Aspira Women's Health Inc.

Good afternoon, ladies and gentlemen, and welcome to the Espira Women's Health Incorporated Third Quarter 2023 Earnings Conference Call. 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 is Nicole Sanford, President and Chief Executive Officer. Joining her is Dr. Torsten Hombach, Chief Financial 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 related to the SBIR'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 subjects to risks and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond the SPIRA women's health control. The company assumes no obligation to update or supplement any forward-looking statements, whether as to 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 ESPERA's most recent annual report on Form 10-K and quarterly report on Form 10-Q, filed with the SEC for 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 good afternoon, everyone. I would like to welcome you to our third quarter 2023 conference call. We'll start the call with highlights from this quarter before handing it to our CFO, Torsten Holmbeck, to review our financial performance in more detail. As always, I'll start with growth. We were excited to see CMS's preliminary approval of our request to crosswalk pricing from Oval One to Overwatch in the 2024 preliminary laboratory test fee schedule. If approved as expected later this month, the pricing will apply to all Medicare beneficiaries beginning in January 2024. Elsewhere on the growth front, we welcome back Michelle Snyder as our Senior Vice President of Commercial Strategy and Operations. She rejoins Aspira following successful leadership roles at Sonic Laboratories and SEMA IV. Michelle and I have been collaborating closely on the execution of the next phase of our commercial refresh. including the development of a physician-focused omnichannel strategy, the reinvigoration of our inside sales organization, and the launch of several high-impact campaigns, including our recent physician-focused Overwatch KOL webinar that attracted over 400 participants. We also launched a point-of-care practice aid to help healthcare providers talk to their patients about anexal masses and how our non-invasive OvaSuite products can help assess their risk of cancer. We believe these efforts will continue to drive our Oversweet test into the patient care pathway and increase provider adoption. We have created a new vice president of business development role and recruited a talented executive with extensive healthcare relationships to accelerate our commercial expansion plan. Elsewhere in sales, we turned around several underperforming territories, further reinforcing a performance culture in the commercial organization. We implemented a new relationship with a contract sales organization to improve flexibility and have seen immediate improvements in many of those territories as a result. This quarter, we continue our track record of year-over-year growth for Oversuite since I became CEO. Product revenues for the third quarter were $2.2 million, representing growth of 9% compared to the third quarter of 2022. The number of Oversuite tests performed this quarter was 5,783, an increase of 5% compared to the third quarter of 2022, with Overwatch contributing nearly 20% of that volume. We performed 18,331 Oversuite tests in the first nine months of this year, an increase of 16% versus the same period of 2022. The volume growth was driven by a much leaner sales team, which demonstrates our commitment to eliminating unprofitable and underperforming territories and a renewed focus on partnerships to drive profitable growth that can sustain the company as we bring new and expanded product lines to market. Turning to our average unit price, I continue to be pleased with our progress. Since we began billing Overwatch under its unique PLA code on April 1st, our Overwatch AUP has shown a steady increase to $347, a 7% increase over the second quarter. Oversuite AUP declined to $383 from $396 in the second quarter. However, as Torsten will cover in more detail shortly, the ongoing focus on cost containment helped to hold gross margin at 59%. Operating expenses dropped again in the third quarter, returning to levels the company has not achieved since 2020, while simultaneously achieving growth in both product revenues and volumes. Let me now turn to innovation. This quarter, we welcome Dr. Jody Berry to our senior leadership team. Jody joined Aspira as chief scientific officer in September, following a distinguished academic and commercial career in biochemistry and diagnostics research and development. Most recently, Jody served as the chief scientific officer of Orisher Technologies, where he led the breakthrough discovery of the first integrated swab test for COVID-19. Not only is he a prolific and award-winning researcher, but he is also passionate about women's health. an interest that goes all the way back to his earliest work in pelvic inflammatory disease and HIV. We made great progress in our effort to expand our OVA Suite portfolio, tests that use machine learning to provide a personalized risk of malignancy score for patients with a maxillomasses. Overwatch was designed to be commercially launched in two stages. The first stage was a point-in-time application for initial clinical assessment. which has now been ordered by physicians 2,440 times, with more than 40% of those tests coming in just this last quarter. I'm pleased to report that we have completed a critical step towards the second stage launch of Overwatch as a longitudinal monitoring application. Our clinical study of the real-world use of Overwatch as a tool for monitoring low-risk patients has been completed, and we have submitted the resulting paper for peer review and publication. We're in the process of completing final launch activities and expect to begin offering the longitudinal monitoring test by the end of the year as planned. Looking beyond Overwatch, we are excited about adding other modalities to expand our Oversuite portfolio. As we recently announced, Dr. Kevin Elias, Director of the Gynecologic Oncology Laboratory at Brigham and Women's Hospital, an Assistant Professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School, recently presented a poster related to an in-development microRNA-based ovarian cancer test at the American Association of Cancer Research Special Conference for Ovarian Cancer. Dr. Elias highlighted data showing microRNA's potential to improve the diagnostic accuracy of noninvasive blood tests for women with anexal masses based on his extensive ovarian cancer research. The study combines serum protein and patient clinical information from Aspire's ovarian cancer clinical studies with microRNA identified by the Elias Laboratory in collaboration with a consortium of world-renowned academic researchers. Among other findings, the presentation concluded that the combination of microRNAs, proteins, and metadata identified 90% of early-stage and 100% of late-stage ovarian cancers in the study population. This research formed the basis of OVA-MDX, which is expected to become part of the company's OVA Suite portfolio under a previously announced licensing agreement. We are currently finalizing an advisory agreement with an experienced lab to assist our team with platform migration and test validation, which we expect will significantly accelerate the development, validation, and launch of a commercial product. Work under this agreement will begin shortly with the support and collaboration of Dr. Elias. Moving now to EndoCheck, our first-generation non-invasive protein-based blood test to aid in the detection of endometriosis. We continue our verification and validation of the test, utilizing samples acquired from both our EndoCheck study sites and the University of Oxford through a material transfer agreement. Upon validation, we will follow a similar launch strategy as was utilized for Overwatch, with a small-scale rollout to clinicians who have been involved in the development of the test, to be followed by a broader commercial launch upon publication of peer-reviewed data. We continue to develop EndoMDX in parallel with the protein-based EndoCheck test. EndoMDX, which will combine proteins and microRNA for a higher-performing test, is being developed through our sponsored research collaboration with a consortium of academic institutions led by Dana-Farber Cancer Institute. We made a second milestone payment of $125,000 in July following the delivery of the signature. We are now working closely with the collaborators to finalize the platform migration and validation strategy for a commercial test. Finally, we established a new clinical advisory board as an element of the company's overall mission to develop and commercialize high-impact diagnostic tools for gynecologic disease. The clinical advisory board will provide clinical input and guidance throughout the development of the company's portfolio of products and will be chaired by Aspira's Director of Medical Affairs, Dr. Leo Twiggs. Our three members include Dr. Levi Downs, medical director for gynecologic oncology with Park Nicollet Health System at Methodist Hospital, Dr. Nisha Garg, gynecologic surgeon with Arizona Gynecology Consultants, and Dr. Tamika See, the founder and owner of Advanced Women's Care Center. Turning now to operational excellence, we have once again decreased cash used in operations to 3.3 million in the third quarter, representing a 56% reduction when compared to the prior year. while still showing sustained growth. We strengthened our balance sheet with a recent equity raise to support our long-term strategic vision. We have a team that is determined to set a new standard of care in gynecologic health while setting an industry standard for prudent, high-impact capital deployment. Now, I would like to turn the call over to Torsten for a review of our financial performance. Torsten?

Thank you, Nicole, and good afternoon, everyone.