Company Leadership Change - CEO Nicole Sandford will step down for personal reasons and will remain as a consultant to ensure a seamless transition [1] - Dr. Sandra Milligan, the President, will serve as interim CEO while a search for a permanent successor is conducted [1][2] - The Board expressed gratitude for Sandford's contributions, including stabilizing the business and launching the OvaWatch multivariate assay [2] Product Development and Portfolio - Aspira Women’s Health Inc. focuses on the development of noninvasive, AI-powered tests for gynecologic diseases [3] - The OvaSuite portfolio includes OvaWatch and Ova1Plus, which provide comprehensive blood tests for ovarian cancer risk assessment [4] - OvaWatch has a negative predictive value of 99% and is used for women with indeterminate or benign adnexal masses [4] - The company is developing tests to enhance ovarian cancer diagnostics and address endometriosis, aiming to combine microRNA and protein biomarkers with patient data [4]

Core Insights - Aspira Women's Health Inc. has successfully completed the first development milestone of its ARPA-H award, receiving a cash payment of $2 million [1][4] - The company is set to receive a total of $10 million in funding over two years for its multi-marker blood test aimed at detecting endometriosis, which will utilize an AI-enabled algorithm [2][4] - The first milestone included initial launch activities and the development of project execution and risk mitigation plans, along with laboratory capability expansions [3][4] Funding and Milestones - Aspira has received a $2 million payment for achieving the first milestone and is entitled to an additional $1.5 million upon completing the second milestone [1][4] - The second milestone is expected to be completed in the first quarter of 2025 and will focus on expanding R&D capabilities and delivering additional product development plans [4] Product Development - The company is developing a non-invasive blood test for endometriosis, leveraging technology previously used in its ovarian cancer risk assessment tests [2][7] - Aspira's current ovarian cancer tests, OvaWatch and Ova1Plus, provide a comprehensive portfolio for assessing ovarian cancer risk, with OvaWatch having a negative predictive value of 99% [6] Market Position and Future Plans - Aspira aims to enhance the sensitivity and specificity of its tests by combining microRNA and protein biomarkers with patient data [7] - The ongoing development program for endometriosis aims to identify all forms of the disease, regardless of location or severity [7]

Company Performance - Aspira reported a quarterly loss of $0.23 per share, better than the Zacks Consensus Estimate of a loss of $0.28, and an improvement from a loss of $0.48 per share a year ago, representing an earnings surprise of 17.86% [1] - The company posted revenues of $2.26 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 13.19%, and showing a slight increase from year-ago revenues of $2.22 million [2] - Over the last four quarters, Aspira has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [2] Stock Outlook - Aspira shares have declined approximately 81.8% since the beginning of the year, contrasting with the S&P 500's gain of 23.6% [4] - The current consensus EPS estimate for the coming quarter is -$0.25 on revenues of $2.9 million, and -$1.26 on revenues of $10.1 million for the current fiscal year [8] - The estimate revisions trend for Aspira is mixed, resulting in a Zacks Rank 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [7] Industry Context - The Medical - Instruments industry, to which Aspira belongs, is currently in the top 24% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [9] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [6]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $2,257,000, compared to $2,217,000 for the same period in 2023, representing a 1.8% increase[15] - Gross profit for the nine months ended September 30, 2024, was $3,990,000, down from $4,043,000 in the same period of 2023, a decrease of 1.3%[15] - Net loss for the three months ended September 30, 2024, was $3,547,000, compared to a net loss of $4,706,000 for the same period in 2023, a reduction of 24.6%[15] - For the nine months ended September 30, 2024, the company incurred a net loss of $11,706,000 and used cash in operations of $11,092,000[26] - Operating expenses decreased by $1.9 million for the nine months ended September 30, 2024, compared to the same period in 2023[163] Assets and Liabilities - Total current assets decreased to $4,113,000 as of September 30, 2024, from $5,280,000 as of December 31, 2023, a decline of 22.1%[12] - Current liabilities increased to $5,466,000 as of September 30, 2024, compared to $5,119,000 as of December 31, 2023, an increase of 6.8%[12] - Total liabilities decreased to $7,279,000 as of September 30, 2024, from $8,627,000 as of December 31, 2023, a decrease of 15.6%[12] - As of September 30, 2024, the company had an accumulated deficit of approximately $530,009,000 and a working capital deficit of approximately $1,353,000[26] Capital Raising and Stock Activity - The company issued 1,248,527 common shares under 2024 Securities Purchase Agreements, raising additional capital[16] - The Company entered into a 2024 At-the-Market Offering agreement to sell shares of common stock with an aggregate sales price of up to $4,450,000, with a commission rate of 3.0% on gross proceeds[81] - The Company sold 1,650,473 shares in the 2023 Direct Offering, resulting in gross proceeds of approximately $4,716,000 before deducting expenses of $597,000[106] - The Company has the right to sell up to $10,000,000 of common stock under the 2023 Equity Line of Credit Agreement with Lincoln Park[113] - The Company sold 1,310,517 shares under the 2023 Equity Line of Credit Agreement for gross proceeds of approximately $3,078,000 as of September 30, 2024[118] Compliance and Regulatory Issues - The Company received a deficiency letter from Nasdaq on July 1, 2024, indicating that its Market Value of Listed Securities was below the minimum requirement of $35 million for continued inclusion on the Nasdaq Capital Market[30] - On October 17, 2024, Nasdaq notified the Company that the bid price for its common stock had closed below the minimum $1.00 per share for the last 30 consecutive business days, resulting in non-compliance with the listing requirement[31] - The Company has a 180-day period until April 15, 2025, to regain compliance with the minimum bid price requirement, which necessitates the closing bid price to meet or exceed $1.00 per share for at least ten consecutive business days[31] - The company received another deficiency letter from Nasdaq on October 17, 2024, for its common stock bid price falling below $1.00, with a compliance deadline of April 15, 2025[192] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $2,766,000, down from $2,958,000 in the same period of 2023, a decrease of 6.5%[15] - The company is developing a new non-invasive test for endometriosis, targeting a market that affects over 6.5 million women in the U.S.[162] - The company was awarded up to $10 million in milestone-based funding from ARPA-H to develop a multi-marker blood test for endometriosis[193] Product and Market Expansion - The company commercializes blood test products including Ova1Plus and OvaWatch, with Ova1 intended to assess malignancy likelihood in women with ovarian masses[165] - The addressable market for the company's tests increased to between 2 and 4 million tests per year following the expansion of the OvaWatch test features[158] - The company plans to broaden its commercial focus to include differential diagnosis of various gynecological diseases beyond ovarian cancer[145] - In November 2024, the company expanded its distribution agreement with BioReference to include OvaWatch, enhancing its market presence in New York[166] Shareholder and Stock Option Information - The weighted average common shares used to compute basic and diluted net loss per common share increased to 15,405,672 for the three months ended September 30, 2024, from 9,776,436 for the same period in 2023[15] - The weighted average exercise price of outstanding options under the 2010 Plan as of September 30, 2024, was $28.11[125] - The weighted average exercise price of outstanding options under the 2019 Plan as of September 30, 2024, was $7.15[129] - Total unrecognized compensation cost related to unvested stock option awards was approximately $551,000 as of September 30, 2024[135] Sales and Revenue Growth - Product revenue for Q3 2024 was $2,257,000, a 2% increase from $2,217,000 in Q3 2023, driven by a 4% increase in OvaSuite test volume[206][207] - The number of OvaSuite tests performed increased to 6,001 in Q3 2024 from 5,783 in Q3 2023[207] - Gross profit margin for product revenue improved to 60.0% in Q3 2024, up from 59.0% in Q3 2023, due to increased revenue and decreased costs[210]

Financial Data and Key Metrics Changes - OvaSuite revenue for Q3 2024 was $2.3 million, a 2% increase from $2.2 million in Q3 2023, but a slight decrease from $2.4 million in Q2 2024 [21] - The number of OvaSuite tests performed increased by 4% year-over-year, with over 6,000 tests delivered in Q3 2024 compared to approximately 5,783 in Q3 2023 [5][21] - Gross margins improved to 60% in Q3 2024 from 59% in Q3 2023 [24] - Cash used in operating activities decreased by 12% to $2.9 million in Q3 2024 compared to $3.3 million in Q3 2023 [26] Business Line Data and Key Metrics Changes - OvaWatch test volume increased by 27% year-over-year for Q3 2024, now making up 22% of total OvaSuite test volume compared to 18% in the same period last year [21][22] - The average unit price for OvaWatch increased by 4% to $360 in Q3 2024 from $347 in Q3 2023 [22] Market Data and Key Metrics Changes - Severe weather, including Hurricane Helene, negatively impacted performance in key markets such as Florida, Georgia, and South Carolina [21][22] - The average unit price for OvaSuite tests decreased to $376 in Q3 2024 from $383 in Q3 2023 [22] Company Strategy and Development Direction - The company is focused on expanding its ovarian cancer portfolio, including the launch of OvaWatch for longitudinal monitoring of ovarian masses [7] - A new agreement with Dorsata aims to enhance clinical decision-making tools integrated into EMR systems for OB-GYNs [8] - The approval of OvaWatch by the New York State Department of Health opens access to a significant healthcare market [9][10] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of severe weather on Q3 performance but noted strong volume days in October and November [6] - The company is optimistic about the future adoption of its OvaSuite portfolio and the potential for reordering behavior to change as providers consider retesting patients [7] - The $10 million federal award for the ENDOinform project is seen as a validation of the company's capabilities and a significant opportunity for expansion [11][12] Other Important Information - The company has filed for an extension to November 19, 2024, for filing its Form 10-Q due to complex accounting matters related to a warrants inducement transaction [27] - Cash and restricted cash as of September 30, 2024, was $2.1 million, down from $2.9 million as of December 31, 2023 [26][27] Q&A Session Summary Question: Can we provide a range of estimated timelines for OVAinform and ENDOinform development to commercialization? - The company is contracted with ARPA-H for full 2 years of funding and is optimistic about accelerating development [31] Question: Any thoughts on possible partnering with a company creating endometriosis therapies in the future? - The company is focused on moving ENDOinform across the line as a diagnostic and will consider partnerships for predictive diagnostics in the future [32] Question: How would the company describe the current overall partnership environment? - The partnership environment is viewed positively, with expectations for increased investment in women's health [33]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share AWH The Nasdaq Stock Market FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 14, 2024 Aspira Women's Health Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-34810 33-0595156 (State or Other ...

Achieved $141.6 million Net Revenue in Q3 2024Reported $25.1 million in Adjusted EBITDAAnticipates $30 million of Annual Savings Through Transformation InitiativesMORRISTOWN, N.J., Nov. 12, 2024 /PRNewswire/ - Ascend Wellness Holdings, Inc. ("AWH," or the "Company" or "Ascend") (CSE: AAWH.U) (OTCQX: AAWH), a vertically integrated multi-state cannabis operator focused on bettering lives through cannabis, today reported its financial results for the three months ended September 30, 2024 ("Q3 2024"). Financial ...

AUSTIN, Texas, Nov. 04, 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 and nine months ended September 30, 2024, on Thursday, November 14, 2024. Management will also host a conference call at 8:30 am ET to discuss financial results and provide a corporate update. Detai ...

AUSTIN, Texas, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, has issued a letter to Company shareholders and announced it will host a virtual Research & Development Day on Tuesday, October 29, 2024, at 3:00 pm ET. The R&D Day will highlight the company’s plans for its miRNA development pipeline, including the recently announced award from the Advanced Res ...

AUSTIN, Texas, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health to address critical unmet challenges in women’s health, champion transformative innovations, and tackle health conditions that uniquely or disproportio ...