Aspira Women's Health Inc 10-Q for FY2025 Q2
Aspira Women's Health Inc. (AWHL)
About this 10-Q
Aspira Women's Health Inc filed this 10-Q on August 13, 2025, covering the quarter ended June 30, 2025 (FY2025 Q2).
Headline figures
Quarter ended June 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $169K
- Net loss
- $2.67M
- compared with a net loss of $3.53M a year earlier
- Diluted EPS
- -$0.07
- compared with -$0.28 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______ to ______
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(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The OTC QB 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.
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
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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 ☐ | |
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. ☐
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by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of August 8, 2025, the registrant had shares of common stock, par value $ per share, outstanding.
ASPIRA WOMEN’S HEALTH INC.
FORM 10-Q
For the Quarter Ended June 30, 2025
Table of Contents
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, ENDOINFORMTM, OVAINFORMTM, OVAInheritSM, Aspira Synergy®, OVA360SM, ASPIRA IVDSM, and YOUR HEALTH, OUR PASSION®.
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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)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net
of reserves of $ | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Inventories | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Right-of-use assets | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Current portion of long-term debt | ||||||||
| Short-term debt | ||||||||
| Current maturities of lease liabilities | ||||||||
| Total current liabilities | ||||||||
| Non-current liabilities: | ||||||||
| Long-term debt | ||||||||
| Non-current maturities of lease liabilities | ||||||||
| Warrant liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 4) | ||||||||
| Stockholders’ deficit: | ||||||||
| Common stock, par value $ per share, and shares authorized at June 30, 2025 and December 31, 2024, respectively; and shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders’ deficit | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 1 |
Aspira Women’s Health Inc.
Condensed Consolidated Statements of Operations (unaudited)
(Amounts in Thousands, Except Share and Per Share Amounts)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product | $ | $ | $ | $ | ||||||||||||
| Total revenue | ||||||||||||||||
| Cost of revenue: | ||||||||||||||||
| Product | ||||||||||||||||
| Total cost of revenue | ||||||||||||||||
| Gross profit | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) income, net: | ||||||||||||||||
| Change in fair value of warrant liabilities | ( | ) | ||||||||||||||
| Change in fair value of convertible notes | ||||||||||||||||
| Loss upon issuance of Convertible Notes carried at fair value | ( | ) | ||||||||||||||
| Interest expense, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) income, net | ( | ) | ( | ) | ( | ) | ||||||||||
| Total other (expense) income, net | ( | ) | ||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share - basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average common shares used to compute basic and diluted net loss per common share | ||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 2 |
Aspira Women’s Health Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Deficit (unaudited)
(Amounts in Thousands, Except Share Amounts)
| Shares | Amount | Additional
Paid-In Capital | Accumulated
Deficit | Total
Stockholders’ Equity (Deficit) | ||||||||||||||||
| Common Stock | ||||||||||||||||||||
| Shares | Amount | Additional
Paid-In Capital | Accumulated
Deficit | Total
Stockholders’ Equity (Deficit) | ||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Common stock issued under 2024 At-the-Market Offering Agreement, net of issuance costs | ||||||||||||||||||||
| Common stock issued for convertible notes settlement | ||||||||||||||||||||
| Common stock issued for vested restricted stock awards | ||||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Balance at March 31, 2025 | ( | ) | ( | ) | ||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Common stock issued under 2024 Equity Line of Credit Agreement, net of issuance costs | ||||||||||||||||||||
| Common stock issued for vested restricted stock awards | ||||||||||||||||||||
| Stock-based compensation expense | - | ( | ) | ( | ) | |||||||||||||||
| Balance at June 30, 2025 | $ | | $ | $ | ( | ) | $ | ( | ) | |||||||||||
| 3 |
Aspira Women’s Health Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Deficit (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, 2023 | | ( | ) | ( | ) | |||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Common stock issued under 2023 Equity Line of Credit Agreement | ||||||||||||||||||||
| Common stock issued under 2024 Direct Offering, net of issuance costs | ||||||||||||||||||||
| Warrant Exercise | ||||||||||||||||||||
| Common stock issued for vested restricted stock awards | ||||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Balance at March 31, 2024 | ( | ) | ( | ) | ||||||||||||||||
| Balance | ( | ) | ( | ) | ||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Issuance costs related to common stock issued under 2024 Direct Offering | - | ( | ) | ( | ) | |||||||||||||||
| Common stock issued under 2023 Equity Line of Credit Agreement | ||||||||||||||||||||
| Common stock issued under Equity Line of Credit Agreement, net of issuance costs | ||||||||||||||||||||
| Common stock issued for vested restricted stock awards | ||||||||||||||||||||
| Stock-based compensation expense | - | |||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 4 |
Aspira Women’s Health Inc.
Condensed Consolidated Statements of Cash Flows (unaudited)
(Amounts in Thousands)
| 2025 | 2024 | |||||||
| Six Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Non-cash lease expense | ( | ) | ||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation expense | ||||||||
| Change in fair value of warrant liabilities | ( | ) | ( | ) | ||||
| Change in fair value of Convertible Notes | ( | ) | ||||||
| Loss upon issuance of Convertible Notes carried at fair value | ||||||||
| Loss on impairment and disposal of property and equipment | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ||||||
| Prepaid expenses and other assets | ||||||||
| Inventories | ||||||||
| Accounts payable | ( | ) | ||||||
| Accrued liabilities | ( | ) | ( | ) | ||||
| Other liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Principal repayment of DECD loan | ( | ) | ( | ) | ||||
| Proceeds from 2023 Equity Line of Credit Agreement | ||||||||
| Proceeds from 2024 Direct Offering | ||||||||
| Payment of issuance costs for 2024 Direct Offering | ( | ) | ||||||
| Proceeds from 2024 At the Market Offering Agreement | ||||||||
| Proceeds from issuance of common stock | ||||||||
| Payment of issuance costs for 2024 At the Market Offering Agreement | ( | ) | ||||||
| Payment of stock issuance costs | ( | ) | ||||||
| Proceeds from Convertible Notes | ||||||||
| Proceeds from Equity Line of Credit | ||||||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash, cash equivalents and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents and restricted cash, beginning of year | ||||||||
| Cash, cash equivalents and restricted cash, end of year | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental disclosure of noncash investing and financing activities: | ||||||||
| Increase in right-of-use assets | $ | $ | ||||||
| Fair value of warrants issued upon conversion of Convertible Notes | $ | $ | ||||||
| Fair value of common stock issued upon conversion of Convertible Notes | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 5 |
Aspira Women’s Health Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. 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, 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, as the primary test and Overa, a second-generation biomarker test intended to maintain Ova1’s high sensitivity while improving specificity, as a reflex for Ova1 intermediate range results, leveraging the strengths of Ova1’s MIA sensitivity and Overa’s (MIA2G) specificity to reduce incorrectly elevated results; and (2) OvaWatch, a lab developed test (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. Overa is currently not offered except as a reflex test performed as part of the Ova1Plus workflow. Collectively, these tests are referred to and marketed as OvaSuite. The Company’s products are distributed through its own national sales force, 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.
For the six months ended June 30, 2025 and 2024, the Company’s product and related revenue was limited to the products described above.
Going Concern and Liquidity
As
of June 30, 2025, the Company had approximately $
| ● | Raising capital through an equity offering via a 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 2025. 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.
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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, 2024 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, 2024 included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 27, 2025.
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 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 three and six months ended June 30, 2025, there
were no adjustments to estimates of variable consideration to derecognize revenue for services provided in a prior period; however, there was additional revenue recognized related to prior quarters
of $
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.
Common Stock 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.
Segment Reporting
The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer. The Company views its operations and manages its business in a single operating segment, which is the discovery, development, and commercialization of noninvasive diagnostic tests. As a result, the CODM evaluates the business on a consolidated basis. The Company’s CODM uses the net loss that is reported on the Company’s consolidated statement of operations as a consolidated net loss for the purpose of allocating resources. The Company also monitors its cash and cash equivalents as reported on its consolidated balance sheets to determine its liquidity needs and to allocate resources. For additional information, see Note 9, Segment Information.
Recent Accounting Pronouncements
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 was effective for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years. The
Company adopted ASU 2022-03 on
| 7 |
In
March 2023, the FASB issued ASU No. 2023-01, Leases (Topic 842): Common Control Arrangements (“ASU 2023-01”).
ASU 2023-01 clarified the accounting for leasehold improvements for leases under common control. The guidance is scheduled to be effective
for fiscal years beginning after December 15, 2024, including interim periods within those fiscal years. Early adoption is permitted.
ASU 2023-01 was adopted by the Company on
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 adopted ASU 2023-06 on January 1, 2025. The adoption of this standard did not have a material impact on the Company’s consolidated 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 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 was adopted by the Company on January 1, 2024. The adoption of this standard did not have a material impact on the Company’s consolidated results of operations, financial position, or cash flows. For additional information, see Note 9, Segment Information.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) that addresses requests for improved income tax disclosures from investors that use the financial statements to make capital allocation decisions. Public entities must adopt the new guidance for fiscal years beginning after December 15, 2024. The amendments in this ASU must be applied on a retrospective basis to all prior periods presented in the financial statements and early adoption is permitted. The Company is still evaluating whether the adoption of ASU 2023-09 will have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”) that requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. The standard will become effective for annual periods beginning after December 15, 2026. The Company is still evaluating whether the adoption of ASU 2024-03 will have a material impact on its results of operations, financial position or cash flows.
2. FAIR VALUE MEASUREMENTS
Fair Value of Financial Instruments
Cash and cash equivalents, accounts receivable, and accounts payable are considered Level 1 due to their short-term nature and their market interest rates.
The
Company recorded warrants in connection with a public offering in 2022 (the “2022 Warrants”) in warrant liabilities. 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
| 8 |
The
fair value of the 2022 Warrants as of June 30, 2025 and December 31, 2024 were approximately $
| June 30, 2025 | December 31, 2024 | |||||||||||||||
2022 | 2022 | 2022 | 2022 | |||||||||||||
| Dividend yield | % | % | % | % | ||||||||||||
| Volatility | % | % | % | % | ||||||||||||
| Risk-free interest rate | % | % | % | % | ||||||||||||
| Expected lives (years) | ||||||||||||||||
| Weighted average fair value | $ | $ | $ | $ | ||||||||||||
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 2022 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 in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets.
The following is a reconciliation of the fair values from December 31, 2024 to June 30, 2025.
SCHEDULE OF A RECONCILIATION OF THE FAIR VALUES
| (in thousands) | Fair Value of August 2022 Warrants | Fair Value of March 2025 Warrants | Total Fair Value of Warrant Liability | |||||||||
| August 2022 Warrant liability – December 31, 2024 | $ | $ | $ | |||||||||
| Warrant liability– March 12, 2025 | ||||||||||||
| Change in fair value (gain) reported in statement of operations | ( | ) | ( | ) | ( | ) | ||||||
| Warrant liability – June 30, 2025 | $ | $ | $ | |||||||||
The
Company recorded warrants in connection with the March conversion of Senior Secured Convertible Promissory Notes (the “Convertible
Notes”) in 2025 (the “March 2025 Warrants”) in warrant liabilities. The March 2025 Warrants were deemed to be derivative
instruments due to certain contingent put features. As discussed in Note 4 to the unaudited condensed consolidated financial statements,
in connection with the conversion of convertible notes in March 2025, the Company issued warrants to purchase up to an aggregate of
The
fair value of the March 2025 Warrants as of June 30, 2025 and March 12, 2025 was approximately $
The Company used the following key inputs to the Monte Carlo simulation pricing model to determine the fair value of the March 2025 Warrants.
| June 30, 2025 | March 12, 2025 | |||||||
| Exercise price (first 24 months) | $ | $ | ||||||
| Exercise price | $ | $ | ||||||
| Volatility | % | % | ||||||
| Risk-free interest rate | % | % | ||||||
| Remaining term (years) | ||||||||
| Weighted average fair value | $ | $ | ||||||
The
Company recorded the Convertible Notes on its books at fair value. The fair value of the Convertible Notes was calculated by backing
out the fair value of the March 2025 Warrants, which was estimated using a Monte Carlo simulation pricing model. The Monte Carlo simulation
pricing model uses Level 3 inputs due to its incorporation of significant inputs that are not observable in the market. The fair value
of the convertible notes at issuance was approximately $
| 9 |
The carrying value of the Company’s insurance promissory note approximates fair value as of June 30, 2025 and December 31, 2024, 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.
SCHEDULE OF CARRYING AND FAIR VALUE OF LOAN PAYABLE
| June 30, | December 31, | |||||||||||||||||||
| 2025 | 2024 | |||||||||||||||||||
| (in thousands) | Fair
Value Hierarchy | Carrying
Value | Fair Value | Carrying
Value | Fair Value | |||||||||||||||
| DECD loan | Level 3 | $ | $ | $ | $ | |||||||||||||||
3. PREPAID AND OTHER CURRENT ASSETS
Prepaid and other current assets at June 30, 2025 and December 31, 2024 consist of the following:
SCHEDULE OF PREPAID AND OTHER CURRENT ASSETS
| June 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Prepaid insurance | $ | $ | ||||||
| Software licenses | ||||||||
| Subscriptions | ||||||||
| Other | ||||||||
| Total prepaid and other current assets | $ | $ | ||||||
4. COMMITMENTS AND CONTINGENCIES, AND DEBT
Convertible Notes
On
March 5, 2025, the Company entered into a securities purchase agreement with certain existing accredited shareholders (the
“Purchasers”) for the issuance and sale in a private placement (the “March 2025 Private Placement”) of an
aggregate gross principal amount of $
The Company elected to measure the Convertible Notes using the fair value option under ASC 825 because the warrants issuable upon conversion of the Convertible Notes are not indexed to the Company’s stock. They include a variable exercise price that violates the fixed-for-fixed concept under ASC 815. Further, as the Convertible Notes were issued at par (gross cash proceeds equaled the principal of the Convertible Notes), the Convertible Notes were not issued at a substantial premium and are eligible for the fair value option under ASC 825.
As
the Company required the proceeds from the Convertible Notes to sustain its operations, the terms were not favorable to the Company and
the Convertible Notes were issued as a discount. This resulted in the fair value of the Convertible Notes upon issuance exceeding the
proceeds received; and as such, the Company recognized the excess of approximately $
| 10 |
The Purchasers of the Convertible Notes are entitled to three representatives on the Company’s board of directors.
In addition, the Company granted the Purchasers of the Convertible Notes certain customary registration rights with respect to the shares of common stock and shares of common stock underlying the March 2025 Warrants.
Pursuant
to the terms of the agreement, the Company exercised its option to convert the Convertible Notes into units at the Conversion Price when
the sum of the net proceeds from the sale of the Convertible Notes and the net proceeds from the sale of any shares of common stock and
warrants by the Company subsequent to the March 2025 Private Placement exceeded $
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 $
The
loan may be prepaid at any time without premium or penalty. An initial disbursement of $
Under
the terms of the DECD Loan Agreement, the Company was eligible for forgiveness of up to $
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.
| 11 |
On October 2, 2024, the Company executed an additional deferral agreement (the “October 2 Deferral”), which provides for both the interest and principal payments on Loan 1 to be deferred for August and September 2024. Payments resumed in October 2024. The October 2 Deferral also provides for both the interest and principal payments on Loan 2 to be deferred from August 2024 to May 2027, with payments resuming in June 2027. The Company determined these loan deferrals also 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, as adjusted for the October 2 Deferral, consisted of the following:
SCHEDULE OF LONG-TERM DEBT
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| (in thousands) | ||||||||
| DECD loan, net of issuance costs | $ | $ | ||||||
| Less: Current portion, net of issuance costs | ( | ) | ( | ) | ||||
| Total long-term debt, net of issuance costs | $ | $ | ||||||
As
of June 30, 2025, 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 $
SCHEDULE OF ANNUAL AMOUNTS OF FUTURE MINIMUM PRINCIPAL PAYMENTS DUE UNDER CERTAIN CONTRACTUAL OBLIGATIONS
| Payments Due by Period | ||||||||||||||||||||||||||||
| (in thousands) | Total | 2025 | 2026 | 2027 | 2028 | 2029 | Thereafter | |||||||||||||||||||||
| DECD Loan | $ | $ | $ | $ | $ | $ | $ | | ||||||||||||||||||||
| Total | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
Insurance Notes
During
2023, the Company entered into an insurance promissory note for the payment of insurance premiums at an interest rate of
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 an administrative office is also located in Shelton, Connecticut. The Company also had an administrative office in Palo Alto, California through May 31, 2024.
In
December 2024, the Company extended the Austin, Texas lease for an additional
In October 2015, the Company entered into a lease agreement for a facility in Trumbull, Connecticut, which was renewed in September 2020. On May 30, 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. The new lease in Shelton, Connecticut cancelled and replaced the Trumbull, Connecticut office lease. The new lease term is for five years, and its commencement date was October 1, 2023. Continuation of the lease after the lease term would be on a month-to-month basis.
| 12 |
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 expired on May 31, 2024. The Company did not renew its lease with the sublessor. The sublessor,
Invitae, filed for bankruptcy on February 15, 2024. The Company has applied for a refund of its approximately $
Effective
October 31, 2023, the Company entered into a new lease agreement for freezer storage for its samples. The lease term is for
The expense associated with these operating leases for the three months ended June 30, 2025 and 2024 is shown in the table below (in thousands).
SCHEDULE OF EXPENSE ASSOCIATED WITH OPERATING LEASES
Three Months Ended June 30, | ||||||||||
| Lease Cost | Classification | 2025 | 2024 | |||||||
| Operating rent expense | ||||||||||
| Cost of revenue | $ | $ | ||||||||
| Research and development | ||||||||||
| Sales and marketing | ||||||||||
| General and administrative | ||||||||||
| Variable rent expense | ||||||||||
| Cost of revenue | ||||||||||
| Cost of Revenue [Member] | ||||||||||
| Research and development | ||||||||||
| Sales and marketing | ||||||||||
| General and administrative | ||||||||||
The expense associated with these operating leases for the six months ended June 30, 2025 and 2024 is shown in the table below (in thousands).
| Six Months Ended June 30, | ||||||||||
| Lease Cost | Classification | 2025 | 2024 | |||||||
| Operating rent expense | ||||||||||
| Cost of revenue | $ | $ | ||||||||
| Research and development | ||||||||||
| Sales and marketing | ||||||||||
| General and administrative | ||||||||||
| Variable rent expense | ||||||||||
| Cost of revenue | $ | $ | ||||||||
| Cost of Revenue [Member] | ||||||||||
| Research and development | ||||||||||
| Sales and marketing | ||||||||||
| General and administrative | ||||||||||
| 13 |
Based on the Company’s leases as of June 30, 2025, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).
SCHEDULE OF FUTURE LEASE PAYMENTS RELATED TO OPERATING LEASES
| Year | Payments | |||
| 2025 (remaining six months) | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | ||||
| Thereafter | ||||
| Total Operating Lease Payments | ||||
| Less: Imputed Interest | ( | ) | ||
| Present Value of Lease Liabilities | ||||
| Less: Unamortized Tenant Improvement Allowance | ( | ) | ||
| Less: Operating Lease Liability, current portion | ( | ) | ||
| Operating Lease Liability, non-current portion | $ | |||
Weighted-average lease term and discount rate were as follows.
SCHEDULE OF WEIGHTED-AVERAGE LEASE TERM AND DISCOUNT RATE
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash paid for amounts included in measurement of lease liabilities: | ||||||||
| Operating cash outflows relating to operating leases | $ | $ | ||||||
| Weighted-average remaining lease term (in years) | ||||||||
| Weighted-average discount rate | % | % | ||||||
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
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 $
| 14 |
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 $
Government Assistance
On
October 23, 2024, the Advanced Research Projects Agency for Health (“ARPA-H”) announced that it had selected the Company
as an awardee of the Sprint for Women’s Health. As an awardee, the Company would have received $
The
Company met the first milestone for payment in the fourth quarter of 2024 and received a payment of $
On June 9, 2025, Aspira received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that Aspira had not met the specifications of Milestone 3, and have therefore elected to terminate the contract award. The Company will continue to work on the design, development and commercial launch of this test.
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.
5. ACCRUED LIABILITIES
The following table describes the principal components of accrued liabilities on the Company’s unaudited condensed consolidated balance sheet as of June 30, 2025 and December 31, 2024.
SCHEDULE OF COMPONENTS OF ACCRUED LIABILITIES
| June 30, | December 31, | |||||||
| (in thousands) | 2025 | 2024 | ||||||
| Payroll and benefits related expenses | $ | $ | ||||||
| Collaboration and research agreements expenses | ||||||||
| Professional services | ||||||||
| Other accrued liabilities | ||||||||
| Total accrued liabilities | $ | $ | ||||||
| 15 |
2025 Delisting from Nasdaq
On
April 15, 2025, the Company received written notice from the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”)
indicating that the Nasdaq Hearings Panel has determined to delist the Company’s shares from Nasdaq due to the Company’s
failure to meet Nasdaq’s continued listing standard under Nasdaq Listing Rule 5550(b)(1), which required the Company to maintain
a minimum of $
2025 Equity Purchase Agreement
On
April 4, 2025, the Company entered into an equity purchase agreement (the “Purchase Agreement”) with Triton Funds L.P. (“Triton”)
for the purchase of up to $
Pursuant
to the Purchase Agreement, the Company issued
shares of restricted common stock to Triton for $
2025 Private Placement Offering
On
March 12, 2025, the Company issued warrants (the “March 2025 Warrants”) upon the conversion of the Convertible Notes (see
Note 4, Commitments and Contingencies, and Debt). The March 2025 Warrants are exercisable for
The March 2025 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets. The March 2025 Warrants are classified as liabilities because the settlement amount is not indexed to the Company’s stock as required by ASC 815, Derivatives and Hedging.
2024 Private Placement Offering
On
July 1, 2024, the Company entered into a securities purchase agreement with certain investors in a private placement (the “2024
Private Placement Offering”). Pursuant to the 2024 Private Placement Offering, the Company issued an aggregate of shares
of its common stock and accompanying warrants (the “July 2024 Purchase Warrants”) to purchase an equal number of shares of
common stock at a price of $ per share and accompanying warrant. The July 2024 Purchase Warrants have an exercise price of $
| 16 |
The Company evaluated the July 2024 Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.
The July 2024 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.
In February 2025, the Company modified of the July 2024 Purchase Warrants to require shareholder approval of the July 2024 Purchase Warrants prior to their becoming exercisable. The Company evaluated the impact of the modification and it was not material to the unaudited condensed consolidated financial statements.
2024 At the Market Offering
On
August 2, 2024, the Company entered into an agreement with H.C. Wainwright in connection with an At the Market offering agreement (the
“2024 At the Market Offering”) to sell shares of its common stock, having an aggregate sales price of up to $
During
the year ended December 31, 2024, the Company sold shares under the 2024 At the Market Offering for gross proceeds of approximately
$
During
the six months ended June 30, 2025, the Company sold shares under the 2024 At the Market Offering Agreement for
gross proceeds of approximately $
2024 Securities Purchase Agreements
In
August 2024, the Company entered into securities purchase agreements with two shareholders under which it sold a total of shares
of common stock and received proceeds of approximately $
2024 Warrant Inducement Agreement
On
July 31, 2024, the Company entered into a warrant inducement agreement (the “Warrant Inducement Agreement”) with a certain
holder (the “Holder”) of (i) warrants to purchase
As
an inducement to such exercise, the Company agreed to issue to the Holder new common stock warrants (collectively, the “August
2024 Purchase Warrants”), to purchase up to
| 17 |
The
transaction, which closed on August 1, 2024, resulted in net proceeds of approximately $
The Company evaluated the August 2024 Purchase Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.
The August 2024 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.
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 shares of its common stock, par value $ per share, and pre-funded warrants
to purchase
Pursuant
to the 2024 Direct Offering Agreement, the Company issued shares of common stock to certain investors at an offering price
of $ per share, and shares of common stock to its Chief Executive Officer, Nicole Sandford, at an offering price of $
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 $ per share plus $
The
Pre-Funded Warrants were exercisable at any time after the date of issuance and had an exercise price of $
The
Purchase Warrants have an exercise price of $
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
| 18 |
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.
2023 Equity Line of Credit
On March 28, 2023, the Company entered into a purchase agreement (the “2023 Equity Line of Credit 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 $ per share, having an aggregate value of up to $ (the “Purchase Shares”), subject to certain limitations and conditions set forth in the 2023 Equity Line of Credit Agreement. The Company will control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the 2023 Equity Line of Credit Agreement.
Under
the 2023 Equity Line of Credit Agreement, on any business day after March 28, 2023 selected by the Company over the
| 1. | the lowest sale price for the common stock on The Nasdaq Capital Market on the date of sale; and |
| 2. | 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 2023 Equity Line of Credit 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 2023 Equity Line of Credit Agreement.
| 19 |
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 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.
During
the year ended December 31, 2024, the Company sold shares under the 2023 Equity Line of Credit Agreement for gross proceeds of
approximately $
Warrants
The following table is a summary of the Company’s warrants outstanding and exercisable as of June 30, 2025.
SCHEDULE OF WARRANTS OUTSTANDING
| Exercise Price | Number
of Warrants Outstanding and Common Stock Underlying Warrants | |||||||||||||||
| Issuance Date | Expiration Date | per Share | June 30, 2025 | December 31, 2024 | ||||||||||||
| Unmodified August 2022 Warrants(1) | $ | |||||||||||||||
| Modified August 2022 Warrants(1) | $ | |||||||||||||||
| January 2024 Purchase Warrants(2) | $ | |||||||||||||||
| July 2024 Purchase Warrants(2) | $ | |||||||||||||||
| August 2024 Purchase Warrants(2) | $ | |||||||||||||||
| March 2025 Warrants(1) | $ | (3) | ||||||||||||||
| (1) | ||
| (2) | ||
| (3) |
| 20 |
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 June 30, 2025, there were shares of the Company’s common stock available for future grants under the 2010 Plan.
There was no stock option activity for the 2010 Plan during the three and six months ended June 30, 2025.
There were outstanding options under the 2010 Plan with the weighted average exercise price of $ and the weighted average remaining life of 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 . On May 9, 2023, the Company’s stockholders approved an increase of 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 shares in the number of shares available for issuance under the 2019 Plan. On June 4, 2025, the Company’s stockholders approved an increase of shares in the number of shares available for issuance under the 2019 Plan for a total of 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 June 30, 2025, shares of Aspira common stock were subject to outstanding stock options, and 18,593 shares of Aspira common stock were subject to unreleased restricted stock awards. A total of shares of Aspira common stock were reserved for future issuance under the 2019 Plan.
SCHEDULE OF STOCK OPTION ACTIVITY
| Options outstanding at December 31, 2024 | ||||
| Options granted | ||||
| Options forfeited or expired | ( | ) | ||
| Options outstanding at June 30, 2025 |
The weighted average exercise price of outstanding options under the 2019 Plan was $ and the weighted average remaining life was years.
SUMMARY OF RSU ACTIVITY
| RSUs outstanding at December 31, 2024 | ||||
| RSUs granted | ||||
| RSUs vested and issued | ( | ) | ||
| RSUs forfeited or expired | ( | ) | ||
| RSUs outstanding at June 30, 2025 | ||||
| RSUs vested and unissued at June 30, 2025 |
| 21 |
Stock-Based Compensation
During the six months ended June 30, 2025, the Company granted option awards under the 2019 Plan with a weighted average grant date fair value of $ and a weighted average exercise price of $.
Assumptions included in the fair value per share calculations were (i) expected terms of two to , (ii) two- to three-year treasury interest rates of % to % and (iii) market close prices ranging from $ to $. The Company recorded $ in forfeitures for the six months ended June 30, 2025.
ALLOCATION OF NON-CASH STOCK BASED COMPENSATION EXPENSE BY FUNCTIONAL AREA
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Cost of revenue | $ | $ | $ | $ | ||||||||||||
| Research and development | ( | ) | ||||||||||||||
| Sales and marketing | ( | ) | ||||||||||||||
| General and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| Stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
As of June 30, 2025, total unrecognized compensation cost related to unvested stock option awards was approximately $, and the related weighted average period over which it is expected to be recognized was years. There was unrecognized compensation costs related to restricted stock units as of June 30, 2025.
The Company calculates basic loss per share using the weighted average number of shares of Aspira common stock outstanding during the period. The Company considers the 2022 Warrants and the March 2025 Warrants, and during the period outstanding, the Convertible Notes (see Note 4, Commitments and Contingencies, and Debt) to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the 2022 Warrants and the March 2025 Warrants and the Convertible Notes do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share.
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net Loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator: | ||||||||||||||||
| Shares used in computing net loss per share, basic and diluted | ||||||||||||||||
| Net loss per share, basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
The dilutive potential shares of common stock are computed using the treasury stock method or the as-if converted method, as applicable. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of common shares outstanding and excludes the effects of potential shares of common stock that are antidilutive.
| 22 |
SCHEDULE OF SECURITIES EXCLUDED FROM EARNINGS PER SHARE
| 2025 | 2024 | |||||||
| Three and Six Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Stock options | ||||||||
| Restricted stock units | ||||||||
| Warrants | ||||||||
| Potential common shares | ||||||||
The Company considered the Convertible Notes to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Convertible Notes did not have a contractual obligation to share in the Company’s losses. As such, losses were attributed entirely to common stockholders.
NOTE 8: RELATED PARTY TRANSACTIONS
On
December 1, 2023, the Company entered into a consulting agreement with Biodesix, Inc. (the “Biodesix Agreement”) to assist
with our miRNA product pipeline. Jack Schuler, a beneficial owner of more than
On
March 5, 2025, the Company entered into the March 2025 Private Placement with the Purchasers for the issuance and sale of Convertible
Notes. The Convertible Notes, including interest accrued, were converted into units consisting of share of common stock and
The Purchasers are entitled to three representatives on the Company’s board of directors. Two of the Purchasers have exercised that right. On April 2, 2025, the Board of Directors (the “Board”) of the Company appointed Jeffrey Cohen, M.D. as a director of the Company. The Board appointed John Fraser as a director of the Company on April 6, 2025.
NOTE 9: SEGMENT REPORTING
The CODM for the Company is the Chief Executive Officer, who reviews financial information presented on a consolidated basis for purposes of allocating resources and assessing financial performance.
The Company is managed as a single operating segment associated with the discovery, development and commercialization of noninvasive diagnostic tests. The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies in Note 1 to the unaudited condensed consolidated financial statements. The CODM assesses the performance of the Company’s single segment and decides how to allocate resources based on consolidated net income. Under the current organizational structure, this measure is not discreetly available or required individually for any of the Company’s business activities and is only available at the consolidated level. The monitoring of budgeted versus actual results are used in assessing performance of the Company’s single segment, allocating resources and in establishing management’s compensation. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. Consolidated revenue does not include any inter-segment sales or transfers.
The following table summarizes financial statement line items regularly reviewed by the CODM (in thousands).
SCHEDULE OF FINANCIAL STATEMENT
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| (in thousands) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Total Assets | $ | $ | $ | $ | ||||||||||||
| Total Revenue | ||||||||||||||||
| Net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
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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, average unit price, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition; |
| ● | 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 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, commercial collaborations and distribution agreements; |
| ● | plans to expand our current or future products to markets outside of the United States through distribution collaborations or out-licensing; |
| ● | 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 ENDOinform (formerly EndoMDx) and OVAinform (formerly 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 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; |
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| ● | 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; |
| ● | expectations 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, ENDOinform and OVAinform, 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; |
| ● | 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; |
| ● | potential plans to pursue clearance designation with the FDA with respect to OvaWatch, ENDOinform and OVAinform; |
| ● | expected potential target launch timing for future products; |
| ● | expectations regarding compliance with federal and state laws and regulations relating to billing arrangements conducted in coordination with laboratories; |
| ● | plans to advocate for legislation and professional society guidelines to broaden access to our products and services; |
| ● | ability to protect and safeguard against cybersecurity risks and breaches; and |
| ● | 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, 2024, as filed on March 27, 2025, 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; 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 or 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 or 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.
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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 expect our extensive experience with gynecologists and healthcare providers, along with the historical adoption of our OvaSuite tests, to continue to drive growth as we introduce new products. We believe our ability to successfully develop novel AI-enabled assays is superior to others based on our know-how and extensive experience in designing and successfully launching FDA-approved and laboratory developed blood tests to aid in the diagnosis of ovarian cancer. Moreover, our history of successfully collaborating with world-class research and academic institutions allows us to innovate and provide outstanding patient care.
We own and operate Aspira Labs, Inc., a research and commercial CLIA laboratory in Texas.
Our product pipeline is focused on two areas: ovarian cancer and endometriosis.
In ovarian cancer, we have developed clinical data to support the use of our OvaWatch test multiple times 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, marking the successful completion of the vision for OvaSuite. The successful expansion of the OvaWatch mass monitoring feature in the second quarter of 2024 resulted in a tenfold increase in the market for our tests when compared to the addressable market for Ova1Plus of approximately 200,000 to 400,000 based on patients identified for surgery. As a result, we believe the addressable market for our tests to have increased to between 2 and 4 million tests per year.
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Our OVAinform development program continues to progress. OVAinform 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. We believe that by including patients with genetic and familial risk, it will increase the addressable market to 2,800,000.
In endometriosis, we are developing and intend to introduce a new non-invasive test to aid in the diagnosis of this debilitating disease that impacts millions of women worldwide. We completed the design of a protein-based non-invasive blood test to aid the detection of endometrioma, one of the most common forms of endometriosis. The algorithm was confirmed with three independent cohorts and is an important input for our ENDOinform program focused on developing a multi-marker test that combines serum proteins, clinical data (metadata) and miRNA for the identification of endometriosis.
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.
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 increase performance; and
(2) OvaWatch, which is intended to assist in the initial and periodic 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. (“BioReference”) and ARUP Laboratories. In November of 2024, we expanded our distribution agreement with BioReference to include OvaWatch. This timing aligns with our approval from New York State to sell OvaWatch and increases our ability to market the test in New York. This important addition will allow providers who currently order Ova1 through BioReference to also order Aspira’s products for any woman with a mass within their existing BioReference workflows.
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 and six months ended June 30, 2025.
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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 June 30, 2025, we had two active Aspira Synergy contracts.
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.
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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.
| ● | OVAinform 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 (providing clinical and trial design expertise), Brigham & Women’s Hospital (providing miRNA technical expertise), and Medical University of Lodz (providing miRNA biomarker and bioinformatics analytic support). | |
| The miRNAs used in the OVAinform 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 that using miRNA in combination with serum proteins, provided superior performance over existing ovarian cancer risk assessment blood tests. | ||
| We have tested our entire set of selected miRNA biomarkers and, based on their performance, we are refining the features on our droplet digital PCR commercial platform. As a next step, we intend to increase our patient sample testing to refine the algorithm. | ||
| ● | ENDOinform (formerly EndoMDx) is a multi-marker test program 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 analyzing the first 180 patient samples to verify protein and miRNA biomarkers. These investigations will establish analytical properties on our droplet digital PCR commercial platform for miRNA detection. Additionally, this data set will provide information on initial disease classification capability of miRNA and proteins. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs and proteins. |
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Recent Developments
Business Updates
In the first quarter of 2025, we rebalanced the salesforce to align with profitable markets. This rebalance resulted in a reduction of field sales representatives in non-profitable markets. Under the rebalanced field team, we realized a 156% increase in sales per full-time equivalent salesperson in the second quarter of 2025, when compared to the second quarter of 2024.
On April 15, 2025, we were notified by the Office of General Counsel of The Nasdaq Stock Market (“Nasdaq”) indicating that the Nasdaq Hearings Panel has determined to delist our shares from Nasdaq due to our failure to meet Nasdaq’s continued listing standard under Nasdaq Listing Rule 5550(b)(1), which required us to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market. Our common stock was traded on the OTC Markets Group effective at the open of trading on April 17, 2025 under the symbol “AWHL.” We successfully applied for trading on the OTC QB Venture Market effective May 7, 2025.
On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of Milestone 3, and have therefore elected to terminate the contract award. We will continue to work on the design, development and commercial launch of this test.
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 March 27, 2025.
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 June 30, 2025 Compared to Three Months Ended June 30, 2024
The selected summary financial and operating data of the Company for the three months ended June 30, 2025 and 2024 were as follows.
| Three Months Ended | ||||||||||||||||
| June 30, | Increase (Decrease) | |||||||||||||||
| (dollars in thousands) | 2025 | 2024 | Amount | % | ||||||||||||
| Revenue: | ||||||||||||||||
| Product | $ | 2,404 | $ | 2,423 | $ | (19 | ) | (1 | ) | |||||||
| Total revenue | 2,404 | 2,423 | (19 | ) | (1 | ) | ||||||||||
| Cost of revenue: | ||||||||||||||||
| Product | 870 | 1,002 | (132 | ) | (13 | ) | ||||||||||
| Total cost of revenue | 870 | 1,002 | (132 | ) | (13 | ) | ||||||||||
| Gross profit | 1,534 | 1,421 | 113 | 8 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 704 | 952 | (248 | ) | (26 | ) | ||||||||||
| Sales and marketing | 679 | 2,137 | (1,458 | ) | (68 | ) | ||||||||||
| General and administrative | 1,961 | 2,725 | (764 | ) | (28 | ) | ||||||||||
| Total operating expenses | 3,344 | 5,814 | (2,470 | ) | (42 | ) | ||||||||||
| Loss from operations | (1,810 | ) | (4,393 | ) | 2,583 | (59 | ) | |||||||||
| Other (expense) income, net: | ||||||||||||||||
| Change in fair value of warrant liabilities | (624 | ) | 889 | (1,513 | ) | (170 | ) | |||||||||
| Interest expense, net | (13 | ) | (10 | ) | (3 | ) | 30 | |||||||||
| Other expense, net | (219 | ) | (16 | ) | (203 | ) | 1,269 | |||||||||
| Total other (expense) income, net | (856 | ) | 863 | (1,719 | ) | (199 | ) | |||||||||
| Net loss | $ | (2,666 | ) | $ | (3,530 | ) | $ | 864 | (24 | ) | ||||||
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Product Revenue. Product revenue was $2,404,000 for the three months ended June 30, 2025, compared to $2,423,000 for the same period in 2024. 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 1% product revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year, partially offset by an increase in AUP.
The number of OvaSuite tests performed decreased 11% to 5,728 during the three months ended June 30, 2025, compared to 6,471 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount. We expect revenue to increase in the second quarter due to our focus on revenue generating payers.
The volume and AUP for the three months ended June 30, 2025 and 2024 were as follows.
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Product Volume: | ||||||||
| Ova1Plus | 4,447 | 5,164 | ||||||
| OvaWatch | 1,281 | 1,307 | ||||||
| Total OvaSuite | 5,728 | 6,471 | ||||||
| Average Unit Price (AUP): | ||||||||
| Ova1Plus | $ | 425 | $ | 381 | ||||
| OvaWatch | 403 | 348 | ||||||
| Total OvaSuite | $ | 420 | $ | 374 | ||||
Cost of Revenue – Product. Cost of product revenue was $870,000 for the three months ended June 30, 2025 compared to $1,002,000 for the same period in 2024, representing a decrease of $132,000, or 13%, due primarily to decreased personnel and postage costs.
Gross Profit Margin. Gross profit margin for product revenue increased to 63.8% for the three months ended June 30, 2025, compared to 58.6% for the same period in 2024.
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 June 30, 2025 decreased by $248,000, or 26%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $151,000, personnel costs of $81,000 and lab supplies of $62,000, partially offset by an increase in clinical trial costs of $8,000. We expect research and development expenses to increase modestly over the third quarter of 2025, 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 June 30, 2025 decreased by $1,458,000, or 68%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $915,000, costs related to our contracted sales team of $234,000, travel costs of $192,000 and other marketing costs of $131,000, partially offset by increased consulting costs of $117,000. We expect sales and marketing expenses to remain flat during the third quarter of 2025.
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 June 30, 2025 decreased by $764,000, or 28%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $606,000 and legal fees of $420,000, offset by an increase in consulting costs of $226,000. We expect general and administrative expenses to decrease during the third quarter of 2025 as a result of decreases in our consulting and public company costs.
Change in fair value of Warrant Liabilities. For the three months ended June 30, 2025, there was a net increase in the fair value of warrant liabilities of $624,000. The increase was due to the increase in our stock price during the quarter. For the three months ended June 30, 2024, there was a net decrease in fair value of $889,000. The change in fair value during the three months ended June 30, 2024 was primarily due to a decrease in our stock price during the quarter.
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Results of Operations – Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024
The selected summary financial and operating data of the Company for the six months ended June 30, 2025 and 2024 were as follows.
| Six Months Ended | ||||||||||||||||
| June 30, | Increase (Decrease) | |||||||||||||||
| (dollars in thousands) | 2025 | 2024 | Amount | % | ||||||||||||
| Revenue: | ||||||||||||||||
| Product | $ | 4,683 | $ | 4,576 | $ | 107 | 2 | |||||||||
| Total revenue | 4,683 | 4,576 | 107 | 2 | ||||||||||||
| Cost of revenue: | ||||||||||||||||
| Product | 1,589 | 1,941 | (352 | ) | (18 | ) | ||||||||||
| Total cost of revenue | 1,589 | 1,941 | (352 | ) | (18 | ) | ||||||||||
| Gross profit | 3,094 | 2,635 | 459 | 17 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,677 | 1,858 | (181 | ) | (10 | ) | ||||||||||
| Sales and marketing | 1,765 | 4,026 | (2,261 | ) | (56 | ) | ||||||||||
| General and administrative | 4,702 | 5,854 | (1,152 | ) | (20 | ) | ||||||||||
| Total operating expenses | 8,144 | 11,738 | (3,594 | ) | (31 | ) | ||||||||||
| Loss from operations | (5,050 | ) | (9,103 | ) | 4,053 | (45 | ) | |||||||||
| Other income (expense), net: | ||||||||||||||||
| Change in fair value of warrant liabilities | 297 | 1,140 | (843 | ) | (74 | ) | ||||||||||
| Change in fair value of convertible notes | 170 | - | 170 | - | ||||||||||||
| Loss upon issuance of Convertible Notes carried at fair value | (1,198 | ) | - | (1,198 | ) | - | ||||||||||
| Interest expense, net | (27 | ) | (15 | ) | (12 | ) | 80 | |||||||||
| Other income (expense), net | 1,289 | (181 | ) | 1,470 | (812 | ) | ||||||||||
| Total other income (expense), net | 531 | 944 | (413 | ) | (44 | ) | ||||||||||
| Net loss | $ | (4,519 | ) | $ | (8,159 | ) | $ | 3,640 | (45 | ) | ||||||
Product Revenue. Product revenue was $4,683,000 for the six months ended June 30, 2025, compared to $4,576,000 for the same period in 2024. The 2% product revenue increase is due to an increase in AUP, offset by a decrease in OvaSuite test volume compared to the prior year.
The number of OvaSuite tests performed decreased 7.3% to 11,407 during the six months ended June 30, 2025, compared to 12,300 product tests for the same period in 2024. This decrease is a result of our reduced field sales headcount.
The volume and AUP for the six months ended June 30, 2025 and 2024 were as follows.
| Six Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Product Volume: | ||||||||
| Ova1Plus | 8,809 | 9,941 | ||||||
| OvaWatch | 2,598 | 2,359 | ||||||
| Total OvaSuite | 11,407 | 12,300 | ||||||
| Average Unit Price (AUP): | ||||||||
| Ova1Plus | $ | 415 | $ | 379 | ||||
| OvaWatch | 397 | 344 | ||||||
| Total OvaSuite | $ | 411 | $ | 372 | ||||
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Cost of Revenue – Product. Cost of product revenue was $1,589,000 for the six months ended June 30, 2025 compared to $1,941,000 for the same period in 2024, representing a decrease of $352,000, or 18%, due primarily to decreased personnel costs and a one-time credit related to phlebotomy expenses, partially offset by an increase in consulting costs.
Gross Profit Margin. Gross profit margin for product revenue increased to 66.1% for the six months ended June 30, 2025, compared to 57.6% for the same period in 2024.
Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 decreased by $181,000, or 10%, compared to the same period in 2024. This decrease was primarily due to a decrease in consulting costs of $327,000 and personnel costs of $156,000, partially offset by an increase in clinical trial costs of $381,000.
Sales and Marketing Expenses. Sales and marketing expenses for the six months ended June 30, 2025 decreased by $2,261,000, or 56%, compared to the same period in 2024. This decrease was primarily due to decreased personnel costs of $1,246,000, costs related to our contracted sales team of $472,000, travel costs of $315,000, other marketing costs of $174,000 and subscriptions of $125,000, partially offset by consulting costs of $111,000.
General and Administrative Expenses. General and administrative expenses for the six months ended June 30, 2025 decreased by $1,152,000, or 20%, compared to the same period in 2024. This decrease was primarily due to a decrease in personnel costs of $1,287,000 and legal fees of $604,000, partially offset by an increase in audit fees of $290,000, consulting costs of $283,000, and public company costs of $263,000.
Change in fair value of Warrant Liabilities. For the six months ended June 30, 2025, there was a net increase in the fair value of warrant liabilities on the balance sheet of $1,180,000. The increase was due to the addition of new warrants in the amount of $1,477,000, offset by a decrease of $297,000 related to a decrease in our stock price during the year. For the six months ended June 30, 2024, there was a net decrease in fair value of $1,140,000. The change in fair value during the three months ended June 30, 2024 was primarily due to a decrease in our stock price during the quarter.
Change in fair value of Convertible Notes. The change in fair value of Convertible Notes for the six months ended June 30, 2025 was $170,000, which was the gain recognized upon the conversion of the Convertible Notes.
Loss upon issuance of Convertible Notes carried at fair value. The loss upon issuance of Convertible Notes carried at fair value for the six months ended June 30, 2025 was $1,198,000. This represents an immediate loss recognized by the Company upon the issuance of the Convertible Notes.
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 $535,916,000 as of June 30, 2025. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2025. 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.
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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 borrowed $4,000,000 from the DECD.
Under the terms of the DECD Loan Agreement, we were eligible for forgiveness of $1,000,000 of the principal amount of the loan after achieving certain job creation and retention milestones. 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. If we choose to repay the loan early, it may be done at any time without premium or penalty.
On March 28, 2023, we entered into a purchase agreement (the “2023 Equity Line of Credit Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and a registration rights agreement (the “LPC Registration Rights Agreement”), pursuant to which we have the right, in our sole discretion, to sell to Lincoln Park shares of our common stock, par value $0.001 per share, having an aggregate value of up to $10,000,000 (the “Purchase Shares”), subject to certain limitations and conditions set forth in the 2023 Equity Line of Credit Agreement. We control the timing and amount of any sales of Purchase Shares to Lincoln Park pursuant to the 2023 Equity Line of Credit Agreement.
During the three and six months ended June 30, 2025, we sold no shares under the 2023 Equity Line of Credit Agreement, respectively. During the three and six months ended June 30, 2024, we sold 475,986 and 587,355 shares under the 2023 Equity Line of Credit Agreement, respectively; resulting in gross proceeds of approximately $1,100,000 and $1,500,000, respectively. Over the life of the 2023 Equity Line of Credit Agreement through August 8, 2025, we sold 1,310,517 shares for gross proceeds of approximately $3,078,000. We incurred approximately $326,000 of costs related to the execution of the 2023 Equity Line of Credit 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 paid for Lincoln Park expenses. These transaction costs were included in other expense in our consolidated statement of operations for the year ended December 31, 2023. We incurred approximately $0 and $40,000 for legal fees during the six months ended June 30, 2025 and 2024, respectively, and included the costs in general and administrative expenses on its consolidated statement of operations. Under the terms of the Warrant Inducement Agreement, we agreed not to sell shares under the 2023 Equity Line of Credit Agreement for six months from the effective date of the Form S-3, which was September 3, 2024. As of May 12, 2025, the remaining availability under the 2023 Equity Line of Credit Agreement was $1,700,000 of shares of common stock that can be sold to Lincoln Park under the 2023 Equity Line of Credit Agreement; however, as we are no longer traded on Nasdaq, we do not have access to this facility.
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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 “2024 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 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 expire 5 years from the initial issuance date.
Effective upon the closing of the 2024 Direct Offering, we 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.
On October 23, 2024, the Advanced Research Projects Agency for Health (“ARPA-H”) announced that we had been selected as an awardee of the Sprint for Women’s Health. We will receive up to $10,000,000 in funding over two years through the Sprint for Women’s Health launchpad track for later-stage health solutions. We will receive payments based on the completion of certain agreed-upon milestones.
We met the first milestone for payment in the fourth quarter of 2024 and received a payment of $2,000,000. The second milestone was met during the first quarter of 2025 and we received a payment of $1,500,000. On June 9, 2025, we received notice from ARPA-H that ARPA-H and the assigned managing contractor, VentureWell, have determined that we had not met the specifications of the third milestone, and have therefore elected to terminate the ENDOinform development program contract.
On March 5, 2025, we entered into a securities purchase agreement with certain existing accredited shareholders (“the “Purchasers”) for the issuance and sale in a private placement (the “March 2025 Private Placement”) of an aggregate gross principal amount of $1,365,500 in the form of Senior Secured Convertible Promissory Notes (the “Convertible Notes”). On March 12, 2025, the Convertible Notes were converted into 5,465,850 shares and warrants to purchase 12,298,177 shares (the “March 2025 Warramts”).
The March 2025 Warrants are exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter.
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 2025. At June 30, 2025 we had an accumulated deficit of $535,916,000 and stockholders’ deficit of $2,685,000. As of June 30, 2025, we had $1,545,000 of cash and cash equivalents, $4,098,000 of current liabilities, and working deficit of $412,000. 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 2025.
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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 $4,836,000 for the six months ended June 30, 2025, resulting primarily from the net loss reported of $4,519,000, which includes the loss upon issuance of convertible notes carried at fair value of $1,198,000, changes in prepaid assets of $426,000, non-cash lease expense of $122,000 and $119,000 in stock based compensation expense, offset by changes in accrued liabilities of $616,000, changes in other liabilities of $459,000, changes in accounts payable of $430,000, changes in the fair value of warrant liabilities of $297,000, changes in accounts receivable of $288,000 and a change in the fair value of Convertible Notes carried at fair value and changes in accounts receivable of $170,000.
Net cash used in operating activities was $8,172,000 for the six months ended June 30, 2024, resulting primarily from the net loss reported of $8,159,000, which includes non-cash expenses in the amount of $682,000 related to changes in accounts payable, stock compensation expense of $484,000 and $379,000 related to changes in prepaid expense offset by $1,140,000 relating to a change in fair value of warrant fair value and changes in other liabilities of $520,000.
Net cash used in investing activities was $0 and $35,000 for the six months ended June 30, 2025 and 2024, respectively, which consisted of property and equipment purchases.
Net cash provided by financing activities was $4,612,000 for the six months ended June 30, 2025, stemming primarily from the at the market offering resulting in net proceeds of $3,337,000 and from convertible notes resulting in gross proceeds of $916,000, in addition to principal payments on the DECD loan.
Net cash provided by financing activities was $6,314,000 for the six months ended June 30, 2024, stemming primarily from a registered direct offering resulting in net proceeds of $4,830,000, after deducting placement agent costs and other expenses of $733,000 and an equity line of credit offering of $1,501,000.
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.
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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 Controller, 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 June 30, 2025. Based on this evaluation, our Chief Executive Officer and Controller have concluded that as of June 30, 2025, our disclosure controls and procedures were not effective. This was due to a material weakness in the internal control over financial reporting that was identified as of December 31, 2024, and disclosed in our 2024 Annual Report Form 10-K related to the operation of internal controls related to our contract review processes and the accounting for such contracts that continue to exist as of June 30, 2025.
Material Weakness
As previously reported, we identified a material weakness related to the accounting for complex financial transactions, including the technical accounting conclusions reached. During the year ended December 31, 2024, we entered into two transactions that were considered to be significant, non-routine or complex transactions, including a warrant inducement and a government grant. While the control was adequately designed, the operation of the control was not effective for either transaction.
Remediation Activities
In order to address material weakness in internal control over financial reporting as of December 31, 2024, previously disclosed, management implemented remediation activities, with direction from the audit committee. The activities that we have taken include retaining outside accounting assistance from a nationally recognized firm for certain significant, non-routine or complex transactions, including warrant valuation, beginning in the first quarter of 2025.
Limitations on Effectiveness of Controls and Procedures and Internal Control over Financial Reporting
In designing and evaluating the disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes in internal controls over financial reporting
Other than as described above, there were no changes in our internal control over financial reporting during the three months ended June 30, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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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 June 30, 2025, 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, 2024, filed with the SEC on March 27, 2025 (the “2024 Annual Report”) and in Part II, Item 1 of our Quarterly Report on Form 10-Q, for the quarter ended March 31, 2025 (the “March 31, 2025 Quarterly Report”), filed with the SEC on May 19, 2025. The risks and uncertainties described in our 2024 Annual Report and the March 31, 2025 Quarterly 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.
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.
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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 | ||||||
| 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.
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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: August 12, 2025 | /s/ Michael Buhle |
Michael Buhle Chief Executive Officer (Principal Executive Officer) | |
| Date: August 12, 2025 | /s/ Julie Carrillo |
Julie Carrillo Controller (Principal Financial Officer and Principal Accounting Officer) |
| 40 |
Exhibit 31.1
Certification of the Chief Executive Officer Pursuant to Section 302 of
The Sarbanes-Oxley Act Of 2002
I, Michael Buhle, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q for the quarter ended June 30, 2025 of Aspira Women’s Health Inc.; |
| 2. | 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; |
| 3. | 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; |
| 4. | 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 |
| 5. | 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: August 12, 2025 | /s/ Michael Buhle | |
| Michael Buhle | ||
| 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, Julie Carrillo, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q for the quarter ended June 30, 2025 of Aspira Women’s Health Inc.; |
| 2. | 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; |
| 3. | 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; |
| 4. | 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 |
| 5. | 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: August 12, 2025 | /s/ Julie Carrillo | |
| Julie Carrillo | ||
| Controller | ||
| (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 June 30, 2025
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:
| 1. | The Company’s quarterly report on Form 10-Q for the period ended June 30, 2025, (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 |
| 2. | Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Date: August 12, 2025 | /s/ Michael Buhle | |
| Michael Buhle | ||
| Chief Executive Officer | ||
| (Duly Authorized Officer and Principal Executive Officer) | ||
| Date: August 12, 2025 | /s/ Julie Carrillo | |
| Julie Carrillo | ||
| Controller | ||
| (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.