovarian Cancer by senior author, Dr. Kevin Elias M.D., Director, Gynecologic Oncology Laboratory at Brigham and Women’s Hospital and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. The poster highlighted data from a study that combined serum protein and patient clinical information (metadata) from Aspira’s ovarian cancer registry studies with miRNA determined by the Elias laboratory. The data showed using miRNA in combination with serum proteins, and provided superior performance over existing ovarian cancer risk assessment blood tests.

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EndoCheck is the first protein biomarker test designed to identify ovarian endometriomas, one of the most common forms of endometriosis. We have confirmed the algorithm with three independent cohorts, achieving preliminary performance that supports its use to aid the detection and treatment of endometrioma. Data related to the performance of EndoCheck was presented at the 71st Annual Scientific Meeting for the Society for Reproductive Investigation (SRI) in Vancouver, Canada in March 2024. We are currently evaluating the potential commercial application and appropriate launch timeline for EndoCheck.

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EndoMDx is a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis. The test is being developed in collaboration with a consortium of academic and clinical partners led by Dana Farber Cancer Institute. We are currently in the process of completing final test design, including conducting verification experiments to transfer the test to an FDA approved PCR system, which is expected to be completed by mid-2024.

Recent Developments

Business Updates

On August 8, 2022, we entered into a sponsored research agreement with DFCI, BWH, and Medical University of Lodz (the “Dana-Farber, Brigham, Lodz Research Agreement”) for the generation of a multi-omic, non-invasive diagnostic aid to identify endometriosis based on circulating microRNAs and proteins. Under the Dana-Farber, Brigham, Lodz Research Agreement, payments of approximately $1,252,000 have or will become due from us to the counterparties upon the successful completion of deliverables as defined in the agreement as follows: 68% was paid in 2022, 15% was paid in 2023, and the remaining 17% will become payable upon completion of certain deliverables estimated to occur in the first half of 2024. During the three months ended March 31, 2024, approximately $34,000 has been recorded as research and development expense in the unaudited condensed consolidated statement of operations for the project. During the three months ended March 31, 2023, approximately $23,000, was recorded as research and development expense in the unaudited condensed consolidated financial statement of operations for the project. From the inception of the agreement through March 31, 2024, research and development expenses in the cumulative amount of $1,117,000 have been recorded.

On March 20, 2023, we entered into a licensing agreement (“Dana-Farber, Brigham, Lodz License Agreement”) with DFCI, BWH, and Medical University of Lodz under which the Company will license certain of our intellectual property to be used in our OvaSuite product portfolio. Under the Dana-Farber, Brigham, Lodz License Agreement, we paid an initial license fee of $75,000 and then will pay a license maintenance fee of $50,000 on each anniversary of the date of the Dana-Farber, Brigham, Lodz License Agreement. The Dana-Farber, Brigham, Lodz License Agreement also requires non-refundable royalty payments of up to $1,350,000 based on certain regulatory approvals and commercialization milestones and further royalty payments based on the net sales of our products included under the Dana-Farber, Brigham, Lodz License Agreement. No milestones have been reached as of March 31, 2024.

We prepared an application for a Proprietary Laboratory Analyses (“PLA Code”) with the American Medical Association for OvaWatch to distinguish it from Ova1Plus with the expectation that Novitas and other payers will apply the Ova1Plus Centers for Medicare & Medicaid Services fee to OvaWatch, ensuring consistent coverage and pricing for both Ova products. In December 2022, we received the approval of PLA Code for OvaWatch from the American Medical Association. Since we began billing OvaWatch with the PLA Code on April 1, 2023, our reimbursement has been consistent with historical Ova1Plus experience, resulting in the OvaWatch average unit price (“AUP”) of $338.

On May 7, 2024, we announced the publication of two peer-reviewed manuscripts. The first manuscript, entitled “Ovarian Cancer Surgical Consideration is Markedly Improved by the Neural Network Powered-MIA3G Multivariate Index Assay” was published in the peer-reviewed journal Frontiers of Medicine on May 2, 2024. The findings of this study demonstrate that use of OvaWatch to stratify risk in patients with an adnexal mass might help to reduce surgical backlogs and unnecessary surgical referrals. The second manuscript, entitled “Neural Network-derived Multivariate Index Assay Demonstrates Effective Clinical Performance in Longitudinal Monitoring of Ovarian Cancer Risk” was published in the journal Gynecologic Oncology on May 3, 2024. The findings of this study demonstrate that OvaWatch could be an effective tool for the monitoring of ovarian cancer risk over time in women with indeterminate or low risk adnexal masses. Based on common practice for adnexal mass management and consistent with the study, OvaWatch can be drawn by the provider every three to six months for active surveillance of an adnexal mass.

Critical Accounting Estimates

There have been no material changes to our critical accounting estimates described in our Annual Report on Form 10-K, filed with the SEC on April 1, 2024.

Our product revenue is generated by performing diagnostic services using our OvaSuite tests, and the service is completed upon the delivery of the test result to the prescribing physician. The entire transaction price is allocated to the single performance obligation contained in a contract with a patient. Under ASC Topic 606, Revenue from Contracts with Customers, all revenue is recognized upon completion of the OvaSuite test and delivery of test 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, we consider factors such as payment history and amount, payer coverage, whether there is a reimbursement contract between the payer and us, and any developments or changes that could impact reimbursement. These estimates require significant judgment by management. For OvaSuite tests, we also review our patient account population and determine an appropriate distribution of patient accounts by payer (i.e., Medicare, patient pay, other third-party payer, etc.) into portfolios with similar collection experience. When evaluated for collectability, this results in a materially consistent revenue amount for such portfolios as if each patient account were evaluated on an individual contract basis.

Results of Operations – Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023

The selected summary financial and operating data of the Company for the three months ended March 31, 2024 and 2023 were as follows.


	Three Months Ended
	March 31,						Increase (Decrease)
(dollars in thousands)	2024			2023			Amount			%
Revenue:
Product	$	2,153		$	2,315		$	(162	)		(7	)
Genetics		—			1			(1	)		—
Total revenue		2,153			2,316			(163	)		(7	)
Cost of revenue:
Product		939			1,130			(191	)		(17	)
Total cost of revenue		939			1,130			(191	)		(17	)
Gross profit		1,214			1,186			28			2
Operating expenses:
Research and development		906			1,267			(361	)		(28	)
Sales and marketing		1,889			2,595			(706	)		(27	)
General and administrative		3,129			3,604			(475	)		(13	)
Total operating expenses		5,924			7,466			(1,542	)		(21	)
Loss from operations		(4,710	)		(6,280	)		1,570			(25	)
Other income (expense), net:
Change in fair value of warrant liabilities		251			(24	)		275			1,146
Interest (expense) income, net		(5	)		26			(31	)		119
Other expense, net		(165	)		(300	)		135			45
Total other income (expense), net		81			(298	)		379			127
Net loss	$	(4,629	)	$	(6,578	)	$	1,949			(30	)

Product Revenue. Product revenue was $2,153,000 for the three months ended March 31, 2024, compared to $2,315,000 for the same period in 2023. Revenue for Aspira Labs is recognized when the Ova1, Overa, Ova1Plus or OvaWatch test is completed based on estimates of what we expect to ultimately realize. The 7% product revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year.

The number of OvaSuite tests performed decreased 4.4% to 5,829 during the three months ended March 31, 2024, compared to 6,259 product tests for the same period in 2023. This decrease is a result of our revised commercial strategy and reduced full-time field sales headcount. We expect revenue to increase in the second quarter due to our investment in key salesforce hires and strategic product development during the first quarter of 2024.

The volume and AUP for the three months ended March 31, 2024 and 2023 were as follows.


	Three Months Ended
	March 31,
	2024		2023
Product Volume:
Ova1Plus		4,777		5,768
OvaWatch		1,052		491
Total OvaSuite		5,829		6,259

Average Unit Price (AUP):
Ova1Plus	$	376	$	390
OvaWatch		338		136
Total OvaSuite	$	369	$	370

Cost of Revenue – Product. Cost of product revenue was $939,000 for the three months ended March 31, 2024 compared to $1,130,000 for the same period in 2023, representing a decrease of $191,000, or 17%, due primarily to decreased consulting, postage and lab supply costs, resulting from the decrease in tests performed compared to the prior year.

Gross Profit Margin. Gross profit margin for product revenue increased to 56.4% for the three months ended March 31, 2024, compared to 51.2% for the same period in 2023.

Research and Development Expenses. Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses for the three months ended March 31, 2024 decreased by $361,000, or 28%, compared to the same period in 2023. This decrease was primarily due to a decrease in personnel costs of $369,000. We expect research and development expenses to increase over the second quarter of 2024, as a result of our focus on the product pipeline.

Sales and Marketing Expenses. Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses. These expenses include the costs of educating physicians and other healthcare professionals regarding our products. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses for the three months ended March 31, 2024 decreased by $706,000, or 27%, compared to the same period in 2023. This decrease was primarily due to decreased consulting costs of $376,000, personnel costs of $339,000 and travel costs of $148,000, offset by the addition of our contracted sales team. We expect sales and marketing expenses to modestly increase over the second quarter of 2024 as we continue to focus on the commercialization of OvaWatch.

General and Administrative Expenses. General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses for the three months ended March 31, 2024 decreased by $475,000, or 13%, compared to the same period in 2023. This decrease was primarily due to a decrease in outside accounting expenses of $130,000 and consulting costs of $98,000. We expect general and administrative expenses to remain flat for the second quarter of 2024.

Change in fair value of Warrant liabilities. The fair values of the warrant liabilities as of March 31, 2024, and December 31, 2023 were $1,400,000 and $1,651,000, respectively, for a net decrease in fair value of $251,000. The decrease consisted of $490,000 due to the modification of certain warrants that were originally issued in 2022, offset by the change in warrant value due to the decrease in our stock price during the quarter. For the three months ended March 31, 2023 there was a net increase in fair value of $24,000.

Liquidity and Capital Resources

We plan to continue to expend resources selling and marketing OvaSuite and developing additional diagnostic tests and service capabilities.

We have incurred significant net losses and negative cash flows from operations since inception, and as a result have an accumulated deficit of approximately $522,932,000 as of March 31, 2024. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2024. Working capital levels may not be sufficient to fund operations as currently planned through the next twelve months, absent a significant increase in revenue over historic revenue or additional financing. Given the above conditions, there is substantial doubt about our ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed.

We expect 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, as well as our existing at-the-market and equity line of credit facilities. However, additional funding may not be available when needed or on terms acceptable to us. If we are unable to obtain additional capital, we 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 our business, results of operations and financial condition.

In March 2016, we entered into a loan agreement (as amended on March 7, 2018 and April 3, 2020, the “DECD Loan Agreement”) with the State of Connecticut Department of Economic and Community Development (the “DECD”), pursuant to which we may borrow up to $4,000,000 from the DECD.

The loan may be prepaid at any time without premium or penalty. An initial disbursement of $2,000,000 was made to us on April 15, 2016 under the DECD Loan Agreement. On December 3, 2020, we received a disbursement of the remaining $2,000,000 under the DECD Loan Agreement, as we 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, we would be eligible for forgiveness of up to $1,500,000 of the principal amount of the loan if we had achieved certain job creation and retention milestones by December 31, 2022. On June 26, 2023, we were notified by the DECD that we had satisfied all job creation and retention requirements under the loan agreement to receive forgiveness of $1,000,000. If we fail to maintain our 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. For additional information, see Note 4 to our unaudited condensed consolidated financial statements.

In connection with a private placement offering of common stock and warrants we completed in May 2013, we entered into a stockholders agreement which, among other things, granted two of the primary investors in that offering the right to participate in any future equity offerings by the Company on the same price and terms as other investors. In addition, the stockholders agreement prohibits us from taking certain material actions without the consent of at least one of the two primary investors in that offering. These material actions include:

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Making any acquisition with a value greater than $2 million;

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Offering, selling or issuing any securities senior to Aspira’s common stock or any securities that are convertible into or exchangeable or exercisable for securities ranking senior to Aspira’s common stock;

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Taking any action that would result in a change in control of the Company or an insolvency event; and

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Paying or declaring dividends on any securities of the Company or distributing any assets of the Company other than in the ordinary course of business or repurchasing any outstanding securities of the Company.

The foregoing rights terminate for a primary investor when that investor ceases to beneficially own less than 50% of the shares and warrants (taking into account shares issued upon exercise of the warrants), in the aggregate, that were purchased at the closing of the 2013 private placement. We believe that the rights of one of the primary investors have so terminated.

On February 10, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor, as agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $12.5 million. In connection with the Direct Offering on July 24, 2023, we delivered written notice to Cantor on July 19, 2023 that it was suspending the prospectus supplement, dated February 10, 2023, related to our common stock issuable under the Cantor Sales Agreement. We will not make any sales of common stock pursuant to the Cantor Sales Agreement unless and until a new prospectus supplement is filed with the SEC. The Cantor Sales Agreement remains in full force and effect during the suspension.

On March 28, 2023, we entered into an agreement with Lincoln Park (the “LPC Purchase Agreement”), pursuant to which we have the right to sell to Lincoln Park shares of our common stock (the “Purchase Shares”), having an aggregate value of up to $10 million, subject to certain limitations and conditions, at our sole discretion during a 36-month period ending March 27, 2026.

The issuance of the Purchase Shares had been previously registered pursuant to our effective shelf registration statement on Form S-3 (File No. 333-252267) (the “Old Registration Statement”), and the related base prospectus included in the Registration Statement, as supplemented by a prospectus supplement filed on March 28, 2023, that has expired. On April 22, 2024, we filed a registration statement on Form S-3 (File No. 333-278867) (the “Registration Statement”), and the related base prospectus included in the Registration Statement, that has been declared effective by the SEC on April 25, 2024.

We sold 472,312 shares of Common Stock under the LPC Purchase Agreement for gross proceeds of approximately $1,578,000 under the Old Registration Statement. In addition, 47,733 shares of Common Stock were issued to Lincoln Park as consideration for entering into the LPC Purchase Agreement. As of April 25, 2024, up to $8,422,000 of shares of Common Stock could be sold to Lincoln Park under the LPC Purchase Agreement, subject to the terms of the LPC Purchase Agreement.

On April 26, 2024, we filed a prospectus supplement to the Registration Statement related to the sale of up to $3,200,000 shares of Common Stock pursuant to the LPC Purchase Agreement.

On July 24, 2023, we completed a direct offering (the “Direct Offering”) resulting in net proceeds of approximately $4,157,000, after deducting underwriting discounts and offering expenses of $597,000.

Under the terms of the July 24, 2023 follow-on equity offering, we agreed not to sell shares under the LPC Purchase Agreement for 90 days. On October 30, 2023, we resumed selling shares under the LPC Purchase Agreement. As of May 10, 2024, the Company has sold 100,408 shares for aggregate gross proceeds of approximately $300,000 subsequent to March 31, 2024.

On January 24, 2024, we entered into a securities purchase agreement (the “2024 Direct Offering Agreement”), with several investors relating to the issuance and sale of 1,371,000 shares of its common stock, par value $0.001 per share, and pre-funded warrants to purchase 200,000 shares of Common Stock (the “Pre-Funded Warrants”), in a registered direct offering, together with accompanying warrants to purchase 1,571,000 shares of Common Stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “Warrants”) in a concurrent private placement (the “Concurrent Private Offering” and together with the registered direct offering, the “2024 Direct Offering”). Our gross proceeds from the 2024 Direct Offering were approximately $5.6 million, before deducting placement agent fees and other estimated expenses of $694,000 payable by us.

The Pre-Funded Warrants were exercised on February 6, 2024 for $20.

The Purchase Warrants have an exercise price of $4.13 per share and will be exercisable beginning six months after issuance and will expire 5 years from the initial exercise date.

Effective upon the closing of the 2024 Direct Offering, the Company also amended certain existing warrants to purchase up to an aggregate of 366,664 shares at an exercise price of $13.20 per share and a termination date of August 25, 2027, so that the

amended warrants have a reduced exercise price of $4.13 per share and a new termination date of January 26, 2029. The other terms of the amended warrants remain unchanged.

As mentioned, we have incurred significant net losses and negative cash flows from operations since inception, and we expect to continue to incur a net loss and negative cash flows from operations in 2023. At March 31, 2024 we had an accumulated deficit of $522,932,000 and stockholders’ deficit of $1,363,000. As of March 31, 2024, we had $3,413,000 of cash and cash equivalents (excluding restricted cash of $260,000), $5,293,000 of current liabilities, and working capital of $829,000. There can be no assurance that we will achieve or sustain profitability or positive cash flow from operations. While we expect to grow revenue through Aspira Labs, there is no assurance of our ability to generate substantial revenues and cash flows from Aspira Labs’ operations. We expect revenue from our products to be our only material, recurring source of cash in 2023.

Our future liquidity and capital requirements will depend upon many factors, including, among others:

•

resources devoted to sales, marketing and distribution capabilities;

•

the rate of OvaSuite product adoption by physicians and patients;

•

the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements for OvaSuite;

•

the insurance payer community’s acceptance of and reimbursement for our products;

•

our plans to acquire or invest in other products, technologies and businesses; and

•

the potential need to add study sites to access additional patients to maintain clinical timelines.

Net cash used in operating activities was $4,431,000 for the three months ended March 31, 2024, resulting primarily from the net loss reported of $4,629,000, which includes non-cash expenses in the amount of $382,000 related to changes in accounts payable, stock compensation expense of $362,000 and $55,000 related to changes in prepaid expense offset by changes in other liabilities of $254,000, $251,000 relating to a change in fair value of warrant fair value, changes in accounts receivable of $72,000 and changes in accrued liabilities of $66,000.

Net cash used in operating activities was $5,706,000 for the three months ended March 31, 2023, resulting primarily from the net loss reported of $6,578,000, which includes non-cash items in the amount of $582,000 related to changes in accrued liabilities, $396,000 related to stock compensation expense, changes in prepaid expense and other assets of $323,000 and $70,000 related to depreciation and amortization, offset by changes in accounts receivable of $309,000 and $216,000 relating to a change in other liabilities.

Net cash used in investing activities was $20,000 and $8,000 for the three months ended March 31, 2024 and 2023, respectively, which consisted of property and equipment purchases.

Net cash provided by financing activities was $5,269,000 for the three months ended March 31, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,869,000, after deducting placement agent costs and other expenses of $694,000 and an equity line of credit offering of $400,000.

Net cash used in financing activities was $55,000 for the three months ended March 31, 2023, stemming primarily from the at the market offering resulting from gross proceeds of $162,000, transaction-related offering costs of $132,000, in addition to principal payments on the DECD loan.

Based on the available objective evidence, we believe it is more likely than not that net deferred tax assets will not be fully realizable. Accordingly, we have provided a full valuation allowance against our net deferred tax assets. Therefore, there was no deferred income tax expense or benefit for the period.

Our pre-2018 federal NOLs will expire in varying amounts from 2023 through 2037, if not utilized, and can offset 100% of future taxable income for regular tax purposes. Any federal NOLs arising after January 1, 2018, can generally be carried forward indefinitely but such federal NOL carryforwards are permitted to be used in any taxable year to offset up to 80% of taxable income in such year. Portions of our state NOLs will expire in varying amounts from 2023 through 2037 if not utilized. Our ability to use our NOLs during this period will be dependent on our ability to generate taxable income, and the portions of our NOLs could expire before we generate sufficient taxable income.

Our ability to use our net operating loss and credit carryforwards to offset future taxable income is restricted due to ownership change limitations that have occurred in the past, as required by Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”), as well as similar state provisions. Net operating losses which are limited from offsetting any future taxable income under Section 382 are not included in the gross deferred tax assets. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on our results of operations or financial position.

Our unrecognized tax benefits attributable to research and development credits will increase during the period for tax positions taken during the year and will decrease for expiration of a portion of the carryforwards during the period.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Per Item 305(e) of Regulation S-K, the information called for by this Item 3 is not required.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of disclosure controls and procedures

Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2024. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of March 31, 2024, our disclosure controls and procedures were not effective. This was due to two material weaknesses in the internal control over financial reporting that were identified as of December 31, 2023 and disclosed in our 2023 Annual Report Form 10-K related to multiple deficiencies and a lack of timely operation of certain internal controls over financial reporting and disclosure that continue to exist as of March 31, 2024.

Material Weaknesses

As previously reported, we identified material weaknesses related to:

•

the operation of internal controls related to information technology general controls (“ITGCs”) that are used to process and record certain revenue and expense transactions and support our financial reporting processes. The internal control around ITGCs resulted in the lack of certain internal controls over these IT systems and over data and reports accumulated in such IT systems; and

•

the design and implementation of our control activities over our revenue process. We did not adequately design controls to validate the delivery of the lab results to ordering physicians to ensure that revenue is being appropriately recognized.

Remediation Activities

In order to address the material weaknesses in internal control over financial reporting described above, management is performing, with direction from the audit committee, the following remediation activities:

•

Retained an internal controls specialist to complement the skills of the existing accounting and financial reporting staff, as well as implement key controls to improve business processes, including revenue and the IT environment.

•

Completed a preliminary process to identify all information technology applications that support the Company’s financial reporting processes and assess the risk of misstatement associated with each.

•

Planned a comprehensive review of the design and performance of internal controls related to information technology applications, including user access and program change controls.

•

Enhanced controls that require the assessment of service organization controls prior to implementation and on an annual basis.

•

Retained additional accounting and financial reporting resources during the year-end close to improve our ability to perform our disclosure controls and procedures on a timely basis, particularly for certain significant, non-routine or complex transactions.

•

Providing additional training and continuing education to accounting staff regarding SEC requirements and required disclosures under GAAP.

•

Enhanced the design of and implementation of controls around the rigor of the review process, and retention of sufficient appropriate evidence over the revenue process.

Management will continue to review and make necessary changes to the overall design of our internal control environment, as well as policies and procedures to improve the overall effectiveness of internal control over financial reporting. The material weaknesses will not be considered remediated, however, until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.

Changes in internal controls over financial reporting

As steps to remediate the material weaknesses discussed above, management has reviewed of the design and performance of internal controls related to information technology applications and enhanced the design of and implementation of controls around the rigor of its review and documentation process. Apart from these steps, there was no change in our internal control over financial reporting that occurred during the period ended March 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially and adversely affect our results of operations, cash flows and financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources and other factors. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of March 31, 2024, that, in the opinion of management, will have a material adverse effect on our financial position, results of operations or cash flows.

ITEM 1A. RISK FACTORS

Except as set forth below, there have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on April 1, 2024 (the “2023 Annual Report”). The risks and uncertainties described in our 2023 Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.

We are currently offering and developing multiple tests as LDTs and intend to develop and perform LDTs at Aspira Labs in the future. FDA’s newly issued rule for LDTs, effective July 5, 2024, which will be phased in over a period of four years, will significantly change the regulatory landscape for LDTs. The final rule included a clause to grandfather in tests already in market on May 6, 2024, which applies to our current commercially available tests. The new rule may lead to additional compliance costs and may delay or prevent market entry for new or modified tests and may add a financial burden to us for future Aspira tests. There is a risk that the commercialization of these tests, and our results of operations and financial condition, will be negatively affected.

The FDA considers an LDT to be a test that is designed, developed, validated, and used within a single, CLIA-certified high complexity laboratory. The FDA has historically taken the position that it has the authority to regulate LDTs as in vitro diagnostic (“IVD”) medical devices under the FDC Act, but it has generally exercised enforcement discretion with regard to LDTs, meaning that most LDTs have not been subject to FDA oversight. On May 6, 2024, the FDA published a final rule amending the definition of an IVD device to include IVDs manufactured by a clinical laboratory.

The specific exception that applies to Aspira is the exception for currently marketed IVDs offered as LDTs that were first marketed prior to the date of the issuance of this rule, May 6, 2024. The FDA intends for this policy to apply to currently marketed IVDs offered as LDTs as long as they are not modified following the issuance of this final rule or are modified but only in certain limited ways that are described below:

1. change the indications for use of the IVD;

2. alter the operating principle of the IVD;

3. include significantly different technology in the IVD or;

4. adversely change the performance or safety specifications of the IVD.

The FDA intends to request that laboratories offering currently marketed IVDs offered as LDTs submit labeling to FDA as provided in §807.26(e). Labeling includes IVD performance information and a summary of supporting validation, as applicable. This information will help FDA more closely monitor currently marketed IVDs offered as LDTs and identify those that may lack analytical validity, clinical validity, or safety. As part of its review of labeling, the FDA also intends to look closely at claims of superior performance and whether those claims are adequately substantiated.

The final rule also announced the FDA’s intention to phase out its general enforcement discretion policy. Unless the rule is overturned by a court or Congress, the medical device requirements for most LDTs will be phased in beginning on May 6, 2025. These requirements include premarket authorization requirements (510(k) clearance, de novo classification, or premarket approval (“PMA”)) for each LDT performed by the laboratory, and postmarket registration and listing, medical device reporting, correction, removal, and recall, complaint handling, labeling, investigational device, and quality system requirements. Certain categories of LDTs will be subject to enforcement discretion with respect to some or all of these requirements. For example, FDA will apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement for premarket authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject to other requirements, including the requirement to submit the labeling for the LDT to FDA for review. FDA will similarly exercise enforcement discretion with respect to premarket authorization for LDTs approved by the New York State Clinical Laboratory Evaluation Program (“NYS-CLEP”).

Compliance with these additional regulatory requirements will be time-consuming and expensive, potentially diverting resources from other aspects of our business, and will potentially affect the sales of our products and how customers use our products and will require reevaluation of our business model in order to maintain compliance with these laws. Moreover, failure to comply with these and other FDA regulations could result in legal actions, including fines and penalties.

If we are unable to comply with FDA requirements, or to do so within the timeframes specified by the FDA, we may be forced to stop selling our tests or be required to modify claims or make such other changes while we update our processes. For existing or future tests subject to FDA clearance, approval or de novo classification, our business, results of operations and financial condition will be negatively affected until such a review is completed and clearance, approval or de novo classification to market were obtained. There can be no assurance that any tests we develop will be cleared, approved or classified on a timely basis, if at all. Obtaining FDA clearance, approval or de novo classification for diagnostics can be expensive, time consuming and uncertain, and for higher-risk devices generally takes several years and requires detailed and comprehensive scientific and clinical data. Ongoing compliance with FDA regulations for those tests will increase the cost of conducting our business, significantly affect our operations, and could have a significant negative impact on our financial performance.

Legislative proposals addressing the FDA’s oversight of LDTs have been previously introduced. In June 2021, Congress introduced the VALID Act, which would have established a new risk-based regulatory framework for in vitro clinical tests (“IVCTs”), a category which would have included IVDs, LDTs, collection devices and instruments used with such tests. This legislation was not enacted during that session of Congress, but was reintroduced in 2023. FDA’s new LDT final rule may renew attention to VALID and may lead to the introduction of new proposals to limit the FDA’s regulatory authority.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

The following exhibits are filed or incorporated by reference with this report as indicated below:

     
     Incorporated by Reference

     
Exhibit

Filing

Filed

    Number

    Exhibit Description 

    Form

    File No. 

    Exhibit 

    Date

    Herewith

    3.1

    Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated January 22, 2010

    8-K

    000-31617

    3.1

    January 25, 2010

    3.2

    Certificate of Amendment of Fourth Amended and Restated Certificate of Incorporation, effective June 19, 2014

    10-Q

    001-34810

    3.2

    August 14, 2014

    3.3

    Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation of Vermillion, Inc. dated June 11, 2020

    8-K

    001-34810

    3.1

    June 11, 2020

    3.4

    Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation, as amended February 6, 2023

    8-K

    001-34810

    3.1

    February 7, 2023

    3.5

    Certificate of Designations, Preferences and Rights of Series B Convertible Preferred Stock

    8-K

    001-34810

    4.1

    April 17, 2018

    3.6

    Amended and Restated Bylaws of Aspira Women's Health Inc., effective February 23, 2022

    8-K

    001-34810

    3.1

    February 28, 2022

    3.7

    Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation, as amended May 11, 2023

    8-K

    001-34810

    3.1

    May 11, 2023

    10.1*

    Employment Agreement between Aspira Women's Health Inc. and Sandra Milligan effective April 1, 2024

    8-K

    001-34810

    10.1

    March 21, 2024

    10.2*

    First Amendment to Employment Agreement between Aspira Women's Health Inc. and Torsten Hombeck, dated March 20, 2024

    8-K

    001-34810

    10.1

    March 25, 2024

    31.1

    Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

    √

    31.2

    Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

    √

    32.1**

    Certification of 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.INS

    Inline XBRL Instance Document - (the instant document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).

    √

    101.SCH

    Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents

    √

    104

    Cover page formatted as Inline XBRL and contained in Exhibit 101

    √

√ Filed herewith

√√ Furnished herewith

* Management contract or compensation plan or arrangement.

** The certification attached as Exhibit 32.1 that accompany this Quarterly Report on Form 10-Q, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Form 10-Q), irrespective of any general incorporation language contained in such filing.

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.



	Aspira Women’s Health Inc.
Date: May 15, 2024	/s/ Nicole Sandford
	Nicole Sandford Chief Executive Officer (Principal Executive Officer) and Director
Date: May 15, 2024	/s/ Torsten Hombeck
	Torsten Hombeck Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

Exhibit 31.1

Certification of the Chief Executive Officer Pursuant to Section 302 of

The Sarbanes-Oxley Act Of 2002

I, Nicole Sandford, certify that:

I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2024 of Aspira Women’s Health Inc.;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

    Date:  May 15, 2024

    /s/ Nicole Sandford

     
    Nicole Sandford
Chief Executive Officer
(Duly Authorized Officer and Principal Executive Officer)

Exhibit 31.2

Certification of the Chief Financial Officer Pursuant to Section 302 of

The Sarbanes-Oxley Act Of 2002

I, Torsten Hombeck, certify that:

I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2024 of Aspira Women’s Health Inc.;

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

    Date:  May 15, 2024

    /s/ Torsten Hombeck

     
    Torsten Hombeck
Chief Financial Officer
(Duly Authorized Officer, Principal Financial Officer and Principal Accounting Officer)

Exhibit 32.1

Certification of 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

with Respect to the Quarterly Report on Form 10-Q

for the Period Ended March 31, 2024

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of Aspira Women’s Health Inc., a Delaware corporation (the “Company”), does hereby certify, to the best of such officer’s knowledge, that:

The Company’s quarterly report on Form 10-Q for the period ended March 31, 2024, (the “Form 10-Q”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: May 15, 2024	/s/ Nicole Sandford
	Nicole Sandford Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer)

Date: May 15, 2024	/s/ Torsten Hombeck
	Torsten Hombeck Chief Financial Officer (Duly Authorized Officer, Principal Financial Officer and Principal Accounting Officer)

The certification set forth above is being furnished as an Exhibit solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not being filed as part of the Form 10-Q or as a separate disclosure document of the Company or the certifying officers.

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2024	May 10, 2024
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
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 Country Code	DE
Entity Tax Identification Number	33-0595156
Entity Address, Address Line One	12117 Bee Caves Road
Entity Address, Address Line Two	Building III
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
Security 12b Title	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		12,449,512
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Entity Central Index Key	0000926617
Amendment Flag	false

Condensed Consolidated Balance Sheets (unaudited) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 3,413,000	$ 2,597,000
Accounts receivable, net of reserves of $2 and $15, as of March 31, 2024 and December 31, 2023, respectively	1,531,000	1,459,000
Prepaid expenses and other current assets	942,000	997,000
Inventories	236,000	227,000
Total current assets	6,122,000	5,280,000
Property and equipment, net	131,000	165,000
Right-of-use assets	620,000	528,000
Restricted cash	260,000	258,000
Other assets	31,000	31,000
Total assets	7,164,000	6,262,000
Current liabilities:
Accounts payable	1,643,000	1,261,000
Accrued liabilities	2,797,000	2,863,000
Current portion of long-term debt	249,000	166,000
Short-term debt	416,000	670,000
Current maturities of lease liabilities	188,000	159,000
Total current liabilities	5,293,000	5,119,000
Non-current liabilities:
Long-term debt	1,347,000	1,430,000
Non-current maturities of lease liabilities	487,000	427,000
Warrant liabilities	1,400,000	1,651,000
Total liabilities	8,527,000	8,627,000
Commitments and contingencies (Note 4)
Stockholders' deficit:
Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at March 31, 2024 and December 31, 2023, respectively; 12,344,104 and 10,645,049 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	12,000	11,000
Additional paid-in capital	521,557,000	515,927,000
Accumulated deficit	(522,932,000)	(518,303,000)
Total stockholders' deficit	(1,363,000)	(2,365,000)
Total liabilities and stockholders' deficit	$ 7,164,000	$ 6,262,000

Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Condensed Consolidated Balance Sheets [Abstract]
Accounts receivable, allowance	$ 2	$ 15
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	150,000,000
Common stock, shares issued	12,344,104	10,645,049
Common stock, shares outstanding	12,344,104	10,645,049

Condensed Consolidated Statements Of Operations (unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenue:
Revenue	$ 2,153,000	$ 2,316,000
Cost of revenue:
Cost of revenue	939,000	1,130,000
Gross profit	1,214,000	1,186,000
Operating expenses:
Research and development	906,000	1,267,000
Sales and marketing	1,889,000	2,595,000
General and administrative	3,129,000	3,604,000
Total operating expenses	5,924,000	7,466,000
Loss from operations	(4,710,000)	(6,280,000)
Other income (expense), net:
Change in fair value of warrant liabilities	251,000	(24,000)
Interest (expense) income, net	(5,000)	26,000
Other expense, net	(165,000)	(300,000)
Total other income (expense), net	81,000	(298,000)
Net loss	$ (4,629,000)	$ (6,578,000)
Net loss per share - basic	$ (0.39)	$ (0.79)
Net loss per share - diluted	$ (0.39)	$ (0.79)
Weighted average common shares used to compute basic net loss per common share	11,846,075	8,313,091
Weighted average common shares used to compute diluted net loss per common share	11,846,075	8,313,091
Product [Member]
Revenue:
Revenue	$ 2,153,000	$ 2,315,000
Cost of revenue:
Cost of revenue	$ 939,000	1,130,000
Genetics [Member]
Revenue:
Revenue		$ 1,000

Condensed Consolidated Statements Of Changes In Stockholders' (Deficit) Equity (unaudited) - USD ($)	Total	Equity Line of Credit Agreement [Member]	Registered Direct Offering [Member]	At the Market Offering Agreement [Member]	Common Stock [Member]	Common Stock [Member] Equity Line of Credit Agreement [Member]	Common Stock [Member] Registered Direct Offering [Member]	Common Stock [Member] At the Market Offering Agreement [Member]	Additional Paid-In Capital [Member]	Additional Paid-In Capital [Member] Equity Line of Credit Agreement [Member]	Additional Paid-In Capital [Member] Registered Direct Offering [Member]	Additional Paid-In Capital [Member] At the Market Offering Agreement [Member]	Accumulated Deficit [Member]
Balance, shares at Dec. 31, 2022					8,306,326
Balance at Dec. 31, 2022	$ 6,979,000				$ 8,000				$ 508,584,000				$ (501,613,000)
Net loss	(6,578,000)												(6,578,000)
Common stock issued, net of issuance costs, shares								23,217
Common stock issued, net of issuance costs				$ 30,000								$ 30,000
Stock-based compensation expense	396,000								396,000
Balance, shares at Mar. 31, 2023					8,329,543
Balance at Mar. 31, 2023	827,000				$ 8,000				509,010,000				(508,191,000)
Balance, shares at Dec. 31, 2023					10,645,049
Balance at Dec. 31, 2023	(2,365,000)				$ 11,000				515,927,000				(518,303,000)
Net loss	(4,629,000)												(4,629,000)
Common stock issued, net of issuance costs, shares						111,369	1,371,000
Common stock issued, net of issuance costs		$ 400,000	$ 4,869,000				$ 1,000			$ 400,000	$ 4,868,000
Warrant Exercise, shares					200,000
Common stock issued for vested restricted stock awards, shares					16,686
Stock-based compensation expense	362,000								362,000
Balance, shares at Mar. 31, 2024					12,344,104
Balance at Mar. 31, 2024	$ (1,363,000)				$ 12,000				$ 521,557,000				$ (522,932,000)

Condensed Consolidated Statements Of Cash Flows (unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Cash flows from operating activities:
Net loss	$ (4,629,000)	$ (6,578,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash lease expense	(3,000)	1,000
Depreciation and amortization	29,000	70,000
Stock-based compensation expense	362,000	396,000
Change in fair value of warrant liabilities	(251,000)	24,000
Loss on impairment and disposal of property and equipment	25,000	1,000
Changes in operating assets and liabilities:
Accounts receivable	(72,000)	(309,000)
Prepaid expenses and other assets	55,000	323,000
Inventories	(9,000)	14,000
Accounts payable	382,000	(14,000)
Accrued liabilities	(66,000)	582,000
Other liabilities	(254,000)	(216,000)
Net cash used in operating activities	(4,431,000)	(5,706,000)
Cash flows from investing activities:
Purchase of property and equipment	(20,000)	(8,000)
Net cash used in investing activities	(20,000)	(8,000)
Cash flows from financing activities:
Principal repayment of DECD loan		(85,000)
Net cash provided by financing activities	5,269,000	(55,000)
Net decrease in cash, cash equivalents and restricted cash	818,000	(5,769,000)
Cash, cash equivalents and restricted cash, beginning of the period	2,855,000	13,557,000
Cash, cash equivalents and restricted cash, end of the period	3,673,000	7,788,000
Reconciliation to Consolidated Balance Sheet:
Cash and cash equivalents	3,413,000	7,535,000
Restricted cash	260,000	253,000
Unrestricted and restricted cash and cash equivalents	3,673,000	7,788,000
Supplemental disclosure of cash flow information:
Cash paid for interest	6,000	18,000
Supplemental disclosure of noncash investing and financing activities:
Net increase in right-of-use assets	169,000
At the Market Offering [Member]
Cash flows from financing activities:
Proceeds from issuance of common stock		162,000
Payment of issuance costs		$ (132,000)
Equity Line of Credit [Member]
Cash flows from financing activities:
Proceeds from issuance of common stock	400,000
Registered Direct Offering [Member]
Cash flows from financing activities:
Proceeds from issuance of common stock	5,563,000
Payment of issuance costs	$ (694,000)

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

3 Months Ended

Mar. 31, 2024

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

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies

ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES

Organization

(2) OvaWatch, a Laboratory Developed Test (“LDT”) intended in the clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass.

Collectively, these tests are referred to and marketed as OvaSuite.

Overa is currently not offered commercially except as a reflex test performed as part of the Ova1Plus workflow.

Going Concern and Liquidity

•

Securing debt, however, no assurance can be given that debt will be available on acceptable terms or at all;

•

Reducing executive bonuses or replacing cash compensation with equity grants;

•

Reducing professional services and consulting fees and eliminating non-critical projects;

•

Reducing travel and entertainment expenses; and

•

Reducing eliminating or deferring discretionary marketing programs.

The Company also has outstanding warrants to purchase shares of its common stock that may be exercised although there can be no assurance that the warrants will be exercised.

Basis of Presentation

Significant Accounting Policies

Revenue Recognition

The Company has discontinued providing Aspira GenetiX, including genetics carrier screening, on the Aspira Synergy platform, effective September 30, 2022.

Recent Accounting Pronouncements

Fair Value Measurements

3 Months Ended

Mar. 31, 2024

Fair Value Measurements [Abstract]

Fair Value Measurements

FAIR VALUE MEASUREMENTS

Fair Value of Financial Instruments


	March 31, 2024						December 31, 2023
	Unmodified Warrants			Modified Warrants
Dividend yield		—	%		—	%		—	%
Volatility		104.9	%		101.7	%		105.1	%
Risk-free interest rate		4.31	%		4.21	%		3.93	%
Expected lives (years)		3.39			4.83			3.64
Weighted average fair value	$	1.329		$	2.247		$	2.064


		March 31,				December 31,
		2024				2023
(in thousands)	Fair Value Hierarchy	Carrying Value		Fair Value		Carrying Value		Fair Value
DECD loan	Level 3	$	1,604	$	1,287	$	1,604	$	1,255

Prepaid And Other Current Assets

3 Months Ended

Mar. 31, 2024

Prepaid And Other Current Assets [Abstract]

Prepaid And Other Current Assets

PREPAID AND OTHER CURRENT ASSETS

Prepaid and other current assets at March 31, 2024 and December 31, 2023 consist of the following:


	March 31,		December 31,
(in thousands)	2024		2023
Prepaid insurance	$	479	$	684
Software licenses		173		103
Subscriptions		128		26
Other		162		184
Total prepaid and other current assets	$	942	$	997

Commitments And Contingencies

3 Months Ended

Mar. 31, 2024

Commitments And Contingencies [Abstract]

Commitments And Contingencies

COMMITMENTS AND CONTINGENCIES

Loan Agreement

Long-term debt consisted of the following:


	March 31,			December 31,
	2024			2023
(in thousands)
DECD loan, net of issuance costs	$	1,596		$	1,596
Less: Current portion, net of issuance costs		(249	)		(166	)
Total long-term debt, net of issuance costs	$	1,347		$	1,430


	Payments Due by Period
(in thousands)	Total		2024		2025		2026		2027		2028		Thereafter
DECD Loan	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413
Total	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413

Insurance Notes

Operating Leases

The expense associated with these operating leases for the three months ended March 31, 2024 and 2023 is shown in the table below (in thousands).


		Three Months Ended March 31,
Lease Cost	Classification		2024		2023
Operating rent expense
	Cost of revenue		$	41	$	24
	Research and development			17		6
	Sales and marketing			1		2
	General and administrative			10		21
Variable rent expense
	Cost of revenue			5		15
	Research and development			-		3
	Sales and marketing			2		2
	General and administrative			9		21


Year	Payments
2024	$	172
2025		229
2026		223
2027		84
2028		52
Total Operating Lease Payments		760
Less: Imputed Interest		(85	)
Present Value of Lease Liabilities		675
Less: Operating Lease Liability, current portion		(188	)
Operating Lease Liability, non-current portion	$	487

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


	Three Months Ended March 31,
	2024			2023
Cash paid for amounts included in measurement of lease liabilities:
Operating cash outflows relating to operating leases	$	117		$	111
Weighted-average remaining lease term (in years)		3.3			3.2
Weighted-average discount rate		7.28	%		9.29	%

Non-cancellable Royalty Obligations

Business Agreements

Contingent Liabilities

Accrued Liabilities

3 Months Ended

Mar. 31, 2024

Accrued Liabilities [Abstract]

Accrued Liabilities

ACCRUED LIABILITIES

The following table describes the principal components of accrued liabilities on the Company’s unaudited condensed consolidated balance sheet as of March 31, 2024 and December 31, 2023.


	March 31,		December 31,
(in thousands)	2024		2023
Payroll and benefits related expenses	$	1,328	$	1,189
Collaboration and research agreements expenses		99		217
Professional services		911		951
Other accrued liabilities		459		506
Total accrued liabilities	$	2,797	$	2,863

Stockholders' Deficit

3 Months Ended

Mar. 31, 2024

Stockholders' (Deficit) Equity [Abstract]

Stockholders' (Deficit) Equity

STOCKHOLDERS’ DEFICIT

2024 Registered Direct Offering

The Purchase Warrants have an exercise price of $4.13 per share and will be exercisable beginning six months after issuance and will expire 5 years from the initial exercise date.

The Company evaluated the Pre-Funded Warrants and the Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.

Approximately $106,000 of the costs related to the 2024 Direct Offering were allocated to the 2022 Warrants and were recorded as other expense in the unaudited condensed statement of operations.

2023 Registered Direct Offering

2023 At the Market Offering

2023 Equity Line of Credit

the lowest sale price for the Common Stock on The Nasdaq Capital Market on the date of sale; and

Subsequent to March 31, 2024, the Company sold 100,408 shares under the LPC Purchase Agreement for gross proceeds of approximately $300,000, as of May 10, 2024.

2010 Stock Incentive Plan

The following table summarizes stock option activity for the 2010 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	245,154
Options forfeited or expired	(33,965	)
Options outstanding at March 31, 2024	211,189

The weighted average exercise price of outstanding options under the 2010 Plan was $24.05 and the weighted average remaining life was 0.70 years.

2019 Stock Incentive Plan

The following table summarizes stock option activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	514,768
Options granted	140,124
Options forfeited or expired	(40,805	)
Options outstanding at March 31, 2024	614,087

The weighted average exercise price of outstanding options under the 2019 Plan was $11.77 and the weighted average remaining life was 1.92 years.

The following table summarizes RSU activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	59,463
RSUs vested and issued	(16,686	)
Options outstanding at March 31, 2024	42,777

RSUs vested and unissued at March 31, 2024	22,777

Stock-Based Compensation

The allocation of non-cash stock-based compensation expense by functional area for the three months ended March 31, 2024 and 2023 was as follows.


	Three Months Ended
	March 31,
(in thousands)	2024		2023
Cost of revenue	$	18	$	17
Research and development		66		103
Sales and marketing		25		(15	)
General and administrative		253		291
Total	$	362	$	396

Loss Per Share

3 Months Ended

Mar. 31, 2024

Loss Per Share [Abstract]

Loss Per Share

LOSS PER SHARE


	Three Months Ended
	March 31,
	2024			2023
Numerator:
Net Loss	$	(4,629	)	$	(6,578	)
Denominator:
Shares used in computing net loss per share, basic and diluted		11,846,075			8,313,091
Net loss per share, basic and diluted	$	(0.39	)	$	(0.79	)

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Policy)	3 Months Ended
	Mar. 31, 2024
Organization, Basis Of Presentation And Significant Accounting And Reporting Policies [Abstract]
Organization	Organization Aspira Women’s Health 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) the Ova1Plus workflow, which uses Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Ova1 is a qualitative serum 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. Overa is a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity. The Ova1 workflow leverages the strengths of Ova1’s (MIA) sensitivity and Overa’s (MIAG2G) specificity to reduce incorrectly elevated results; and (2) OvaWatch, a Laboratory Developed Test (“LDT”) intended in the clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass. Collectively, these tests are referred to and marketed as OvaSuite. For the three months ended March 31, 2024 and 2023, the Company’s product and related revenue was limited to the products described above, as well as residual revenue from Aspira GenetiX, which was discontinued in the third quarter of 2022. The Company’s products are distributed through its own national sales force, including field sales, inside sales and a contracted sales team, through its proprietary decentralized testing platform and cloud service marketed as Aspira Synergy, and through marketing and distribution agreements with BioReference Health, LLC and ARUP Laboratories. Overa is currently not offered commercially except as a reflex test performed as part of the Ova1Plus workflow.
Going Concern and Liquidity	Going Concern and Liquidity As of March 31, 2024, the Company had approximately $3,413,000 of cash and cash equivalents (excluding restricted cash of $260,000), an accumulated deficit of approximately $522,932,000, and working capital of approximately $829,000. For the three months ended March 31, 2024, the Company incurred a net loss of $4,629,000, and used cash in operations of $4,431,000. The Company has incurred significant net losses and negative cash flows from operations since inception. The Company also expects to continue to incur a net loss and negative cash flows from operations for the remainder of 2024. In order to fund operations, meet its capital requirements or satisfy the anticipated obligations as they become due, the Company expects to take further action to protect its liquidity position, which include, but are not limited to: • Raising capital through equity or debt offerings either in the public markets or via private placement offering, to the extent that the Company raises additional funds by issuing equity securities, the Company’s stockholders may experience significant dilution. However, no assurance can be given that capital will be available on acceptable terms, or at all; • Securing debt, however, no assurance can be given that debt will be available on acceptable terms or at all; • Reducing executive bonuses or replacing cash compensation with equity grants; • Reducing professional services and consulting fees and eliminating non-critical projects; • Reducing travel and entertainment expenses; and • Reducing eliminating or deferring discretionary marketing programs. The Company also has outstanding warrants to purchase shares of its common stock that may be exercised although there can be no assurance that the warrants will be exercised. There can be no assurance that the Company will achieve or sustain profitability or positive cash flow from operations. Management expects cash from product sales and licensing to be the Company’s only material, recurring source of cash in 2024. Given the above conditions, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date these consolidated interim financial statements are filed. The unaudited condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.
Basis of Presentation	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 unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The consolidated balance sheet at December 31, 2023 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, 2023 included in the Company’s Annual Report on Form 10-K, filed with the SEC on April 1, 2024. 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.
Revenue Recognition	Revenue Recognition Product Revenue – OvaSuite: The Company recognizes product revenue in accordance with the provisions of Financial Accounting Standards Board Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Product revenue is recognized upon completion of the OvaSuite 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 March 31, 2024, there were $8,000 of 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 three months ended March 31, 2024. The Company has discontinued providing Aspira GenetiX, including genetics carrier screening, on the Aspira Synergy platform, effective September 30, 2022. Accounts Receivable: Virtually all accounts receivable are derived from sales made to customers located in North America. The Company grants credit to customers in the normal course of business and the resulting trade receivables are stated at their net realizable value. The Company maintains an allowance for credit losses based upon the expected collectability of accounts receivable, including the historical collection cycle. Amounts are written off against the allowances for credit losses when the Company determines that a customer account is not collectable. The Company believes its exposure to concentrations of credit risk is limited due to the diversity of its payer base. Warrants: 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. Warrants that meet all of the criteria for equity classification are recorded as a component of additional paid-in capital at the time of issuance and are not remeasured. Warrants that do not meet the required criteria for equity classification are classified as liabilities. The Company adjusts such warrants to fair value at each reporting period until the warrants are exercised or expire. Any change in fair value is recognized in the Company’s statement of operations.
Recent Accounting Pronouncements	Recent Accounting Pronouncements In August 2020, the FASB issued ASU 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 is scheduled to be effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. The Company adopted the new standard on January 1, 2024. The adoption of this standard did not have a material impact on its consolidated results of operations, financial position, or cash flows. In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions (“ASU 2022-03”) to clarify guidance in Topic 820 on the fair value measurement of an equity security that is subject to a contractual sale restriction and also requires specific disclosures related to an equity security. ASU 2022-03 is scheduled to be effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect a material impact as a result of this standard on its results of operations, financial position, or cash flows. In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (“ASU 2023-06”). The amendments in this ASU are expected to clarify or improve disclosure and presentation requirements of a variety of ASC topics by aligning them with the SEC’s regulations. ASU 2023-06 will become effective for each amendment on the effective date of the SEC's corresponding disclosure rule changes. The Company does not expect ASU 2023-06 will have a material impact on its results of operations, financial position, or cash flows. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”) to update reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses and information used to assess segment performance. This ASU requires disclosure of significant segment expenses that are regularly provided to the Company’s Chief Operating Decision Maker (“CODM”) and included within the reported measure of a segment’s profit or loss, requires interim disclosures about a reportable segment’s profit or loss and assets that are currently required annually, requires disclosure of the position and title of the CODM, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, and contains other disclosure requirements. ASU 2023-07 is scheduled to be effective for fiscal years beginning after December 15, 2023 and interim periods beginning after December 15, 2024. The adoption of this standard is not expected to have a material impact on its consolidated results of operations, financial position, or cash flows.

Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2024

Fair Value Measurements [Abstract]

Schedule Of Assumptions Used To Calculate Fair Value Of Warrants


	March 31, 2024						December 31, 2023
	Unmodified Warrants			Modified Warrants
Dividend yield		—	%		—	%		—	%
Volatility		104.9	%		101.7	%		105.1	%
Risk-free interest rate		4.31	%		4.21	%		3.93	%
Expected lives (years)		3.39			4.83			3.64
Weighted average fair value	$	1.329		$	2.247		$	2.064

Carrying And Fair Value Of Loan Payable


		March 31,				December 31,
		2024				2023
(in thousands)	Fair Value Hierarchy	Carrying Value		Fair Value		Carrying Value		Fair Value
DECD loan	Level 3	$	1,604	$	1,287	$	1,604	$	1,255

Prepaid And Other Current Assets (Tables)

3 Months Ended

Mar. 31, 2024

Prepaid And Other Current Assets [Abstract]

Schedule Of Prepaid And Other Current Assets

Prepaid and other current assets at March 31, 2024 and December 31, 2023 consist of the following:


	March 31,		December 31,
(in thousands)	2024		2023
Prepaid insurance	$	479	$	684
Software licenses		173		103
Subscriptions		128		26
Other		162		184
Total prepaid and other current assets	$	942	$	997

Commitments And Contingencies (Tables)

3 Months Ended

Mar. 31, 2024

Commitments And Contingencies [Abstract]

Schedule Of Long-Term Debt

Long-term debt consisted of the following:


	March 31,			December 31,
	2024			2023
(in thousands)
DECD loan, net of issuance costs	$	1,596		$	1,596
Less: Current portion, net of issuance costs		(249	)		(166	)
Total long-term debt, net of issuance costs	$	1,347		$	1,430

Annual Amounts Of Future Minimum Principal Payments Due Under Certain Contractual Obligations


	Payments Due by Period
(in thousands)	Total		2024		2025		2026		2027		2028		Thereafter
DECD Loan	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413
Total	$	1,604	$	170	$	335	$	342	$	215	$	129	$	413

Expense Associated With Operating Leases

The expense associated with these operating leases for the three months ended March 31, 2024 and 2023 is shown in the table below (in thousands).


		Three Months Ended March 31,
Lease Cost	Classification		2024		2023
Operating rent expense
	Cost of revenue		$	41	$	24
	Research and development			17		6
	Sales and marketing			1		2
	General and administrative			10		21
Variable rent expense
	Cost of revenue			5		15
	Research and development			-		3
	Sales and marketing			2		2
	General and administrative			9		21

Future Lease Payments Related To Operating Leases


Year	Payments
2024	$	172
2025		229
2026		223
2027		84
2028		52
Total Operating Lease Payments		760
Less: Imputed Interest		(85	)
Present Value of Lease Liabilities		675
Less: Operating Lease Liability, current portion		(188	)
Operating Lease Liability, non-current portion	$	487

Summary Of Weighted-Average Lease Term And Discount Rate

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


	Three Months Ended March 31,
	2024			2023
Cash paid for amounts included in measurement of lease liabilities:
Operating cash outflows relating to operating leases	$	117		$	111
Weighted-average remaining lease term (in years)		3.3			3.2
Weighted-average discount rate		7.28	%		9.29	%

Accrued Liabilities (Tables)

3 Months Ended

Mar. 31, 2024

Accrued Liabilities [Abstract]

Components Of Accrued Liabilities

The following table describes the principal components of accrued liabilities on the Company’s unaudited condensed consolidated balance sheet as of March 31, 2024 and December 31, 2023.


	March 31,		December 31,
(in thousands)	2024		2023
Payroll and benefits related expenses	$	1,328	$	1,189
Collaboration and research agreements expenses		99		217
Professional services		911		951
Other accrued liabilities		459		506
Total accrued liabilities	$	2,797	$	2,863

Stockholders' Deficit (Tables)

3 Months Ended

Mar. 31, 2024

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Summary of RSU Activity

The following table summarizes RSU activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	59,463
RSUs vested and issued	(16,686	)
Options outstanding at March 31, 2024	42,777

RSUs vested and unissued at March 31, 2024	22,777

Allocation of Non-Cash Stock-Based Compensation Expense By Functional Area

The allocation of non-cash stock-based compensation expense by functional area for the three months ended March 31, 2024 and 2023 was as follows.


	Three Months Ended
	March 31,
(in thousands)	2024		2023
Cost of revenue	$	18	$	17
Research and development		66		103
Sales and marketing		25		(15	)
General and administrative		253		291
Total	$	362	$	396

2010 Stock Incentive Plan [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Summary of Stock Option Activity

The following table summarizes stock option activity for the 2010 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	245,154
Options forfeited or expired	(33,965	)
Options outstanding at March 31, 2024	211,189

2019 Stock Incentive Plan [Member]

Share-based Compensation Arrangement by Share-based Payment Award [Line Items]

Summary of Stock Option Activity

The following table summarizes stock option activity for the 2019 Plan during the three months ended March 31, 2024.


Options outstanding at December 31, 2023	514,768
Options granted	140,124
Options forfeited or expired	(40,805	)
Options outstanding at March 31, 2024	614,087

Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2024

Loss Per Share [Abstract]

Reconciliation Of Numerators And Denominators Of Basic And Diluted Loss Per Share


	Three Months Ended
	March 31,
	2024			2023
Numerator:
Net Loss	$	(4,629	)	$	(6,578	)
Denominator:
Shares used in computing net loss per share, basic and diluted		11,846,075			8,313,091
Net loss per share, basic and diluted	$	(0.39	)	$	(0.79	)

Organization, Basis Of Presentation And Significant Accounting And Reporting Policies (Narrative) (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]
Cash and cash equivalents	$ 3,413,000	$ 7,535,000	$ 2,597,000
Restricted cash	260,000	253,000	258,000
Accumulated deficit	(522,932,000)		$ (518,303,000)
Adjustments to estimates of variable consideration to derecognize revenue	8,000
Working capital	829,000
Net loss	(4,629,000)	(6,578,000)
Net cash used in operating activities	(4,431,000)	(5,706,000)
Receivable impairment	0
Stock-based compensation expense	$ 362,000	$ 396,000
ASU No. 2020-06 [Member]
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]
Change in Accounting Principle, Accounting Standards Update, Adoption Date	Jan. 01, 2024
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false]	true
Change in Accounting Principle, Accounting Standards Update, Adopted [true false]	true
ASU No. 2022-03 [Member]
Organization Consolidation And Summary Of Significant Accounting Policies [Line Items]
Change in Accounting Principle, Accounting Standards Update, Early Adoption [true false]	true
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false]	true

Fair Value Measurements (Narrative) (Details) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Fair value of warrants	$ 1,400,000	$ 1,651,000
Modified Warrants [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares of common stock called by warrants	366,664
Unmodified Warrants [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Shares of common stock called by warrants	433,321
2022 Offering [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Fair value of warrants	$ 1,400,000	$ 1,651,000

Fair Value Measurements (Assumptions Used to Estimate Fair Value of Warrants) (Details) - 2022 Offering [Member] - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Volatility		105.10%
Risk-free interest rate		3.93%
Expected lives (years)		3 years 7 months 20 days
Weighted average fair value		$ 2.064
Unmodified Warrants [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Volatility	104.90%
Risk-free interest rate	4.31%
Expected lives (years)	3 years 4 months 20 days
Weighted average fair value	$ 1.329
Modified Warrants [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Volatility	101.70%
Risk-free interest rate	4.21%
Expected lives (years)	4 years 9 months 29 days
Weighted average fair value	$ 2.247

Fair Value Measurements (Carrying And Fair Value Of Loan Payable) (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]
DECD loan, Carrying value	$ 1,604	$ 1,604
DECD loan, Fair value	$ 1,287	$ 1,255

Prepaid And Other Current Assets (Schedule Of Prepaid And Other Current Assets) (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Prepaid And Other Current Assets [Abstract]
Prepaid insurance	$ 479	$ 684
Software licenses	173	103
Subscriptions	128	26
Other	162	184
Total prepaid and other current assets	$ 942	$ 997

Commitments And Contingencies (Narrative) (Details)				3 Months Ended		12 Months Ended
Commitments And Contingencies (Narrative) (Details)	Dec. 03, 2020 USD ($)	Apr. 15, 2016 USD ($)	Mar. 22, 2016 USD ($)	Mar. 31, 2024 USD ($) Item	Mar. 31, 2023 USD ($)	Dec. 31, 2024	Dec. 31, 2023 USD ($)
Commitments And Contingencies [Line Items]
Other income							$ 1,000,000
Amended Loan Agreement [Member]
Commitments And Contingencies [Line Items]
Unamortized debt issuance costs				$ 8,000			$ 8,000
DECD Loan [Member]
Commitments And Contingencies [Line Items]
Proceeds from loan	$ 2,000,000	$ 2,000,000
Maximum loan forgiveness amount under loan agreement			$ 1,500,000
Line of Credit, reduction in principal amount				$ 1,000,000
Percentage of penalty included in loan agreement			5.00%
Line of credit, maturity date				Jan. 01, 2032
Line of credit, maximum borrowing capacity				$ 4,000,000
Line of credit fixed interest rate			2.00%
DECD Loan [Member] \| Loan Agreement Target Employment Milestone [Member]
Commitments And Contingencies [Line Items]
Proceeds from loan	$ 1,000,000
Insurance Promissory Notes [Member]
Commitments And Contingencies [Line Items]
Debt instrument interest rate							7.79%
Aggregate principal outstanding amount				416,000			$ 670,000
Interest paid				$ 6,000	$ 6,000
Notes payable number of monthly payment installment \| Item				9
Notes payable frequency of periodic payment, description				monthly
Insurance Promissory Notes [Member] \| Forecast [Member]
Commitments And Contingencies [Line Items]
Maturity date						Oct. 01, 2024

Commitments And Contingencies (Schedule Of Long-Term Debt) (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Commitments And Contingencies [Abstract]
DECD loan, net of issuance costs	$ 1,596	$ 1,596
Less: Current portion, net of issuance costs	(249)	(166)
Total long-term debt, net of issuance costs	$ 1,347	$ 1,430

Commitments And Contingencies (Annual Amounts Of Future Minimum Principal Payments Due Under Certain Contractual Obligations) (Details) $ in Thousands	Mar. 31, 2024 USD ($)
Debt Instrument [Line Items]
Contractual obligation, 2024	$ 170
Contractual obligation, 2025	335
Contractual obligation, 2026	342
Contractual obligation, 2027	215
Contractual obligation, 2028	129
Contractual obligation, Thereafter	413
Total	1,604
DECD Loan [Member]
Debt Instrument [Line Items]
Contractual obligation, 2024	170
Contractual obligation, 2025	335
Contractual obligation, 2026	342
Contractual obligation, 2027	215
Contractual obligation, 2028	129
Contractual obligation, Thereafter	413
Total	$ 1,604

Commitments And Contingencies (Operating Leases) (Narrative) (Details)		3 Months Ended
	Oct. 31, 2023 USD ($) Freezer	Mar. 31, 2024 USD ($)	Mar. 31, 2023 USD ($)	May 30, 2023
Commitments And Contingencies [Line Items]
Fixed lease payment		$ 117,000	$ 111,000
Freezer Storage [Member]
Commitments And Contingencies [Line Items]
Lease renewal term	12 months
Operating lease term	36 months
Lease cost per month	$ 5,200
Number of freezers leased \| Freezer	6
Lessee, Operating Lease, Option to Extend	with a twelve-month automatic renewal provision
Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Lease termination date		Feb. 28, 2027
Lease renewal term		37 months
Operating lease term		12 months
Lessee, Operating Lease, Option to Extend		option to extend the lease for an additional three years
Palo Alto, California [Member]
Commitments And Contingencies [Line Items]
Lease termination date		May 31, 2024
Lessee, Operating Lease, Option to Extend		no option for renewal with the sublessor
Shelton, CT [Member]
Commitments And Contingencies [Line Items]
Lease renewal term				5 years
Fixed lease payment		$ 8,900
June 1, 2023 to September 30, 2023 [Member] \| Shelton, CT [Member]
Commitments And Contingencies [Line Items]
Reduced fixed lease payment		5,000
October 1, 2024 to September 30, 2027 [Member] \| Shelton, CT [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		5,383
October 1, 2027 to September 30, 2028 [Member] \| Shelton, CT [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		5,768
April 1, 2023 to December 31, 2023 [Member] \| Palo Alto, California [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		9,000
January 1, 2024 to May 31, 2024 [Member] \| Palo Alto, California [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		10,000
July 1, 2023 to January 31, 2024 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		9,490
February 1, 2024 to January 31, 2025, Except August 2024 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		7,100
August 2024 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		0
February 1, 2025 to January 31, 2026 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		8,600
February 1, 2026 to January 31, 2027 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		8,900
February 2027 [Member] \| Austin, Texas Facility [Member]
Commitments And Contingencies [Line Items]
Fixed lease payment		$ 9,100

Commitments And Contingencies (Expense Associated With Operating Leases) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Cost Of Revenue [Member]
Lessee, Lease, Description [Line Items]
Operating rent expense	$ 41	$ 24
Variable rent expense	5	15
Research And Development [Member]
Lessee, Lease, Description [Line Items]
Operating rent expense	17	6
Variable rent expense	0	3
Sales And Marketing [Member]
Lessee, Lease, Description [Line Items]
Operating rent expense	1	2
Variable rent expense	2	2
General And Administrative [Member]
Lessee, Lease, Description [Line Items]
Operating rent expense	10	21
Variable rent expense	$ 9	$ 21

Commitments And Contingencies (Future Lease Payments Related To Operating Leases) (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Commitments And Contingencies [Abstract]
2024	$ 172
2025	229
2026	223
2027	84
2028	52
Total Operating Lease Payments	760
Less: Imputed Interest	(85)
Present Value of Lease Liabilities	675
Less: Operating Lease Liability, current portion	(188)	$ (159)
Operating Lease Liability, non-current portion	$ 487	$ 427

Commitments And Contingencies (Summary Of Weighted-Average Lease Term And Discount Rate) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Commitments And Contingencies [Abstract]
Operating cash outflows relating to operating leases	$ 117	$ 111
Weighted-average remaining lease term (in years)	3 years 3 months 18 days	3 years 2 months 12 days
Weighted-average discount rate	7.28%	9.29%

Commitments And Contingencies (Non-Cancellable Royalty Obligations And Business Agreements) (Narrative) (Details) - USD ($)		3 Months Ended				6 Months Ended	12 Months Ended	20 Months Ended
	Aug. 08, 2022	Mar. 31, 2024	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Jun. 30, 2024	Mar. 20, 2024	Mar. 31, 2024
Commitments And Contingencies [Line Items]
Royalty expense		$ 72,000		$ 90,000
Research and development		$ 906,000		1,267,000
Research Collaboration Agreement With Johns Hopkins University School Of Medicine [Member]
Commitments And Contingencies [Line Items]
Percent of royalty paid		4.00%
Royalty payments		$ 57,500
Sponsored Research Agreement With Multiple Entities [Member]
Commitments And Contingencies [Line Items]
Agreement amount	$ 1,252,000
Agreement amount, percent paid or payable					68.00%
Research and development		34,000		$ 23,000				$ 1,117,000
License Agreement With Multiple Entities [Member]
Commitments And Contingencies [Line Items]
Initial license fee		75,000
Annual license fee		50,000					$ 50,000
Forecast [Member] \| Sponsored Research Agreement With Multiple Entities [Member]
Commitments And Contingencies [Line Items]
Agreement amount, percent paid or payable						17.00%
Completion of certain deliverables, first [Member] \| Sponsored Research Agreement With Multiple Entities [Member]
Commitments And Contingencies [Line Items]
Agreement amount, percent paid or payable			15.00%
Maximum [Member] \| License Agreement With Multiple Entities [Member]
Commitments And Contingencies [Line Items]
Royalty expense		$ 1,350,000

Accrued Liabilities (Components Of Accrued Liabilities) (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Accrued Liabilities [Abstract]
Payroll and benefits related expenses	$ 1,328	$ 1,189
Collaboration and research agreements expenses	99	217
Professional services	911	951
Other accrued liabilities	459	506
Total accrued liabilities	$ 2,797	$ 2,863

Stockholders' Deficit (Narrative) (Details) - USD ($)									3 Months Ended		12 Months Ended		14 Months Ended
Stockholders' Deficit (Narrative) (Details) - USD ($)	May 13, 2024	May 10, 2024	Feb. 26, 2024	Jan. 24, 2024	Jul. 20, 2023	May 09, 2023	Mar. 28, 2023	Feb. 10, 2023	Mar. 31, 2024	Mar. 31, 2023	Mar. 31, 2024	Dec. 31, 2023	Mar. 31, 2024	Apr. 25, 2024	Jan. 26, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, shares authorized									200,000,000		200,000,000	150,000,000	200,000,000
Common stock, par value									$ 0.001		$ 0.001	$ 0.001	$ 0.001
Change in fair value of warrant liabilities									$ (251,000)	$ 24,000
2022 Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Change in fair value of warrant liabilities									$ 106,000
Shares of common stock called by warrants												366,664
Exercise price of warrants															$ 13.2
2022 Amended Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Reduction in exercise price									$ 4.13
Change in fair value of warrant liabilities									$ 490,000
Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, par value				$ 0.001	$ 0.001
Payment of stock issuance expenses				$ 694,000	$ 597,000
Common stock shares issued				1,371,000	1,694,820
Proceeds from public offering				$ 5,563,000	$ 4,700,000
Issuance costs				$ 694,000	$ 597,000
Shares issued price per share deduction				$ 0.0001
Purchase Agreement [Member] \| Directors And Executive Officers [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued					44,347
Share Price					$ 3.98
Purchase Agreement [Member] \| Investors [Members]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued				1,368,600	1,650,473
Share Price				$ 3.5	$ 2.75
Purchase Agreement [Member] \| Chief Executive Officer [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued				2,400
Stock price per share				$ 4.2555
Purchase Agreement [Member] \| Pre-Funded Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares of common stock called by warrants				200,000
Gross proceeds warrants exercised			$ 20
Exercise price of warrants				$ 0.0001
Warrant restriction, threshold common stock held, percent				9.99%
Purchase Agreement [Member] \| Purchase Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price				$ 0.125
Shares of common stock called by warrants				1,571,000
Exercise price of warrants				$ 4.13
Warrant term				5 years
Placement Shares [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, par value								$ 0.001
Maximum aggregate offering price								$ 12,500,000
Payment of stock issuance expenses									$ 0
Common stock shares issued									0				35,552
Proceeds from public offering													$ 211,000
Issuance costs									$ 0
Stock issuance expenses, net equity impact									134,000
Purchase Shares [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Maximum aggregate offering price							$ 10,000,000
LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock, par value							$ 0.001
Stock issuance expenses									$ 326,000
Common stock shares issued									111,369		472,312
Proceeds from public offering									$ 400,000		$ 1,578,000
Purchase agreement term							36 months
Maximum number of shares per purchase							6,667
Stock issued for services									258,000
Legal expenses									40,000	$ 0		$ 38,000
Lincoln Park Capital Fund [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued											47,733
Stock transaction costs									$ 30,000
Alliance Global Partners [Member] \| Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Placement agent cash fee paid				7.00%	7.00%
Non-accountable expense allowance				$ 30,000	$ 30,000
Legal expenses				$ 75,000	$ 75,000
Placement agent cash fee				3.50%
Alliance Global Partners [Member] \| Purchase Agreement [Member] \| Directors And Executive Officers [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Placement agent cash fee paid					3.50%
Alliance Global Partners [Member] \| Purchase Agreement [Member] \| Investors [Members]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued					182,447
Not below $7.50 [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price							$ 7.5
Maximum number of shares per purchase							13,333
Not below $11.25 [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price							$ 11.25
Maximum number of shares per purchase							16,666
Not below $15.00 [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price							$ 15
Maximum number of shares per purchase							20,000
Subsequent Event [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares issued		100,408
Proceeds from public offering		$ 300,000
2010 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation shares reserved for issuance									0		0		0
Share based compensation, options outstanding									211,189		211,189	245,154	211,189
Weighted average exercise price of outstanding									$ 24.05		$ 24.05		$ 24.05
Weighted average remaining life									8 months 12 days
2019 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reserved for issuance									66,542		66,542		66,542
Share based compensation shares authorized for grants									699,485		699,485		699,485
Additional shares authorized						333,333
Share based compensation, options outstanding									614,087		614,087	514,768	614,087
Share based compensation, nonvested restricted shares									42,777		42,777	59,463	42,777
Interest rate, minimum									4.33%
Interest rate, maximum									4.56%
Forfeitures amount									$ 12,000
Weighted average exercise price of outstanding									$ 11.77		$ 11.77		$ 11.77
Weighted average remaining life									1 year 11 months 1 day
Weighted average grant date fair value									$ 2.97
Weighted average exercise price									4.77
2019 Stock Incentive Plan [Member] \| Subsequent Event [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation shares authorized for grants	2,032,818
Additional shares authorized	1,000,000
Minimum [Member] \| 2019 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price									$ 4		4		4
Expected term									2 years
Maximum [Member] \| LPC Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Maximum amount per purchase							$ 1,000,000
Maximum [Member] \| Subsequent Event [Member] \| Lincoln Park Capital Fund [Member] \| Purchase Agreement [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Remaining number of shares to be sold under the agreement														8,422,000
Maximum [Member] \| 2019 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price									$ 4.87		$ 4.87		$ 4.87
Expected term									3 years
Common Stock [Member] \| Purchase Agreement [Member] \| Chief Executive Officer [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share Price				$ 4.13
Unvested Stock Option Awards [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unrecognized compensation costs related to nonvested stock option awards									$ 696,000		$ 696,000		$ 696,000
Weighted average period over which unrecognized cost expected to be recognized									1 year 11 months 1 day
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total unrecognized compensation costs related to nonvested stock option awards									$ 52,000		$ 52,000		$ 52,000
Weighted average period over which unrecognized cost expected to be recognized									3 months

Stockholders' Deficit (Summary Of Stock Option Activity) (Details)	3 Months Ended
	Mar. 31, 2024 shares
2010 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options outstanding	245,154
Options forfeited or expired	(33,965)
Options outstanding	211,189
2019 Stock Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options outstanding	514,768
Options granted	140,124
Options forfeited or expired	(40,805)
Options outstanding	614,087

Stockholders' Deficit (Summary of RSU Activity) (Details) - 2019 Stock Incentive Plan [Member]	3 Months Ended
	Mar. 31, 2024 shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
RSUs outstanding	59,463
RSUs vested and issued	(16,686)
RSUs outstanding	42,777
RSUs vested and unissued	22,777

Stockholders' Deficit (Allocation of Non-Cash Stock-Based Compensation Expense By Functional Area) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 362	$ 396
Cost Of Revenue [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	18	17
Research And Development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	66	103
Sales And Marketing [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	25	(15)
General And Administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 253	$ 291

Loss Per Share (Narrative) (Details) - shares	3 Months Ended
Loss Per Share (Narrative) (Details) - shares	Mar. 31, 2024	Mar. 31, 2023
Potential Shares Of Aspira Common Stock [Member]
Antidilutive securities excluded from computation of earnings per share	3,239,038	1,583,982
Warrant [Member]
Antidilutive securities excluded from computation of earnings per share	2,370,985	799,985

Loss Per Share (Reconciliation Of Numerators And Denominators Of Basic And Diluted Loss Per Share) (Details) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Loss (Numerator)
Net loss	$ (4,629,000)	$ (6,578,000)
Shares (Denominator)
Shares used in computing net loss per share, basic	11,846,075	8,313,091
Shares used in computing net loss per share, diluted	11,846,075	8,313,091
Per Share Amount
Net loss per share - basic	$ (0.39)	$ (0.79)
Net loss per share - diluted	$ (0.39)	$ (0.79)

Aspira Womans Health (NASDAQ:AWH)
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Aspira Womans Health (NASDAQ:AWH)
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