Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to a Spira Women's Health Inc.' 's full year 2021 and fourth quarter 2021 conference call. My name is Kyle, and I will be your coordinator for the call today. 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 conference call is being recorded today. Leading the call today are Valerie Palmieri, Executive Chair of the Board, Nicole Sanford, President and Chief Executive Officer, and Bob Beachy, Chief Financial 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 defined under the Private Securities Litigation Reform Act of 1995 will be made during this call, including statements relating to a SPIRA's expected future performance, future business prospects, or future events or plans. Although the company believes that the expectations reflected in such forward-looking statements 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 the control of aspira the company assumes no obligation to update or supplement any forward-looking statements whether 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 factors set forth in ESPERA's most recent Form 10-K and our second quarter 2021 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 Valerie Palmieri, Executive Chair of the Board. Valerie?

Thank you, Operator. Good morning, everyone, and thank you for joining us today. As previously announced, I have been elevated to the role of Executive Chair of the Board. I look forward to leading the company at a higher level, and I will be working side by side with our new President and Chief Executive Officer, Nicole Sanford, who is joining me today to speak with each of you. As Executive Chair of the Board, I intend to focus on specific strategic imperatives and enterprise value drivers, including the launch of critical new products further development of Aspire's thought leadership, including key strategic commercial, scientific, and advocacy partnerships, as well as our clinical and scientific leadership via our KOL advisory boards. As president and CEO, Nicole will lead the business, execute strategic and operational plans, and scale and transform operational and functional areas to support our planned growth. We have forged a strong and positive relationship working with one another over the past year, and it has only gotten stronger since we took on our new responsibilities. We look forward to partnering with one another to drive strategic milestones while delivering growth, revenue, and profitability to all of you, our shareholders. In addition to the executive level changes, we have recently announced the appointment of Celeste Fralick, Ph.D., to our Board of Directors. Dr. Freilich recently retired as Chief Data Scientist at McAvee, where she was responsible for developing enterprise and consumer product analytics and data ecosystems for cardiomyopathy and neurostimulation. Dr. Freilich is an accomplished executive who brings over four decades of data strategy experience to the board. She brings a broad background in technology and specifically healthcare in several markets with customer and industry-facing experience. She has been recognized globally for cross-industry leading analytics, ideation, strategic leadership, and results-orientated competencies. In addition, Dr. Freilich was named to Forbes inaugural 2018 list of America's top 50 women in technology. I would now like to update you on some recent strategic developments, which we are very pleased with, before I move on to the 2021 review. As discussed in our March 2021 call, we entered into a strategic research collaboration agreement for the development and commercialization of a microRNA high-risk ovarian cancer early detection test with Harvard Dana-Farber Cancer Institute, Brigham and Women's Hospital, and the Medical University of Lutz. They have published on a novel microRNA panel, which we intend to use in combination with current technology. After completion of multiple experiments interrogating diverse sample sets and data sets, we have consistently found the technologies to be complementary, improving the accuracy compared to the microRNA and protein biomarkers alone. Based on this outcome data, we have met the success criteria together. This month, Aspira has exercised the option for an exclusive worldwide license of this cutting edge microRNA technology and will continue development of a novel combined assay utilizing a new platform as well. We believe the high specificity demonstrated by this technology coupled with our strong sensitivity of our technology has the potential to be the base technology for a diagnostic which will function as a test for women with a high genetic risk of ovarian cancer. the end goal for truly developing a personalized risk solution for patients who are genetically predisposed to ovarian cancer. The brand name for this study is Ovinherit. There will be more to come as we move forward with publishing our early data. Nicole will also discuss additional new pipeline updates in her remarks. I am now moving on to our recap. We believe Aspire Women's Health has effectively weathered the storm of the pandemic and is rapidly gaining momentum. We have delivered solid test volume recovery, improved price year-over-year considerably, added to our covered lives, and lastly made significant additions to our board and executive team. We continue to advance our product pipeline and strengthen our financial position in 2021. We accomplished five major milestones. Number one are Oval-1 and platform adoption. In terms of full-year 2021 metrics, volume grew 28% year-over-year. For Q4 2021, we performed 4,750 Oval-1 plus tests, which represented an increase of 23% compared to the same period in 2020 and an 11% increase sequentially compared to the third quarter of 2021. Looking forward, we experienced headwinds in January due to the surge in the COVID-19 variant, which resulted in a slower than expected start to the first quarter of 2022. However, over one plus volumes recovered quickly and are trending higher in February and March. Our units per day increased from about 65 in the first few weeks of January to about 91 in the first week of March, which is a new average record per day. October was our prior record of 81 tests per day. We believe this recent growth is a result of our ongoing commercial investments and increased patient visits, as well as improved COVID access. In addition to unit adoption, we also successfully entered into four Synergy contracts, of which two are with two of the largest independent women's healthcare groups in the U.S., with access to approximately 750 providers and 950,000 patients annually. The last contract we announced in January 2022 is a five-year contract with Axia Women's Health. The goal of these relationships is to allow our clients to offer our best-in-class clinical diagnostic testing services directly to their patients via our universal platform. We believe this will provide a significant growth as we gain the ability to touch more providers through the larger provider bases that are associated with larger Aspira Synergy customers. Our platform strategy is key to mass adoption coupled with our direct-to-provider strategy. The number of base ordering physicians increased to approximately 3,216 for the fourth quarter of 2021, representing a year-over-year increase of 23% and a sequential increase of 10% for the quarter. The total number of new physicians in the fourth quarter of 2021 was 584, an increase of 25% over the same period in the prior year, and we noticed significant new customer increase of 32% sequentially versus the third quarter of 2021. I am now moving on to our second major milestone, which is payer and price improvement. Full year for 2021, in comparison to full year of 2020, grew by 45%, while total price per unit, including Medicaid, improved 13%. Without Medicaid, the price improved to $414, which is a 15% improvement year-over-year. We also reached 194 million covered lives, representing 59% of the lives in the U.S. We believe inclusion in the AIM and Evercore guidelines provides us with further validation and credibility in our discussions with all payers. We expect this momentum to continue as we prepare to submit the latest evidence on Oval 1's clinical utility with 12 to 24-month outcomes. We plan to share more on this in 2022. On the Medicaid front, we added a total of 6.9 million lives with the addition of New York State, New Hampshire, and Washington, D.C. Having this coverage in place is critical to managing the underserved population, as we believe Oval-1 is the only technology available today that has adequate sensitivity for early-stage ovarian cancer risk detection specifically in black women. With New York State, this brings our total credentialed Medicaid population to 61 million Medicaid lives, which is over 80% of the US Medicaid population. I'm now moving on to our third milestone, which is government support and momentum following our two congressional briefings in 2021. We actively engage with members of Congress and several noteworthy advocacy organizations including Healthy Women, the National Ovarian Cancer Coalition, the Ovarian Cancer Research Alliance, and the Black Women's Health Imperative in an effort to increase awareness about Oval-1 and ovarian cancer. Our goal was to encourage legislation to provide financial support for additional clinical trials as we focus on diversity in trials. We also started the discussions on the trial requirements for adding the company's ovarian cancer technology into guidelines, such as the U.S. Preventative Services Task Force, which would support the company's objective to launch a product that is broadly applicable for women with a high genetic risk for ovarian cancer. In addition, we are laying the groundwork for a bill for national coverage determination for Medicare for Oval 1 as part of expanding access. Our work with these representatives, our congressional briefings, and other advocacy work, including with members of the Appropriations Committee, has supported the NIH's recent funding increase of 25% for ovarian cancer research and the Department of Defense's congressionally directed medical research program's increase in funding for ovarian cancer of 29%. We were very pleased with these recent results and the speed with which the government took action. Further, in response to President Biden's recent outreach to industry for suggestions on how we can better identify cancer early as part of the Cancer Moonshot 2.0 initiative, the companies had correspondence with the Biden administration to support the inclusion of early detection technologies for ovarian cancer among its key priorities. I am now moving on to the fourth milestone, which is our publication progress. We completed a paper which has been published in a special edition of Diagnostics entitled Salvaging Detection of Early-Stage Ovarian Cancer Malignancies when CA125 is Not Informative. In a retrospective study of 2,305 patients, over one detected over 50% of the ovarian malignancies in premenopausal women that CA125 would have missed. Over one also correctly identified 63% of the early stage cancers missed by CM125. This paper further validates and supports the superior early stage detection of ovarian cancer versus CM125, the most common test used today in a large population. In addition, we have several other key manuscripts in submission, more to come on this front. Our last milestone, is our strategic partnerships and study collaborations, which finished the year with three major ones, in addition to the Harvard Dana-Farber Cancer Institute. The first one centers around endo-check products. We execute an agreement with Abziva SA, whereby they provided us a sizable specimen and data bank from their therapeutic trials. We now have trial specimens from two of the three pharmaceutical companies, and these specimens will support our development of our endo-check products. Our second is our platform partnership with Genox. This partnership will enhance our data and biobank platform. Genox and Aspira seek to tackle the most difficult diseases in women's health, and this platform should allow us to reduce the development time for potentially groundbreaking data solutions. And third is our key partnership with Northwell Health. This study will enroll over 600 prospective women with ignexal masses. The study will also enroll 2,000 women at high-risk for ovarian cancer, either due to personal or family risk of cancer or carriers of a germline variant associated with hereditary breast and ovarian cancer syndrome. Northwell is the largest healthcare provider in New York State and treats over 2 million patients annually and employs over 16,000 credentialed physicians. As you can see, our overall goal was to merge from the three phases of pandemic operationally stronger, and we believe we did just that. We believe we are well positioned to grow, scale, drive adoption, and most importantly, save lives. I am now pleased to introduce our new president and CEO, Nicole Sanford. Nicole?

Thank you, Valerie. Before I start, I'd like to say that it has been an honor to assume the role of Chief Executive Officer and to continue working closely with you to achieve our mission. As I've transitioned from board member to leader, my respect for the team of talented professionals that you have assembled has only grown. Your leadership has certainly set the stage for an outstanding future for the company. I'm now going to spend a few minutes providing an update on our strategic priorities and the path forward for 2022. Our theme this year is focused execution. We've made a number of critical investments, and now is the time to capitalize on those efforts. I intend to do that through focused execution in three areas, growth, innovation, and operational excellence. Starting with growth, you've already heard from Valerie about the increases in new physicians and volume from our existing physicians in 2021, despite several distinct COVID surges that challenged our field sales team throughout the year. We're learning to live with COVID and intend to improve our response and recovery to flatten the volume curve should additional variants cause disruption in 2022. I intend to work with the team to mine our learnings and ensure that we continue to see improvements in our sales-related metrics regardless of COVID disruptions. Staying with growth for a minute, you'll recall that we brought on Michael Newton as our new head of commercial, and I'm happy to report that he's already making a big impact. Drawing on his over 20 years of diagnostic healthcare sales experience, Michael helped to execute a commercial strategic refresh and reorganization in February of 2022 to enhance our national sales force and drive the accelerated adoption of O01 Plus as the standard of care for early risk detection of ovarian cancer in women who have been identified for surgery. This strategic refresh is aimed at positioning us to take full advantage of our commercial scale-up over the past 18 months focusing on the most promising territories and rationalizing sales reporting structures. Early indications are that it was the right approach to achieve our growth plans for Oval1+, and to set us up for the successful launch of Overwatch, which we expect to occur in the second half of the year, 2022. And it is already working. Daily volumes in Q1 2022 have surpassed daily highs from 2021, as Valerie mentioned in her remarks. Let's shift gears to innovation. As you know, we've invested in building a pipeline of products that provides women's health care providers with a broad set of solutions for patients with a range of gynecological diseases. As a reminder, many of the products in our pipeline are expected to be launched as LDTs, or lab-developed tests, and it may be helpful to provide some additional background context on LDTs before going into specific products. LVTs are a class of in vitro diagnostic device that is designed, manufactured, and used within a single laboratory. Currently, the majority of novel technology and genetic tests are LVTs. Estimates for the number of LVTs in the U.S. range from 60,000 to 100,000 plus, with between 15,000 and 20,000 of those falling under moderate or high risk for FDA classification. In comparison, there are less than 500 FDA-cleared moderate to high-risk tests on the market. LVTs are often used to test for conditions or diseases that are either rapidly changing or that are the subject of quickly advancing scientific research. So, the LVT approach might be the best approach in an evolving technology situation, and it allows for ongoing improvement in machine learning algorithms. With that in background, I will provide an update on Overwatch, our next generation ovarian cancer test. An ovarian cancer risk assessment test for women who present with an anexal mass, Overwatch will be launched as an LBT in two stages. Phase one is a single use point in time test and phase two will allow for serial monitoring. We will focus on advancing to the commercial phase of the Overwatch launch plan including driving provider adoption during the second half of 2022. We believe the single-use product has the potential to triple the addressable market over Oval1 Plus, our current ovarian cancer test. The launch of the serial monitoring test remains targeted for 2023 upon publication of data from the ongoing prospective serial monitoring clinical study. Now let's move on to EndoCheck, our non-invasive aid in the detection of endometriosis. As we previously reported, we have received two pharmaceutical companies' specimen contributions, which we believe demonstrate the critical need for a diagnostic test. The collaboration between each of Obziva SA and Abdi Inc. with Aspira represents a mutual dedication to create solutions to help the 6 to 7 million women in the U.S. suffering from endometriosis by radically improving the time to diagnosis, as today it may take 7 to 10 years for a diagnosis. We believe EndoCheck, our in-development diagnostic test for endometriosis, will enable earlier detection, more effective treatment, and perhaps avoid unnecessary surgery. We previously announced the dual-track approach for the launch of EndoCheck as either an LDT or as an FDA-designated breakthrough device, and we continue to pursue both paths at this time. Accelerating EndoCheck is a top priority for the company in 2022. In summary, our pipeline is advancing and is a priority for me and the entire company, which will be aided significantly by the expansion of our relationship with the Harvard Dana-Farber Cancer Institute. With respect to operational excellence, the entire company is focused on building the infrastructure we need to sustain our growth through 2022 and into the future. We are also very focused on the stewardship of our resources on behalf of our shareholders. including the appropriate allocation of cash to those activities that are most likely to drive our immediate and longer-term growth, and as importantly, shorten the distance to positive cash flow. We are a fast-growing company that is developing complex women's health products, and as you might expect, there are opportunities to enhance the efficiency of our operations. It is important to note, however, that we are facing the same tight labor conditions as the rest of the industry. We are working hard to retain our top talent and avoid costly turnover, but we expect that to be a challenge for most of the coming year. Before I hand off to Bob to provide a financial update, I want to take a moment to acknowledge Kylie Zager, our Chief Operating Officer, who has decided to leave the company to pursue another opportunity. We are grateful to Kylie for her dedication to Aspira and wish her the best in her future endeavors. And now over to you, Bob.