Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to a Spiral Women's Health Incorporated third quarter 2021 conference call. My name is Paul, 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, President and Chief Executive Officer, Bob Beachy, Chief Financial Officer, and Dr. Leslie Northrup, Chief Scientific Officer. 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 question and answer session relating to Aspire's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Security 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 that 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 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 ASPIRE's most recent annual report and second quarterly filed report with the SEC, or a description of factors that will cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Valerie Palmieri, President and Chief Executive Officer. Valerie?

Thank you, Operator. Good morning, everyone, and thank you for joining us today. This morning, we will review our third quarter 2021 accomplishments, financial performance, as well as provide an update on our core strategic developments. Our end in mind is to truly transform women's health, starting with ovarian cancer. Our goal is to eradicate late stage detection of ovarian cancer and ensure our solutions will meet the needs of women for all ages, races, ethnicities, and stages of disease. We seek to develop a lifelong relationship with each patient from puberty to cure, ensuring each woman has access to the best in class diagnostics. This morning, I'd like to make comments on our core operations, provide an update in our pipeline, as well as an update on managed care progress and our government affairs initiative. First, I would like to address a recent departure from our board, Dr. Sandra Brooks. Dr. Brooks, has resigned due to family reasons, which limits her time and availability. We wish Dr. Brooks well as she deals with the family situation and thank her for the many insights and support she has provided our team. I am now going to begin with a review of our core business. We are reporting third quarter over one plus revenue of 1.6 million, an increase of 33% over the same period in 2020, and 6% decline sequentially from the second quarter of 2021. This is a result of significant COVID-related access restriction in July and August 2021 in key markets. Our Over 1 Plus product volume was 4,281 tests, which represented an increase of 19% compared to the same period in 2020 and a 6% decrease sequentially compared to the second quarter of 2021. We believe our 2021 Q3 product volume was significantly impacted by restricted access and customer office closures in the summer timeframe, and specifically in high volume areas such as Michigan, Florida, New York, and Kentucky. In these areas, our team had an 18% reduction in volume and a 19% reduction in physician events as a result of COVID. In terms of COVID access, we categorize each sales territory relative to access restrictions with a green, yellow, and red designation. This represents over 90% access for green, between 55 to 75% access for yellow, and under 50% access for red, respectively. At the end of the third quarter, the green territory is represented only 13% access. yellow was 66% access, and red was 20% access overall. The total number of ordering physicians in the third quarter of 2021 was 2,914, an increase of 20% compared to the same period in the prior year, and essentially flat sequentially from Q2 2021. The total number of new physicians in the third quarter of 2021 was 444, an increase of 13% over the same period in the prior year and up slightly sequentially from Q2 2021 or 1.6%. Both total and new customers in Q3 2021 were impacted due to decreased access due to COVID. Volumes are starting to pick up and are trending higher in September and October with a volume on a units per day basis of 63.2 in July, 66 in August, 71.6 in September, and 81.1 in October. We believe this recent growth is a combination of our commercial investment as well as increased patient visits. For October, we also had a record number of new physicians of 214. As we have previously shared, one of our strategic objectives is to increase awareness of our brand and product to drive adoption. Our marketing function has implemented a series of new strategic digital initiatives, including paid search, social, and display media. Some of the key statistics we are tracking are as follows. Paid search has driven over 35,000 clicks to the website since launch in May. This is a click-through rate of 2.67%, which is above average. Social media engagement on media platforms such as Facebook, Instagram, and LinkedIn have increased triple digits year-to-date, and our followership has increased double digits on a year-to-date basis. Our display media helped drive awareness and created a halo effect that made our page search more effective. As a result of these initiatives, website traffic is up triple digits on a year-to-date basis with a 239% increase in new users. In addition, organic search is up 761% on a year-to-date basis. These stats indicate that our initiatives are growing our awareness. In addition, we are focusing on select geographies and have seen progress as a result of a multiple front approach in some beta markets in Q3. This includes marketing support with commercial activation, KOLs, strategic partnerships, digital media, and paid media. More to come on this front. I'm now moving on to review our decentralized software algorithm platform known as Aspira Synergy. We are making progress in our implementation phase for two of the largest gynecologic networks in the U.S. We recently announced we have entered into additional technology transfer agreements, which now include a total of four technology transfer agreements since the launch of Aspira Synergy. Two of the agreements are with two of the nation's largest and leading independent women's healthcare groups, incorporating more than 750 providers and more than 950,000 patients annually. The other two agreements, which are in the implementation phase, are with two independent laboratories providing service across five states. Dr. Northrup will share further comments shortly. I will now move on to provide an update on our core strategic developments regarding our pipeline, payer and evidence development, as well as government affairs. First, I will start with our pipeline of products. Our pipeline is built for aiding gynecologic health providers with personalized solutions during the entire patient life cycle, starting with benign disease, such as endometriosis, to ovarian cancer diagnostics, to suspected benign mass management, and ending with women who are planned for pelvic mass surgery. I am now going to start with our endometriosis update as well as our EndoCheck breakthrough device program application. As we previously reported, we have two pharmaceutical company specimen contributions which demonstrate the critical need for a diagnostic test. The collaboration between each of Obziva SA and AbbVie Incorporated with Aspira represents a mutual dedication to create solutions to help the six to seven million women in the US suffering with endometriosis by radically improving the time to diagnosis as today it may take seven to nine years for a diagnosis. We believe EndoCheck will allow patients to have their endometriosis detected earlier and potentially to be treated more effectively and perhaps without the need for unnecessary surgery. In late October, the FDA Center for Devices and Radiological Health issued an updated guidance for the content of premarket submission for software contained in medical devices. specific to artificial intelligence machine learning-based software as a medical device action plan, which will provide a much-needed framework for such Aspira future devices. We are currently working to ensure our EndoCheck development process is aligned to the proposed framework. We are still in communications with the FDA regarding our Breakthrough Device Program application. Importantly, 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. As discussed previously, the FDA indicated they are very interested in continuing to work with Aspira and EndoCheck, and we will continue our discussions with the agency on the breakthrough device designation. We believe EndoCheck will allow patients to have their endometriosis detected earlier, enable their physicians to further personalize their treatment plans, and potentially enable more effective treatments without the need for unnecessary surgery. We expect to make a determination on our optimal regulatory path forward by the end of this year. I am now moving on to our second technology I'd like to update you on, which is our proof of concept study, which we've been working diligently with the teams at Dana-Farber, Brigham and Women's, and the University of Lutz. The evaluation has met the acceptance criteria, and based on the outcome data, the Aspira Innovation Team, along with the collaborators from the institutions, have begun the implementation of phase two. I am now moving on to oversight. We have determined that we will be branding the test as Overwatch, which we believe is more descriptive of the utility of the test. The test was developed through a rigorous scientific and clinical-based process based on data from New York State LDT and from our FDA regulatory processes in over 3,000 patients. As you know, we have estimated this product would launch in Q4 2021. As part of the process, we need to do additional scientific and market review. We are just wrapping up an analytical validation manuscript and will be submitting it to a peer-reviewed journal. In effect, our goal is to have more than one peer-reviewed publication with robust data prior to launch. As this careful work progresses, we will adjust our scheduling accordingly. To that end, we are also continuing our prospective serial monitoring clinical study and ultimately plan to publish data demonstrating the clinical validity of Overwatch as a serial monitoring test by the end of 2022, early 2023. We believe this product has the opportunity to have three times the total market opportunity as Overwatch, not including the serial monitoring option. I am now moving on to an update regarding our payer and evidence development, and we have a number of updates. During this past year, we have been working on a large 12 to 24 month outcome study of over one clinical utility. This study is specifically aggregating and analyzing data from the multiple sites that are participating in the study. The data from the study sites will represent a broad section of the country in a diverse population of women. The company expects to submit a manuscript to a peer reviewed journal with the results in Q1 2022 and publish and Q2 to Q3 of 2022. The purpose of this study is to demonstrate the impact over one testing has on patient outcomes compared to the broadly used CA-125 single marker assay using 12 to 24-month follow-up data. It will measure the impact over one has on patient care, including both clinical and cost measures, which will be included in the published results. This manuscript will be supplementing our current peer review publications including the over one impact on the quality adjusted life year paper and our budget impact model paper for payers. I am now moving on to our clinical benefits guidelines as we discussed on our last earnings call. Over one technology is now considered medically necessary according to AIM's specially held clinical appropriateness guidelines. Notably, they have not included a competitive product called ROMA in their guidelines and consider it still to be investigational and experimental. AIM is a member of the Anthem Blue Cross Blue Shield family of companies which promotes optimal care through the use of evidence-based clinical guidelines and real-time decision support for both providers and their patients. We have commenced a targeted program to obtain contractual coverage with all of the AIM member plans. We have now increased our covered lives during the third quarter to a total of 194 million. This is an 8% increase from our prior reported base of 179 million covered lives. In addition, we are making strong progress on the Medicaid front, as Aspira is now credentialed in the top five states by Medicaid population, which are ranked in the order of Medicaid beneficiaries. They include California, New York, Texas, Florida, and Pennsylvania. bringing the total credentialed national Medicaid population for over one to nearly 61 million, which represents approximately 77% of the total U.S. Medicaid population. In addition, as an adjunct to the recently announced coverage of over one by the state of New York for its Medicaid population, two of the largest managed Medicaid plans in the state of New York have adopted a favorable policy for over one, and are now under contract to provide access to OVA to an additional four million covered lives throughout the state. Specifically, we have entered into an agreement with Health First, New York's largest not-for-profit health insurer, offering Medicaid plans, Medicare Advantage plans, qualified health plans, and individual and small group plans. Health First serves 1.7 million members in New York City, Long Island, Westchester, Sullivan, Orange and Rockland counties. Health First is a pioneer of a value-based healthcare model where hospitals and physicians are paid based on patient outcomes. We have also entered into an agreement with Fidelis Care, which is one of the largest managed Medicaid plans in New York with 2.3 million covered lives across the state. Further, Aspira Women's Health is now contracted with Highmark of Delaware for their Medicare Advantage membership. This will ensure that women in this plan will have access to the over one technology. Overall, our market access strategy is making significant progress with our reaching 194 million covered lives, representing 59% of the lives in the U.S., and we believe inclusion in the AIM and EvoCorp guidelines, along with the increased access to both Medicaid and Medicare Advantage plans, 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 over one's clinical utility with 12 to 24 month outcomes. I am now moving on to our government affairs front. We are continuing to gain momentum following our congressional briefings in March and September of 2021. The company is actively engaged with members of Congress and several 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 and encourage legislation that provides financial support for additional clinical trials as well as our focus on diversity in trials. This also includes discussions on trial requirements for adding the company's ovarian cancer technology into guidelines, such as the U.S. Preventative Services Task Force's which would support the company's objective to launch a product that is broadly applicable as a high-risk screening tool in time. We are also engaged with multiple state legislators about Medicaid in their states, as well as national coverage determination for Medicare for OVA as part of the expanding access. In addition, the company is also working on the Medicare Innovative Technology Initiative to obtain coverage and reimbursement immediately following any FDA breakthrough approval for any of its products. In summary, we continue to work on our overall strategic goal, which was to emerge from the pandemic stronger. Our team is now much stronger on all fronts with a solid financial position. We believe we are well positioned to invest, to grow, and to drive adoption, and most importantly, save lives. I would now like to hand the call over to Dr. Leslie Northrup to provide an update on our momentum to becoming the standard of care and driving the awareness of our technology. Dr. Northrup?

Thank you, Valerie. In support of our multi-omic approach to developing diagnostic tests in women's health, we have entered into a partnership with GINA, one of the world's largest community-driven genomic data platforms, to develop solutions to advance women's health and rapid results diagnosis, and insights. Genox's global platform brings together all publicly available genomic information, allowing for the complete analysis of the data and better patient care. We plan to leverage this knowledge base to expand our proprietary algorithm development across multiple product lines. Further to Valerie's comments on our high-risk early detection programs, I would like to update you on is the proof of concept study we have been working diligently with the teams at Dana-Farber, Brigham and Women's, and University of Lutz. This study included specimens from our enriched biobank. One-third were malignant across all stages, as well as benign and healthy controls. We were able to quantify the microRNA expression levels and confirm that the microRNA biomarkers demonstrated the same performance in our independent sample set as previously published in the eLife publication in 2017. The evaluation met the acceptance criteria and based on the outcome data, the Aspira innovation team along with the collaborators from the institutions have begun implementation of phase two. With this initial stage gate passed, the team is proceeding to evaluate the combined potential impact of our protein biomarker algorithms coupled with this new microRNA technology in the development of this assay on a new platform, which we believe will set the foundation for a non-invasive diagnostic in ovarian cancer. We plan to further validate the same technology as a high-risk ovarian cancer application in genetically predisposed women, which is currently in a clinical study for OVA Inherit. We anticipate that we will have preliminary data in early 2022 to support the verification of a multi-omic approach in detecting ovarian cancer. Please keep in mind this is a long-term phased product, and we are delighted to be working with world-class institutions in the development of this assay, which we believe will have a significant impact on women's health and ovarian cancer. We continue our utmost commitment to increasing provider awareness and education through our medical affairs team. This team has hosted multiple successful, highly attended educational series and are currently launching gynecologic and gynecologic oncology advisory boards directed at better management of pelvic masses and improvement ovarian cancer early detection. Regarding clinical studies, we are continuing to recruit more academic sites to support both the clinical validity and utility of our tests. We have also launched our physician-initiated research program for healthcare systems. I am incredibly excited about the direction of our clinical studies, and we continue to build our study program to strengthen the data around our products. We have recently completed a study combining data from our Philippines and U.S. clinical studies of diverse race and ethnicities. Preliminary data supports that use of single biomarkers such as TA125 and HE4 has varying average values across different ethnic groups, resulting in increased false positive and false negatives of ovarian cancer malignancies. These biomarkers were validated in Caucasian populations as were their standard cutoffs, which do not translate to non-Caucasian women. The abstract is in the process of submission to ACOG. I would now like to hand over the call to Bob to provide our financial update. Bob?