As filed with the Securities and Exchange Commission on December 31, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ASPIRA WOMEN'S HEALTH INC. (Exact name of registrant as specified in its charter) | Delaware | 2835 | 33-0595156 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classificatio ...

Financial Performance - Total revenue for Q3 2025 was $2,305,000, a 2.1% increase from $2,257,000 in Q3 2024[10] - Gross profit for Q3 2025 was $1,383,000, compared to $1,355,000 in Q3 2024, reflecting a gross margin improvement[10] - Net loss for Q3 2025 was $4,892,000, compared to a net loss of $3,547,000 in Q3 2024, representing an increase in losses[10] - For the nine months ended September 30, 2025, the company reported a net loss of $9,411,000, an improvement from a net loss of $11,706,000 for the same period in 2024, representing a 19.7% reduction in losses[14] - Product revenue for the three months ended September 30, 2025, was $2,305,000, a 2% increase from $2,257,000 in the same period in 2024[190] - Product revenue for the nine months ended September 30, 2025, was $6,988,000, a 2% increase from $6,833,000 in 2024[202]. Expenses and Cost Management - Operating expenses for Q3 2025 totaled $2,962,000, down from $5,099,000 in Q3 2024, indicating a significant reduction in costs[10] - Research and development expenses for Q3 2025 were $739,000, down from $908,000 in Q3 2024, indicating a focus on cost management[10] - Personnel costs for the three months ended September 30, 2025, were $1,635,000, down from $3,294,000 in the same period of 2024, showing a reduction of 50.5%[32] - Sales and marketing expenses for the three months ended September 30, 2025, decreased by $1,460,000, or 68%, compared to the same period in 2024[196]. - General and administrative expenses for the three months ended September 30, 2025, decreased by $508,000, or 25%, compared to the same period in 2024[197]. Cash and Assets - Cash and cash equivalents increased to $3,809,000 as of September 30, 2025, up from $1,769,000 at December 31, 2024[9] - Total assets rose to $7,296,000 as of September 30, 2025, compared to $5,491,000 at December 31, 2024[9] - Total liabilities increased to $11,640,000 as of September 30, 2025, up from $8,054,000 at December 31, 2024[9] - The accumulated deficit increased to $540,808,000 as of September 30, 2025, compared to $531,397,000 at December 31, 2024[9] Shareholder and Capital Management - The company issued 6,550,000 shares under a private placement offering, raising approximately $2,815,000 net of issuance costs[12] - The company plans to raise capital through equity offerings and may experience significant dilution for existing shareholders[20] - The company has outstanding warrants that may be exercised, although there is no assurance that they will be[19] Market and Product Development - The company’s operations are focused on developing and commercializing diagnostic tests for gynecologic disease, including the Ova1Plus workflow and OvaWatch[17] - The company plans to broaden its commercial focus from ovarian cancer to include differential diagnosis of other gynecological diseases, which is expected to enhance market opportunities[154] - The addressable market for the company's tests is projected to increase to between 2 and 4 million tests per year following the successful expansion of the OvaWatch test features[166] - The ENDOinform program aims to develop a multi-marker test for diagnosing endometriosis, targeting a market of over 6.5 million women in the U.S.[165] Operational Highlights - The number of OvaSuite tests performed decreased by 5% to 5,727 during the three months ended September 30, 2025, compared to 6,001 tests in the same period in 2024[191] - The company rebalanced its salesforce, resulting in a 167% increase in sales per full-time equivalent salesperson in Q3 2025 compared to Q3 2024[180] - OvaWatch was approved for sale in New York State, expanding the distribution agreement with BioReference to include this product[169] Regulatory and Compliance - The company’s common stock was delisted from Nasdaq on April 15, 2025, due to failure to meet the minimum stockholders' equity requirement[22] - The company has applied for an LCD for OvaWatch, which is currently under review, to enhance reimbursement coverage[173] Future Outlook - The company expects to continue incurring net losses and negative cash flows from operations for the remainder of 2025[18] - The company is evaluating the potential impact of ASU 2023-09, which addresses income tax disclosures, effective for fiscal years beginning after December 15, 2024[43]

Revenue Performance - Aspira reported total product revenues of $2.3 million for Q3 2025, remaining flat compared to Q3 2024, with a 7.0% year-over-year increase in average unit price per test[1][2] - The company generated approximately $7.0 million in revenue for the nine months ending September 30, 2025, with a 9.3% increase in average unit price, offset by a 6.4% decrease in the number of tests sold[6] - Total revenue for Q3 2025 was $2,305,000, a 2.1% increase from $2,257,000 in Q3 2024[16] Profitability and Expenses - Gross profit increased to approximately $4.5 million for the nine months ended September 30, 2025, representing a 12.2% increase, with gross margins improving to 64.1% from 58.4% year-over-year[6] - Operating expenses in Q3 2025 totaled $2,962,000, down from $5,099,000 in Q3 2024, indicating a significant reduction[16] - Total operating expenses decreased to $11.1 million for the nine months ended September 30, 2025, a 34.0% reduction from $16.8 million in the same period in 2024[6] - Cash used in operations was $5.0 million for the nine months ended September 30, 2025, representing a 54.5% reduction compared to $11.1 million in the same period in 2024[6] - Net loss for Q3 2025 was $4,892,000, compared to a net loss of $3,547,000 in Q3 2024, showing an increase in losses[16] - Net loss per share for Q3 2025 was $0.13, compared to $0.23 in Q3 2024[16] - Research and development expenses decreased to $739,000 in Q3 2025 from $908,000 in Q3 2024[16] - Sales and marketing expenses significantly decreased to $683,000 in Q3 2025 from $2,143,000 in Q3 2024[16] - General and administrative expenses were $1,540,000 in Q3 2025, down from $2,048,000 in Q3 2024[16] Assets and Liabilities - Aspira's current liabilities decreased to $4.2 million as of September 30, 2025, a 23.2% reduction from $5.5 million reported on December 31, 2024[7] - Total assets increased to $7.3 million as of September 30, 2025, compared to $5.5 million as of December 31, 2024[15] Sales Performance - The company achieved a 167% increase in sales per full-time equivalent salesperson in Q3 2025 compared to Q3 2024, driven by a focus on large healthcare systems[6] Strategic Focus - Aspira is emphasizing profitable revenue growth over specimen volume, with a compensation shift to incentivize this change starting in Q3 2025[3][4] - The company is maintaining strong momentum in research and development, particularly with the ENDOinform™ test, expecting to share updates as it approaches commercial readiness[8] Cost of Revenue - Total cost of revenue for Q3 2025 was $922,000, compared to $902,000 in Q3 2024, showing a slight increase[16]

Core Insights - Ascend Wellness Holdings, Inc. reported Q3 2025 net revenue of $124.7 million, a 2.0% sequential decline, primarily due to a 3.1% decrease in retail revenue, which was partially offset by a slight increase in wholesale revenue [4][5][6] - The company achieved an Adjusted EBITDA of $31.1 million for Q3 2025, representing a margin of 24.9%, with an 8.9% increase quarter-over-quarter [3][11] - Ascend expanded its market presence by adding seven new stores year-to-date, bringing its total to 46 locations nationwide, and plans to open additional stores in New Jersey [6][19] Financial Highlights - Q3 2025 net revenue was $124.7 million, down from $127.3 million in Q2 2025 [4][10] - Retail revenue totaled $83.8 million, reflecting a 3.1% sequential decline due to price compression and lower transaction volumes [5][10] - Wholesale revenue increased by 0.3% to $41.0 million, driven by a strategic shift towards higher-margin finished products [7][10] - Adjusted Gross Profit was $57.8 million, or 46.4% of revenue, compared to $55.3 million, or 43.4% in Q2 2025 [8][10] - The company reported a net loss of $25.8 million for Q3 2025, compared to a loss of $24.4 million in the previous quarter [10][11] Operational Developments - The company executed a densification strategy by adding seven new retail stores, with plans for 13 additional stores to reach a target of 60 locations within the next 12 months [6][19] - Ascend launched over 420 new SKUs year-to-date, with a goal of nearly 550 SKU launches for the full year [6][8] - The company introduced new product lines, including effects-based vapes and gummies, enhancing its brand portfolio [6][8] Capital and Financing - Ascend completed a $9.3 million mortgage financing secured by its Ohio assets at an interest rate of 8.5% [3][10] - Cash and cash equivalents at the end of Q3 2025 were $87.3 million, with net debt reported at $281.8 million [12][14]

As filed with the Securities and Exchange Commission on October 20, 2025 Registration Statement No. 333-290633 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 ASPIRA WOMEN'S HEALTH INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2835 33-0595156 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) REGISTRATION STATEMENT UNDER THE S ...

Core Points - Ascend Wellness Holdings, Inc. (AWH) will hold a conference call on November 10, 2025, at 5:00 PM ET to discuss its third quarter 2025 financial results [1][2] - The conference call can be accessed via a dial-in number or a live webcast, which will also be archived for replay [2] Company Overview - AWH is a multi-state, vertically integrated cannabis operator with assets in Illinois, Maryland, Massachusetts, Michigan, New Jersey, Ohio, and Pennsylvania [2] - The company owns and operates advanced cultivation facilities, producing award-winning strains and a curated selection of products for both retail and wholesale customers [2] - AWH's product lines include in-house brands such as Simply Herb, Ozone, Ozone Reserve, High Wired, Effin', Common Goods, and Royale [2]

As filed with the Securities and Exchange Commission on September 30, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ASPIRA WOMEN'S HEALTH INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2835 33-0595156 (I.R.S. Employer Identification Number) 1 ...

Core Insights - Ascend Wellness Holdings, Inc. (AWH) has successfully closed a secured financing transaction amounting to $9,345,000 with CF Bank, utilizing real estate as collateral on three properties in Ohio [1] - The financing carries an interest rate of 8.5% per annum and is set to mature in September 2030, which is expected to enhance AWH's balance sheet and support its growth in Ohio's cannabis market [1] - AWH operates in multiple states, including Illinois, Maryland, Massachusetts, Michigan, New Jersey, Ohio, and Pennsylvania, and produces a variety of cannabis products under several brands [1] Financing Details - The secured financing transaction is referred to as the Ohio Mortgage Loan, which is backed by real estate owned by AWH in Cincinnati, Sandusky, and Piqua, Ohio [1] - The competitive interest rate of 8.5% is positioned as a low-cost capital financing option for the company [1] Company Positioning - AWH's CEO, Sam Brill, emphasized that this financing transaction positions the company well to serve patients and local communities while pursuing further growth opportunities [1] - The company aims to deliver value to shareholders through strategic financial maneuvers and operational expansions in the emerging Ohio market [1]

Executive Summary & Business Update [Second Quarter 2025 Highlights](index=1&type=section&id=Second%20Quarter%20Highlights) Aspira reported stable total product revenue of **$2.404 million** in Q2 2025, with **12% year-over-year AUP growth** for its commercial portfolio despite significant business model changes and a reduced sales team Second Quarter 2025 Key Metrics: | Metric | Q2 2025 | Q2 2024 | YoY Change | | :-------------------------------- | :---------- | :---------- | :--------- | | Total Product Revenue (Millions) | $2.404 | $2.423 | -0.78% | | Commercial Product Portfolio AUP Growth | - | - | 12% | | Ova1Plus AUP Growth | - | - | 11% | | OvaWatch AUP Growth | - | - | 16% | - Aspira underwent a significant reset of its business model and market strategies, focusing heavily on relationships with leading large-scale healthcare systems and Integrated Delivery Networks (IDNs) to improve efficiency and profitability[4](index=4&type=chunk) - The specialist field sales team delivered Q2 results with a team of **7**, a substantial reduction from **19** in the same period of 2024, indicating improved sales efficiency[4](index=4&type=chunk) [First Half 2025 Financial & Operational Performance](index=1&type=section&id=Key%20financial%20highlights%20for%20the%20six%20months%20ended%20June%2030%2C%202025) Aspira's H1 2025 revenue grew **2.3%** to **$4.683 million**, driven by **10.3% AUP increase**; gross profit rose **17.4%** to **$3.1 million** with **66.1% margin**, while operating expenses decreased **31%** and cash burn reduced **41%** First Half 2025 Key Financial & Operational Highlights: | Metric | H1 2025 | H1 2024 | YoY Change | | :-------------------------------- | :---------- | :---------- | :--------- | | Total Revenue (Millions) | $4.683 | $4.576 | 2.3% | | Gross Profit (Millions) | $3.1 | $2.6 | 17.4% | | Gross Margin | 66.1% | 57.6% | +8.5 pts | | Total Operating Expenses (Millions) | $8.1 | $11.7 | -31% | | Cash Used in Operations (Millions) | $4.8 | $8.2 | -41% | | Current Liabilities (as of period end, Millions) | $4.1 (Jun 30, 2025) | $5.5 (Dec 31, 2024) | -25.1% | - Sales per full-time equivalent salesperson (FTE) increased by **156%** in Q2 2025 compared to Q2 2024, reflecting improved sales productivity due to marketing strategy changes and emphasis on large healthcare systems[5](index=5&type=chunk) - The increase in **gross profit** and **improved margins** were primarily due to an adjustment to prior quarter revenue from collections exceeding previous estimates and improved profitability of the OvaWatch product line[7](index=7&type=chunk) - **Operating expense reductions** were driven by decreases in selling expenses (**$2.3 million**), general and administrative expenses (**$1.1 million**), and research and development expenses (**$0.2 million**), largely due to headcount reductions and cost containment[7](index=7&type=chunk) [Management and Board Commentary](index=2&type=section&id=Management%20and%20Board%20Commentary) CEO Mike Buhle highlighted improved sales productivity and gross profit margins, emphasizing efforts to reduce operating expenses and strengthen financial position, while reiterating commitment to ENDOInform™ R&D timeline with updates expected by end of 2025 - CEO Mike Buhle's **top priorities** include driving **commercial team efficiencies**, **reducing operating expenses and liabilities**, and **strengthening Aspira's financial position**[6](index=6&type=chunk) - Aspira remains committed to completing R&D milestones for **ENDOInform™** and expects to provide **material updates by the end of 2025**[6](index=6&type=chunk) - The Board of Directors is **optimistic** about the new strategy and operating initiatives, believing the company is making **unprecedented advancements** in ovarian cancer and endometriosis diagnostic tools[8](index=8&type=chunk) [Summary Financial Metrics (Q2 & H1 2025 vs. 2024)](index=3&type=section&id=The%20following%20table%20summarizes%20the%20key%20financial%20metrics) This section presents key financial metrics for Q2 and H1 2025 versus 2024, including total revenue, gross margin, OvaSuite volume, and Average Unit Price Key Financial Metrics (Amounts in Thousands, Except Percentages): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Total Revenue | $2,404 | $2,423 | $4,683 | $4,576 | | Gross Margin | 63.8% | 58.6% | 66.1% | 57.6% | | Total OvaSuite Volume | 5,728 | 6,471 | 11,407 | 12,300 | | Total AUP | $420 | $374 | $411 | $372 | Company Overview [About Aspira Women's Health Inc.](index=3&type=section&id=About%20Aspira%20Women%27s%20Health%20Inc.) Aspira Women's Health Inc. is an AI-enhanced bio-analytics company developing noninvasive diagnostic tests for gynecologic diseases like ovarian cancer and endometriosis - Aspira Women's Health Inc. focuses on **noninvasive, AI-powered tests** for diagnosing gynecologic diseases[11](index=11&type=chunk) [Product Portfolio and Pipeline](index=3&type=section&id=Product%20Portfolio%20and%20Pipeline) Aspira's commercial portfolio, OvaSuite, offers blood tests for ovarian cancer risk assessment, while its pipeline focuses on enhanced ovarian cancer tests and the first non-invasive tests for endometriosis - Current commercial products (**OvaSuite**) include **OvaWatch** (**99% negative predictive value** for indeterminate/benign masses) and **Ova1Plus** (a reflex process of FDA-cleared tests Ova1® and Overa® for ovarian malignancy risk)[11](index=11&type=chunk)[12](index=12&type=chunk) - The in-development pipeline includes **enhanced ovarian cancer tests** combining microRNA and protein biomarkers with patient data, and the **first-ever non-invasive test for endometriosis**, initially targeting endometriomas and later all endometriosis types[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements, emphasizing inherent risks and uncertainties that may cause actual results to differ materially, with no obligation to update except as legally required - Forward-looking statements involve **risks and uncertainties**, and actual results could **differ materially** from those discussed[14](index=14&type=chunk) - Aspira expressly **disclaims any obligation to update** these forward-looking statements, except as required by law[14](index=14&type=chunk) Financial Statements [Condensed Consolidated Balance Sheets (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28unaudited%29) As of June 30, 2025, Aspira's total assets decreased to **$4.934 million**, total liabilities decreased to **$7.619 million**, and stockholders' deficit slightly increased to **$(2.685) million** Condensed Consolidated Balance Sheets (Amounts in Thousands): | Asset/Liability | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $1,545 | $1,769 | | Accounts receivable, net | $1,278 | $990 | | Prepaid expenses and other current assets | $590 | $1,098 | | Inventories | $273 | $326 | | **Total current assets** | **$3,686** | **$4,183** | | Property and equipment, net | $44 | $69 | | Right-of-use assets | $1,077 | $1,194 | | Other assets | $127 | $45 | | **Total assets** | **$4,934** | **$5,491** | | **Liabilities and Stockholders' Deficit** | | | | Accounts payable | $1,743 | $2,173 | | Accrued liabilities | $1,829 | $2,445 | | Current portion of long-term debt | $232 | $229 | | Short-term debt | $154 | $614 | | Current maturities of lease liabilities | $140 | $7 | | **Total current liabilities** | **$4,098** | **$5,468** | | Long-term debt | $1,160 | $1,278 | | Non-current maturities of lease liabilities | $1,121 | $1,248 | | Warrant liabilities | $1,240 | $60 | | **Total liabilities** | **$7,619** | **$8,054** | | **Stockholders' deficit** | **$(2,685)** | **$(2,563)** | | **Total liabilities and stockholders' deficit** | **$4,934** | **$5,491** | [Condensed Consolidated Statements of Operations (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28unaudited%29) For H1 2025, Aspira reported **$4.683 million** in revenue, with net loss significantly improving to **$(4.519) million** from **$(8.159) million** year-over-year, and loss from operations narrowing to **$(5.050) million** Condensed Consolidated Statements of Operations (Amounts in Thousands, Except Per Share Data): | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Product Revenue | $2,404 | $2,423 | $4,683 | $4,576 | | Total Revenue | $2,404 | $2,423 | $4,683 | $4,576 | | Cost of Revenue | $870 | $1,002 | $1,589 | $1,941 | | Gross Profit | $1,534 | $1,421 | $3,094 | $2,635 | | Research and development | $704 | $952 | $1,677 | $1,858 | | Sales and marketing | $679 | $2,137 | $1,765 | $4,026 | | General and administrative | $1,961 | $2,725 | $4,702 | $5,854 | | Total operating expenses | $3,344 | $5,814 | $8,144 | $11,738 | | Loss from operations | $(1,810) | $(4,393) | $(5,050) | $(9,103) | | Change in fair value of warrant liabilities | $(624) | $889 | $297 | $1,140 | | Change in fair value of convertible notes | - | - | $170 | - | | Loss upon issuance of Convertible Notes | - | - | $(1,198) | - | | Interest expense, net | $(13) | $(10) | $(27) | $(15) | | Other (expense) income, net | $(219) | $(16) | $1,289 | $(181) | | Total other (expense) income, net | $(856) | $863 | $531 | $944 | | Net loss | $(2,666) | $(3,530) | $(4,519) | $(8,159) | | Net loss per share - basic and diluted | $(0.07) | $(0.28) | $(0.16) | $(0.67) | | Weighted average common shares | 35,564,032 | 12,518,725 | 28,579,132 | 12,181,481 |

[PART I - Financial Information](index=4&type=section&id=PART%20I%20Financial%20Information) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis for Aspira Women's Health Inc [Item 1. Financial Statements (unaudited)](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements of Aspira Women's Health Inc for the periods ended June 30, 2025, and December 31, 2024, including balance sheets, statements of operations, changes in stockholders' deficit, and cash flows, along with accompanying notes detailing accounting policies, fair value measurements, commitments, and other financial disclosures [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the Company's financial position, detailing assets, liabilities, and stockholders' deficit at specific reporting dates | Metric | June 30, 2025 (Thousands) | December 31, 2024 (Thousands) | | :----------------------------- | :-------------------------- | :---------------------------- | | **Assets** | | | | Cash and cash equivalents | $1,545 | $1,769 | | Total current assets | $3,686 | $4,183 | | Total assets | $4,934 | $5,491 | | **Liabilities** | | | | Total current liabilities | $4,098 | $5,468 | | Warrant liabilities | $1,240 | $60 | | Total liabilities | $7,619 | $8,054 | | **Stockholders' Deficit** | | | | Total stockholders' deficit | $(2,685) | $(2,563) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the Company's revenues, expenses, and net loss for the specified reporting periods | Metric (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue: Product | $2,404 | $2,423 | $4,683 | $4,576 | | Total revenue | $2,404 | $2,423 | $4,683 | $4,576 | | Cost of revenue: Product | $870 | $1,002 | $1,589 | $1,941 | | Gross profit | $1,534 | $1,421 | $3,094 | $2,635 | | Total operating expenses | $3,344 | $5,814 | $8,144 | $11,738 | | Loss from operations | $(1,810) | $(4,393) | $(5,050) | $(9,103) | | Total other (expense) income, net | $(856) | $863 | $531 | $944 | | Net loss | $(2,666) | $(3,530) | $(4,519) | $(8,159) | | Net loss per share - basic and diluted | $(0.07) | $(0.28) | $(0.16) | $(0.67) | [Condensed Consolidated Statements of Changes in Stockholders' Deficit](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Deficit) This section outlines changes in the Company's equity, including net loss, stock issuances, and stock-based compensation | Metric (Thousands) | Balance at December 31, 2024 | Net Loss (Q1 2025) | Common Stock Issued (ATM) | Common Stock Issued (Convertible Notes) | Common Stock Issued (RSAs) | Stock-based Compensation | Balance at March 31, 2025 | Net Loss (Q2 2025) | Common Stock Issued (Equity Line) | Common Stock Issued (RSAs) | Stock-based Compensation | Balance at June 30, 2025 | | :------------------------------------ | :--------------------------- | :----------------- | :------------------------ | :-------------------------------------- | :------------------------- | :----------------------- | :-------------------------- | :----------------- | :-------------------------------- | :------------------------- | :----------------------- | :--------------------------- | | Common Stock (Shares) | 17,407,120 | - | 12,277,441 | 5,465,850 | 79,687 | - | 35,230,098 | - | 354,988 | 52,239 | - | 35,637,325 | | Common Stock (Amount) | $17 | - | $12 | $6 | $- | $- | $35 | - | $1 | $- | $- | $36 | | Additional Paid-In Capital | $528,817 | - | $3,325 | $910 | $37 | $66 | $533,155 | - | $24 | $45 | $(29) | $533,195 | | Accumulated Deficit | $(531,397) | $(1,853) | - | - | - | - | $(533,250) | $(2,666) | - | - | - | $(535,916) | | Total Stockholders' Deficit | $(2,563) | $(1,853) | $3,337 | $916 | $37 | $66 | $(60) | $(2,666) | $25 | $45 | $(29) | $(2,685) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash flows from operating, investing, and financing activities for the specified periods | Metric (Thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(4,836) | $(8,172) | | Net cash used in investing activities | $0 | $(35) | | Net cash provided by financing activities | $4,612 | $6,314 | | Net decrease in cash, cash equivalents and restricted cash | $(224) | $(1,893) | | Cash, cash equivalents and restricted cash, end of year | $1,545 | $962 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements [1. Organization, Basis of Presentation and Significant Accounting and Reporting Policies](index=9&type=section&id=1.%20ORGANIZATION,%20BASIS%20OF%20PRESENTATION%20AND%20SIGNIFICANT%20ACCOUNTING%20AND%20REPORTING%20POLICIES) This section details the Company's business of developing and commercializing diagnostic tests for gynecologic disease, including Ova1Plus and OvaWatch. It highlights the Company's going concern risk due to significant net losses and negative cash flows, outlining planned actions to improve liquidity. It also covers the basis of financial statement presentation, key accounting policies like revenue recognition and common stock warrants, and recent accounting pronouncements - Aspira Women's Health Inc develops and commercializes diagnostic tests for gynecologic disease, primarily Ova1Plus and OvaWatch, distributed through its sales force, Aspira Synergy platform, and partnerships[23](index=23&type=chunk) - The Company faces substantial doubt about its ability to continue as a **going concern** due to an **accumulated deficit of $535.9 million**, a **working deficit of $412,000**, and ongoing **net losses** and negative **cash flows** from operations as of **June 30, 2025**[25](index=25&type=chunk)[27](index=27&type=chunk)[218](index=218&type=chunk) - Management plans to address liquidity by raising **capital** through **equity offerings**, securing **debt**, reducing executive bonuses, cutting professional services, and deferring discretionary marketing programs[29](index=29&type=chunk) - **Revenue** from OvaSuite tests is recognized upon completion and delivery of results, based on estimates of collectability considering payment history, payer coverage, and reimbursement contracts[32](index=32&type=chunk) - The Company operates as a single segment focused on the discovery, development, and commercialization of noninvasive diagnostic tests, with the CEO acting as the Chief Operating Decision Maker[36](index=36&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) - The Company adopted several new accounting standards (ASU 2022-03, ASU 2023-01, ASU 2023-06, ASU 2023-07) effective **January 1, 2025** (or **2024** for **2023-07**), none of which had a material impact on its financial statements[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk)[43](index=43&type=chunk) [2. Fair Value Measurements](index=12&type=section&id=2.%20FAIR%20VALUE%20MEASUREMENTS) This section details the fair value measurements of the Company's financial instruments, including common stock warrants and the DECD loan. It explains the classification of warrants as liability- or equity-classified based on specific terms and the use of Black-Scholes and Monte Carlo simulation models for valuation, highlighting the significant increase in warrant liabilities due to new issuances - **Cash and cash equivalents**, accounts receivable, and accounts payable are classified as **Level 1** fair value instruments due to their short-term nature and market interest rates[44](index=44&type=chunk) | Warrant Type | June 30, 2025 Fair Value (Thousands) | December 31, 2024 Fair Value (Thousands) | Valuation Model | Inputs Level | | :-------------------- | :----------------------------------- | :------------------------------------- | :---------------- | :----------- | | 2022 Warrants | $10 | $60 | Black-Scholes | Level 2 | | March 2025 Warrants | $1,230 | N/A (issued March 2025) | Monte Carlo | Level 3 | | Total Warrant Liabilities | $1,240 | $60 | | | - The fair value of the **March 2025 Warrants**, issued upon conversion of Convertible Notes, was estimated using a Monte Carlo simulation pricing model due to its incorporation of significant unobservable **Level 3** inputs[50](index=50&type=chunk) - The DECD **loan** is classified within **Level 3** of the fair value hierarchy, with its fair value estimated based on discounted cash flows using prevailing market interest rates[55](index=55&type=chunk) [3. Prepaid and Other Current Assets](index=15&type=section&id=3.%20PREPAID%20AND%20OTHER%20CURRENT%20ASSETS) This section provides a breakdown of the Company's prepaid expenses and other current assets | (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------- | :-------------- | :---------------- | | Prepaid insurance | $251 | $629 | | Software licenses | $62 | $90 | | Subscriptions | $11 | $66 | | Other | $266 | $313 | | Total prepaid and other current assets | $590 | $1,098 | [4. Commitments and Contingencies, and Debt](index=15&type=section&id=4.%20COMMITMENTS%20AND%20CONTINGENCIES,%20AND%20DEBT) This section outlines the Company's debt obligations, including Convertible Notes, the DECD Loan, and insurance notes, along with operating lease commitments and non-cancellable royalty obligations. It also details business agreements for research and licensing, government assistance, and contingent liabilities - In **March 2025**, the Company issued **$1.366 million** in Convertible Notes in a private placement, which were converted into common stock and **warrants** on **March 12, 2025**, resulting in a **$1.198 million loss** upon issuance due to fair value exceeding proceeds[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk) - The DECD **Loan** Agreement, totaling **$4 million**, had **$1 million** forgiven in **2023** due to job creation milestones[63](index=63&type=chunk)[65](index=65&type=chunk) - **Payments** on Loan 2 were deferred from **August 2024** to **May 2027** due to **troubled debt restructuring**[67](index=67&type=chunk) | (in thousands) | Total | 2025 (remaining six months) | 2026 | 2027 | 2028 | 2029 | Thereafter | | :------------- | :---- | :-------------------------- | :--- | :--- | :--- | :--- | :--------- | | DECD Loan | $1,395 | $117 | $237 | $145 | $213 | $217 | $466 | - The Company has **operating lease commitments** for facilities in Austin, Texas, and Shelton, Connecticut, with **total future lease payments of $1.644 million** as of **June 30, 2025**[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk)[78](index=78&type=chunk) - Aspira is obligated to pay **4% royalties** on **net sales** of diagnostic tests or annual minimum **royalties of $57,500** under a research collaboration agreement with Johns Hopkins University[80](index=80&type=chunk) - The Company received **$3.5 million** in **government funding** from ARPA-H for the Sprint for Women's Health program but the **contract was terminated** on **June 9, 2025**, due to not meeting Milestone 3 specifications[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[215](index=215&type=chunk) [5. Accrued Liabilities](index=20&type=section&id=5.%20ACCURRED%20LIABILITIES) This section details the Company's accrued expenses, including payroll, collaboration, and professional services | (in thousands) | June 30, 2025 | December 31, 2024 | | :----------------------------- | :-------------- | :---------------- | | Payroll and benefits related expenses | $1,070 | $1,448 | | Collaboration and research agreements expenses | $235 | $228 | | Professional services | $334 | $253 | | Other accrued liabilities | $190 | $516 | | Total accrued liabilities | $1,829 | $2,445 | [6. Stockholders' Deficit](index=21&type=section&id=6.%20STOCKHOLDERS'%20DEFICIT) This section details changes in stockholders' deficit, including the delisting from Nasdaq, various equity offerings (2025 Equity Purchase Agreement, 2025 Private Placement, 2024 Private Placement, 2024 At the Market Offering, 2024 Registered Direct Offering), warrant inducement agreements, and stock incentive plans - On **April 15, 2025**, the Company's shares were **delisted from Nasdaq** due to failure to meet the **$2.5 million stockholders' equity** requirement and now trade on the OTC QB Venture Market[89](index=89&type=chunk)[175](index=175&type=chunk) - The Company entered into a **2025 Equity Purchase Agreement** with Triton Funds L.P. for up to **$2 million** of common stock, issuing **354,988 restricted shares** for **$25,000** and incurring **$214,000** in transaction costs[90](index=90&type=chunk)[91](index=91&type=chunk) - **March 2025 Warrants**, issued upon conversion of Convertible Notes, are exercisable for **five years** at **$0.25 per share** for the first **24 months** and **$0.50** thereafter, and are classified as **liability** due to variable exercise price[92](index=92&type=chunk)[93](index=93&type=chunk)[217](index=217&type=chunk) - The **2024 At the Market Offering** generated **$3.484 million** in gross proceeds from selling **12,277,441 shares** during the **six months ended June 30, 2025**, with **$62,000** remaining availability[100](index=100&type=chunk) - A Warrant Inducement Agreement in **July 2024** led to the exercise of **1,711,111 warrants** at a reduced **price of $1.25 per share**, generating **$1.862 million** in **net proceeds** and issuing new **August 2024 Purchase Warrants**[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - The **2024 Direct Offering** in **January 2024** raised approximately **$5.563 million gross proceeds** from the sale of common stock and pre-funded **warrants**, which were fully exercised for **$20** in **February 2024**[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - The **2019 Stock Incentive Plan** had **4,532,818 shares** authorized for issuance as of **June 30, 2025**, with **680,493 options** and **18,593 RSUs** outstanding, and **3,210,004 shares** reserved for future issuance[125](index=125&type=chunk) | Stock-Based Compensation (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cost of revenue | $2 | $8 | $9 | $26 | | Research and development | $(9) | $24 | $1 | $90 | | Sales and marketing | $(5) | $19 | $18 | $44 | | General and administrative | $27 | $71 | $90 | $324 | | Total | $15 | $122 | $118 | $484 | [7. Loss Per Share](index=27&type=section&id=7.%20LOSS%20PER%20SHARE) This section details the calculation of basic and diluted loss per share, noting that for periods with a net loss, potential common shares are antidilutive | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net Loss (Thousands) | $(2,666) | $(3,530) | $(4,519) | $(8,159) | | Weighted average common shares (basic and diluted) | 35,564,032 | 12,518,725 | 28,579,132 | 12,181,481 | | Net loss per share - basic and diluted | $(0.07) | $(0.28) | $(0.16) | $(0.67) | | Potential Common Shares Excluded (Antidilutive) | June 30, 2025 | June 30, 2024 | | :---------------------------------------------- | :------------ | :------------ | | Stock options | 695,400 | 905,458 | | Restricted stock units | 18,593 | 25,277 | | Warrants | 16,773,245 | 2,370,985 | | Total Potential common shares | 17,487,238 | 3,301,720 | [8. Related Party Transactions](index=28&type=section&id=8.%20RELATED%20PARTY%20TRANSACTIONS) This section discloses related party transactions, including a consulting agreement with Biodesix, Inc., where a significant shareholder of Aspira also holds a substantial stake, and the participation of a significant shareholder in the March 2025 Private Placement of Convertible Notes - The Company has a consulting agreement with Biodesix, Inc., incurring **$125,000** in R&D **expenses**, where Jack Schuler is a beneficial owner of over **5%** of Aspira's stock and over **10%** of Biodesix's stock[137](index=137&type=chunk) - Jack Schuler, a significant shareholder, purchased **$200,000** of the Convertible Notes in the **March 2025 Private Placement**, which were subsequently converted into common stock and **warrants**[138](index=138&type=chunk) - Two purchasers of the Convertible Notes, Jeffrey Cohen, M.D. and John Fraser, were appointed to the Company's board of directors in **April 2025**[139](index=139&type=chunk) [9. Segment Reporting](index=28&type=section&id=9.%20SEGMENT%20REPORTING) This section reiterates that the Company operates as a single operating segment focused on the discovery, development, and commercialization of noninvasive diagnostic tests, with the CEO as the Chief Operating Decision Maker. Financial performance is assessed on a consolidated basis - The Company's **Chief Executive Officer** acts as the **Chief Operating Decision Maker** (CODM) and reviews financial information on a consolidated basis for resource allocation and performance assessment[140](index=140&type=chunk)[141](index=141&type=chunk) - Aspira manages its business as a single operating segment dedicated to noninvasive diagnostic tests, with accounting policies consistent across the segment[141](index=141&type=chunk) | Financial Metric (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Assets | $4,934 | $5,491 | $4,934 | $5,491 | | Total Revenue | $2,404 | $2,423 | $4,683 | $4,576 | | Net Loss | $(2,666) | $(3,530) | $(4,519) | $(8,159) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and operational results, including forward-looking statements, a company overview, detailed analysis of financial performance for the three and six months ended June 30, 2025 and 2024, and a discussion of liquidity and capital resources [Forward-Looking Statements](index=29&type=section&id=Forward-Looking%20Statements) This section highlights statements about future expectations, subject to risks and uncertainties, and should not be considered guarantees of future performance - The report contains forward-looking statements regarding future test volumes, **revenue**, **expenses**, **cash flow**, business strategy, product development, market expansion, regulatory approvals, and liquidity, subject to significant risks and uncertainties[144](index=144&type=chunk)[146](index=146&type=chunk)[149](index=149&type=chunk) - Key risks include the Company's ability to continue as a **going concern**, changes in payer reimbursement, ability to develop and commercialize new products, FDA compliance, competition, and securing additional **capital**[148](index=148&type=chunk) [Company Overview](index=33&type=section&id=Company%20Overview) This section provides an overview of Aspira's business, vision, product pipeline, and commercialization strategies for diagnostic tests - Aspira's vision is to develop and commercialize noninvasive, AI-powered tests for gynecologic diseases, expanding beyond ovarian cancer to conditions like endometriosis[152](index=152&type=chunk)[153](index=153&type=chunk) - The Company's product pipeline focuses on ovarian cancer (OvaWatch, OVAinform) and endometriosis (ENDOinform), aiming to significantly expand the addressable market[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) - **OvaWatch's** expanded mass monitoring feature in **Q2 2024 increased** the addressable market for Aspira's tests tenfold, from **200,000-400,000 patients** to **2-4 million tests per year**[157](index=157&type=chunk) - Current commercialized products include Ova1Plus (Ova1 and Overa) for assessing malignancy likelihood in ovarian adnexal masses and OvaWatch for initial and periodic risk assessment of indeterminate or benign adnexal masses[161](index=161&type=chunk) - Products are distributed through a national sales force, the Aspira Synergy decentralized testing platform, and agreements with BioReference Health, LLC and ARUP Laboratories[162](index=162&type=chunk) - Aspira Labs, a CLIA-certified lab in Austin, Texas, performs Ova1Plus and OvaWatch testing and holds ISO 13485 certification[167](index=167&type=chunk) - Novitas Solutions provides national Medicare coverage for Ova1, and an LCD for OvaWatch is under review[168](index=168&type=chunk) - ACOG Practice Bulletin Number 174 recommends Ova1 ("Multivariate Index Assay") with parity to CA-125 for adnexal mass management[170](index=170&type=chunk) - OVAinform and ENDOinform are multi-marker tests combining serum proteins, clinical data, and miRNA, developed in collaboration with Harvard's Dana-Farber Cancer Institute, Brigham & Women's Hospital, and Medical University of Lodz[172](index=172&type=chunk)[173](index=173&type=chunk) [Recent Developments](index=37&type=section&id=Recent%20Developments) This section outlines key operational and financial events that have recently impacted the Company - In **Q1 2025**, salesforce rebalancing led to a **156% increase** in **sales per full-time equivalent salesperson** in **Q2 2025** compared to **Q2 2024**[174](index=174&type=chunk) - The Company's shares were **delisted from Nasdaq** on **April 15, 2025**, due to not meeting the minimum **stockholders' equity** requirement and now trade on the OTC QB Venture Market[175](index=175&type=chunk) - The ARPA-H **contract award** for the ENDOinform development program was **terminated** on **June 9, 2025**, as the Company did not meet Milestone 3 specifications[176](index=176&type=chunk)[215](index=215&type=chunk) [Results of Operations – Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024](index=37&type=section&id=Results%20of%20Operations%20%E2%80%93%20Three%20Months%20Ended%20June%2030,%202025%20Compared%20to%20Three%20Months%20Ended%20June%2030,%202024) This section analyzes the Company's financial performance for the three months ended June 30, 2025, compared to the same period in 2024 | Metric (Thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (Amount) | Change (%) | | :------------------------------------ | :--------------------------- | :--------------------------- | :-------------- | :--------- | | Total revenue | $2,404 | $2,423 | $(19) | (1)% | | Cost of revenue | $870 | $1,002 | $(132) | (13)% | | Gross profit | $1,534 | $1,421 | $113 | 8% | | Gross profit margin | 63.8% | 58.6% | 5.2 pp | | | Research and development expenses | $704 | $952 | $(248) | (26)% | | Sales and marketing expenses | $679 | $2,137 | $(1,458) | (68)% | | General and administrative expenses | $1,961 | $2,725 | $(764) | (28)% | | Total operating expenses | $3,344 | $5,814 | $(2,470) | (42)% | | Loss from operations | $(1,810) | $(4,393) | $2,583 | (59)% | | Change in fair value of warrant liabilities | $(624) | $889 | $(1,513) | (170)% | | Net loss | $(2,666) | $(3,530) | $864 | (24)% | - **Product revenue decreased by 1%** due to an **11% decrease** in **OvaSuite test volume** (**5,728 tests** in **Q2 2025** vs. **6,471** in **Q2 2024**), partially offset by an **increase** in **Average Unit Price** (AUP) from **$374** to **$420**[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) - **Operating expenses significantly decreased by 42%**, driven by **reductions** in sales and marketing (**68%**), general and administrative (**28%**), and research and development (**26%**) **expenses**[180](index=180&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) [Results of Operations – Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024](index=40&type=section&id=Results%20of%20Operations%20%E2%80%93%20Six%20Months%20Ended%20June%2030,%202025%20Compared%20to%20Six%20Months%20Ended%20June%2030,%202024) This section analyzes the Company's financial performance for the six months ended June 30, 2025, compared to the same period in 2024 | Metric (Thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (Amount) | Change (%) | | :------------------------------------ | :--------------------------- | :--------------------------- | :-------------- | :--------- | | Total revenue | $4,683 | $4,576 | $107 | 2% | | Cost of revenue | $1,589 | $1,941 | $(352) | (18)% | | Gross profit | $3,094 | $2,635 | $459 | 17% | | Gross profit margin | 66.1% | 57.6% | 8.5 pp | | | Research and development expenses | $1,677 | $1,858 | $(181) | (10)% | | Sales and marketing expenses | $1,765 | $4,026 | $(2,261) | (56)% | | General and administrative expenses | $4,702 | $5,854 | $(1,152) | (20)% | | Total operating expenses | $8,144 | $11,738 | $(3,594) | (31)% | | Loss from operations | $(5,050) | $(9,103) | $4,053 | (45)% | | Change in fair value of warrant liabilities | $297 | $1,140 | $(843) | (74)% | | Change in fair value of convertible notes | $170 | $- | $170 | - | | Loss upon issuance of Convertible Notes | $(1,198) | $- | $(1,198) | - | | Net loss | $(4,519) | $(8,159) | $3,640 | (45)% | - **Product revenue increased by 2%** to **$4.683 million**, driven by an **increase** in AUP from **$372** to **$411**, despite a **7.3% decrease** in **OvaSuite test volume** (**11,407 tests** in **H1 2025** vs. **12,300** in **H1 2024**)[192](index=192&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) - **Operating expenses decreased by 31%** to **$8.144 million**, primarily due to significant **reductions** in sales and marketing (**56%**), general and administrative (**20%**), and research and development (**10%**) **expenses**[191](index=191&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - **Net loss decreased by 45%** to **$4.519 million**, largely due to reduced **operating expenses**, partially offset by a **$1.198 million loss** upon issuance of Convertible Notes[191](index=191&type=chunk)[201](index=201&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the Company's financial position, cash flows, and ability to meet its short-term and long-term obligations - The Company has an **accumulated deficit of $535.9 million** and a **stockholders' deficit of $2.685 million** as of **June 30, 2025**, with **$1.545 million** in **cash and cash equivalents**, indicating substantial doubt about its ability to continue as a **going concern**[203](index=203&type=chunk)[218](index=218&type=chunk) - Future liquidity depends on raising **capital** through **equity offerings**, **debt financings**, **warrant** exercises, collaborations, grants, and strategic alliances, as current working capital may not sustain operations for the next **twelve months**[204](index=204&type=chunk)[228](index=228&type=chunk) | Cash Flow Activity (Thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(4,836) | $(8,172) | | Net cash used in investing activities | $0 | $(35) | | Net cash provided by financing activities | $4,612 | $6,314 | - The Company has a **full valuation allowance** against its **net deferred tax assets** and its ability to use **net operating loss (NOL) carryforwards** is restricted by ownership change limitations (**Section 382**)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the information required by Item 305(e) of Regulation S-K regarding quantitative and qualitative disclosures about market risk is not required for this filing [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) This section reports that the Company's disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness in internal control over financial reporting related to contract review processes and accounting for complex transactions. Remediation efforts include retaining outside accounting assistance - As of **June 30, 2025**, the Company's **disclosure controls and procedures** were **not effective** due to a **material weakness** in internal control over financial reporting[231](index=231&type=chunk) - The **material weakness** stems from inadequate operation of internal controls related to contract review processes and accounting for significant, non-routine, or complex transactions, such as a **warrant** inducement and a government grant[231](index=231&type=chunk)[232](index=232&type=chunk) - Remediation activities include retaining outside accounting assistance from a nationally recognized firm for complex transactions, starting in **Q1 2025**[233](index=233&type=chunk) [PART II - Other Information](index=46&type=section&id=PART%20II%20Other%20Information) This part provides additional information including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the Company is not currently a party to any legal or regulatory proceedings whose adverse outcome would have a material adverse effect on its financial position or results of operations as of June 30, 2025 - As of **June 30, 2025**, the Company is not involved in any legal proceedings or regulatory actions that are expected to have a material adverse effect on its financial position or results of operations[237](index=237&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) This section indicates that there have been no material changes to the risk factors previously disclosed in the Company's 2024 Annual Report on Form 10-K and the March 31, 2025 Quarterly Report on Form 10-Q, but acknowledges that additional unknown or immaterial risks may arise - No material changes to risk factors have occurred since the **2024 Annual Report on Form 10-K** and the **March 31, 2025 Quarterly Report on Form 10-Q**[238](index=238&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=46&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period [Item 3. Defaults Upon Senior Securities](index=46&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities to report for the period [Item 4. Mine Safety Disclosures](index=46&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable to the Company [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report for the period [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed or incorporated by reference with the report, including certifications from the CEO and CFO, and Inline XBRL documents - The report includes certifications from the **Chief Executive Officer** and **Chief Financial Officer** pursuant to **Sections 302** and **906** of the **Sarbanes-Oxley Act of 2002**[244](index=244&type=chunk)[246](index=246&type=chunk) - Inline XBRL Instance Document, Taxonomy Extension Schema, and Cover page formatted as Inline XBRL are filed as exhibits[244](index=244&type=chunk) [SIGNATURES](index=48&type=section&id=SIGNATURES) This section contains the signatures of the Company's authorized officers, including the Chief Executive Officer and Controller, certifying the filing of the report - The report is signed by Michael Buhle, **Chief Executive Officer** (**Principal Executive Officer**), and Julie Carrillo, **Controller** (**Principal Financial Officer and Principal Accounting Officer**), on **August 12, 2025**[249](index=249&type=chunk)