Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to Aspira Women's Health Inc's second quarter 2022 conference call. My name is Bikram, 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 call is being recorded today. Leading the call today are Nicole Sanford, President and Chief Executive Officer, Bob Beachy, Chief Financial Officer, and Dr. Ryan Fan, Chief Scientific Officer and Chief Operating Officer. After the prepared remarks, we will open the call for Q&A. Before we begin, I'd 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 manufacturers beyond the control of Aspira. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise expect as required by law. Participants are directed to cautionary note set forth in today's press release. as well as the risk factors set forth in ASPIRE's most recent Form 10-K filled 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.

Thank you, Operator, and thank you, everyone, for joining us today. We are very pleased to provide an update on our progress in the second quarter. Joining me on the call today are Bob Beachy, our Chief Financial Officer, and Dr. Ryan Phan, our Chief Scientific and Chief Operating Officer. I will begin with an overview of our second quarter performance and an update on a number of important strategic developments. Dr. Phan will follow with an update on our product pipeline before handing the call to Bob, who will provide a financial update. After our prepared remarks, we will then open the lines for a question and answer session. Last quarter, I shared my priorities for 2022. I told you then that my focus and the focus of the entire company would be on execution across three dimensions, growth, innovation, and operational excellence. While we still have much to do, I am happy to report encouraging progress in all three areas in the second quarter of 2022. Let's begin with an update on our cash utilization as it sets an important context for the rest of the conversation. When I joined the company, I made it a priority to align our spending and resources to the most important business needs. I asked my executive leadership team to exercise fiscal conservatism, but to do so without jeopardizing our strategic vision. We have made significant progress since then. In the second quarter of 2022, we utilized $6.4 million in cash, roughly 40% less than we utilized in the first quarter of 2022 and 16% less than the fourth quarter of 2021. This was a major achievement that required the attention of every Aspira team member, and I'm extremely proud of our progress. We achieved this reduction in utilization without sacrificing our growth or innovation goals, as you'll hear shortly. We continue to hire individuals to fill key roles, especially in the commercial and R&D organizations, and invest in the infrastructure required to increase our volume and deliver on our Aspira Synergy contracts. We plan to operate the business this way going forward. I'll ask that you keep that reduced cash utilization number in mind as Ryan, Bob, and I detail our second quarter achievements. First, let's talk about growth. In Q2, we broke through the $2 million revenue threshold for the first time in a single quarter with a volume of 5,411 tests performed. This represents an 11% increase in revenue over the first quarter of 2022 and an 18% increase over the same period in 2021. Our testing volume increased to 83 tests performed per day in Q2 compared to 75 tests performed per day in Q1. We achieved this growth while continuing to execute our previously disclosed commercial transformation, which I'm happy to report is largely complete. As of today, 67% of our sales professionals have been with the company for more than three months, and 58% have been with us for more than six months. In the second quarter of 2022, approximately 593 physicians ordered an overproduct for the first time, which is essentially flat with new ordering physicians in the first quarter. We aim to increase the number of physicians ordering for the first time and do more to drive repeat orders from existing physicians. The latter will be a focus area for the rest of the year. Bob will provide additional information about revenue and AUP later in the call. While I'm happy to see the uptick in volume, I'm far from satisfied with overall revenue growth. This quarter, I've spent time in the field with our reps and physicians, and I will continue to do so in the third quarter to better understand challenges to adoption and overall growth. Elsewhere on the growth front, Aspira and BioReference established a national collaboration to co-market and distribute Oval One+. BioReference is one of the largest full-service specialty laboratories in the United States, with a leading position in women's health, oncology, and urology, and 40 years of expertise in clinical diagnostics. We are targeting a launch of the arrangement no later than the fourth quarter of this year. It is our expectation that the relationship will drive incremental volume in 2023 and beyond. Both Aspira and BioReference are deeply committed to enhancing health outcomes for women, and I've found the cultures to be very complementary. I believe this is the beginning of a mutually beneficial long-term relationship, and I'm working hard to ensure a strong start. Separately, Aspira Women's Health has established a standalone agreement with Scarlet Health, an innovative mobile phlebotomy solution, providing collections for Aspira's patients from the comfort of their home. As an update to the Aspira Synergy platform rollout, we are encouraged by adoption from our first physician supergroup, which I am now able to identify as Women's Care. we were able to design and implement a commercially reproducible solution and playbook for future Aspira Synergy opportunities while implementing an arrangement that has helped both Women's Care and Aspira achieve their shared mission to expand patient access. Now turning to innovation, it is my pleasure to welcome Dr. Ryan Phan to our call for the first time. Dr. Phan, can I ask you to briefly introduce yourself and then provide an update related to our product portfolio including today's announcement of an expansion to our relationship with Harvard's Dana-Farber Cancer Institute and a number of other academic institutions to include endometriosis in addition to our ongoing collaboration related to ovarian cancer.

Thank you, Nicole. I am honored to join ASPRA, a chief scientific and operating officer, after many rewarding years in leadership at academic institutions, healthcare systems, and most recently at KDS. where I was the senior vice president of lab service and medical director. As a member of KDX leadership executive team, I led the commercial testing operation, clinical development pipelines, manufacturing, supply chain, regulatory affairs and compliance, and automation and engineering divisions. In addition, I served as the licensed medical director of the company's ClearCap laboratory, and played a key role in the growth and expansion of the company's testing revenues and portfolio. Prior to joining KDF, I was managing director and head of regional molecular genetic pathology and cytogenetics at Kaiser Permanente in Northern California. Before that, I was a faculty member of the University of California at Los Angeles and the Los Angeles VA Medical Center. I received my bachelor's degree from UC Berkeley and my PhD from Columbia University in New York. I completed my postdoctoral training at Harvard Medical School, where I was a Cancer Research Institute Fellow and American Society of Hematology Scholar. I look forward to working with everyone at ASPRA to strengthen our innovation efforts, accelerate the expansion of our product portfolio, and scale our commercial testing service as we move forward. Now let me turn to our product portfolio by reiterating our intention to launch Overwatch, our next generation of anticancer risk assessment by the end of the year. With a superior negative predictive value, Overwatch is non-invasive tests that provide additional data points for clinician initial assessment in women with anaxial masses. This lab-developed test will support physicians in making informed clinical decisions in the management of women with anaxial masses. Overwatch represents a significant expansion of our potential patient population when compared with our existing FDA CLEAR over 1 plus tests, which are only approved for use in women with masses that have been referred for surgery. We estimate the total addressable market for Overwatch to be three or more times the addressable market for over 1 plus. As we previously disclosed, our paper entitled Analytical Validation of a deep neural network algorithm for the detection of ovarian cancer were accepted for publication by JCO Clinical Cancer Informatics, while our ability to collect samples for the study was significantly impacted by COVID surge over the past two years. Today, I can report that we recently completed enrollment of our multi-site prospective study based on real-world data in support of our plan to launch Overwatch. we are in the final stage of analysis and are preparing a manuscript for peer review publication. We are satisfied that the data provided in the analytical and clinical validation study will be sufficient to write physician and payer adoption. Overwatch and Overwatch Plus will be marketed together as part of our newly reimagined ovarian cancer portfolio we have branded as Oversuite. Physicians will be encouraged to consider an Oversquid test for all women with anastomosis to provide a more informed clinical decision in the assessment and management of their patient's risk of ovarian cancer. In this regard, a single test requisition form of Oversquid will allow clinicians to determine which test is appropriate for their patient. We are on track to launch the product in the fourth quarter of this year. and expect to see meaningful volume from Overwatch during the early months of 2023. We can also report on our ongoing efforts to support research related to the impact of RAGE on the detection of ovarian cancer. Sponsored by ASPRAS clinical research efforts in the Philippines, a manuscript entitled Clinical Performance of a Multivariate Index Assay in Detecting Early-State Ovarian Cancer in Philippine or Women, has been accepted for publication in the International Journal of Environmental Research and Public Health in its special issue on ovarian cancer prevention and treatment. The study was designed to validate the effectiveness of a multivariate index assay, SIRS-A over 1+, in the assessment of ovarian cancer risk in Filipino women. As soon as the report is published, we will share it on our website. You will hear more about our switch of ovarian cancer offerings, including a presentation regarding the clinical application of over 1 plus and overwatch on August 24th at 12 p.m. Eastern Time, where Nico and I host a webinar with Dr. Charles Dunton, Aspera Chief Medical Officer, Dr. Nico Williams of the Gynecological Institute of Chicago, and Dr. Cheryl Riley of Axial Women's Health. An invitation to the event was distributed by life-size advisors. Registration details can be found on the Investor Relations page of our website. Moving on to our endometriosis product offerings, we are excited to announce that we have entered into a sponsored research agreement with Harvard's Daniel Farber Cancer Institute, Brigham and Women's Hospital, and Medical University of Los Angeles for the generation of a multi-armed non-invasive diagnostic ads to identify endometriosis based on circulating microRNAs and proteins. We will collaborate with this prestigious group of world-renowned institutions to identify candidate markers and build a series of diagnostic models for women being evaluated for possible endometriosis. We intend for the collaboration to be completed via phases and anticipate the total cost of the partnership to be approximately $1.2 million. The result of the technology to guide medical and clinical management of women without pelvic mass presenting with symptoms of endometriosis and to limit surgical evaluation for those cases where non-invasive tests are equivocal or in whom surgical accession of endometriosis is clinically indicated. This research collaboration agreement will build on our extensive R&D efforts and will expand our access to appropriate samples as well as scientific resources required to accelerate the commercialization of our EndoCheck diagnostic test. We believe this agreement helps to ensure a launch of an endometriosis diagnostic test in 2023, which continues to be our goal. We plan to host a second webinar to provide additional insight on our endometriosis test, and we will announce the timing of that webinar soon. I now turn to Bob Peachey for a discussion about financial performance. Bob?