Aspira Women's Health Files 2023 10-K, Details Financials and Strategic Agreements

TL;DR

<b>Aspira Women's Health Inc. filed its 2023 10-K, outlining financial results and key strategic agreements, including recent purchase agreements.</b>

AI Summary

Aspira Women's Health Inc. (AWHL) filed a Annual Report (10-K) with the SEC on April 1, 2024. Aspira Women's Health Inc. filed its 10-K for the fiscal year ending December 31, 2023. The filing details financial performance and strategic agreements, including a Purchase Agreement dated July 20, 2023. Subsequent events include a Purchase Agreement on January 24, 2024, involving the CEO and purchasers. The company's former names include Vermillion, Inc., Ciphergen Biosystems Inc., and Abiotic Systems. Aspira Women's Health Inc. is incorporated in Delaware and headquartered in Austin, Texas.

Why It Matters

For investors and stakeholders tracking Aspira Women's Health Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Aspira Women's Health's financial standing and operational activities for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. Details on significant agreements, such as the July 20, 2023, and January 24, 2024, purchase agreements, offer insights into potential financing, strategic partnerships, or equity transactions impacting the company's capital structure and growth strategy.

Risk Assessment

Risk Level: medium — Aspira Women's Health Inc. shows moderate risk based on this filing. The company's financial health and operational status are not fully detailed in the provided text, making a definitive risk assessment difficult. However, the nature of 10-K filings often implies ongoing business operations with inherent market and financial risks.

Analyst Insight

Investors should review the full 10-K filing to understand the detailed financial statements, risk factors, and management's discussion and analysis to make informed investment decisions.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-04-01 — Filing Date (Filed as of date)
• 2023-07-20 — Purchase Agreement Date (awh:PurchaseAgreementMember)
• 2024-01-24 — Subsequent Purchase Agreement Date (awh:PurchaseAgreementMember)

Key Players & Entities

• Aspira Women's Health Inc. (company) — Filer name
• Vermillion, Inc. (company) — Former company name
• Ciphergen Biosystems Inc (company) — Former company name
• Abiotic Systems (company) — Former company name
• Austin, Texas (company) — Business address city and state
• 2023-12-31 (date) — Fiscal year end
• 2024-01-24 (date) — Subsequent event date
• 2023-07-20 (date) — Purchase agreement date

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-04-01: 10-K Filing Date — Date the annual report was filed with the SEC.
• 2023-07-20: Purchase Agreement — Key strategic agreement date mentioned in the filing.
• 2024-01-24: Subsequent Purchase Agreement — Significant event occurring after the fiscal year end.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share AWH The Nasdaq Capital Ma
• $11.3 m — we decreased our operating expenses by $11.3 million, while increasing our gross profi
• $20.72 — increasing our gross profit per unit by $20.72 per test. Additionally, we achieved o
• $4.7 million — evelopment. We raised gross proceeds of $4.7 million in July 2023 in a follow-on equity offe
• $5.5 million — as well as additional gross proceeds of $5.5 million in January 2024 in a separate follow-on

Filing Documents

• awh-20231231x10k.htm (10-K) — 3567KB
• awh-20231231xex4_7.htm (EX-4.7) — 37KB
• awh-20231231xex10_18.htm (EX-10.18) — 44KB
• awh-20231231xex10_28.htm (EX-10.28) — 392KB
• awh-20231231xex23_1.htm (EX-23.1) — 5KB
• awh-20231231xex31_1.htm (EX-31.1) — 23KB
• awh-20231231xex31_2.htm (EX-31.2) — 22KB
• awh-20231231xex32_1.htm (EX-32.1) — 15KB
• awh-20231231xex97_1.htm (EX-97.1) — 59KB
• 0000926617-24-000015.txt (&nbsp;) — 12747KB
• awh-20231231.xsd (EX-101.SCH) — 54KB
• awh-20231231_cal.xml (EX-101.CAL) — 64KB
• awh-20231231_def.xml (EX-101.DEF) — 204KB
• awh-20231231_lab.xml (EX-101.LAB) — 479KB
• awh-20231231_pre.xml (EX-101.PRE) — 422KB
• awh-20231231x10k_htm.xml (XML) — 2418KB

Business

Business 3 ITEM 1A.

Risk Factors

Risk Factors 20 ITEM 1B. Unresolved Staff Comments 35 ITEM 1C . Cybersecurity 35 ITEM 2.

Properties

Properties 36 ITEM 3.

Legal Proceedings

Legal Proceedings 37 ITEM 4. Mine Safety Disclosures 37 PART II 38 ITEM 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 38 ITEM 6. [Reserved] 38 ITEM 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 39 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 46 ITEM 8. Consolidated Financial Statements and Supplementary Data 46 ITEM 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 46 ITEM 9A.

Controls and Procedures

Controls and Procedures 46 ITEM 9B. Other Information 48 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 48 PART III 49 ITEM 10. Directors, Executive Officers and Corporate Governance 49 ITEM 11.

Executive Compensation

Executive Compensation 49 ITEM 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 49 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 49 ITEM 14. Principal Accountant Fees and Services 49 PART IV 50 ITEM 15 . Exhibits and Financial Statement Schedules 50 ITEM 16. Form 10-K Summary 53

SIGNATURES

SIGNATURES F-29 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 , OVASUITE SM , ASPiRA GenetiX SM , OVA1PLUS , OVAWATCH , EndoCheck SM , OvaInherit SM , Aspira Synergy , , OVA360 SM , ASPIRA IVD SM , and YOUR HEALTH, OUR PASSION . SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), about us and our industry that involve substantial risks and uncertainties. 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," "projects" 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 the was filed with the Securities and Exchange Commission (the "SEC"), and, except as required by law, Aspira Women's Health Inc. ("Aspira" and, together with its subsidiaries, the "Company," "we," "our," or "us") does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date . Examples of forward-looking statements include, without limitation: projections or expectations regarding our future test volumes, revenue, price, cost of revenue, operating expenses, research and development expenses, gross profit margin, cash flow, results of operations and financial condition; ability to maintain listing of our common stock on the Nasdaq Capital Market; our plan to broaden our commercial focus from ovarian cancer to differential diagnosis of women

BUSINESS

ITEM 1. BUSINESS Company Overview Aspira Women's Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases. Our commercially available portfolio includes OvaWatch and the Ova1Plus workflow, offered to clinicians as OvaSuite. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer for the more than 1.2 million women in the United States diagnosed with an adnexal mass each year. OvaWatch is used to assess ovarian cancer risk for women with an adnexal mass where their initial clinical assessment indicates the mass is indeterminate or benign. With a negative predictive value of 99%, OvaWatch can help physicians determine the appropriate care pathway. The Ova1Plus workflow is designed to assess the risk of ovarian malignancy in women planned for surgery and uses two FDA-cleared tests, Ova1 as the primary test and Overa as a reflex for Ova1 intermediate range results. Our focus remains on three key initiatives: growth, innovation, and operational excellence: Growth . As a revenue-generating diagnostics company focused exclusively on gynecologic disease, our commercial capabilities are one of our most important differentiators. We expect our extensive experience with gynecologists and healthcare providers, along with the historical adoption of our OvaSuite tests, to drive growth as we introduce new products. Improving our commercial capabilities was one of our most important strategic priorities in 2023. At the beginning of the year, we conducted a comprehensive review of our commercial programs to identify people, processes, and technology enhancements. As a result of the findings of that review, we launched a strategic commercial refresh (the "Commercial Refresh") in the second half of the year. Enhancements focused on improving the profitability, efficiency, and effectiveness of the sales and marketing

View Full Filing

View this 10-K filing on SEC EDGAR