AUSTIN, Texas, July 01, 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 it has entered into a securities purchase agreement dated June 30, 2024 with certain existing accredited shareholders and Company insiders to issue and sell an aggregate of 1,264,739 shares of its common stock ("Common Stock") and warrants to purchase an equal num ...

AUSTIN, Texas, July 01, 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 it has entered into a securities purchase agreement dated June 30, 2024 with certain existing accredited shareholders and Company insiders to issue and sell an aggregate of 1,264,739 shares of its common stock (“Common Stock”) and warrants to purchase an equal nu ...

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 ...

Core Viewpoint - Aspira Women's Health Inc. is set to report its financial results for Q1 2024 on May 15, 2024, and will host a conference call to discuss these results and provide a corporate update [1]. Company Overview - Aspira Women's Health Inc. focuses on the development of noninvasive, AI-powered diagnostic tests for gynecologic diseases, particularly ovarian cancer [3]. - The company offers OvaWatch® and Ova1Plus® as part of its OvaSuite®, which is the only comprehensive portfolio of blood tests for detecting ovarian cancer in over 1.2 million American women diagnosed with an adnexal mass annually [3]. - OvaWatch has a negative predictive value of 99%, helping to assess ovarian cancer risk in cases where initial assessments are indeterminate or benign [3]. Product Development - Aspira is expanding its ovarian cancer portfolio and developing noninvasive diagnostics for endometriosis, which affects millions of women globally [4]. - The OvaMDxSM risk assessment aims to enhance the sensitivity and specificity of current tests by combining microRNA and protein biomarkers with patient data [4]. - EndoCheckSM is the first noninvasive test designed to identify endometriomas, while EndoMDxSM will also combine microRNA and protein biomarkers with patient data to identify all forms of endometriosis [4].

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]