Aspira Women's Health Inc.

Good afternoon, ladies and gentlemen, and welcome to Aspira Women's Health Incorporated first quarter 2023 earnings conference call. During the presentation, all participants will be in a listen-only mode. Following management's prepared remarks, we will open the call for your questions. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star and zero. As a reminder, this call is being recorded today. Leading the call today are Nicole Sanford, President and Chief Executive Officer, Marlene McLennan, Interim Chief Financial Officer, and Dr. Ryan Fon, Chief Scientific Officer and Chief Operating Officer. After the prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that forward-looking statements as 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 risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond Aspira 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 Aspira's most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC for a description of factors that cause actual results to differ materially from those anticipated in the forward-looking statement. At this time, I'd like to turn the call over to Nicole Sanford, President and Chief Executive Officer. Please go ahead.

Thank you, Operator, and good afternoon, everyone. I would like to welcome you to our first quarter 2023 conference call. With me today are Dr. Ryan Zahn, our Chief Scientific and Operating Officer, and Marlene McLennan, our Interim Chief Financial Officer. After my prepared remarks, Ryan and Marlene will provide a brief update on our product portfolio and financial performance, respectively, before we open the call for questions. Let me begin with a review of our performance this quarter. In the few weeks since our 2022 year-end earnings call, we have continued to make progress on a number of fronts. Our sales and revenues for the quarter fluid in part from the launch of Overwatch in December reached new record highs. A total of 491 Overwatch tests were performed in the first full quarter after launch, contributing about 8% to the total over-sweet volume. Our strategy has been to leverage the trust and brand recognition that has been established with Overwatch Plus for a rapid adoption of Overwatch by the OB-GYN community. Total product volume increased 29% over the first quarter of last year, one of the strongest performances ever recorded by the company. Our pivot to a more physician-focused portfolio approach and awareness marketing for the entire overshoot of tests appears to be effective. We have also seen progress with alternative sales channels, such as our relationship with bioreference laboratories and our Aspyrus Energy relationship. As a result of these efforts, we achieved volume growth while simultaneously cutting sales and marketing expenses by 43%, and nearly doubling the number of tests per full-time sales representative from 173 to 348. We also saw increases in our new ordering positions and average daily test volume. As is common with newly launched products, the majority of Overwatch tests in the first quarter were not covered by insurance, which led to a larger number of patient bill accounts. Our historical collection patterns appear to be holding across the Oversweep portfolio. However, we expect a shift in product volume to create some volatility in the average selling price of our tests for the rest of the year. We are focusing on securing broad reimbursement as a key driver to revenue growth and announced in March that Overwatch will be covered under our existing contract with a leading national payer. In addition, our Overwatch-specific TLA code went into effect on April 1st. We expect to make an announcement regarding the publication of a sponsored over one clinical utility study in the coming weeks and plan to use that as an accelerator to continue our progress with the remaining national payers for over one plus and as a catalyst for the expansion of coverage for Overwatch. While we are confident that our reimbursement strategy will be successful, we cannot control the timing of payer coverage decisions. We intend to continue aggressively driving provider adoption as we execute upon our strategy. and will closely monitor the resulting impact on our cash needs. Let me now turn to our progress on our operational performance. I believe it remains prudent to extend our cash runway as much as possible through strategic reductions in discretionary spending. As a result of the personnel cuts in 2022 and continued focus on cost containment, we significantly reduced our net operating cash spending in the first quarter to 5.7 million compared to 10.2 million in the first quarter of last year. We really iterate our operating cash utilization target for the remainder of 2023 to be between 10.3 and 13.3 million. Given our first quarter ending cash balance of 7.5 million, we are keenly aware of the need to identify additional sources of liquidity. We continue to meet with potential partners and I'm pleased to see the positive momentum the launch of Overwatch has created. We have proven ourselves to be capable of launching innovative diagnostic products to address unmet needs in gynecologic health. We are in a stronger position for partnership discussions than at any time since I joined the company. We have increased our efforts to attract investors and partners since the beginning of the year and will continue to make that a top priority. In the meantime, we have significantly increased our access to just-in-time capital by $22.5 million this quarter, by implementing an ATM sales agreement with Cantor Fitzgerald and securing a committed stock purchase agreement with Lincoln Park Capital. We intend to utilize these facilities prudently over the next one to three years to close funding gaps. These are valuable tools that provide access to the market at an attractive cost of capital, especially compared to transactions that have been closed by microcap companies in recent months. Aspira's strategy and science is sound, and has helped us to attract talent and retain our top performers. Our attrition remains very low. We were also able to attract three outstanding new board members, Stephanie Cavanaugh, Danny Herchuk, and Lynn O'Connor-Voss. They bring the experience and passion we need in these challenging times. With that, it is now my pleasure to turn the call over to Ryan for a closer look at our product portfolio.

Thank you, Nicole. I am very pleased to say that we continue to make progress on the development front. Let me begin with Overwatch. Overwatch has been very well received by physicians since the recent launch in December last year, as it provides a personalized risk assessment for women presenting with anastomosis. The Overwatch Clinical Validation Manage Group was accepted for publication in January. This peer-reviewed publication in the Frontiers in Medicine provides real-world evidence so physicians can be confident in utilizing Overwatch in the management of anastomosis. including to safely decrease premature ovary removal and reduce surgical backlog. As excited as we are to have Overwatch available to patients, our work is not done. Overwatch's true benefit lies with its potential as a serial monitoring test for managing anastomosis. Currently, physicians view Overwatch as a one-time test to determine the clinical management of a patient, including whether a woman can continue to be monitored or needs additional workup or surgical consideration. As a serial monitoring test, physicians would use Overwatch multiple times to follow up on the woman at natural mass status. These personalized risk scores will guide the physician decision to monitor the mass or to refer her for additional testing or surgery. We continue to follow and enroll patients in the prospective Overwatch multi-center clinical study via additional periodic blood draws As a result, we are collecting real-world evidence to support the use of Overwatch as a serial monitoring assay. We anticipate this phase of the study to be completed in the third quarter of this year. Moving to EndoCheck, our in-development non-invasive test to aid the diagnosis of endometriosis. We are making progress on both internal development efforts and the development program with a consortium of institutions led by Harvard's Dana-Farber Cancer Institute. Starting with our internal development process, we recently succeeded in identifying and cataloging a large number of patient samples from our own biobank. This is a significant milestone given the previous concerns about the adequacy of available samples needed for the development of our assays. We are in the process of validating our tests using those samples. We remain focused on the launch of the first-generation endometriosis assay in the second half of this year. With respect to our partnership with Dana-Farber, the endometriosis research collaboration continues to be productive. Through our collective efforts, we have obtained sufficient cohort data enabling us to move forward. This project is on track to meet expect development goals for 2023. Turning to the recent announcement on our partnership with Dana-Farber Cancer Institute, we are very excited to expand the collaboration to include the development of a microRNA-based ovarian cancer test. Because microRNAs are easy to extract from blood samples and appear earlier compared with other testing targets, like circulating tumor cells or proteins, they are a good target for an early stage diagnostic test. This new non-invasive molecular-based risk assessment test will become part of our over-sweep portfolio. We look forward to having a deeper discussion on our portfolio during the Investor R&D Day on May 21, featuring our physician collaborator, Dr. Kevin Elliott, a Harvard Medical School gynecology professor. I will now turn to Marlene for discussion of financial performance. Marlene?