Aspira Women's Health Inc.

Good morning ladies and gentlemen and welcome to Aspira's Women's Health Incorporated second quarter 2024 earnings conference call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will open the call for your questions. As a reminder, this call is being recorded today. Before we begin, I would like to remind everyone that forward-looking statements are defined under the private securities litigation reform act of 1995 will be made during this call, including statements relating to Aspira's expected future performance, future business prospects, and future events or plans. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risk and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond Aspira's women's health control. The company assumes no obligations to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Participants are directed to the cautionary note set forth in today's press release, as well as the risk factor set forth in Aspira's most recent annual report on Form 10-K and quarterly report on Form 10Q filed with the SEC for a description of factors that could cause actual results to differ materially from those anticipated in forward-looking statements. At this time, I would like to turn the call over to Nicole Sanford, Chief Executive Officer. Please go ahead.

Thank you, Operator, and welcome everyone to our second quarter 2024 earnings conference call. With me today is our president, Dr. Sandy Milligan. I will begin with an overview of our strategy, execution, and operations, followed by an update from Sandy on product development. I will then review our financials before opening the call for questions. The most important development for the quarter was the launch of the longitudinal mass monitoring application for Overwatch, following the publication of powerful new data at the beginning of May. This is the latest development in our effort to expand both the clinical utility and commercial opportunity for our over-sweet portfolio of ovarian cancer risk assessment blood tests for women with an anexal mass. The launch of the longitudinal monitoring application means that we have achieved our goal of offering a life-changing suite of blood tests, the first and only tool of its kind available anywhere in the world. This is a major accomplishment and one that we share with the many long-term shareholders who have believed in the company and supported us on this important journey. Let's reflect on the addressable market for our tests over the past few years to set the stage for our future growth. Overwatch Plus, the only test that was commercially available when I joined the company in early 2022, has a total addressable market of between 200,000 and 400,000 tests per year in the United States. We increased that to more than 1.2 million with the launch of the initial assessment application of Overwatch in December of 2022. Now, with the launch of the longitudinal monitoring application this quarter, we believe the total addressable market for our OVA suite tests is between 2 and 4 million tests per year. This is a tenfold increase in the revenue potential for the tests that have already been trusted by healthcare providers more than 200,000 times. It is important to keep the dramatically increased addressable market in mind as we review our performance for the second quarter and look out to the rest of 2024 and beyond. You may recall that we began a refresh of our commercial strategy and program elements in the second half of 2023 with the goal of identifying people, process, and technology enhancements, as well as refining our market messaging to increase both impact and reach. The refresh was completed and fully implemented in the first quarter of 2024, and as a result, I believe we are well positioned to take advantage of the expanded adjustable market for our test. Moreover, the enhanced commercial organization is more efficient and cost-effective than ever, which is critical to our cost containment goals. I'm happy to report that we have seen positive momentum resulting from our refresh efforts, with sequential growth during the first half of 2024. Our total oversweet test volume in the second quarter hit a new company high watermark of 6,471, with more than 20% of that volume coming from the Overwatch test. We achieved this test volume with 17% fewer full-time field salespeople when compared to the second quarter of 2023. By comparison, we had an average of 16 field salespeople in the first half of this year compared to 21 field salespeople for the same period last year, resulting in an impressive 29% increase in volume for field sales representative to 769 tests. We added an additional two field salespeople in the third quarter and expect the enhanced commercial programs, along with the expanded application of the Overwatch test and the powerful new data published in May to support rapid success in these territories. Our primary focus now is to drive adoption of our Oversweet test portfolio to become the universal standard of care for every woman diagnosed with an Enexil mask. There are many important initiatives underway, including working with partners to have our tests added to the protocols for Enexil mask care, which we expect to come together in the third and fourth quarters of this year. Our commercial success and growth also rely on our ability to increase coverage and reimbursement for our Oversweet products, and I'm proud of the progress we have made. On the commercial plan side, we recently contracted with Anthem Plans in California and the Northeast states, adding 8 million covered lives. We expect the Anthem Central and Virginia geographic regions to complete contracting before the end of 2024, which would add an additional 16 million lives. Also of note, we have added Blue Cross Blue Shield of Texas, Blue Cross Blue Shield of Illinois, and Superior Plan Texas so far this year. On the Medicaid side, we added Maryland and Kentucky in the second quarter, bringing the total number of states covering one or more of our overseas tests to nine, including the critical states of California, New York, and Illinois. Medicare and Medicare Advantage reimbursement for Overwatch has also increased meaningfully in the first half of 2024. Despite these achievements, we know we have more to do to convert additional payers. The study we published in May was instrumental in helping to swing momentum our way. The data clearly demonstrated the benefit of adding Overwatch to a physician's clinical assessment in women presenting with adenexal mass. We've created a model to help payers quantify the potential savings that can result from a reduction in surgical interventions on low-risk patients if the Overwatch test is used. We believe the potential savings, while dependent on circumstances, are both significant and compelling. To further accelerate our reimbursement progress, we have initiated a comprehensive analysis of national, regional, and integrated delivery network payers with the assistance of an experienced third-party consultant. The objective of the project is to gather specific and direct insight regarding evidence requirements we must meet to support broader coverage and reimbursement for Overwatch. The first phase of the study, which we expect to complete in the third quarter of 2024, consists of interviews with senior stakeholders to identify evidentiary and other gaps we must fill. These findings will be incorporated into a clinical utility study that we expect will help expand commercial coverage for Overwatch and Overwatch Plus while also informing our market access and reimbursement strategies for future product launches. Now it is my pleasure to turn the call over to Sandy to talk about product development. Then I will come back on to discuss our operating performance and balance sheet position. Sandy? Thank you, Nicole.

In my role as president, my focus continues to be the acceleration of our research and product development program. I'm pleased with the progress we have made in the second quarter, which I'll share with you today. As Nicole mentioned, we announced the publication of two Overwatch-focused manuscripts in May. Together, these peer-reviewed publications demonstrate the potential for significantly improved physician triaging of malignancies for surgery over their clinical impression alone and supported the use of Overwatch as an ovarian cancer risk serial assessment tool. This data demonstrates that Overwatch could substantially reduce surgeries for low-risk patients performed out of concern for malignancy risk, especially for asymptomatic and premenopausal women. Indeed, Overwatch may have reduced the number of surgeries in women with low risk of malignancy by 62% in all patients and 77% in premenopausal women. With the added feature of serial mass monitoring, Overwatch can be drawn at provider-prescribed intervals for active surveillance of an adnexal mass determined by initial clinical assessment as indeterminate or low risk. This is the strongest clinical support for Overwatch and its value proposition for physicians and patients to date. Let me turn now to our product development updates with a brief overview of our progress on EndoCheck, our protein-based test that has been shown to identify certain endometriosis located on the ovary, including endometrioma. Following a robust discussion with healthcare providers upon our presentation of EndoCheck data, At the Society for Reproductive Investigation annual scientific meeting in February, we believe that the EndoCheck protein biomarker signature will significantly contribute to a test with broader endometriosis application, as well as offer insights to improve the understanding of this devastating and complex disease. We are currently processing nearly 400 samples collected in our endometriosis clinical study and expect to have new data for analysis during the third quarter. With this data in hand, we will have the opportunity to further assess the commercial application of the test and expand our outreach to potential development partners. This may include pharma companies with drug therapies in development that could potentially utilize EndoCheck as a research-focused test to identify or track patient response to drug therapies in ongoing clinical trials. We are also considering how the addition of an EndoCheck score to our Overwatch test reports would allow healthcare providers to assess the risk of both ovarian cancer and endometrioma for women presenting with an indexal mass. We believe this may have a positive impact on clinical utility, provider adoption, and pricing of the test. Clearly, we have work to do in deciding how best to proceed with EndoCheck, and for now have focused the majority of our development resources towards our molecular testing portfolio. With that, let me turn to OVA MDX. which is being developed in collaboration with the Dana-Farber Cancer Institute. We have completed assay analytical feasibility on an FDA-approved PCR system, a critical milestone which confirms the ability to perform a test that utilizes the microRNA technology discovered by Dana-Farber on a commercially viable diagnostic platform. Our next phase, which is currently underway, is the design and assay verification process, which we expect to provide additional data prior to the end of 2024. As we have shared previously, we believe that this test will have the power to improve sensitivity for early-stage ovarian cancer, as well as broader detection for various histological subtypes, solidifying our position as the leader in non-invasive ovarian cancer testing for women with adnexal masses. As we complete development steps for the OVA MDX program, we will leverage the learnings and experience in developing a microRNA and protein biomarker test into the development of our broad general endometriosis blood test that leverages proteins from endocheck and proprietary microRNAs identified through our research agreement with Dana-Farber. We are working to establish analytical feasibility and the selection of microRNAs and protein candidates as part of the ongoing test design for this broader endometriosis test. Now that the FDA has finalized its rule to regulate lab-developed tests, we are in the process of determining the regulatory pathway and related requirements for our in-development molecular tests for both ovarian cancer and endometriosis. We do not anticipate the new rule to have any impact on our ability to offer our existing products, including the longitudinal testing application of Overwatch nor do we anticipate the regulation to cause a significant extension of our prior development or launch timelines for the combination microRNA and protein biomarker tests. We continue to focus on identifying non-dilutive sources of funding for our R&D activities, including funding from multiple research grants. Our developments related to our in-process molecular tests are groundbreaking. We believe that related research has created new grant opportunities, which we intend to aggressively pursue. In addition, we are waiting for a funding decision on a sizable grant opportunity, which requires confidentiality until such decision is made. Regardless of the outcome, the application processes have helped us consolidate to a compelling and data-driven development and commercialization strategy to bring to potential development partners. Another potential source of non-diluted funding is through our research biobank, where a recent analysis showed that we have as many as 70,000 serum, plasma, and whole blood samples available for secondary research. In July, we executed a number of small material transfer agreements with third parties who intend to utilize the samples for validation of gynecological disease diagnostic tests. We recognized an average selling price of approximately $500 per sample. This is an important step in establishing a baseline market value for the purchase material and realizing another opportunity for non-dilutive cash through sample disposition. We also believe that there may be opportunities to work with foundations to identify additional academic and research activities in women's health that could benefit from access to our sample bank. Finding the right path for this initiative is complex and requires a strategic approach, but we have made tremendous progress in 2024. With that, let me now turn it back to Nicole for an update in our financials. Nicole?