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(AWH) Q3 2022 Earnings Call Transcript | Seeking Alpha Aspira Women',s Health Inc. (NASDAQ:NASDAQ:AWH) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Nicole Sandford - President and Chief Executive Officer... Aspira Women's Health Inc.

 

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(AWH) Q3 2022 Earnings Call Transcript. Good morning, ladies and gentlemen, and welcome to Aspira Women’s Health Incorporated Third Quarter 2022 Conference Call. My name is David, 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 Sandford, President and Chief Executive Officer, Bob Beechey, Chief Financial Officer, and Dr. Ryan Phan, Chief Scientific Officer and Chief Operating 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 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 many factors beyond Aspira Women’s Health control. 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 note set forth in today’s press release as well as the risk factors set forth in Aspira’s most recent Annual Report on Form 10-K and Quarterly Report on 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 Nicole Sandford, President and Chief Executive Officer. Please go ahead, ma’am. Nicole Sandford. Thank you, operator, and thank you, everyone, for joining us today. We are very pleased to provide an update on our progress in the third quarter. Joining me on the call today are Bob Beechey, our Chief Financial Officer, and Dr. Ryan Phan, our Chief Scientific and Chief Operating Officer. I will begin with an update on our key strategic initiatives and provide an overview of our third quarter performance. Ryan will follow with an update on our product development pipeline before handing the call to Bob, who will provide a financial update. After our prepared remarks, we will then open the line for a question-and-answer session. In the third quarter, we continued to make sustained progress across our three critically important strategic dimensions, growth, innovation and operational excellence. Let me start with an update on our innovation efforts in OvaWatch, and confirming today that we will launch OvaWatch this quarter. Our sales team is fully trained and ready to go, and we have several well respected physicians signed on to become early adopters, including Dr. Gerard Reilly of Axia Women’s Health, and Dr. Nicole Williams of The Gynecology Institute of Chicago. We applied for a unique PLA code for OvaWatch in October, and the CPT Advisory Committee reviewed the submission on November 7. We expect to be notified by the end of 2022 regarding approval of our requests, which would be effective on April 1, 2023. We completed our manuscript related to an OvaWatch clinical validation study that will be submitted for peer-review and publication this week. We believe this study will drive additional provider and payer adoption post-launch. The laboratory processes have been tested or in the final stages of validation. Kits are complete and ready for distribution and we are waiting for New York state approval to launch the test to New York patients. We have been receiving positive physician feedback on OvaWatch and are excited by the potential to change the practice of medicine for women with adnexal masses. Healthcare providers will now have access to a suite of non-invasive blood tests that together with their clinical experience provide unprecedented confidence and their chosen medical management decisions. In recognition of the applicability of our offerings to a broader population of women, or ovarian cancer portfolio will now be known as OvaSuite. For the first time ever healthcare providers that identify a pelvic mass in a female patient have an OvaSuite tool that will provide potentially lifesaving information, whether the provider has decided to perform surgery or not. This is a significant expansion of our patient population beyond Ova1 and OVERA are FDA-cleared phase. We believe the number of women who undergo premature or unnecessary removal of their ovaries on a preventative basis may be meaningfully reduced, now that physicians have an opportunity to effectively assess malignancy risk and their initial assessment. The launch of OvaWatch will also provide an opportunity to expand the population of potential ordering physician beyond gynecologist and gynecological oncologist, who are the primary users of Ova1 and OVERA test. Following the launch of OvaWatch, our OvaSuite products will be marketed more broadly to other women’s and family health practitioners. In fact, there was already some momentum in that direction. On July 5, a Policy and Practice Review article entitled Management of the Adnexal Mass, considerations for the family medicine physician was published by the Family Medicine and Primary Care Journal. The article clearly identifies Ova1 as an effective tool available to family physicians for youth, and assessing ovarian cancer malignancy risk. With all that said, we have updated and refreshed our marketing strategy. We will shift more of our marketing spending to high impact presentations at key conferences, where we can launch OvaSuite to a larger physician population. We expect to formally launch our Physician Advisory Board before the end of the year, and plan to implement best practices for physician programs in the field based on approaches that have worked in our most successful territory.

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