AWHL 10-Q
Aspira Women's Health Inc. (AWHL)
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 ______
Commission File Number:
(Exact name of registrant as specified in its charter)
| ||
(State or other jurisdiction of incorporation or |
| (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 QX 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 was required to submit such files).
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of August 12, 2026, the registrant had
ASPIRA WOMEN’S HEALTH INC.
FORM 10-Q
For the Quarter Ended June 30, 2026
Table of Contents
Page | ||
1 | ||
1 | ||
Condensed Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025 | 1 | |
2 | ||
3 | ||
5 | ||
6 | ||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 28 | |
41 | ||
42 | ||
43 | ||
43 | ||
43 | ||
43 | ||
43 | ||
43 | ||
43 | ||
44 | ||
45 | ||
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®.
i
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, | ||||||
| 2026 | | 2025 | | |||
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 |
| |
| | |||
Intangible assets, net | | | |||||
Operating lease right-of-use assets |
| |
| | |||
Finance lease 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 operating lease liabilities | | - | |||||
Current maturities of finance lease liabilities |
| |
| | |||
Total current liabilities |
| |
| | |||
Non-current liabilities: |
|
| | ||||
Long-term debt |
| |
| | |||
Non-current maturities of operating lease liabilities |
| |
| | |||
Non-current maturities of finance lease liabilities | | - | |||||
Warrant liabilities |
| |
| | |||
Total liabilities |
| |
| | |||
Commitments and contingencies (Note 5) |
|
| | ||||
Stockholders’ deficit: |
|
| | ||||
Preferred stock, par value $ | |||||||
Common stock, par value $ |
| |
| | |||
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)
Three Months Ended | Six Months Ended | |||||||||||
June 30, | June 30, | |||||||||||
| 2026 | | 2025 | | 2026 | | 2025 | |||||
| |
| |
| |
| | |||||
Revenue | $ | | $ | | $ | | $ | | ||||
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)
| Common Stock | | | | ||||||||||
| Additional | Total | ||||||||||||
Paid-In | Accumulated | Stockholders’ | ||||||||||||
Shares | Amount | Capital | Deficit | Deficit | ||||||||||
Balance at December 31, 2025 |
| | $ | | $ | | $ | ( | $ | ( | ||||
Net income |
| - |
| - |
| - |
| |
| | ||||
Common stock issued under equity line of credit with Lincoln Park |
| |
| |
| |
| - |
| | ||||
Stock-based compensation expense |
| - |
| - |
| |
| - |
| | ||||
Balance at March 31, 2026 |
| | | | ( | ( | ||||||||
Net loss |
| - |
| - |
| - | ( |
| ( | |||||
Common stock issued under 2026 Equity Purchase Agreement, net of issuance costs |
| | | |
| | ||||||||
Stock-based compensation expense |
| |
| | ||||||||||
Balance at June 30, 2026 |
| | $ | | $ | | $ | ( | $ | ( | ||||
3
Aspira Women’s Health Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Deficit (unaudited) (continued)
(Amounts in Thousands, Except Share Amounts)
| Common Stock | | | | ||||||||||
| Additional | Total | ||||||||||||
Paid-In | Accumulated | Stockholders’ | ||||||||||||
Shares | Amount | Capital | Deficit | 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 |
| | $ | | $ | | $ | ( | $ | ( | ||||
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)
Six Months Ended | ||||||
June 30, | ||||||
| 2026 | | 2025 | |||
Cash flows from operating activities: |
| |
| | ||
Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
|
| ||||
Non-cash operating lease expense |
| |
| | ||
Interest expense on finance leases | | - | ||||
Depreciation and amortization |
| |
| | ||
Stock-based compensation expense |
| |
| | ||
Change in fair value of warrant liabilities |
| ( |
| ( | ||
Change in fair value of March 2025 Convertible Notes | - | ( | ||||
Loss upon issuance of March 2025 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 2024 At the Market Offering Agreement |
| - |
| | ||
Payment of issuance costs for 2024 At the Market Offering Agreement |
| - |
| ( | ||
Proceeds from 2026 Private Placement Offering | | - | ||||
Payment of issuance costs for 2026 Private Placement Offering | ( | - | ||||
Proceeds from March 2025 Convertible Notes | - | | ||||
Proceeds from 2024 Equity Line of Credit | - | | ||||
Proceeds from 2025 Equity Purchase Agreement | | - | ||||
Net cash provided by financing activities |
| |
| | ||
Net decrease in cash and cash equivalents |
| ( |
| ( | ||
Cash and cash equivalents, beginning of period |
| |
| | ||
Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information: |
| |
| | ||
Cash paid for interest | $ | | $ | | ||
Equipment financing | $ | | $ | - | ||
Supplemental disclosure of noncash investing and financing activities: |
| |
| | ||
Fair value of warrants issued upon conversion of March 2025 Convertible Notes | $ | - | $ | | ||
Fair value of common stock issued upon conversion of March 2025 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 (“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 direct national sales force, including field sales and inside sales. OvaSuite tests are marketed to both physicians via a direct referral to Aspira as well as to laboratories via the Aspira Synergy platform. The Company also engages in channel distribution partnerships by which OvaSuite is distributed via laboratory partners such as BioReference Health, LLC, Associated Regional University Pathologists (“ARUP”) and Mayo Clinic Laboratories (“Mayo”).
Going Concern and Liquidity
As of June 30, 2026, 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.
6
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 2026. 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 issued. 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.
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 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 $
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.
The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The consolidated balance sheet at December 31, 2025 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, 2025, included in the Company’s Annual Report on Form 10-K, filed with the SEC on April 1, 2026.
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
Revenue – OvaSuite: The Company recognizes revenue in accordance with the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). 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
7
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, 2026 and 2025, there were
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. The requirements for equity classification are that 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 and (4) are indexed to the Company’s common stock. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and each subsequent reporting period. 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 Change in fair value of warrant liabilities on the Company’s statement of operations.
Segment Reporting
The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer, who reviews financial information presented on a consolidated basis for purposes of allocating resources and assessing financial performance. 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.
The accounting policies of the Company’s single segment are the same as those described in this summary of significant accounting policies. The CODM assesses the performance of the Company’s segment and decides how to allocate resources based on consolidated net loss. Under the current organizational structure, this measure is not discretely 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.
8
The following table summarizes financial statement line items regularly provided to the CODM (in thousands).
| Three Months Ended | | Six Months Ended | |||||||||
June 30, | June 30, | |||||||||||
(in thousands) | 2026 | | 2025 | 2026 | | 2025 | ||||||
Total Assets | $ | | $ | | $ | | $ | | ||||
Total Revenue | $ | | $ | | $ | | $ | | ||||
Less: | ||||||||||||
Personnel costs | ( | ( | ( | ( | ||||||||
Professional fees | ( | ( | ( | ( | ||||||||
Postage and kit costs | ( | ( | ( | ( | ||||||||
Travel expenses | ( | ( | ( | ( | ||||||||
Lab related expenses | ( | ( | ( | ( | ||||||||
Software licenses and maintenance costs | ( | ( | ( | ( | ||||||||
Other segment items(1) | ( | ( | ( | ( | ||||||||
Other expense, net | ( |
| ( | |
| | ||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
(1)
Property and Equipment
Property and equipment are carried at cost less accumulated depreciation and amortization. Property and equipment are depreciated when placed into service using the straight-line method over the estimated useful lives, generally to
Property and equipment are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If property and equipment are considered to be impaired, an impairment loss is recognized.
Intangible Assets
Intangible assets are carried at cost less accumulated depreciation and amortization. Intangible assets are amortized when placed into service using the straight-line method over the estimated useful lives. Upon sale or retirement of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations.
Intangible assets are reviewed for impairment when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. If Intangible assets are considered to be impaired, an impairment loss is recognized.
Recent Accounting Pronouncements
Standards Yet to be Adopted
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
9
Company is currently evaluating whether the adoption of ASU 2024-03 will have a material impact on its results of operations, financial position or cash flows.
In July 2025, the FASB issued ASU No. 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”) to reduce the complexity of applying credit losses under ASC 326-320. ASU 2025-05 provides a practical expedient permitting an entity to assume current conditions as of the balance sheet date that do not change for the remaining life of the current accounts receivable and current contract assets. ASU 2025-05 also provides for an accounting election which allows an entity to consider cash collection activity after the balance sheet date when estimating expected credit losses on current accounts receivable and current contract assets. The standard will become effective for annual periods beginning after December 15, 2025. The Company is currently evaluating whether the adoption of ASU 2025-05 will have a material impact on the Company’s consolidated results of operations, financial position, or cash flows.
In September 2025, the FASB issued ASU No. 2025-06, Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which clarifies and modernizes the accounting for costs related to internal-use software in ASC Topic 350-40, Intangibles —Goodwill and Other — Internal-Use Software (ASC 350-40). ASU 2025-06 removed all references to project stages throughout ASC 350-40, and requires entities to begin capitalizing software costs when both of the following occur: (1) management, with the relevant authority, implicitly or explicitly authorizes and commits to funding a computer software project; and (2) it is probable that the project will be completed and the software will be used to perform the function intended (referred to as the probable-to-complete recognition threshold). The guidance is effective for annual periods beginning after December 15, 2027 and interim periods within those annual reporting periods. Early adoption is permitted. ASU 2025-06 can be either applied on a prospective basis, retrospective or modified prospective basis based on the status of the project and whether software costs were capitalized before the date of adoption. The Company is currently evaluating the impact the adoption of ASU 2025-06 may have on its results of operations, financial position or cash flows.
In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements (“ASU 2025-11”), which clarifies interim disclosure requirements by improving the navigability of the required interim disclosures and clarifying when that guidance is applicable. The standard is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. ASU 2025-11 can be applied either prospectively or retrospectively to any or all periods presented in the financial statements. The Company is currently evaluating the impact the adoption of ASU 2025-11 may have on its results of operations, financial position or cash flows.
In December 2025, the FASB issued No. ASU 2025-12, Codification Improvements (“ASU 2025-12”), which amends various areas of the Codification to enhance consistency and make the standards easier for preparers and users to interpret. ASU 2025-12 intends to refine and simplify the original guidance where it may have been unclear. ASU 2025-12 is effective for annual periods beginning after December 15, 2026, and interim periods within those annual periods, with early adoption permitted. Entities may adopt the guidance using a prospective or retrospective approach. The Company is currently evaluating the impact the adoption of ASU 2025-12 may have 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 “August 2022 Warrants”) in warrant liabilities. As discussed in Note 7 to the unaudited condensed consolidated financial statements, in connection with a registered direct offering in 2024, the Company amended certain of the August 2022 Warrants to purchase up to an aggregate of
10
The fair value of the August 2022 Warrants as of June 30, 2026 and December 31, 2025 was approximately $
| June 30, 2026 | | December 31, 2025 |
| |||||||||
Unmodified | Modified | Unmodified | Modified |
| |||||||||
August 2022 | August 2022 | August 2022 | August 2022 | ||||||||||
Warrants | Warrants | Warrants | Warrants |
| |||||||||
Dividend yield |
| - | - | - | - | ||||||||
Volatility |
| | % | | % | | % | | % | ||||
Risk-free interest rate |
| | % | | % | | % | | % | ||||
Expected lives (years) |
|
|
|
| |||||||||
Weighted average fair value | $ | | $ | | $ | | $ | | |||||
The August 2022 Warrants were deemed to be derivative instruments due to certain contingent put features. The fair value of the August 2022 Warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the August 2022 Warrants issued, including a fixed term and exercise price.
The fair value of the August 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 August 2022 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets.
The Company recorded warrants in connection with the March conversion of Senior Secured Convertible Promissory Notes (the “March 2025 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 5 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, 2026 and December 31, 2025 was approximately $
Following the modification, the fair value of the Amended March 2025 Warrants was determined using the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the Amended March 2025 Warrants issued, including a fixed term and exercise price.
11
The following table presents the Company’s transfers from Level 3 to Level 2 during the year ended December 31, 2025.
(Amounts in Thousands) | Balance as of January 1, 2025 | Issuance of Warrants | Exercises | Transfer out to Level 2 | Balance as of December 31, 2025 | |||||||||||||
Level 3 Warrant Liabilities | $ | - | $ | | $ | | $ | ( | $ | ( | $ | - |
These transfers were primarily due to the change from the Monte Carlo simulation pricing model to the Black-Scholes option pricing model, deemed to be an appropriate model due to the terms of the Amended March 2025 Warrants issued, including a fixed term and exercise price. The fair value of the Amended March 2025 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 Amended March 2025 Warrants are classified in warrant liabilities on the Company’s unaudited condensed consolidated balance sheets. There were
The Company used the following key inputs to determine the fair value of the March 2025 Warrants using the Black-Scholes option pricing model.
| June 30, 2026 | | December 31, 2025 |
| |||
Dividend yield |
| - | - | ||||
Volatility |
| | % |
| | % | |
Risk-free interest rate |
| | % |
| | % | |
Remaining term (years) |
|
| |||||
Weighted average fair value | $ | | $ | | |||
The Company recorded the March 2025 Convertible Notes on its books at fair value. The fair value of the March 2025 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 March 2025 Convertible Notes at issuance was approximately $
The following is a reconciliation of the fair values from December 31, 2024 to June 30, 2026.
| Fair Value of | | Fair Value of | | Total Fair Value | ||||
August 2022 | March 2025 | of Warrant | |||||||
(in thousands) | Warrants | Warrants | Liability | ||||||
August 2022 Warrant liability – December 31, 2024 | $ | | $ | - | $ | | |||
Warrant liability – March 12, 2025 |
| - | |
| | ||||
Change in fair value (loss) reported in statement of operations | | | | ||||||
Warrants exercised |
| - |
| ( |
| ( | |||
Warrant liability – December 31, 2025 | | | | ||||||
Change in fair value (gain) reported in statement of operations | ( | ( | ( | ||||||
Warrant liability – June 30, 2026 | $ | | $ | | $ | | |||
12
The carrying value of the Company’s insurance promissory note approximates fair value as of June 30, 2026 and December 31, 2025, 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.
| | June 30, | | December 31, | ||||||||||
2026 | 2025 | |||||||||||||
(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, 2026 and December 31, 2025 consist of the following:
| June 30, | | December 31, | |||
(in thousands) | 2026 | 2025 | ||||
Prepaid insurance | $ | | $ | | ||
Software licenses |
| |
| | ||
Subscriptions |
| |
| | ||
Other |
| |
| | ||
Total prepaid and other current assets | $ | | $ | | ||
4. INTANGIBLE ASSETS
The Company owns capitalized software for providing integrated care plans for adnexal mass risk management. The Company classified the software as an Intangible asset.
Intangible assets as of June 30, 2026 and December 31, 2025 were as follows.
Estimated | June 30, | December 31, | ||||||
(in thousands) | Useful Life | 2026 | | 2025 | ||||
Capitalized software | | | ||||||
Accumulated amortization | ( | ( | ||||||
Capitalized software, net | $ | | $ | | ||||
Amortization expense was $
As of June 30, 2026, the estimated annual amounts of future amortization of the Company’s intangible assets are shown in the table below.
Amortization by Period | ||||||||||||
(in thousands) | | Total | | 2026 | | 2027 | | 2028 | ||||
Estimated future amortization | $ | | $ | | $ | | $ | | ||||
Total | $ | | $ | | $ | | $ | | ||||
13
5. 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 March 2025 Convertible Notes using the fair value option under ASC 825 because the warrants issuable upon conversion of the March 2025 Convertible Notes are not indexed to the Company’s stock. They included a variable exercise price that did not meet the fixed-for-fixed concept under ASC 815. Further, as the March 2025 Convertible Notes were issued at par (gross cash proceeds equaled the principal of the March 2025 Convertible Notes), the March 2025 Convertible Notes were not issued at a substantial premium and were eligible for the fair value option under ASC 825.
The March 2025 Convertible Notes were issued at a discount. This resulted in the fair value of the March 2025 Convertible Notes upon issuance exceeding the proceeds received, As such, the Company recognized the excess of approximately $
The Purchasers of the March 2025 Convertible Notes are entitled to three representatives on the Company’s board of directors.
In addition, the Company granted the Purchasers of the March 2025 Convertible Notes certain customary registration rights with respect to the shares of common stock and shares of common stock underlying the March 2025 Warrants. The registration statement was filed on September 30, 2025.
Pursuant to the terms of the agreement, the Company exercised its option to convert the March 2025 Convertible Notes into Units at the Conversion Price. The March 2025 Convertible Notes, including interest accrued, for a total of $
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 $
14
The loan may be prepaid at any time without premium or penalty. An initial disbursement of $
On June 26, 2023, the Company was notified by the DECD that the Company satisfied all job creation and retention requirements under the loan agreement to receive forgiveness of $
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.
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. As such, no gain was recognized as a result of the deferrals. Long-term debt consisted of the following:
| June 30, | | December 31, | |||
(in thousands) | | 2026 | | 2025 | ||
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, 2026, 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 $
Payments Due by Period | |||||||||||||||||||||
(in thousands) | | Total | | 2026 | | 2027 | | 2028 | | 2029 | | 2030 | | Thereafter | |||||||
DECD Loan | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Total | $ | | $ | | $ | | $ | | $ | | $ | | $ | | |||||||
Insurance Notes
During 2025, the Company entered into an insurance promissory note for the payment of insurance premiums at an interest rate of
Other Current Liabilities
On January 30, 2026, the Company entered into a Subordinated Business Loan and Security Agreement (the “Subordinated Loan Agreement”) with Agile Lending, LLC, as lead lender, and Agile Capital Funding, LLC, as collateral agent, pursuant to which the Lenders (as such term is defined in the Subordinated Loan Agreement) agreed to make a secured term loan to the Company and certain subsidiary co-borrowers.
The term loan is evidenced by a Subordinated Secured Promissory Note (the “Promissory Note”), which was issued in the principal amount of $
15
2026. The Promissory Note is expressly subordinated in right of payment to all Senior Indebtedness, as described in the Promissory Note. The Promissory Note is secured by a pledge on all assets. The collateral agent is authorized to take actions to perfect the security interests; however, the Subordinated Loan Agreement provides that a financing statement may be filed only upon an event of default. During the three and six months ended June 30, 2026, the Company has made payments of approximately $
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.
In December 2024, the Company extended the Austin, Texas lease for an additional
On October 1, 2023, the Company began a five- year lease in Shelton, Connecticut. The Shelton, Connecticut lease extends through September 30, 2028. Continuation of the lease after the lease term would be on a month-to-month basis.
Effective October 31, 2023, the Company entered into a 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, 2026 and 2025 is shown in the table below (in thousands).
| | Three Months Ended | ||||||
June 30, | ||||||||
Lease Cost | Classification | 2026 | 2025 | |||||
Operating rent expense |
| |
| |
| | ||
| Cost of revenue | $ | | $ | | |||
| Research and development |
| |
| | |||
| Sales and marketing |
| |
| - | |||
| General and administrative |
| |
| | |||
Variable rent expense |
| |
| |
| |||
| Cost of revenue |
| |
| | |||
| Research and development |
| |
| | |||
| Sales and marketing |
| |
| - | |||
| General and administrative |
| |
| | |||
16
The expense associated with these operating leases for the six months ended June 30, 2026 and 2025 is shown in the table below (in thousands).
| | Six Months Ended June 30, | | ||||||
Lease Cost | Classification | 2026 | 2025 | ||||||
Operating rent expense | |||||||||
| Cost of revenue | $ | | $ | | ||||
| Research and development |
| |
| | ||||
| Sales and marketing |
| |
| | ||||
| General and administrative |
| |
| | ||||
Variable rent expense |
| |
| |
| | |||
| Cost of revenue | $ | | $ | | ||||
| Research and development |
| |
| | ||||
| Sales and marketing |
| |
| | ||||
| General and administrative |
| |
| | ||||
Based on the Company’s leases as of June 30, 2026, the table below sets forth the approximate future lease payments related to operating leases with initial terms of one year or more (in thousands).
Year | | Payments | |
2026 | $ | | |
2027 | | ||
2028 |
| | |
2029 |
| | |
2030 |
| | |
Thereafter |
| | |
Total Operating Lease Payments |
| | |
Less: Imputed Interest |
| ( | |
Present Value of Lease Liabilities |
| | |
Less: Operating Lease Liability, current portion |
| ( | |
Operating Lease Liability, non-current portion | $ | | |
Weighted-average lease term and discount rate were as follows.
| Six Months Ended June 30, |
| |||||
| 2026 | | 2025 |
| |||
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 |
| | % |
| | % | |
Finance Lease
Effective June 8, 2026, the Company entered into an embedded lease agreement with Roche Diagnostics Corporation (the “Roche Agreement”) for a Roche Cobas Pure on which the Company will run its tests beginning in the third quarter of 2026, after validation testing is completed. Under the Roche Agreement, the Company has an annual minimum supply purchase of $
17
Based on the Company’s leases as of June 30, 2026, the table below sets forth the approximate future lease payments related to the finance lease (in thousands).
Year | | Payments | |
2026 | $ | | |
2027 | | ||
2028 |
| | |
2029 |
| | |
2030 |
| | |
Thereafter |
| | |
Total Finance Lease Payments |
| | |
Less: Imputed Interest |
| ( | |
Present Value of Lease Liabilities |
| | |
Less: Finance Lease Liability, current portion |
| ( | |
Finance Lease Liability, non-current portion | $ | | |
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 $
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 $
18
The Dana-Farber, Brigham, Lodz License Agreement also requires non-refundable royalty payments of up to $
On May 20, 2026, the Company entered into a Master Collaboration and License Agreement (the “CCF Agreement”) with Cleveland Clinic Foundation (“CCF”), a non-profit educational, research and health care institution. Under the CCF Agreement, the Company and CCF will collaborate on biomedical research and development projects. The Company expensed an initial fee in the amount 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 the third milestone, and have therefore elected to terminate the ENDOinform development program contract.
On July 15, 2025, the Company received $
19
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.
6. 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, 2026 and December 31, 2025.
June 30, | December 31, | |||||
(in thousands) | | 2026 | | 2025 | ||
Payroll and benefits related expenses | $ | | $ | | ||
Collaboration and research agreements expenses |
| |
| | ||
Professional services |
| |
| | ||
Other accrued liabilities |
| |
| | ||
Total accrued liabilities | $ | | $ | | ||
7. STOCKHOLDERS’ DEFICIT
2026 Private Placement Offering
On June 5, 2026, the Company entered into a securities purchase agreement with certain investors in a private placement (the “2026 Private Placement Offering”). Pursuant to the 2026 Private Placement Offering, the Company issued an aggregate of
The 2026 Private Placement Offering included a non-dilutive clause, which indicates that if the Company consummates the next arm’s-length equity or equity-linked financing transaction following the Closing Date that results in gross cash proceeds to the Company (before deduction of placement agent fees and expenses) of at least $
The Company evaluated the June 2026 Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.
The May 2026 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.
20
2025 Lincoln Park Equity Line of Credit Agreement
On December 23, 2025, the Company entered into an equity purchase agreement (the “2025 Lincoln Park Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase, at the Company’s direction from time to time, up to an aggregate of $
registration statement covering the resale by Lincoln Park of the shares of Common Stock that have been and may be issued and sold to Lincoln Park under the 2025 Lincoln Park Agreement, including the commitment shares described below, and to take such other actions as are reasonably necessary to maintain the effectiveness of such registration statement as provided in the Registration Rights Agreement.
Under the terms of the 2025 Lincoln Park Agreement, from and after the date on which the conditions to Lincoln Park’s purchase obligations have been satisfied, including that the registration statement described above is declared effective by the SEC and a final prospectus is filed with the SEC (the “Commencement Date”), the Company will have the right, but not the obligation, in its sole discretion to direct Lincoln Park to purchase shares of Common Stock from time to time over a period of up to
From and after the Commencement Date, on any business day on which the closing sale price of the Common Stock is greater than $
In addition, if the Company directs Lincoln Park to purchase the maximum number of shares permitted in a Regular Purchase on an applicable purchase date, then, in addition to such Regular Purchase and subject to the satisfaction of certain conditions and limitations set forth in the Purchase Agreement, the Company may also direct Lincoln Park to purchase additional shares of Common Stock in one or more accelerated purchases (each, an “Accelerated Purchase”) on the following business day. The Company may set a minimum price threshold for any Accelerated Purchase in the related notice. For any Accelerated Purchase, Lincoln Park will purchase the lesser of (i)
The 2025 Lincoln Park Agreement contains customary terms, conditions, representations and warranties, and indemnification obligations of the parties. The Company may terminate the 2025 Lincoln Park Agreement at any time, for any reason or no reason, upon business day’s prior written notice to Lincoln Park, at no cost or penalty. Following the Commencement Date, upon the occurrence of specified suspension events described in the 2025 Lincoln Park Agreement, including, among others, the unavailability of the registration statement for resales, trading suspensions, certain breaches of representations or covenants having or reasonably likely to have a material adverse effect, and certain listing or eligibility events, the Company will not be permitted to direct Lincoln Park to purchase shares until the applicable suspension event is cured or waived; provided that Lincoln Park does not have the right to terminate the 2025 Lincoln Park Agreement as a result of any such suspension event. In addition, the 2025 Lincoln Park Agreement prohibits the
21
Company from directing Lincoln Park to purchase any shares of Common Stock if such shares, when aggregated with all other shares then beneficially owned by Lincoln Park and its affiliates, would result in Lincoln Park beneficially owning more than
As consideration for Lincoln Park’s commitment to purchase shares under the 2025 Lincoln Park Agreement, on the date of the 2025 Lincoln Park Agreement the Company issued to Lincoln Park
Agreement were incurred, all of which are recognized in Other expense (income), net in the consolidated financial statements for the year ended December 31, 2025. Also included in Other expense (income), net, was a referral fee related to the 2025 Lincoln Park Agreement in the amount of $
The 2025 Lincoln Park Agreement prohibits the Company from entering into another equity line of credit or substantially similar arrangement during the term of the 2025 Lincoln Park Agreement; however, the Company may enter into or maintain an at-the-market offering program with a registered broker-dealer.
During the three and six months ended June 30, 2026, the Company sold
2025 Private Placement Offering
On September 16, 2025, the Company entered into a securities purchase agreement with certain investors and board members in a private placement (the “2025 Private Placement Offering”). Pursuant to the 2025 Private Placement Offering, the Company issued an aggregate of
The Company evaluated the September 2025 Warrants and concluded that they met the criteria to be classified as equity within additional paid-in-capital.
2025 Equity Line of Credit Agreement
On April 4, 2025, the Company entered into an equity purchase agreement (the “2025 Equity Line of Credit Agreement”) with Triton Funds L.P. (“Triton”) for the purchase of up to $
Pursuant to the 2025 Equity Line of Credit Agreement, the Company issued
The 2025 Equity Line of Credit expired on September 30, 2025. The Company opted not to renew the agreement upon its expiration on September 30, 2025.
22
March 2025 Convertible Notes Settlement
On March 12, 2025, the Company issued warrants (the “March 2025 Warrants”) upon the conversion of the Convertible Notes (see Note 5, Commitments and Contingencies, and Debt). The March 2025 Warrants were 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
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.
2024 At the Market Offering
On August 2, 2024, the Company entered into an At the Market offering agreement (the “2024 At the Market Offering”) with H.C. Wainwright to sell shares of its common stock, having an aggregate sales price of up to $
During the year ended December 31, 2025, the Company sold
23
Warrants
The following table is a summary of the Company’s warrants outstanding and exercisable as of June 30, 2026 and December 31, 2025.
Number of Warrants | ||||||||||||||
Exercise | Outstanding and Common | |||||||||||||
Price | Stock Underlying Warrants | |||||||||||||
| Issuance Date | | Expiration Date | | Classification | per Share | | June 30, 2026 | | December 31, 2025 | | |||
Unmodified August 2022 Warrants | Liability | $ | | | | |||||||||
Modified August 2022 Warrants | Liability | $ | | | | |||||||||
January 2024 Purchase Warrants | Equity | $ | | | | |||||||||
July 2024 Purchase Warrants | Equity | $ | | | | |||||||||
August 2024 Purchase Warrants | Equity | $ | | | | |||||||||
Amended March 2025 Warrants | Liability | $ | | |
| |
| |||||||
September 2025 Warrants | Equity | $ | | |
| |
| |||||||
June 2026 Warrants | Equity | $ | | | - |
| ||||||||
| | |||||||||||||
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, 2026, there were
During the six months ended June 30, 2026,
24
As of June 30, 2026, there were
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 was
The following table summarizes stock option activity for the 2019 Plan during the six months ended June 30, 2026.
| | ||
Options outstanding at December 31, 2025(1) |
| |
|
Options granted |
| |
|
Options forfeited or expired |
| ( |
|
Options outstanding at June 30, 2026(1) |
| |
|
Vested and Exercisable options at June 30, 2026 |
| |
|
| (1) | Options outstanding include options vested and expected to vest |
As of June 30, 2026, the weighted average exercise price of outstanding options under the 2019 Plan was $
Stock-Based Compensation
During the six months ended June 30, 2026, the Company granted option awards under the 2019 Plan with a weighted average grant date fair value of $
25
The following table summarizes weighted average assumptions used in calculating the fair value per share for the three and six months ended June 30, 2026 and 2025.
June 30, | | June 30, | |||||||||||
| 2026 | | 2025 | 2026 | | 2025 |
| ||||||
Dividend yield |
| - | - | - | - | ||||||||
Volatility |
| | % | | % | | % | | % | ||||
Risk-free interest rate |
| | % | | % | | % | | % | ||||
Expected lives (years) |
|
|
|
| |||||||||
Weighted average fair value | $ | | $ | | $ | | $ | | |||||
The Company recorded $
The allocation of non-cash stock-based compensation expense by functional area for the three and six months ended June 30, 2026 and 2025 was as follows.
| Three Months Ended | | Six Months Ended | | |||||||||
June 30, | June 30, | ||||||||||||
(in thousands) | 2026 | | 2025 | 2026 | | 2025 | |||||||
Cost of revenue | $ | | $ | | $ | | $ | | |||||
Research and development |
| |
| ( |
| |
| | |||||
Sales and marketing |
| |
| ( |
| |
| | |||||
General and administrative |
| |
| |
| |
| | |||||
Total | $ | | $ | | $ | | $ | | |||||
As of June 30, 2026, total unrecognized compensation cost related to unvested stock option awards was approximately $
8. EARNINGS (LOSS) PER SHARE
The Company calculates basic earnings (loss) per share using the weighted average number of shares of Aspira common stock outstanding during the period. The Company considers the August 2022 Warrants and the March 2025 Warrants, and during the period outstanding, the Convertible Notes (see Note 5, 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 August 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.
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2026 | | 2025 | 2026 | | 2025 | ||||||||
Numerator: |
|
| |
| |
| |
| | ||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Denominator: |
| |
| |
| |
| | |||||
Shares used in computing the 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 was in a net loss position, diluted loss per share is calculated using the
26
weighted average number of common shares outstanding and excludes the effects of potential shares of common stock that are antidilutive.
The potential shares of common stock that have been excluded from the diluted loss per share calculation above for the three and six months ended June 30, 2026 and 2025 were as follows:
| Three and Six Months Ended June 30, | | |||
2026 | | 2025 | |||
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.
9. RELATED PARTY TRANSACTIONS
On December 1, 2023, the Company entered into a consulting agreement with Biodesix, Inc. (the “Biodesix Agreement”) to assist with our micro RNA (“miRNA”) product pipeline. Jack Schuler, a beneficial owner of more than
On March 5, 2025, the Company entered into the March 2025 Private Placement Offering with the Purchasers for the issuance and sale of Convertible Notes. The Convertible Notes, including interest accrued, were converted into units consisting of
The Purchasers are entitled to nominate
10. SUBSEQUENT EVENTS
On July 6, 2026, the Company entered into a Subordinated Business Loan and Security Agreement (the “Second Subordinated Loan Agreement”) with Agile Lending, LLC, as lead lender, and Agile Capital Funding, LLC, as collateral agent, pursuant to which the Lenders (as such term is defined in the Second Subordinated Loan Agreement) agreed to make a second secured term loan to the Company and certain subsidiary co-borrowers. The Second Subordinated Loan Agreement is dated as of July 1, 2026.
The Second Subordinated Loan Agreement is evidenced by a Subordinated Secured Promissory Note (the “Second Promissory Note”), which was issued in the principal amount of $
27
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,” “predicts,” “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 and OVAinform; |
| ● | 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; |
28
| ● | plans to develop informatics products as laboratory developed tests (“LDTs”) and potential Food and Drug Administration (“FDA”) oversight changes of LDTs; |
| ● | expectations regarding existing and future collaborations and partnerships for our products, including plans to enter into decentralized arrangements for our Aspira Synergy platform and to provide and expand access to our risk assessment tests; |
| ● | plans regarding future publications and presentations; |
| ● | expectations regarding potential collaborations with governments, legislative bodies and advocacy groups to enhance awareness and drive policies to provide broader access to our tests; |
| ● | our ability to continue to comply with applicable governmental regulations, including regulations applicable to the operation of our clinical lab, expectations regarding pending regulatory submissions and plans to seek regulatory approvals for our tests within the United States and internationally, as applicable; |
| ● | our continued ability to expand and protect our intellectual property portfolio; |
| ● | anticipated liquidity and capital requirements; |
| ● | anticipated future losses and our ability to continue as a going concern; |
| ● | expectations regarding raising capital and the amount of financing anticipated to be required to fund our planned operations; |
| ● | 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; |
29
| ● | 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, 2025, as filed on April 1, 2026, 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.
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.
30
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 through both in-house and distributed pathways. 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 performance of our tests in detecting ovarian cancer risk in different racial 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: endometriosis and ovarian cancer.
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. Our ENDOinform program is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata for the identification of endometriosis.
Our endometriosis portfolio reaches a larger addressable market than our ovarian cancer portfolio. According to the U.S. Office on Women’s Health, endometriosis affects approximately 10% of reproductive age women, representing more than 6.6 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.
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 results in an addressable market for our tests of between 2 and 4 million tests per year, based on 1.5 million women presenting with an indeterminate adnexal mass.
Our OVAinform development program continues to progress. OVAinform is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata for assessing the risk of ovarian cancer. We believe there is utility in expanding the OVAinform indication to include asymptomatic women at elevated risk due to genetic risk or first degree relatives with ovarian cancer. The inclusion of this cohort in our indication will increase the addressable market to include another 2.5 million women, increasing the total to 4 million women.
Our Business and Products
We currently commercialize the following blood test 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 |
31
| (2) | OvaWatch, which is intended to assist in the initial and ongoing periodic clinical assessment of malignancy risk in all women thought to have an indeterminate or benign adnexal mass. |
Our products are distributed through our direct national sales force, including field sales and inside sales. OvaSuite tests are marketed to both physicians via a direct referral to Aspira as well as to laboratories via our Aspira Synergy platform. We also engage in channel distribution partnerships by which OvaSuite is distributed via laboratory partners such as BioReference Health, LLC. (“BioReference”) and Associated Regional University Pathologists (“ARUP”). In December 2025, we executed an agreement with Mayo Clinic Laboratories (“Mayo”) as a new channel partner for Ova1 and OvaWatch distribution.
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 Ova1 and OvaWatch is included in the results of operations in total revenue for the three and six months ended June 30, 2026.
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. OvaWatch is the only commercially available blood test available for assessment of the risk of ovarian cancer in women diagnosed with an adnexal mass considered indeterminate or benign by a physician’s preliminary clinical assessment.
We collected clinical data to support the utility of OvaWatch to aid in surgical referral and as a longitudinal monitoring test, resulting in two manuscripts that were published in peer review journals in May 2024. In addition, an abstract highlighting data evaluating the use of OvaWatch to assess ovarian cancer risk in pre- and post-menopausal women was presented at the Annual Meeting of The Menopause Society in September 2024.
In August 2025, after integrating Ova1 into its care pathway, Cleveland Clinic Foundation, a preeminent research laboratory, issued a newsletter reporting that use of Ova1 improved gynecologic oncology referral patterns to increase personalized surgical management based on patient risk stratification.
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 needs. Aspira 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 provides national coverage for patients enrolled in Medicare as well as Medicare Advantage health plans. We have applied for an LCD for OvaWatch, which is currently under review.
In November 2016, the American College of Obstetricians and Gynecologists (“ACOG”) issued Practice Bulletin Number 174 which included Ova1, defined as the “Multivariate Index Assay,” outlining ACOG’s clinical management guidelines for adnexal mass management. Practice Bulletin Number 174 recommends that obstetricians and gynecologists evaluating women with adnexal masses who do not meet Level A criteria of a low-risk transvaginal ultrasound should proceed with Level B clinical guidelines. Level B guidelines state that the physician may use risk-assessment tools such
32
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 an ACOG 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.
| ● | ENDOinform, a key pipeline development focus, is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata for the identification of endometriosis. The initial test development was in collaboration with a consortium of academic and clinical partners: 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). Investigations with intended use samples show that serum miRNA and proteins demonstrate favorable analytical properties and sufficient performance to detect of endometriosis cases when analyzed on commercial platforms. Additionally, this data set will provide information on disease classification capability of miRNA and proteins. This is a critical step in evaluating the strength of algorithms that incorporate miRNAs and proteins. The total addressable market is 6.5 million women in the U.S. affected by endometriosis. |
| ● | OVAinform is in the development stage and is a multi-omic biomarker test program including a proprietary combination of serum proteins, miRNAs and clinical metadata for assessing the risk of ovarian cancer in women with an adnexal mass, with an expanded indication as a surveillance tool for women determined to be at elevated risk of ovarian cancer due to genetic risk or a first degree relative with ovarian cancer, increasing our total addressable market to 4 million women. The discovery work was developed in collaboration with 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 November 2024 a peer review journal publication entitled “Serum miRNA improves the accuracy of a multivariate index assay for triage of an adnexal mass” was published by our collaborator Dr. Kevin Elias’ lab in the journal Gynecologic Oncology. This paper demonstrated that the combination of miRNAs with serum protein biomarkers from Aspiras’s ovarian cancer risk tests 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 for the expanded utility of OVAinform.
33
Recent Developments
Business Updates
On April 23, 2026, we issued a press release announcing that we are completing the buildout of our molecular laboratory in the second quarter of 2026 to facilitate the development of ENDOinform.
On May 20, 2026, we entered into a Master Collaboration and License Agreement (the “CCF Agreement”) with Cleveland Clinic Foundation (“CCF”), a non-profit educational, research and health care institution. Under the CCF Agreement, Aspira and CCF will collaborate on biomedical research and development projects. Aspira shall pay to CCF a partnering fee in the amount of $50,000 for the first year and $25,000 on each of the first, second, and third anniversaries of the CCF Agreement date.
On June 5, 2026, we entered into a securities purchase agreement with certain investors in a private placement (the “2026 Private Placement Offering”). Pursuant to the 2026 Private Placement Offering, we issued an aggregate of 3,133,333 shares of our common stock and accompanying warrants (the “June 2026 Warrants”) to purchase 4,230,000 shares of our common stock at a price of $0.45 per share and accompanying warrant. The June 2026 Warrants have an exercise price of $0.75 per share and are exercisable until their expiration on the third anniversary of the issuance date. The gross proceeds from the 2026 Private Placement Offering were approximately $1,410,000, before deducting expenses of approximately $58,000 payable.
Critical Accounting Estimates
There have been no material changes to our critical accounting estimates described in our Annual Report on Form 10-K, filed with the SEC on April 1, 2026.
Our 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.
34
Results of Operations – Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025
The selected summary financial and operating data of the Company for the three months ended June 30, 2026 and 2025 were as follows.
| Three Months Ended | | Increase | ||||||||
June 30, | (Decrease) | ||||||||||
(dollars in thousands) | 2026 | 2025 | Amount | % | |||||||
| |
| |
| |
| | ||||
Revenue | $ | 2,046 | $ | 2,404 | $ | (358) |
| (15) | |||
Cost of revenue |
| 915 |
| 870 |
| 45 |
| 5 | |||
Gross profit |
| 1,131 |
| 1,534 |
| (403) |
| (26) | |||
Operating expenses: |
| |
| |
| |
| | |||
Research and development |
| 692 |
| 704 |
| (12) |
| (2) | |||
Sales and marketing |
| 567 |
| 679 |
| (112) |
| (16) | |||
General and administrative |
| 1,707 |
| 1,961 |
| (254) |
| (13) | |||
Total operating expenses |
| 2,966 |
| 3,344 |
| (378) |
| (11) | |||
Loss from operations |
| (1,835) |
| (1,810) |
| (25) |
| 1 | |||
Other expense, net: |
| |
| |
| |
| | |||
Change in fair value of warrant liabilities |
| (485) |
| (624) |
| 139 |
| (22) | |||
Interest expense, net |
| (227) |
| (13) |
| (214) |
| 1,646 | |||
Other income (expense), net |
| 127 |
| (219) |
| 346 |
| (158) | |||
Total other expense, net |
| (585) |
| (856) |
| 271 |
| (32) | |||
Net loss | $ | (2,420) | $ | (2,666) | $ | 246 |
| (9) | |||
Revenue. 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 15% revenue decrease is primarily due to a decrease in OvaSuite test volume compared to the prior year.
The number of OvaSuite tests performed decreased 12% to 5,059 during the three months ended June 30, 2026, compared to 5,728 tests for the same period in 2025. This decrease is a result of our reduced field sales headcount. We expect revenue to increase in the third quarter due to our focus on higher revenue generating payers.
The volume and AUP for the three months ended June 30, 2026 and 2025 were as follows.
| Three Months Ended | |||||
June 30, | ||||||
2026 | 2025 | |||||
Test Volume: | ||||||
Ova1Plus |
| 3,889 |
| 4,447 | ||
OvaWatch |
| 1,170 |
| 1,281 | ||
Total OvaSuite |
| 5,059 |
| 5,728 | ||
Average Unit Price (AUP): |
| |
| | ||
Ova1Plus | $ | 409 | $ | 425 | ||
OvaWatch |
| 388 |
| 403 | ||
Total OvaSuite | $ | 402 | $ | 420 | ||
Cost of Revenue. The increase in Cost of revenue was primarily due to an increase in consulting costs of $53,000, postage costs of $24,000 and software licenses of $21,000, partially offset by a decrease in lab supplies of $33,000, and royalties of $11,000. We expect the cost of revenue to increase slightly in 2026 as the number of tests performed increases.
35
Gross Profit Margin. Gross profit margin for revenue decreased from 63.8% to 55.3% for the three months ended June 30, 2026, compared to the same period in 2025.
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. The decrease in research and development expenses for the three months ended June 30, 2026 when compared to the same period in 2025 was primarily due to a decrease in clinical trial costs of $58,000, partially offset by an increase in consulting costs of $32,000. We expect research and development expenses to increase modestly over the third quarter of 2026, 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 decreased for the three months ended June 30, 2026 when compared to the same period in 2025, primarily due to decreased personnel costs of $61,000, costs related to our contracted sales team of $40,000, and consulting costs of $28,000, partially offset by an increase in software costs of $13,000. We expect sales and marketing expenses to decrease slightly during the third quarter of 2026.
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 decreased for the three months ended June 30, 2026 when compared to the same period in 2025. This decrease was primarily due to a decrease in consulting costs of $415,000, board fees of $60,000, temporary help costs of $53,000, audit and tax costs of $44,000, partially offset by public company costs of $114,000 and legal fees of $242,000. We expect general and administrative expenses to remain flat during the third quarter of 2026.
Change in fair value of Warrant Liabilities. For each of the three months ended June 30, 2026 and 2025, an increase in our stock price during the quarter resulted in a loss recognized in the Change in fair value of Warrant Liabilities.
36
Results of Operations – Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025
The selected summary financial and operating data of the Company for the six months ended June 30, 2026 and 2025 were as follows.
Six Months Ended | | | | | ||||||||
June 30, | Increase (Decrease) | |||||||||||
(dollars in thousands) | | 2026 | | 2025 | | Amount | | % | | |||
| |
| |
| |
| |
| ||||
Revenue | $ | 4,013 | $ | 4,683 | $ | (670) |
| (14) | ||||
Cost of revenue |
| 1,811 |
| 1,589 |
| 222 |
| 14 | ||||
Gross profit |
| 2,202 |
| 3,094 |
| (892) |
| (29) | ||||
Operating expenses: |
| |
| |
| |
| | ||||
Research and development |
| 1,918 |
| 1,677 |
| 241 |
| 14 | ||||
Sales and marketing |
| 1,110 |
| 1,765 |
| (655) |
| (37) | ||||
General and administrative |
| 3,212 |
| 4,702 |
| (1,490) |
| (32) | ||||
Total operating expenses |
| 6,240 |
| 8,144 |
| (1,904) |
| (23) | ||||
Loss from operations |
| (4,038) |
| (5,050) |
| 1,012 |
| (20) | ||||
Other income, net: |
| |
| |
| |
| | ||||
Change in fair value of warrant liabilities |
| 2,625 |
| 297 |
| 2,328 |
| 784 | ||||
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 |
| (458) |
| (27) |
| (431) |
| 1,596 | ||||
Other income, net |
| 127 |
| 1,289 |
| (1,162) |
| (90) | ||||
Total other income, net |
| 2,294 |
| 531 |
| 1,763 |
| 332 | ||||
Net loss | $ | (1,744) | $ | (4,519) | $ | 2,775 |
| (61) | ||||
Revenue. 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 14% revenue decrease is due to a decrease in OvaSuite test volume compared to the prior year.
The number of OvaSuite tests performed decreased 13% to 9,955 during the six months ended June 30, 2026, compared to 11,407 tests for the same period in 2025. This decrease is a result of our reduced field sales headcount.
The volume and AUP for the six months ended June 30, 2026 and 2025 were as follows.
Six Months Ended | ||||||
June 30, | ||||||
| 2026 | | 2025 | |||
Test Volume: |
| |
| | ||
Ova1Plus |
| 7,659 |
| 8,809 | ||
OvaWatch |
| 2,296 |
| 2,598 | ||
Total OvaSuite |
| 9,955 |
| 11,407 | ||
Average Unit Price (AUP): |
| |
| | ||
Ova1Plus | $ | 410 | $ | 415 | ||
OvaWatch |
| 380 |
| 397 | ||
Total OvaSuite | $ | 403 | $ | 411 | ||
Cost of Revenue. The increase in Cost of revenue was primarily due to a one-time increase in phlebotomy expenses of $286,000 and increases in software license costs of $47,000 and personnel costs of $40,000, partially offset by a decrease in consulting costs of $50,000, and lab supplies of $50,000.
37
Gross Profit Margin. Gross profit margin for revenue decreased from 66.1% to 54.9% for the six months ended June 30, 2026, compared to the same period in 2025.
Research and Development Expenses. The increase in research and development expenses for the six months ended June 30, 2026 when compared to the same period in 2025 was primarily due to an increase in clinical trial costs of $237,000 and personnel costs of $59,000, partially offset by a decrease in lab supplies of $36,000.
Sales and Marketing Expenses. Sales and marketing expenses decreased for the six months ended June 30, 2026 when compared to the same period in 2025, primarily due to decreased personnel costs of $493,000, costs related to our contracted sales team of $89,000, and consulting costs of $69,000.
General and Administrative Expenses. General and administrative expenses decreased for the six months ended June 30, 2026 when compared to the same period in 2025. This decrease was primarily due to a decrease in consulting costs of $448,000, audit and tax costs of $301,000, personnel costs of $268,000, board fees of $149,000, temporary help costs of $90,000, public company costs of $81,000, business insurance costs of $50,000 and legal fees of $25,000,.
Change in fair value of Warrant Liabilities. For each of the six months ended June 30, 2026 and 2025, a decline in our stock price during the quarter resulted in a gain recognized in the Change in fair value of Warrant Liabilities.
Liquidity and Capital Resources
We plan to continue to expend resources selling and marketing our ovarian cancer and endometriosis offering and developing our pipeline 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 $545,921,000 as of June 30, 2026. We also expect to incur a net loss and negative cash flows from operations for the remainder of 2026. 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 issued.
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 $1,500,000 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 5 to our unaudited condensed consolidated financial statements Commitments, Contingencies and Debt. If we choose to repay the loan early, it may be done at any time without premium or penalty. As of June 30, 2026, the remaining balance outstanding under the DECD Loan Agreement is $1,160,000.
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 would 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 would receive payments based on the completion of certain agreed-upon milestones.
38
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 Warrants”).
The March 2025 Warrants were exercisable for five years at $0.25 per share for the first 24 months after issuance, and $0.50 per share thereafter. In September 2025, the March 2025 Warrants were amended to have an exercise price of $0.35 and an expiration date of March 5, 2031.
On September 16, 2025, we entered into a securities purchase agreement with certain investors and board members in a private placement (the “2025 Private Placement Offering”). Pursuant to the 2025 Private Placement Offering, we issued an aggregate of 6,550,000 shares of our common stock and accompanying warrants (the “September 2025 Warrants”) to purchase an equal number of shares of common stock at a price of $0.45 per share and accompanying warrant. The September 2025 Warrants have an exercise price of $0.75 per share and are exercisable until their expiration on the fifth anniversary of the issuance date. The gross proceeds from the 2025 Private Placement Offering were approximately $2,949,000, before deducting issuance costs of approximately $140,000.
On December 23, 2025, we entered into an equity purchase agreement (the “2025 Lincoln Park Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), for the purchase of up to an aggregate of $10.0 million of our Common Stock.
Pursuant to the 2025 Lincoln Park Agreement, on any business day on which the closing sale price of the Common Stock is greater than $0.10 per share, we may direct Lincoln Park to purchase up to 50,000 shares of Common Stock (a “Regular Purchase”), which amount may be increased to up to 75,000 shares if the closing sale price is not below $0.50 per share and up to 100,000 shares if the closing sale price is not below $0.75 per share, in each case subject to a maximum dollar amount of $500,000 per Regular Purchase. The purchase price per share for each Regular Purchase will be equal to 95% of the lower of (i) the lowest sale price of the Common Stock on the applicable purchase date and (ii) the average of the three lowest closing sale prices of the Common Stock during the ten business days immediately preceding the applicable purchase date. Regular Purchases may be effected as frequently as each business day after the close of trading so that the applicable purchase price is fixed and known at the time we elect to sell shares to Lincoln Park.
In addition, if we direct Lincoln Park to purchase the maximum number of shares permitted in a Regular Purchase on an applicable purchase date, then, in addition to such Regular Purchase and subject to the satisfaction of certain conditions and limitations set forth in the Purchase Agreement, we may also direct Lincoln Park to purchase additional shares of Common Stock in one or more accelerated purchases (each, an “Accelerated Purchase”) on the following business day. We may set a minimum price threshold for any Accelerated Purchase in the related notice. For any Accelerated Purchase, Lincoln Park will purchase the lesser of (i) three times the number of shares purchased in the corresponding Regular Purchase and (ii) 30% of the trading volume on the Accelerated Purchase date, at a purchase price per share equal to the lower of 95% of (x) the closing sale price on the Accelerated Purchase date and (y) the volume-weighted average price for such date. Subject to satisfaction of the applicable conditions, we may direct multiple Accelerated Purchases in a single trading day, provided share deliveries for prior purchases have been completed.
As of June 30, 2026, we have sold 20,000 shares under the Lincoln Park Agreement and the value of the remaining availability under the Lincoln Park Agreement as of June 30, 2026 was $9,994,080.
On January 30, 2026, we entered into a Subordinated Business Loan and Security Agreement (the “Subordinated Loan Agreement”) with Agile Lending, LLC, as lead lender, and Agile Capital Funding, LLC, as collateral agent, pursuant
39
to which the Lenders (as such term is defined in the Subordinated Loan Agreement) agreed to make a secured term loan to the Company and certain subsidiary co-borrowers.
The term loan is evidenced by a Subordinated Secured Promissory Note (the “Promissory Note”), which was issued in the principal amount of $1,050,000, includes an interest rate of 42%, and is scheduled to mature on August 26, 2026. The Promissory Note is expressly subordinated in right of payment to all Senior Indebtedness, as described in the Promissory Note. The Promissory Note is secured by a pledge on all assets. The collateral agent is authorized to take actions to perfect the security interests; however, the Subordinated Loan Agreement provides that a financing statement may be filed only upon an event of default. As of June 30, 2026, the remaining balance outstanding under the Promissory Note was $344,000.
On July 6, 2026, we entered into a second Subordinated Business Loan and security Agreement (the “Second Subordinated Loan Agreement”) with the same parties, which is evidenced by a Subordinated Secured Promissory Note (the “Second Promissory Note”) in the form attached to the Subordinated Loan Agreement. The Second Subordinated Loan Agreement was effective July 1, 2026. The Note was issued in the principal amount of $1,050,000, includes an interest rate of 42%, and settled the Promissory Note, which was secured in January. The Second Promissory Note is scheduled to mature on January 26, 2027. The Second Promissory Note is expressly subordinated in right of payment to all Senior Indebtedness, as described in the Second Promissory Note. The Promissory Note is secured by a pledge on all assets. The collateral agent is authorized to take actions to perfect the security interests; however, the Subordinated Loan Agreement provides that a financing statement may be filed only upon an event of default.
On June 5, 2026, we entered into a securities purchase agreement with certain investors in a private placement (the “2026 Private Placement Offering”). Pursuant to the 2026 Private Placement Offering, we issued an aggregate of 3,133,333 shares of our common stock and accompanying warrants (the “June 2026 Warrants”) to purchase 4,230,000 shares of common stock at a price of $0.45 per share and accompanying warrant. The June 2026 Warrants have an exercise price of $0.75 per share and are exercisable until their expiration on the third anniversary of the issuance date. The gross proceeds from the 2026 Private Placement Offering were approximately $1,410,000, before deducting issuance costs of approximately $58,000.
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 2026. At June 30, 2026 we had an accumulated deficit of $545,921,000 and stockholders’ deficit of $7,256,000. As of June 30, 2026, we had $477,000 in cash and cash equivalents, $5,338,000 in current liabilities, and a working capital deficit of $2,542,000. 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 for the remainder of 2026.
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 product adoption by physicians and patients; |
| ● | the rate of product adoption by healthcare systems and large physician practices of the decentralized distribution agreements; |
| ● | 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. |
40
Net cash used in operating activities was $2,370,000 for the six months ended June 30, 2026, resulting primarily from changes in the fair value of warrant liabilities of $2,625,000, net loss of $1,744,000 and changes in accounts receivable of $278,000, offset by changes in accounts payable of $1,516,000, changes in accrued liabilities of $287,000 and changes in prepaid assets of $242,000.
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 investing activities was $150,000 and none for the six months ended June 30, 2026 and 2025, respectively.
Net cash provided by financing activities was $1,241,000 for the six months ended June 30, 2026, stemming primarily from $1,352,000 in proceeds from the 2026 Private Placement Offering, net of issuance costs, partially offset by principal payments on the DECD loan.
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 $1,366,000, partially offset by principal payments on the DECD loan.
Based on the available objective evidence, we believe it is more likely than not that net deferred tax assets will not be fully realizable. Accordingly, we have provided a full valuation allowance against our net deferred tax assets. Therefore, there was no deferred income tax expense or benefit for the period.
Our pre-2018 federal NOLs will expire in varying amounts from 2025 through 2037, if not utilized, and could 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 2025 through 2044 if not utilized. Our ability to use our NOLs during this period will be dependent on our ability to generate taxable income, and the portions of our NOLs could expire before we generate sufficient taxable income.
Our ability to use our net operating loss and credit carryforwards to offset future taxable income is restricted due to ownership change limitations that have occurred in the past, as required by Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”), as well as similar state provisions. Net operating losses which are limited from offsetting any future taxable income under Section 382 are not included in the gross deferred tax assets. Due to the existence of a valuation allowance, it is not expected that such limitations, if any, will have an impact on our results of operations or financial position.
Our unrecognized tax benefits attributable to research and development credits will increase during the period for tax positions taken during the year and will decrease for expiration of a portion of the carryforwards during the period.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Per Item 305(e) of Regulation S-K, the information called for by this Item 3 is not required.
41
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2026. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of June 30, 2026, our disclosure controls and procedures were effective.
Changes in Internal Controls Oeever Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended June 30, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
42
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, 2026, 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, 2025, filed with the SEC on April 1, 2026 (the “2025 Annual Report”). The risks and uncertainties described in our 2025 Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations. We may disclose changes to such factors or disclose additional factors from time to time in our future filings with the SEC.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
There were no sales of equity securities during the period covered by this report that were not registered under the Securities Act and were not previously reported in a Current Report on Form 8-K filed by the Company.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION
During the fiscal quarter ended June 30, 2026,
43
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 |
4.1 | 8-K | 001-34810 | 4.1 | June 9, 2026 | ||||||||
10.1 | √ | |||||||||||
10.2 | Master Collaboration and License Agreement, dated as of May 20, 2026 | 8-K | 001-34810 | 10.1 | May 26, 2026 | |||||||
10.3 | Form of Securities Purchase Agreement, dated as of June 5, 2026 | 8-K | 001-34810 | 10.1 | June 9, 2026 | |||||||
10.4 | Subordinated Business Loan and Security Agreement, dated as of July 1, 2026 | 8-K | 001-34810 | 10.1 | July 15, 2026 | |||||||
10.5 | 8-K | 001-34810 | 10.2 | July 15, 2026 | ||||||||
31.1 |
|
|
|
|
|
|
|
|
|
| √ | |
31.2 |
|
|
|
|
|
|
|
|
|
| √ | |
32.1** |
|
|
|
|
|
|
|
|
|
| √√ | |
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 accompanies 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. |
44
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 14, 2026 | /s/ John Fraser |
| John Fraser |
Interim Chief Executive Officer | |
(Principal Executive Officer) | |
|
|
Date: August 14, 2026 | /s/ John Strahley |
John Strahley | |
Chief Financial Officer | |
| (Principal Financial Officer and Principal Accounting Officer) |
45