Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to the Aspira Women's Health Incorporated First 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 as defined under the Private Security Litigation Reform Act of 1995 will be made during this call, including statements related 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 risks and uncertainty that could cause results to differ materially from those anticipated due to the impact of many factors beyond the SPIRA Women's Health Control. The company assumes no obligation 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 notes set forth in today's press release, as well as the risk factors set forth in ASPIRE's most recent annual Form 10-K and quarterly report on Form 10-Q filed with the SEC for a description of factors that could cause actual results to differ materially from those anticipated in a forward-looking statement.

At this time, I'd like to turn the call over to Nicole Sanford, Chief Executive Officer. Please go ahead.

Thank you and welcome everyone to our first quarter 2024 earnings conference call. With me today are Dr. Sandy Milligan, our new president, and Torsten Holmbach, our chief financial officer. I will begin with an overview of our strategy, execution, and operation, followed by Sandy with an update on our development plans and Torsten with a review of our financials. We will then open the call for questions. Let me begin with our strategy and commercial execution this quarter. We were excited to see Overwatch grow by 114% to 1,052 in the first quarter of 2024 over the same period last year, representing approximately 18% of total test volume, which declined slightly to 5,829. This is important as we believe the largest opportunity for future growth rests with Overwatch now that we are offering it as a tool for the longitudinal monitoring of masses, creating an opportunity for repeat testing for the more than 1.2 million patients a year that develop an inexorable mass and potentially multiplying the total addressable market by more than two to three times that of a single-use test. Overwatch is designed to help physicians determine the risk of cancer for women with potentially benign or indeterminate masses, something for which there is no other non-invasive tool available. We believe the broad adoption of Overwatch will help women avoid unnecessary surgery for the benefit of patients, physicians, and payers. In fact, data published just last week in the peer-reviewed journal Frontiers in Medicine showed that physician accuracy in predicting malignancy would have improved by more than 400% had Overwatch been used for those patients. You'll hear more about the data shortly, but let's stop there for a minute and talk about the power of this paper. It clearly demonstrates Overwatch's utility for physicians to improve the accuracy of their assessment of malignancy risk and offers an incredible benefit to premenopausal women who may have resorted to surgery in the past. These women face the onset of surgical menopause if their ovaries are removed, causing a host of near and long-term health risks due to the abrupt drop in circulating hormones compared to women that experience menopause naturally and gradually. Surgical menopause has been found to increase women's long-term risk of cardiovascular disease, osteoporosis, Parkinson's disease, and dementia, to name a few. We believe this data will play a central role in driving adoption of Overwatch by both physicians and payers and are currently executing an aggressive campaign to share the paper and findings with our various stakeholders. We also saw the publication of data supporting periodic testing published in the peer-reviewed journal Gynecologic Oncology earlier this month. The validation of Overwatch as a reliable test in the monitoring of ovarian cancer risk in women with indeterminate or low-risk anexal masses especially in a prestigious journal for gynecologic oncology, is a major milestone. Data in this analysis of over 500 women supports the use of Overwatch for monitoring masses over time, offering women and physicians peace of mind if they choose to avoid surgery when malignancy risk is low. Turning now to our commercial activities, our team is more prepared than ever to take advantage of the expanded features of Overwatch. Our sales efficiency numbers continue to improve, with volume for full-time representative increasing 22% to 364 in the first quarter this year when compared to the first quarter of last year. In addition, March was the strongest month of the first quarter, and the momentum has carried into April, which was the second largest volume month in company history, despite two remaining open territories. Another key factor to growth is average unit pricing, or AUP, which was at $369 for the quarter, consistent with the first full quarter of last year. Importantly, the volatility we anticipated with the launch of Overwatch never materialized, and our gross margin remains strong at 56%. Moving to an update on innovation, we are aggressively seeking alternative sources of funding for our product development, including the pursuit of research grants under the leadership of our new president, Sandy Milligan. We submitted ARPA-H grants for OVA-MDX and ENDO-MDX last month to take advantage of the opportunity to obtain funds made available by the Biden administration to support women's health research. The ARPA-H grant process is expected to be condensed with funding decisions to be made as early as the fourth quarter. Other grant applications have been submitted for our portfolio, some of which have been submitted in partnership with collaborators. In addition to an NIH grant submitted by Dana-Farber Cancer Institute, our endo-check test was included in a third ARPA-H grant proposal submitted by a scientific researcher owns a patent that may be used in a promising drug therapy for the treatment of endometrioma. EndoCheck is the only non-invasive test that has been shown to accurately identify endometrioma, making it the perfect pairing for a combined solution and collaboration on clinical research. Positioning EndoCheck as a research test in this manner may generate income while simultaneously validating the algorithm. I continue to believe in the promise of EndoCheck as an inexpensive, non-invasive tool for women with suspected endometrioma, especially for women with comorbidities that create higher surgical risk, adolescents, and underinsured patients. However, we need to be smart about how we build the market to meet the needs of clinicians as well as patients. We are extraordinarily conscious of our spending, and while we would like to fully fund all of our programs, we must be thoughtful in deciding where our research dollars go. While we are pursuing alternative sources of funding for EndoCheck, we are focusing our attention on the MDX portfolio. Now it is my pleasure to turn the call over to Dr. Sandy Milligan, who joined us just a month ago. Her impact is already being felt throughout the organization, providing incredible insight, expertise, leadership, and relationships. Sandy brings a refreshing discipline from her years in the military, a depth of medical knowledge from training as a physician, and strategic clarity from her prior senior roles with a variety of market-leading life sciences companies. She has been a tremendous addition to the team. I will now turn the call over to her.