Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to Aspira Women's Health Incorporated fourth quarter and year-end 2022 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. Leading the call today are Nicole Sanford, President and Chief Executive Officer, Marlene McLennan, Interim Chief Financial Officer, and Dr. Ryan Fahn, Chief Scientific and Operating Officer. 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 subjected to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the company's 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 could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I'd like to turn the call over to Nicole Sanford, President and Chief Executive Officer. Please go ahead, ma'am.

Thank you, Operator, and good afternoon, everyone. It is my pleasure to welcome you to our 2022 year-end conference call. Today, we plan to share with you highlights from a year of company-wide necessary change for Aspira Women's Health. Since stepping into the CEO role last year, I have said that achievement of our mission rested on focused execution in three areas, growth, innovation, and operational excellence. I made a commitment to be transparent with our stakeholders and to earn your trust by clearly stating our intentions and then following through. I've also given my word that I would utilize our resources, your capital, and our time as effectively and efficiently as possible in pursuit of the long-term success of the company. While it has not been an easy year, I am proud of our progress and believe we have emerged stronger than ever before. I hope you will feel the same before this call is over. Let me pause and introduce Dr. Ryan Phan, our Chief Scientific and Operating Officer, and Marlene McLennan, our interim chief financial officer. You will hear from each of them shortly with an update on our product portfolio and financial performance, respectively, before we open the call for questions. Let me start with an overview of our commercial progress in 2022. We grew product revenue last year to $8.2 million, a 20% increase over 2021. At the same time, we increased gross profit eight percentage points, and reduced sales and marketing expense by 13% on a full-year basis. Test volumes increased to 21,423, a 23% increase, continuing the sequential and year-over-year growth trends that we have sustained for every quarter since I became CEO. Oversuite test volumes have continued their upward momentum in the first quarter of 2023. Despite major weather events that caused weeks of delivery disruptions around the country, we saw dramatic daily volume growth in both January and February. In 2022, we rebanded our ovarian cancer portfolio under the name OvaSuite. Our Ova1 Plus test, which has now been ordered more than 60,000 times, continues to displace inferior but deeply entrenched single biomarker tests. With the successful launch of Overwatch in December 2022, we now offer a non-invasive risk assessment test for all of the more than 1 million women a year that develop an anexal mass. Our OvaSuite tests have the potential to replace fear with data when women and their healthcare providers make decisions about how, when, or even if they remove a woman's reproductive organs. With one of the most extensive ovarian cancer biobanks and decades of bioinformatics expertise, we believe there is no one better positioned to become the market leader in the development of the most advanced diagnostic tools for this devastating and deadly disease. Before moving on, I want to remind you that we face no competition in the market for Overwatch. It is a completely new risk assessment blood test with a clinically validated 99% negative predictive value that can significantly reduce the number of indeterminate masses and provides a previously unattainable level of confidence in a physician's decision about the care of their patient. We learned a great deal about our Oversuite sales and marketing strategies in the last year. In addition to completely rebooting our marketing program, we reallocated funds to high-impact provider conferences, streamlined our KOL program, and reworked our incentive plans to drive behaviors that result in provider adoption. In 2023, we will engage in more market-focused, high-impact media, starting with an interview on Lifetime Channel's morning show, The Balancing Act, in April. Last year, we announced an Oval One Plus co-marketing and distribution agreement with BioReference. Following an October launch, momentum among the joint sales teams has been slower than anticipated. However, we believe our partnership continues to be an important part of the women's health care program. We are working together to implement more effective sales incentives as part of a relaunch between the commercial teams. We intend to make the most of this experience and the lessons learned as we look towards the development of commercial partnerships for our other products, including Overwatch. On the reimbursement front, we are actively pursuing payer adoption and fair pricing for the OvaSuite test portfolio, hitting a number of important milestones in 2022. Starting with Overwatch, the American Medical Association moved quickly to assign Overwatch a unique PLA code, which will facilitate efficient coverage and reimbursement when it goes into effect in April of 2023. We also secured Overwatch coverage from an industry-leading global payer just two months after our official launch and only weeks after the publication of our clinical validation study. Meanwhile, we continue to press holdout commercial payers on Oval1 Plus coverage, adding Centene of Oklahoma and Molina of Ohio coverage in the first quarter of 2023. The Oval1 clinical utility study, which experienced significant COVID delays, has been completed and a manuscript has been submitted for publication. On the Medicare front, we joined with ovarian cancer advocacy groups to educate Congress on the failures of single biomarker tests and the need for better diagnostic tools to save women's lives. Our combined efforts resulted in the call for national Medicare coverage for multi-marker ovarian cancer tests in the omnibus spending bill passed late last year. While we continue to pursue the crosswalk of Overwatch coverage via our Novitas OVA-1 LCD, the implementation of this provision by CMS in 2023 would potentially provide a national coverage determination for all of our ovarian cancer testing portfolio. On the Medicaid front, we became credentialed in a number of additional states in 2022 and are actively engaged with Medicaid decision makers since launching Overwatch in December. Turning to our operational excellence initiative, we have aggressively reduced back office and discretionary spending and reallocated funds to activities that drive our strategic goals. We are a smaller, more nimble organization today compared to a year ago. We eliminated nearly 30% of the workforce, creating significant payroll and payroll-related savings that we will see in 2023. While this has meant that the team that remains must do even more to support our success, I know each individual shares a passion for our mission to improve outcomes for women with gynecologic diseases. Last quarter, we used $7.1 million in cash, a meaningful step down from the trajectory we were on at the beginning of 2022. We will continue to streamline spending while growing top-line revenues. In 2023, our cash usage for operations is expected to be between $16 and $19 million, a significant reduction when compared to the $32.3 million of cash used in operations in 2022. While this is meaningful progress, we recognize that our cash needs exceed our year-end cash balance of $13.6 million. We are actively identifying additional sources of liquidity and in February put a $12.5 million ATM in place with Cantor Fitzgerald. I'm confident in our ability to secure additional funding to meet our needs and in our ability to navigate these difficult market conditions without sacrificing revenue growth. That being said, our cash needs will drive how quickly we can move some of our programs, products, and activities forward. Now I will turn the call over to Ryan for a closer look at our product development and innovation progress.

Thank you, Nicole. I am proud to share that inspired challenges. We have found opportunities and have made significant progress in our growth and innovation goals. I will spend the next few minutes updating you on our overall product development and pipeline progress. Let me start with Overwatch, which will launch in December. Overwatch is the first and only of its kind non-invasive ovarian cancer risk assessment test. It provides healthcare providers with a personalized result based on seven biomarkers, age and menopausal status for women presented with benign and indeterminate anastomosis. Historically, physicians and patients might have chosen preventative surgery, potentially causing lifelong implications for women who have their ovaries unnecessarily removed with the launch of the overwatch. Clinicians are able to make better informed care decisions for women than they were previously possible. I am also pleased to say that the Overwatch Clinical Validation Manuscript was published in the peer-reviewed journal Frontiers in Medicine just a few weeks ago. This publication highlights real-world evidence to support the clinical usefulness of Overwatch in the management of anaxiomasis. It demonstrated Overwatch's high negative predictive value across diverse data sets and saw its utility as an effective assessment tool for clinicians to safely decrease premature or unnecessary surgeries. Enrollment in the prospective overwatch study has been completed. However, we continue to follow with the enrolled patient via additional periodic blood draws. As a result, we are collecting real-world evidence to support the second phase of the overwatch launch, a serial monitoring assay for women with anaxial masses who are not identified for surgical intervention. Let's move on to AndroCheck. or in-development tests for the identification of endometriosis. You may recall that we expanded our development activity in 2022. The results of our internal development of a protein-based test were expanded to consider a multi-omid, non-invasive diagnosis test via a sponsored agreement with a consortium of academic institutions led by Harvard Dana-Farber Cancer Institute. I will provide an update of each, starting with the internal efforts. While I am pleased that we have made much progress on the development of an effective assay, the speed of development and commercialization of any endometriosis test will depend on the availability and cost of usable high-quality samples that align with our test intended use. While we have recently succeeded in identifying and cataloging a large number of patient samples from our own biobank, additional samples from other sources will be needed to develop a commercially viable test. The search for sufficient samples continues, and we remain focused on the launch of the first-generation assay in the second half of the year. With respect to the sponsor research agreement with Dana-Farber, we are pleased to report that the development efforts with this group of scientists and collaborators are on track. Sufficient and highly qualified endometriosis patients and control cohorts will obtain it for this study, and the development efforts are well underway, utilizing a next-generation sequencing-based approach and proteomic analysis for the identification of microRNAs and proteins. We believe that the progress of this collaborative effort will meet our expected development goals for 2020-30. To support the development of an endometriosis diagnosis assay, our multicenter clinical study for endometriosis were designed and is currently enrolling patients to confirm the clinical performance of AndroCheck as a non-invasive tool to aid the diagnosis of endometriosis. This is a prospective observational study. We are pleased with our enrollment of sites and patients so far. We are closely monitoring progress and potentially competitive efforts both in the U.S. and globally, but are optimistic about the competitive positioning of our AndroCheck tests. We believe our experience with gynecology diseases and our ability to develop and validate a clinical assay in a clear laboratory setting offers an advantage over others. The strategy and approach for an endotracheal launch will be discussed as an R&D day that we plan to host on May 21st. We will also highlight the potential for the serial monitoring application of our Overwatch test. and set our plans for growing the Oversweep portfolio. It has indeed been a very dynamic and exciting time for Aspera. I've been with the company for less than a year and have focused on building momentum through the first phase launch of Overwatch and steady progress in the development of AndroCheck. I am confident in the progress we've made in the development of powerful products to help improve women's gynecology health. I will now turn to Marlene for discussion of our financial performance. Marlene.