Aspira Women's Health Inc.

Good afternoon, ladies and gentlemen, and welcome to the Aspira Women's Health First Quarter 2021 Conference Call. My name is Rob, and I'll 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 to your questions. As a reminder, this conference call is being recorded today. Leading the call today are Valerie Palmieri, President and Chief Executive Officer, Bob Beachy, Chief Financial Officer, and Kylie Zager, Chief Operating Officer. Dr. Leslie Northrup, Chief Scientific Officer, and Dr. Elena Ratner, Global Chief Medical Advisor, Clinical and Translational Medicine. After the prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to Aspera's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. 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 the control of Aspera. 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 ISFARA's annual report with the SEC for a description of factors that could cause actual results that differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Valerie Promire, President and Chief Executive Officer. Valerie?

Good afternoon, everyone, and thank you for joining us today. This afternoon, we will review our first quarter accomplishments, financial performance, as well as provide an update on Q2 developments, including... our first Aspira Synergy executed agreement with a very large women's health network, an endo check update, a strategic study agreement with the largest healthcare provider in New York, our confirmed acceleration of our oversight product launch for Q4 2021, and lastly, a new addition to our executive team. Our end in mind is to transform women's health starting with ovarian cancer. Our initial goal is to eradicate late stage detection of ovarian cancer and ensure that all of our solutions will meet the needs of all women of all ages, race, ethnicities, and stage of disease. Our core patient goal is to develop a lifelong relationship with each patient from puberty to cure, ensuring each woman has access to the best-in-class diagnostics. We at Aspira aspire women to take control of their gynecologic health and empower providers to deliver optimal care. I would now like to update you on six recent developments in the second quarter. First, Aspira Women's Health is announcing today that it has executed an Aspira Synergy Agreement with one of the largest women's health networks whereby the over one plus testing will be performed in their laboratory with data interpretation by Aspira. The health network employs 300 plus physicians and is responsible for 500,000 patient visits per year. We are extremely pleased with this development and milestone This is a fundamental building block to changing the standard of care. Number two, I will provide an update on EndoCheck. We are in very productive communications with the FDA regarding our breakthrough request. The FDA has acknowledged that there are many compelling reasons why this type of device is needed for both the treating physicians and for patients. The FDA indicated that they are very interested in continuing to work with Aspira on EndoCheck and Aspira will be continuing our discussions with the agency on the breakthrough device designation. Number three, we are very pleased to announce we initiated a prospective clinical study for benign risk monitoring and high-risk early ovarian cancer detection with Northwell Health. This is a study with the science arm of Northwell Health, which is the Feinstein Institute for Medical Research. Northwell is the largest private healthcare provider in New York State. Today, Northwell treats over 2 million patients annually and employs over 16,000 credentialed physicians. Number four, we are reaffirming the acceleration of the target launch date of oversight to the fourth quarter of 2021. This test will initially will allow physicians to assess benign pelvic masses with much better performing technology versus CA-125. In our next revision, we will allow a mass to be monitored over time. This new test will leverage its high negative predictive value to assist in rule out, as well as its high positive predictive value to assist in risk of malignancy. The first review of this product's data will occur at the American Society of Clinical Oncology, better known as ASCO, at their 2021 meeting, which will be held virtually on June 4th. Number five, we are building a strong patient provider and payer awareness foundation. Awareness, education, and advocacy is the key to changing the standard of care. We are establishing a foundation with clinical social media influencers, participating in congressional briefings, and establishing a social media strategy with patients and clinicians. Kylie and Dr. Ratner will discuss further in their sections. And lastly, we are extremely pleased to announce we have added a diagnostics industry leader to the team to round out the breadth of experience needed to achieve our short and long-term objectives. Greg Richard joined the company as head of corporate strategy, reimbursement, and managed care. In this role, Greg will be responsible for our overall corporate strategy, enhancing our blueprint for reimbursement for the company's current products, as well as the new products and services in our robust pipeline. He will lead our overall managed care and managed market strategy as we expand into integrated healthcare systems and leverage the company's recent successes in gaining coverage for over one with New York State Medicaid and other important payers. In addition, he will also be responsible for managing the internal revenue cycle management team and will support the company's strategic business development initiatives. Greg has served in several senior executive leadership positions at Interpace Diagnostics, Quest Diagnostics, and LabCorp. Before I turn the call over to Kylie to provide a commercial update, As previewed on our fourth quarter call, our test volumes were sequentially flat in the first quarter versus fourth quarter 2020. This was due to the continued COVID restrictions and weather disruptions. I am pleased to report we are gaining traction in March, April, and May, and we see increased patient access, patients returning to the doctors, coupled with our increased commercial investment. This is promising as 24% of our territories still have less than 50% access to offices due to COVID. And with COVID reducing in the U.S., we are hopeful that things will continue to improve. If COVID continues to stay in check, we are confident our commercial momentum will continue as we continue to invest in our commercial organization, drive adoption, and prepare for a larger sales footprint for oversight commercialization in Q4 2021. In summary, we continue to work towards our overall strategic goal, which was to emerge from the pandemic stronger and we believe we have accomplished this with our stronger team, our stronger financial position, and our stronger pipeline. We are well positioned to invest, to grow, and to drive adoption, and most importantly, save lives. I would now like to turn the call over to Kylie Zager, our Chief Operating Officer. Kylie?

Thank you, Valerie. We have studied the complexities of how ovarian cancer presents through the patient journey and have mirrored our go-to-market strategy to capture that journey and intersect the patient prior to late stage diagnosis. One year ago, we had two-pronged approach with the direct sales channel and a decentralized platform channel. We are proud to announce that we added to the direct sales channel a new healthcare system sales team. They include a dedicated dual sales and integration team as the health system team that will integrate our technology into the clinical pathways across various ologies that intersect ovarian cancer patients and integrate into the complex workflow environments of these systems. With over 80% of physicians anticipated to be owned or affiliated by health systems by 2023 and our large target launch of oversight, which we expect will be actively deployed in the health system, we are confident that these strategies are critical and timely for our organization. We are actively constructing our team of healthcare industry experts who have a strong history of disrupting current standards of care and we are attracting nearly double the size of the commercial and operations organizations by the end of Q4 2021. Our integration team comprised of highly experienced healthcare executives with informatics expertise. This team is working to drive integration within the health system and create seamless workflows for adoption of our products. We are working with a number of institutions and believe this approach will enable the Aspira suite of products to gain adoption and become the standard of care. Regarding our decentralized platform channel called our Synergy Salesforce, we are happy to announce Aspira Women's Health is announcing today that it has executed an Aspira Synergy agreement with one of the largest women's health networks, whereby the OVA1 plus testing will be performed in their laboratory with data interpretation by Aspira. The health network employs 300 plus physicians and is responsible for 500,000 patient visits per year. We are extremely pleased with this development and milestone. This is a fundamental building block to change the standard of care. We expect Synergy to also expand access for all Aspira commercialized products, and we will expect that the future pipeline innovations will be blended into the Synergy platform. We are now poised for growth to allow standard of care adoption of both OVA1 Plus and Genetics as a solution offering. Finally, the glue to our strategy is commercial activation of the market and awareness of the greater population. We believe in increasing awareness as a critical factor to driving adoption. We have expanded our digital marketing presence and have acutely invested in commercial activation over the last two quarters. In addition, we were present at ACOG and SDO held virtually in 2021 and will be presenting our oversight abstract at ASCO in June. The number of over one plus tests performed increased 3% to 3,775 over one plus tests during the three months ended March 31st, 2021, compared to 3,654 over one plus tests for the same period in 2020, which was slightly down on a sequential basis. COVID-19 restrictions have continued in the second quarter. We are gaining traction quarter to date. April volumes were a record month for the company. Also, we just received New York State Medicaid coverage as of April 1st, 2021. So we are just starting to gain traction in this market. In terms of ordering physicians for the first quarter, 2,595 physicians ordered over one plus. The number of ordering physicians was essentially flat from the fourth quarter levels. As we continue to focus on larger health systems to generate adoption and lay the groundwork for new product introduction, I would like to note that we are receiving orders from 65% of healthcare institutions listed in the top 20 of US News and World Report Best Hospital Honor Rule. This supports the foundational use of OVA1 Plus and demonstrates the potential to drive standard of care adoption as we expand our health system commercial team. I would now like to hand the call over to Dr. Alaina Ratner to provide an update on our momentum to becoming the standard care and driving the awareness of our technology and its impacts on early stage risk detection of ovarian cancer, particularly in racial and ethnic diverse populations.