Core Insights - Aspira Women's Health Inc. reported a significant growth in product volume, with a more than 26% increase in May 2024 compared to January 2024, and an 88% year-to-date increase in OvaWatch volume compared to the same period in 2023 [1][2][3] Group 1: Product Performance - Monthly product volume for OvaSuite grew by over 26% in May 2024 compared to January 2024 [1] - Year-over-year growth in monthly product volume per full-time sales representative increased to 569 for the five months ended May 2024, up from 484 for the same period in 2023 [2] - OvaWatch volume year-to-date through May 2024 is up by more than 88% compared to the same period in 2023 [2] Group 2: Sales Strategy and Market Expansion - The company is focusing on a leaner sales team, with approximately 20% of the 19-person team being cost-effective inside sales representatives [2] - The addressable market for OvaWatch is estimated to be between 2 to 4 million tests per year, significantly larger than the Ova1Plus® market of approximately 200,000 tests per year [3] - Aspira's expansion into the Philippines is on track for a commercial launch of OvaWatch in the third quarter, with expected higher margins compared to the U.S. market [3] Group 3: Reimbursement Developments - Aspira executed an OvaSuite contract with Anthem Plans, adding over 2 million covered lives, with expectations to add up to 16 million covered lives in the coming quarters [4][5] - Medicaid coverage for OvaWatch has expanded in Maryland and Kentucky, adding the test to the fee schedule at $897 per test, now covering nine states [4] Group 4: Financial Guidance - The company anticipates a downward revision of the 2024 cash used in operations guidance during the second quarter 2024 earnings call [6]

Monthly OvaSuiteSM product volume grew by more than 26% in May compared to January Reimbursement momentum continued with expanded Anthem and Medicaid coverage for OvaSuite Cash used in operations guidance for 2024 expected to be lowered AUSTIN, Texas, June 13, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today provided interim commercial and oper ...

[PART I Financial Information](index=3&type=section&id=PART%20I%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201%20Financial%20Statements) The company reported a reduced net loss of $4.6 million for Q1 2024, improved by lower operating expenses, but faces a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,413 | $2,597 | | Total current assets | $6,122 | $5,280 | | Total assets | $7,164 | $6,262 | | Total current liabilities | $5,293 | $5,119 | | Total liabilities | $8,527 | $8,627 | | Total stockholders' deficit | $(1,363) | $(2,365) | - The company's cash and cash equivalents increased by approximately **$0.8 million**, while the total stockholders' deficit decreased from **$(2.4) million** to **$(1.4) million** during the first quarter of 2024[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total revenue | $2,153 | $2,316 | | Gross profit | $1,214 | $1,186 | | Total operating expenses | $5,924 | $7,466 | | Loss from operations | $(4,710) | $(6,280) | | Net loss | $(4,629) | $(6,578) | | Net loss per share | $(0.39) | $(0.79) | - Despite a **7% decrease in revenue**, the company reduced its **net loss by 30%** year-over-year, primarily due to a **21% reduction in total operating expenses**[11](index=11&type=chunk)[85](index=85&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,431) | $(5,706) | | Net cash used in investing activities | $(20) | $(8) | | Net cash provided by (used in) financing activities | $5,269 | $(55) | - Financing activities provided **$5.3 million in cash** during Q1 2024, a significant shift from the prior year that more than offset the cash used in operations[20](index=20&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has substantial doubt about its ability to continue as a **going concern** due to significant net losses, an accumulated deficit of **$522.9 million**, and negative cash flows from operations[25](index=25&type=chunk) - In January 2024, the company raised gross proceeds of approximately **$5.6 million** through a registered direct offering of common stock and warrants[51](index=51&type=chunk) - The company has an equity line of credit with Lincoln Park Capital, under which it sold 111,369 shares for gross proceeds of approximately **$400,000** during Q1 2024[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a 7% revenue decline due to lower test volumes, offset by a 21% reduction in operating expenses and progress in its product pipeline Q1 2024 vs. Q1 2023 Operating Results (in thousands) | Metric | Q1 2024 | Q1 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Product Revenue | $2,153 | $2,315 | (7%) | | Gross Profit | $1,214 | $1,186 | 2% | | Total Operating Expenses | $5,924 | $7,466 | (21%) | | Loss from Operations | $(4,710) | $(6,280) | (25%) | | Net Loss | $(4,629) | $(6,578) | (30%) | Product Volume and Average Unit Price (AUP) | Product | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | :--- | | Ova1Plus | Volume | 4,777 | 5,768 | | | AUP | $376 | $390 | | OvaWatch | Volume | 1,052 | 491 | | | AUP | $338 | $136 | | **Total OvaSuite** | **Volume** | **5,829** | **6,259** | | | **AUP** | **$369** | **$370** | - The company's key strategic initiatives are focused on growth, innovation, and operational excellence, with a "Commercial Refresh" strategy increasing average test volume per sales representative from **298 to 364** year-over-year[73](index=73&type=chunk) - The product pipeline includes **OvaMDx** for ovarian cancer and **EndoCheck/EndoMDx** for endometriosis, leveraging multi-marker approaches including proteins and miRNA[78](index=78&type=chunk)[79](index=79&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide disclosures for this item - Per Item 305(e) of Regulation S-K, the information for this item is not required[93](index=93&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of March 31, 2024, due to two material weaknesses in internal controls - Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were **not effective**[94](index=94&type=chunk) - Two material weaknesses persist: one related to **information technology general controls (ITGCs)** and another related to the design and implementation of controls over the **revenue process**[95](index=95&type=chunk) - Remediation activities are in progress, including retaining an internal controls specialist, reviewing IT application controls, and enhancing the rigor of the review process for revenue[96](index=96&type=chunk) [PART II Other Information](index=29&type=section&id=PART%20II%20Other%20Information) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201%20Legal%20Proceedings) The company reports no material legal proceedings as of the end of the reporting period - The company states there are no legal matters as of March 31, 2024, that would have a material adverse effect on its financial position or results of operations[99](index=99&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A%20Risk%20Factors) A new significant risk factor arises from the FDA's final rule on Laboratory Developed Tests (LDTs), potentially increasing future compliance costs - A new risk factor has emerged from the FDA's final rule, published May 6, 2024, which will phase out enforcement discretion for most **Laboratory Developed Tests (LDTs)** over four years[101](index=101&type=chunk) - The company's current commercially available tests are expected to be **grandfathered in** under an exception for IVDs marketed prior to May 6, 2024, as long as they are not significantly modified[101](index=101&type=chunk) - Future tests or significant modifications to existing tests will face **increased regulatory burdens**, including potential premarket authorization, which could be time-consuming, expensive, and negatively affect the company's operations and financial condition[101](index=101&type=chunk)[102](index=102&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[103](index=103&type=chunk)

Aspira Women's Health Inc. (NASDAQ:AWH) Q1 2024 Results Conference Call May 15, 2024 8:30 AM ET Company Participants Nicole Sandford - CEO Sandy Milligan - President Torsten Hombeck - CFO Conference Call Participants Ross Osborn - Cantor Fitzgerald Maggie Boeye - William Blair Do Kim - Water Tower Research Operator Good morning, ladies and gentlemen, and welcome to Aspira Women's Health, Incorporated. First Quarter 2024 Earnings Conference Call. At this time, all participants are in listen-only mode. Follo ...

Aspira (AWH) came out with a quarterly loss of $0.39 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to loss of $10.94 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.33%. A quarter ago, it was expected that this diagnostic and bio-analytical company would post a loss of $0.39 per share when it actually produced a loss of $0.30, delivering a surprise of 23.08%.Over the last four quarters, the ...

Aspira Women's Health Reports First Quarter 2024 Financial Results Q1 2024 OvaSuiteSM revenue of $2.2 million and volume of 5,829 units Q1 2024 cash utilization of $4.4 million, a decrease of 22% compared to Q1 2023 Conference Call and Webcast scheduled for today at 8:30 am ET AUSTIN, Texas, May 15, 2024 (GLOBE NEWSWIRE) -- Aspira Women's Health Inc. ("Aspira" or the "Company") (Nasdaq: AWH), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, to ...

AUSTIN, Texas, May 08, 2024 (GLOBE NEWSWIRE) -- Aspira Women's Health Inc. ("Aspira" or the "Company") (NASDAQ:AWH), a bio-analytical based women's health company focused on the development of gynecologic disease diagnostic tools, today announced that the Company will report its financial results for the three months ended March 31, 2024, on Wednesday, May 15, 2024. Management will also host a conference call at 8:30 a.m. Eastern Time to discuss financial results and provide a corporate update. Details for ...

Core Insights - Aspira Women's Health Inc. has announced a new agreement with Anthem Blue Cross for reimbursement coverage of its OvaSuiteSM portfolio of risk assessment tests, effective June 1, 2024, covering approximately six million lives in California [1][2] Company Overview - Aspira Women's Health Inc. focuses on the development of noninvasive, AI-powered diagnostic tests for gynecologic diseases [3] - The company offers OvaWatch® and Ova1Plus® as part of the OvaSuiteSM, which provides comprehensive blood tests for ovarian cancer detection [4] Product Details - OvaWatch has a negative predictive value of 99% and is used for assessing ovarian cancer risk in women with indeterminate or benign adnexal masses [4] - Ova1Plus is a reflex process involving two FDA-cleared tests to evaluate the risk of ovarian malignancy in women scheduled for surgery [4] - The company is developing additional tests, including OvaMDxSM for ovarian cancer and EndoCheckSM for endometriosis, addressing significant diagnostic needs [4] Strategic Focus - The agreement with Anthem Blue Cross is part of Aspira's strategic focus on payer adoption, which is gaining momentum following the successful completion of the credentialing process [2] - Anthem Blue Cross serves over 118 million people, with more than 45 million within its health plans, indicating a substantial market opportunity for Aspira [2]

PART I [ITEM 1. Business](index=3&type=section&id=ITEM%201.%20Business) The company develops and commercializes AI-powered diagnostic tests for gynecologic diseases like ovarian cancer - Aspira Women's Health Inc. focuses on the discovery, development, and commercialization of noninvasive, AI-powered tests for gynecologic diseases[11](index=11&type=chunk) - The company's commercially available portfolio, OvaSuite (OvaWatch and Ova1Plus workflow), provides comprehensive blood tests for ovarian cancer detection[12](index=12&type=chunk) - A strategic Commercial Refresh in 2023 improved profitability and efficiency, leading to a **14.8% increase in OvaSuite revenue** and an **11.9% increase in volume**, while sales and marketing expenses decreased by 48%[14](index=14&type=chunk)[15](index=15&type=chunk) - Key product pipeline initiatives include OvaMDx for ovarian cancer and EndoCheck/EndoMDx for endometriosis, with EndoCheck being the first protein-based blood test for ovarian endometriomas[17](index=17&type=chunk)[18](index=18&type=chunk)[36](index=36&type=chunk)[38](index=38&type=chunk) - Operational excellence in 2023 led to a **$11.3 million decrease in operating expenses** and a **$20.72 increase in gross profit per unit**[19](index=19&type=chunk) - The company's scientific approach involves monitoring and combining multiple biomarkers using advanced algorithms to improve diagnostic accuracy, sensitivity, and specificity[21](index=21&type=chunk)[22](index=22&type=chunk) - Ova1 received FDA de novo classification in 2009, and Overa received FDA 510(k) clearance in 2016; OvaWatch, an LDT, was launched in Q4 2022[25](index=25&type=chunk)[26](index=26&type=chunk) - Aspira Labs, a CLIA-certified lab in Austin, Texas, performs Ova1Plus workflow and OvaWatch testing and holds ISO 13485 certification[28](index=28&type=chunk) - Effective January 1, 2024, OvaWatch and Ova1 tests for Medicare patients will be reimbursed at **$897**[29](index=29&type=chunk)[62](index=62&type=chunk) - The company faces competition from other diagnostic companies and clinical laboratories, including Fujirebio Diagnostics (ROMA test) for ovarian cancer[66](index=66&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - Aspira holds a patent portfolio including **19 issued U.S. patents** and 8 pending U.S. patent applications related to diagnostic technologies[71](index=71&type=chunk) - The FDA has proposed regulations to classify Laboratory Developed Tests (LDTs) as medical devices, which could subject Aspira's LDTs to more stringent requirements[105](index=105&type=chunk)[106](index=106&type=chunk) [ITEM 1A. Risk Factors](index=23&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant financial viability, reimbursement, regulatory, and operational risks - Aspira has incurred significant operating losses, with an **accumulated deficit of $518.3 million** as of December 31, 2023, raising substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk)[257](index=257&type=chunk) - The company expects to require additional financing, which may lead to **significant dilution for stockholders** or may not be available on acceptable terms[132](index=132&type=chunk)[134](index=134&type=chunk)[137](index=137&type=chunk) - Failures by third-party payers to reimburse for products or changes in reimbursement rates could materially and adversely affect business operations[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk) - The FDA's proposed regulation to classify LDTs as medical devices could subject Aspira's LDTs to stringent premarket approval requirements, increasing costs[154](index=154&type=chunk)[155](index=155&type=chunk) - The diagnostics market is highly competitive, with numerous companies developing ovarian cancer and endometriosis diagnostic assays[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - Aspira identified **two material weaknesses in its internal control** over financial reporting as of December 31, 2023, related to IT general controls and revenue recognition[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) - The company's ability to utilize its net operating loss (NOL) carryforwards may be limited by Section 382 of the Internal Revenue Code[178](index=178&type=chunk)[180](index=180&type=chunk) - The trading price of Aspira's common stock has been highly volatile, ranging from **$2.40 to $8.70 per share in 2023**[223](index=223&type=chunk) [ITEM 1B. Unresolved Staff Comments](index=35&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) There are no unresolved comments from the SEC staff - The company has no unresolved staff comments[229](index=229&type=chunk) [ITEM 1C. Cybersecurity](index=35&type=section&id=ITEM%201C.%20Cybersecurity) The company has implemented a cybersecurity risk management program overseen by the Audit Committee - Aspira implements information security processes to identify, assess, and manage cybersecurity threats to its critical computer networks and sensitive data[229](index=229&type=chunk) - Risk management strategies include automated tools, vulnerability assessments, incident detection and response, data encryption, and employee training[230](index=230&type=chunk)[231](index=231&type=chunk)[233](index=233&type=chunk) - The **Audit Committee of the Board of Directors** is responsible for overseeing the company's cybersecurity risk management processes[235](index=235&type=chunk)[237](index=237&type=chunk) [ITEM 2. Properties](index=39&type=section&id=ITEM%202.%20Properties) The company leases three facilities in Texas, Connecticut, and California for its operations Leased Facilities Overview | Location | Approximate Square Feet | Primary Functions | Lease Expiration Date | | :--- | :--- | :--- | :--- | | Austin, Texas | 4,218 sq. ft. | Aspira Labs facility, research and development, clinical and regulatory and administrative offices | February 28, 2027 | | Shelton, Connecticut| 4,614 sq. ft. | Administrative offices | September 30, 2028 | | Palo Alto, California| 2,714 sq. ft. | Administrative offices | May 31, 2024 | [ITEM 3. Legal Proceedings](index=40&type=section&id=ITEM%203.%20Legal%20Proceedings) The company is not party to any material legal proceedings - The company is not a party to any legal proceedings that would materially adversely affect its financial position or results of operations[241](index=241&type=chunk) [ITEM 4. Mine Safety Disclosures](index=40&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Mine Safety Disclosures are not applicable[242](index=242&type=chunk) PART II [ITEM 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=41&type=section&id=ITEM%205.%20Market%20For%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, and it does not anticipate paying cash dividends - Aspira's common stock trades on The Nasdaq Capital Market under the symbol **"AWH"**[243](index=243&type=chunk) - As of March 28, 2024, there were 40 registered holders of record, and the closing price was **$3.10**[243](index=243&type=chunk) - The company has **never paid cash dividends** and does not anticipate paying them in the foreseeable future, prioritizing reinvestment in business expansion[244](index=244&type=chunk) [ITEM 6. [Reserved]](index=41&type=section&id=ITEM%206.%20%5BReserved%5D) This item is intentionally left blank [ITEM 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=ITEM%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's revenue grew in 2023, but it faces liquidity concerns and going concern uncertainty - Aspira is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests for gynecologic diseases[247](index=247&type=chunk) - The company plans to launch Phase II of OvaWatch in Q2 2024 for longitudinal monitoring and is evaluating the commercial launch of EndoCheck[249](index=249&type=chunk) Key Financial and Operating Data (2023 vs. 2022) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change Amount (in thousands) | Change % | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $9,154 | $8,184 | $970 | 12% | | Product Revenue | $9,153 | $7,970 | $1,183 | 15% | | Genetics Revenue | $1 | $214 | ($213) | (100)% | | Total Cost of Revenue | $3,892 | $3,861 | $31 | 1% | | Gross Profit | $5,262 | $4,323 | $939 | 22% | | Total Operating Expenses | $24,114 | $35,461 | ($11,347) | (32)% | | Loss from Operations | ($18,852) | ($31,138) | $12,286 | (39)% | | Total Other Income (Expense), net | $2,162 | $1,253 | $909 | 73% | | Net Loss | ($16,690) | ($29,885) | $13,195 | (44)% | OvaSuite Volume and Average Unit Price (2023 vs. 2022) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | **Product Volume:** | | | | Ova1Plus | 20,579 | 21,373 | | OvaWatch | 3,411 | 50 | | Total OvaSuite | 23,990 | 21,423 | | **Average Unit Price (AUP):** | | | | Ova1Plus | $394 | $373 | | OvaWatch | $308 | $140 | | Total OvaSuite | $382 | $372 | - Research and development expenses **decreased by $1.9 million (32%)** in 2023 but are expected to increase in 2024[266](index=266&type=chunk) - Sales and marketing expenses **decreased by $7.1 million (48%)** in 2023 but are expected to increase in 2024 to support product growth[267](index=267&type=chunk) - General and administrative expenses **decreased by $2.4 million (16%)** in 2023, with further decreases expected in 2024[268](index=268&type=chunk) - Net cash used in operating activities was **$15.9 million in 2023**, a significant reduction from $31.1 million in 2022[273](index=273&type=chunk) - The company received **$1.0 million in loan forgiveness** from the State of Connecticut DECD in 2023[269](index=269&type=chunk)[283](index=283&type=chunk) - Aspira raised gross proceeds of **$4.7 million** in a July 2023 equity offering and an additional **$5.5 million** in January 2024[270](index=270&type=chunk)[275](index=275&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk)[482](index=482&type=chunk) - The company has significant net operating loss (NOL) carryforwards but their utilization is subject to Section 382 limitations and a full valuation allowance[276](index=276&type=chunk)[277](index=277&type=chunk)[475](index=475&type=chunk) - Aspira entered into research and licensing agreements with Harvard's Dana-Farber Cancer Institute for multi-omic diagnostic development[285](index=285&type=chunk)[287](index=287&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk) [ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=ITEM%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, these disclosures are not required - The company is not required to provide quantitative and qualitative disclosures about market risk[297](index=297&type=chunk) [ITEM 8. Consolidated Financial Statements and Supplementary Data](index=49&type=section&id=ITEM%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) This section includes the company's audited consolidated financial statements for 2023 and 2022 - The consolidated financial statements for 2023 and 2022, along with supplementary data and the independent auditor's report, are included[297](index=297&type=chunk) [ITEM 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=49&type=section&id=ITEM%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no disagreements with its accountants - There are no changes in or disagreements with accountants on accounting and financial disclosure[299](index=299&type=chunk) [ITEM 9A. Controls and Procedures](index=49&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to two material weaknesses in internal controls - Management concluded that **disclosure controls and procedures were not effective** as of December 31, 2023[300](index=300&type=chunk) - **Two material weaknesses** were identified: (1) deficiencies in IT general controls and (2) inadequate design of control activities over revenue recognition[302](index=302&type=chunk)[303](index=303&type=chunk) - Remediation activities include retaining internal controls specialists, reviewing IT controls, and providing additional accounting training[306](index=306&type=chunk) - The material weaknesses will not be considered remediated until controls operate for a sufficient period and are tested as effective[307](index=307&type=chunk) [ITEM 9B. Other Information](index=51&type=section&id=ITEM%209B.%20Other%20Information) No other information is reported in this section - No other information is reported under this item[310](index=310&type=chunk) [ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=51&type=section&id=ITEM%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This disclosure is not applicable to the company - This item is not applicable[310](index=310&type=chunk) PART III [ITEM 10. Directors, Executive Officers and Corporate Governance](index=49&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information is incorporated by reference from the 2024 Proxy Statement - Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement[312](index=312&type=chunk) - Aspira has a Code of Business Conduct and Ethics for its directors, officers, and employees, available on its website[312](index=312&type=chunk) [ITEM 11. Executive Compensation](index=49&type=section&id=ITEM%2011.%20Executive%20Compensation) Executive compensation details are incorporated by reference from the 2024 Proxy Statement - Executive compensation information is incorporated by reference from the 2024 Proxy Statement[313](index=313&type=chunk) [ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=49&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information is incorporated by reference from the 2024 Proxy Statement - Security ownership information for beneficial owners and management, and equity compensation plan details, are incorporated by reference from the 2024 Proxy Statement[314](index=314&type=chunk) [ITEM 13. Certain Relationships and Related Transactions, and Director Independence](index=49&type=section&id=ITEM%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Related transaction details are incorporated by reference from the 2024 Proxy Statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement[314](index=314&type=chunk) [ITEM 14. Principal Accountant Fees and Services](index=49&type=section&id=ITEM%2014.%20Principal%20Accountant%20Fees%20and%20Services) Accountant fee information is incorporated by reference from the 2024 Proxy Statement - Information on principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement[315](index=315&type=chunk) PART IV [ITEM 15. Exhibits, Financial Statement Schedules](index=50&type=section&id=ITEM%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed with the report - The financial statements and notes, along with the independent registered public accounting firm's report, are included on pages F-1 through F-29[318](index=318&type=chunk) - All financial statement schedules have been omitted as the information is not required or is already included in the financial statements or notes[319](index=319&type=chunk) - A detailed list of exhibits, including corporate documents, agreements, and certifications, is provided[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) [ITEM 16. FORM 10-K Summary](index=56&type=section&id=ITEM%2016.%20FORM%2010-K%20Summary) No Form 10-K summary is provided by the company - No Form 10-K Summary is provided[325](index=325&type=chunk) [Consolidated Financial Statements](index=57&type=section&id=Consolidated%20Financial%20Statements) This section presents audited financial statements, which note a going concern uncertainty - The independent auditor issued an unqualified opinion but included an explanatory paragraph regarding **substantial doubt about the company's ability to continue as a going concern**[330](index=330&type=chunk)[331](index=331&type=chunk) Consolidated Balance Sheet Highlights (in thousands) | Metric | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,597 | $13,306 | | Total current assets | $5,280 | $16,309 | | Total assets | $6,262 | $17,373 | | Total current liabilities | $5,119 | $5,527 | | Total liabilities | $8,627 | $10,394 | | Stockholders' (deficit) equity | ($2,365) | $6,979 | Consolidated Statements of Operations Highlights (in thousands) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total revenue | $9,154 | $8,184 | | Gross profit | $5,262 | $4,323 | | Total operating expenses | $24,114 | $35,461 | | Loss from operations | ($18,852) | ($31,138) | | Net loss | ($16,690) | ($29,885) | | Net loss per share - basic and diluted | ($1.81) | ($3.85) | Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($15,894) | ($31,068) | | Net cash used in investing activities | ($24) | ($232) | | Net cash provided by financing activities | $5,216 | $7,427 | | Net decrease in cash, cash equivalents and restricted cash | ($10,702) | ($23,873) | [Notes to Consolidated Financial Statements](index=64&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies and reiterate the substantial doubt about going concern - Aspira's **accumulated deficit was $518.3 million** and working capital was $0.2 million as of December 31, 2023, indicating substantial doubt about its ability to continue as a going concern[354](index=354&type=chunk)[355](index=355&type=chunk) - Product revenue is recognized upon test completion and delivery of results, based on estimates of ultimate realization[371](index=371&type=chunk) - Genetics revenue from Aspira GenetiX was discontinued effective September 30, 2022[375](index=375&type=chunk) - Research and development costs are expensed as incurred, including payroll, materials, and fees to third parties[376](index=376&type=chunk) - The company completed a **one-for-fifteen reverse stock split** on May 12, 2023, retrospectively adjusting all share and per share amounts[381](index=381&type=chunk) - Aspira received approximately **$347,000 from the IRS** in August 2023 for Employee Retention Credits (ERC)[382](index=382&type=chunk) - The DECD loan agreement saw **$1.0 million forgiven in 2023** due to job creation and retention milestones[412](index=412&type=chunk)[414](index=414&type=chunk) - As of December 31, 2023, the company had **799,985 warrants outstanding** with an exercise price of $13.20 per share, classified as derivative liabilities[435](index=435&type=chunk)[437](index=437&type=chunk) - In January 2024, Aspira completed a follow-on equity offering, raising approximately **$5.5 million in gross proceeds**[482](index=482&type=chunk)[485](index=485&type=chunk) - Total unrecognized compensation cost for unvested stock options was **$677,000** as of December 31, 2023[468](index=468&type=chunk) - The company has a **full valuation allowance** against its net deferred tax assets ($57.2 million at Dec 31, 2023) due to a history of operating losses[470](index=470&type=chunk)[476](index=476&type=chunk) [SIGNATURES](index=86&type=section&id=SIGNATURES) This section contains the authorized signatures for the Form 10-K filing - The report is signed by the Chief Financial Officer and President and Chief Executive Officer, along with the Board of Directors, on March 29, 2024[487](index=487&type=chunk)[490](index=490&type=chunk) - A Power of Attorney is granted to the President & CEO and CFO to sign amendments to the Form 10-K[488](index=488&type=chunk)

Aspira Women's Health Inc. (NASDAQ:AWH) Q4 2023 Results Conference Call March 28, 2024 8:30 AM ET Company Participants Nicole Sandford - President and Chief Executive Officer Torsten Hombeck - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Sally Yanchus - Water Tower Research Operator Good morning, ladies and gentlemen, and welcome to Aspira Women's Health, Incorporated. Fourth Quarter and '23 Year-end Earnings Conference Call. [Operator Instructions] As a reminder, thi ...