Hello ladies and gentlemen. Good afternoon, and welcome to Aspira Women's Health Third Quarter 2020 Conference Call. My name is Jane, and I will be your coordinator for the call today. [Operator Instructions] As a reminder, this conference is being recorded today. Leading the call today are Valerie Palmieri, President and Chief Executive Officer; and Bob Beechey, Chief Financial Officer. After their prepared remarks, we will open the call for Q&A. Before we begin, I'd like to remind everyone that some statements made during the prepared remarks and the Q&A session, including statements relating to Aspira Women's Health 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 Aspira Women's Health. Except as required by law, the company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise. Participants are directed to the cautionary note in today's press release as well as the risk factors set forth in Aspira Women's Health Annual report on Form 10-K and Form 10-Q for the first and second quarters filed with the SEC. For factors that could 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 afternoon, everyone, and thank you for joining us today. We delivered a strong third quarter across multiple measures of success. Our revenue and volumes increased significantly over the prior quarter, rebounding to pre-pandemic levels in September ahead of our projected timing. We believe Aspira Women's Health is effectively weathering the storm of the pandemic and building on the momentum. We have delivered solid test volume recovery, improved price sequentially, added to our covered lives, and lastly made significant additions to our board, medical and executive team. We continue to advance our product pipeline and strengthen our financial position in 2020. We have also launched a digital and media campaign to strengthen our brand identity, as well as increased awareness of our test and its advantages of early detection of risk and racial disparity compared to CA125. We also recently received coverage from two investment bank analysts. We are very proud of this progress, and we'll expand upon each of these in turn. Starting with our team, we have made efforts to bring on a prestigious appointment to our board, and recently announced the appointment to our board, Dr. Sandra Brooks, MD, Senior Vice President and Chief Medical Officer at Thomas Jefferson University Hospital. Given Dr. Brooks longstanding research interest in health equity, she will be an invaluable resource in advising the company on driving awareness of racial and health disparities, as well as to drive overall adoption of the OVA suite of products into the care pathway. I would also note this appointment brings our board to majority female status, which we feel as important as a woman's health company. We have several additional announcements, we are adding Dr. Elena Ratner, Co-Chief of Gynecologic Oncology at Yale University School of Medicine as our Chief Medical Advisor. She is also serving as the Co-Director of the ovarian cancer early detection program for women. That is part of discovery to cure. Yale medicines initiative focused on combating all reproductive cancers. This initiative resonates totally with Aspira's company's mission envision. In addition to Dr. Ratner, we have added Dr. Gary Altwerger, Associate Professor of Gynecologic Oncology at Yale Medicine, who is an avid clinical translational researcher as well. At the executive level, we have two cornerstone announcements, one is the promotion of Dr. Lesley Northrop to Chief Scientific Officer, and the addition of Kalie Zagger as Chief Operating Officer. Kalie, will be responsible for the entire commercial and operating organization comprised of sales and marketing, as well as our overall operations, including IT and the laboratory. And lastly, we have added a Chief Spokeswoman, Dr. Diane Powis. Dr. Powis is an ovarian cancer patient and survivor, whose role is to lead how we meet, serve and educate patient. With her clinical background and journey, she'll be responsible for the patient advocacy, testimonial storytelling and the coordination and the management of an ethnically diverse patient advisory board. As we build momentum and scale the as an organization, it's time to make these strategic additions to our board and senior leadership team. Aspira is now a company led by women for women for women and these additions will significantly help to propel our growth. I am now moving on to our Q3 update. From an operational perspective, we experienced somewhat of a V-curve on volumes and the lows of Q2. We ended the third quarter at 95% of pre-COVID levels, comparing February 2020 versus September 2020 on a per day basis. Our volume increased 46% sequentially from the second quarter, and is equivalent to the volume of the third quarter of 2019. Our average unit price of OVA1plus one plus increased sequentially by 15% as well, versus the second quarter. Regarding our platform strategy, we continue to believe our decentralization strategy to penetrate large integrated delivery networks and OB/GYN super groups will ultimately pay-off and accelerated overall adoption of our products. The decentralized arrangement should help our products integrate into the care pathway of the respective institutions and super groups. These large deals have a significant lead time and the COVID-19 pandemic has slowed some of the efforts to finalize these deals. That being said, our partners continue to engage and are excited about the prospect of internalizing our technology. More to come on this front. On the payer front, we announced in October that we are participating providers with Anthem Blue Cross Blue Shield of Georgia. For an estimated additional 3.3 million members across the state. We now have approximately 72% of the covered lives in Georgia, which is considerable. As of November 1, 2020, we have approximately 173 million lives covered in the U.S. In terms of total ordering submissions for the quarter, 2,450 physicians ordered OVA1, with 84% of those customers being repeat customers, consistent with Q2 rate. This clearly illustrates the impact the technology has on patient care, the stickiness of the technology and the overall retention and growth opportunity we have with our expanded portfolio. In addition, the number of ordering physicians increased 37% in the second quarter, and the number of tests ordered per practice is up 32% compared to prior year third quarter. We also recently surveyed 341 customers, who saw that the majority of these customers were using OVA1 to determine who needs surgery immediately or determine who can postpone surgery. In fact, based on this survey, 53% of these patients were high risk or symptomatic, it needed to be seen with a high sense of urgency or post an ER visit. We believe that the triage benefit of OVA1 may be invaluable in this new low touched environment. Thus the improvement of repeat rate and specimens per practice. Our number one goal overall is to drive adoption and make OVA1 the standard of care. We believe lack of awareness is a major obstacle in adoption. We are winning a virtual and non-virtual commercial strategy together to expedite impact in the following ways. Number one, strategically magnify our newly designed brand, and its impact the entire patient lifecycle for the short-term and long-term driving clinical trial enrolment at the community and academic level. Number two, lift awareness of the devastating nature of ovarian cancer and the importance of the focus of woman's health coupled with our KLO call in September and our increased KLO participation at an academic level, as demonstrated by our board and executive addition. Number three, illuminate health disparity awareness and advanced clinical pathways to earlier and more effective diagnosis. As illustrated by our digital campaign. We launched our first major awareness campaign in the third quarter. I hope you all have had the opportunity to witness that campaign through social media or in television and print outlets in your area. We conducted a Virtual Media interview tour that was picked up by 26 television and radio outlets. The interviews featured Dr. Elena Ratner, as well as Montana May Hazel, a patient advocate. As a result we had 133 placements, including Associated Press, Bloomberg and Ferris Pharma, to name a few and a 139 million total media impressions. The power of earned and shared media is significant, in a cost driven subject like ovarian cancer. We consider this level of interest to be quite successful while the campaign is driving awareness of ovarian cancer risk in general, we are emphasizing ethnic disparity and early detection. As reported previously, our commercial organization continue to transform and perform in a virtual environment. We do anticipate a mix of virtual and face-to-face marketing continuing into 2021 as we have higher emphasis on inside sales personnel to maximize the effectiveness of those reps in the field. In addition, our approach will be leveraging digital marketing, search engine optimization, social media, website initiatives and the construction of deep and wide virtual and non-virtual clinical champion team across North America to drive awareness. I will now be moving on to our innovation pipeline and product enhancement update. Despite the pandemic, we have made tremendous progress on clinical site expansion and participation in our studies. We are also in execution mode on enlarging our clinical studies to ensure a broad geographic and increase patient enrollment during the pandemic. With over 10 years of experience in ovarian cancer risk assessment, we are creating a portfolio which is comprised of products that impact a woman's entire life cycle starting at a young adult with ENDOCHECK to our hereditary risk for cancer genetics, including high-risk OvaInherit, to premenopausal benign mass monitoring was OVANEX. And lastly, our ovarian cancer risk assessment prior to surgery OVA1Plus. In addition, we are also doubling down on our research on ethnic disparity front with new sites in the queue. I am now going to start with ENDOCHECK. We are very excited about this product. This product is expected to reach a total addressable market in the U.S. of roughly $6 million to $7 million. Today a surgical biopsy is the only way to confirm an endometriosis diagnosis and it's still used as a leading primary diagnostic tool. Our end goal is to develop a liquid biopsy test with both the sensitivity and specificity equal to or greater than surgical biopsy. There is a very large unmet clinical need as endometriosis is treated based on symptoms and may take on average seven to nine years to diagnose sometimes with multiple surgeries. Not only does endometriosis impact a large number of women, but the cost per patient is extremely high as it is similar to a type 2 diabetic. This product was initially developed from a Biobank, which contains women who have a pelvic mass, in addition to endometrial mass and other benign masses. Based on the initial algorithm performance, we formed an agreement with AbbVie, which allowed us to access their Elagolix trial specimen. Elagolix is a pharmaceutical treatment for the management of moderate to severe pain associated with endometriosis. These samples are from two robust multicenter double blinded placebo-controlled Phase 3 trials that enrolled women with surgically diagnosed endometriosis, and moderate to severe endometriosis associated pain. We are very excited about the acquisition of these samples from AbbVie for ENDOCHECK product development, and believe this will strengthen our ability to bring this product to market swiftly. As previously discussed, we are preparing an FDA breakthrough device designation for submission by the end of the year. In addition to the AbbVie specimen, we are also finalizing a collaboration with a notable academic reproductive consortium and collecting enriched endometriosis cohorts to further validate the product. A liquid biopsy is essential for the detection of endometriosis, as it has the potential to help women begin treatment without surgery, thereby improving their speed to treatment and quality of life with ultimately improving outcomes from this debilitating disease. Second, I would like to update everyone on our third-generation ovarian cancer risk assessment test, which is now granted is OVANEX. OVANEX is designed to address a market of three times that of OVA1, specifically it is for women who have a benign mask and are currently monitored two to four times per year with CA125 and transvaginal ultrasound. In October, we published a paper in current medical research and opinion, titled, Low Risk Multivariant Index Assay Scores, Physician Referral and Surgical Choices in Women with Adnexal Masses. A total of 282 independent patient charts reviews, of which 146 were low risk results. Surgery was performed on 56% of patients with low risk scores, the other 44% had no surgery and were followed clinically. There were no invasive cancers in the patients who had surgery and clinicians were comfortable with expected management of pelvic masses when OVA1 is low risk. These results demonstrated to us that there is an immediate need to assessing the status of pelvic mass, even though surgery is not performed. Keep in mind besides CA125, there is no known competitive product on the market to monitor pelvic masses. In June, we launched our IRB approved prospective trial with the goal of on-boarding five clinical sites. Due to the challenges, we have face with the pandemic, we have increased our recruitment to 10 individual sites, with seven already actively consenting patients. We will be looking at three cohorts for this study. Number one is patients who are symptomatic with a pelvic mass. Number two are patients with a mass who are asymptomatic, the masses were incidentally found. And number three are those who are genetically predisposed with and without a mass. We believe that this test will help clinicians and patients to better understand the risk of malignancy and provide a monitoring tool to manage patients overtime who are not candidates for surgery. We continue to be on track to launch the product in phases projecting the end of 2021 to early 2022. This product coupled with OVA1 provides a solution for monitoring as well as a solution for surgical triage risk assessment. I am now moving on to our next product which is OVAInherit. Keep in mind the protein foundation of OVAInherit is OVANEX. And we are coupling this with genomic target specifically designed as our high-risk early detection solution. This study is designed across two separate cohorts. Number one is a symptomatic women with a genetic predisposition. And number two, a symptomatic women who are at risk that are being reserved with a pelvic mass. It is a real time multi-site study being performed at five of our current OVA and genetics commercial testing sites that are also established clinical research institutions. We will also be adding a prestigious academic centre to assist with the research which will be announced soon. The name of the study behind OVAInherit is OVA360 and is just defined as a study demonstrating a 360 degree view and combining the established prevalence proteins with molecular targets of gynaecological cancers. This study will explore specific genomic targets that define key drivers of female gynaecologic cancer, starting with ovarian cancer. Foundational development of a cell free, cell tumor DNA based test to identify cancer early at high diagnostic accuracy is planned. We believe that our algorithms will outperform the current standard of care, which is CA125 coupled with transvaginal ultrasound, and provide a precise measurement of a tissue specific type of cancer as an early detection test. We will also be partnering with several key thought leaders in the genomic community to support the development of the OVAInherit product. I will now move beyond product development into expanding our research on ethnic disparity with OVA1Plus. We are expanding this research by increasing site recruitment from our initial partner at Einstein Medical Center in Philadelphia, to two more institutions with more to come. Again, we are mining our clinical study recruitment during a pandemic and decided to increase our study goals to meet our product portfolio timelines across all studies. Especially at a time when healthcare inequality is becoming more recognized during COVID, Aspire Women's Health core values as healthcare quality, as we continue to lead the charge in bringing ovarian cancer risk assessment disparity to the forefront. Our number one goal is to place CA125 as a standard of care for ovarian cancer, with this virus on-suite of products, performing with a greater accuracy and precision of disease across all ethnicities. Our goal for this study is to expand upon our two previously published studies to validate OVA1 across populations outside of Caucasian women as compared to CA125 and truly change the standard of care. I would like to now turn the call over to Bob for review of our financial results. Bob?

Thank you, Valerie. As Valerie noted, we've seen a V-shaped volume recovery test performed in the third quarter as compared to the second quarter. The number of OVA1 tests performed increased sequentially 46% to approximately 3596 during the third quarter compared to 2458 for the second quarter. We feel this rebound validated our decision to focus on continued investment in long-term growth and coming out of the pandemic stronger. OVA1Plus product revenue was $1,217,000 million for the three months ended September 30, 2020 compared to $726,000 for the second quarter. This 68% product revenue increase is primarily due to increase in the number of tests and as well as improvement in our average selling price to $338, a 15% increase from the as reported average unit price in the second quarter. The increase was primarily due to a full quarter realization of our new contract price from Cigna as of April 1 2020, and improvement in mix of payers as Medicare patients, who given their demographic had reduced visits to doctors as many older patients self-quarantine due to COVID in the second quarter versus the third quarter. We've seen the mix of Medicare and Medicare Advantage patient revert back to historical pre COVID levels near the end of the third quarter. Gross profit margin of OVA1 was 45% in the third quarter as compared to 37% in the second quarter, driven by improved volume and improved price realization. Total operating expenses were approximately $4.7 million in third quarter as compared to $4 million in the second quarter, as we have resumed travel and entertainment and increased our spend on marketing and R&D. Our cash balance at September 30 2020 was approximately $19 million. As we previously announced, we achieved the target employment milestones as well as trailing 12-month revenue target for the state of Connecticut financing. The funding has been approved, and we anticipate receiving $2 million of funding during the fourth quarter. Our cash utilization for third quarter was $3.1 million, compared to $3.3 million in the prior quarter and $3.6 million in the prior year third quarter. There were sequential reduction in cash utilization was driven primarily by stronger revenue and gross margin, while the year-on-year increase was primarily increased research and development, as well as headcount additions offset by reduced spending on sales and marketing. As Valerie mentioned in her opening remarks, two banks have initiated coverage on Aspira Women's Health. William Blair recently initiated coverage as well as Brookline Capital Markets. We view this long-awaited development as a validation of our strategy and we look forward to long-term relationships with both of these institutions. I'll now turn it back to Valerie.

Thank you, Bob. Before we open up the cost for Q&A, let me restate [Technical Difficulty] focused this company for sustainable growth for the near and the long term. We firmly believe that our strategy is the right one, and that our technology and pipeline will be vital to lowering the overall health care burden, and reducing significant inefficiencies in the care pathway. It's all about getting the right patient to the right doctor, and finding cancer at its early stage and all women. This mission is the core of our company. Ovarian cancer accounts are more deaths than any other cancer of the female reproductive system, and is the only gender specific cancer with greater than a 50% mortality rate. Our work and products are at the forefront of changing the standards of care and the detection of ovarian malignancies. We believe we are helping close the gap in the testing and more importantly survival for women. In the near term, we believe OVA1plus coupled with our disparity differentiation, and genetic testing will become the standard of care and pelvic mass risk assessment for ovarian cancer. For the longer term, we are moving full steam ahead with our planned launches of ENDOCHECK for endometriosis, over next pelvic mass monitoring, and lastly OVAInherit for high risk genetic predisposition monitoring. We also believe in this new COVID era, that healthcare disparities and the importance of diagnostic information might actually be further elevated to reduce disparate care and ensure that all women of every socio-economic background receive the best possible care. We are now happy to open up the call for Q&A and answer any of your questions. Operator. Q - Unidentified Analyst: Hi, good afternoon. This is Andrew on for Brian. Valerie, maybe to start on ENDOCHECK here. Can you just talk sort of about your confidence level as it relates to getting that fast track approval with FDA? And I guess maybe as we think here about 2021 and first catalysts for that product, anything you can tell us to be sort of on the lookout for as it relates to confirmation of that process path and any additional data that's going to be published for that.

Sure. It's really twofold Andrew. And thanks for the question. So first off is we are - we've got the breakthrough applications in review right now and has been sent to the FDA. We had our initial legal console that actually FDA cleared both of our products review it. And now we're actually having a group review is that actually worked for the breakthrough device organization is now a separate firm. So we're going through this review process, it is big shot on goal, since you have one shot, so we are crossing the t's and dotting the i's. We do anticipate submitting that by the end of Q4. And the day - in terms of the timeframe on that it's 60 days minimum and might be more because of COVID. But that's kind of the timeframe. We're also - so that's answered on one part of the answer. The second part of the answer is, we are also pulling together a publication on our initial, I want to say discovery. So there is some fine tuning of that, that's in the queue, but there will be a publication in terms of our initial validation. And but those are really the two big catalyst in terms of the submission and getting that through. And by the way, if it doesn't go through breakthrough, because breakthrough really is an expedited review, we will be submitting it through the standard FDA clearance process. But we are going to be striving for breakthrough because of the difference this technology makes and in terms of meeting the FDA criteria, Hopefully that answers your questions. Thanks for that.

Yes, thanks for that, Valerie. And then maybe just switching the private pay here. You make nice progress on that throughout the quarter. So congrats on that progress. But maybe as it relates to some of the recent conversations you've had with some other private payers, can you just sort of give us an idea of how those are progressing? And maybe how you're using that disparity data as sort of a means to advance some of those negotiation?

Yes. So I think a couple of things on that. One is, and I think I've said this before, but just to clarify. So the disparity data, even before it was published, that in early detection data was really what drove Cigna over the edge. And that was when it was not published. Given the current climate, plus our disparity data plus our continuing data that we are building, we do believe it becomes a - I don't want to say truck as a Trojan horse, but it becomes a sphere, because of the current climate that we're in. So absolutely, with the payers, also with the providers. I think that during COVID, there is a heightened awareness of healthcare disparity. And so I do think it's not only the payers, but it's also the providers. And there's more to come on that, as I said, we've added two other sites, we have a couple more in the queue. And right now we have a total of three.

Great. And then last one for me. Bob, this one for you. Maybe can you just give us a little bit of color as relates to sort of what you're seeing in the field right now, in light of the sort of recent resurgence in COVID-19? And maybe just more broadly, how are you prepared for this wave versus the earlier in the year with sort of the first wave. Thanks for taking the questions.

I think the big thing is that we haven't seen a complete across the board lockdown. But we've invested pretty heavily in the digital marketing and detailing tools for the team. I think what's happening in the field is a lot of folks are doing more remote lunches. It's kind of crude, but getting food delivered to practitioners to do a little bit of a lunch and learn. But with our folks being remote, we've also previously discussed the fact that we're ramping up the use of in-house sales people kind of a zero sum rather than adding reps, we've added some in house sales people. So I think that we've already largely adapted to that. And we're seeing somewhat of a decrease in the spend on T&E just because our focus is so restricted, but I think we're upping our game and the marketing awareness as well to offset that. So we're learning as we go, Andrew, but I appreciate the question.

Great, thanks for taking the question.

Thank you, Andrew.

Thank you. [Operator Instructions] And our next question comes from the line of Kari Ho [ph] with Baird. Please proceed with your question.

Hi, Valerie and team congrats on a great quarter and all the momentum in the business. Curious sort of a bigger picture. As you see the diagnostics industry, the cancer diagnostics industry consolidating to exact and thrive and illuminate Grail, these big platform companies are evolving with deep pockets, and they're targeting really all areas of cancer diagnostics. And I'm just kind of wondering, as you look at the roadmap for the next three to five years, maybe even near-term, kind of, you do need some partnering opportunities to help you scale and to survive in this increasingly consolidating world.

So, I think it's a good question. I mean, I think that twofold. One is our moat that we have in terms of IP and focusing on ovarian cancer. So, I think that's number one. We go deep in ovarian and like none other. So, I do think that's our differentiator. Number two is, and for those that have been with the company and understanding our clinical journey over the last couple of years, we have not only built a CLIA laboratory, but we built a decentralization platform. And it is not only for OVA, but it's also for genetics. So, as things evolve and consolidate with the affordable Care Act, and it looks like it's here to stay for sure. I see Doctor is becoming employees of hospitals, I see groups consolidating. So we have stayed Terry, I want to say a step ahead of these other laboratories that have still relied on a point-to-point, but we go one to many, in terms of decentralizing our products in all of our products going forward, we'll be able to be run, let's say at the local level, the hospital would like to run it or a large super group. So, I do see it as an opportunity. And I love those valuations too. So, I think all positives from my viewpoint.

Then maybe just a quick follow-up. When you look at an ENDOCHECK, obviously, it's a big breakthrough opportunities, 7 million patient population, big, big market, it's going to attract other players. Can you talk more about the IP modes that you think you're developing for that because your window of time in ENDOCHECK of recognizing that CA125 is really kind of your only compare and or, I'm sorry, - biopsy rather, is the only reasonable comparison. But what is the window of time and kind of the IP mode, you think you have with ENDOCHECK?

So, the IP mode is ENDOCHECK just to know how much you've studied endometriosis in terms of the IP that is out there and companies that have tried to make it, it comes down to number one is that, we have 10-years of history in terms of proteins. And as we interrogated the ovarian proteins, guess what the most common benign disease was endometriosis. So, with our 10-years of history, thousands of patients, which actually became the I want to say validation of AbbVie giving us access to their specimens, we believe our IP will be number one, created around protein. Number two, and also, I will say in the last year and a half, we have vastly increased our genetics, offering and our genetics what it calls subject matter expertise. Lesley Northrop is on the line as well. And this genetics connection to ENDO is also going to be very critical. So, I see endometriosis products coming out, in what I want to say versions, version one will be proteins and age, it'll be multiple proteins beyond the over proteins. And also, version II will be genetics. So, the combination of both of them. And then the last piece of this is will be other modalities to. But keep in mind that our process has been pulling together imaging data. And other modalities be beyond just proteins and genetics. So, I think our shots on goal are pretty good for this. And we would not be going for breakthrough devices. We didn't think we could compare ourselves to laparoscopic biopsy.

And then lastly, just a little more near-term, just the momentum we saw in third quarter. I don't know if there's a lot of seasonality and fourth quarter or just with winter and whatnot, can you give me help, just looking into kind of continuity of the momentum and you kind of done that?

Sure. Well, typically Q4 does tend to be a growth quarter last year, we increase from Q3 to Q4 by about 8%. I would say that the momentum has been strong, going into September and then going into October. So, going into the Q4, I would say the biggest wildcard and we're seeing that actually in states that have don't have as much COVID. So, I would say that, California, Florida, Tennessee, those don't have much COVID, but Michigan and Georgia have a little bit more COVID. Those are kind of our top five. So, I think that the wild card is going to be COVID. I think and if you can look at the map on CDC [ph], you'll see it's mostly the Midwest and kind of upper Midwest. But I do think that if COVID stays stable, our growth is going to continue. But that is definitely a wild card for us at this time. But right now all systems go.

Hey, thanks.

Thank you, Terry.

Thank you, ladies and gentlemen, if there are no further questions at this time. I'd like to turn the floor back to management for closing comments. End of Q&A:

Thank you. Thank you, operator. And thank you everyone for joining us today and a big thank you to our team for going above and beyond and bringing us back to over 95% pre-COVID volume and increasing our repeat customer rate during very difficult market conditions. With the executive and clinical additions to our team, we believe we are in a position to support continued growth and profitability for the long-term. We appreciate your support and interest in Aspira Women's Health.

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.