Aspira Women's Health Inc.

Good morning, ladies and gentlemen, and welcome to Aspira Women's Health Incorporated third quarter 2024 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. 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's 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 notes 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 Sanford, Chief Executive Officer. Please go ahead.

Thank you, and welcome everyone to our third quarter 2024 earnings conference call. With me today are Dr. Sandra Milligan, our president, and John Colassi, our interim chief financial officer. I will begin with highlights from our progress in the third quarter, followed by Sandy with an update on our development strategy, and then John with a review of our financials. We will answer questions submitted through the online platform. I want to start with a brief discussion of our commercial performance for the quarter. We delivered more than 6,000 OVA suite tests during the three months ended September 30th, 2024. a 4% increase compared to the approximately 5,783 OVA suite tests for the same period in 2023. Our growth for the quarter was moderated by several factors, including seasonality, something we've seen in the summer months and prior years. Our expanded field sales team had a very strong start in September, hitting new highs daily and weekly for volume. Severe weather, including Hurricane Helene, impacted many of our most productive territories in the southeast at the end of the quarter, causing a short-term reversal of that positive momentum. We were not alone. Severe weather has been reported as a factor for the third quarter performance of many diagnostic companies. Nonetheless, the number of tests per sales rep for the nine months ended September 30, 2024, increased by 21% when compared to the same period in 2023. And although severe weather events continued into the fourth quarter with Hurricane Milton, We have had several of our strongest volume days and weeks of the year in October and November. It is clear that our tasks play a critical role in delivering quality patient care. We believe our focus on improving commercial capabilities across the country helped to reduce the impact of regional interruptions this quarter and will continue to do so in the future. John will provide additional commentary on our financial performance later on in his remarks. The second half of the year has been extremely important for the expansion of our ovarian cancer portfolio to include OvaWatch, which was launched for longitudinal monitoring of ovarian masses in May. With the expectation that providers will consider retesting of patients sometime between three and nine months, we believe reordering behavior will begin to change as we head into 2025. To further accelerate the adoption of our OvaSuite portfolio, we announced a new agreement with Dorsata. a healthcare software company with a mission to empower healthcare providers with best-in-market clinical decision-making tools. Dorsata's solutions are integrated into the EMR system of doctors, including OBGYNs, to improve consistency of patient care via automated clinical workflow processes. Together, we are collaborating with medical leadership of a 250-plus OBGYN physician group based in the Northeast, to create a clinical workflow tool that will be embedded in the practice's EMR system and guide clinical assessment of patients with an ovarian mass. The workflow tool will include automated access to biomarker testing, such as our OVA suite test, when appropriate. The tool is in the development phase, and Dorsata is planning for pilot user feedback in the first quarter. We expect the completed workflow tool to be ready for integration into the EMR system in 2025. In October, we announced that the New York State Department of Health Clinical Laboratory Evaluation Program approved Overwatch for use in New York State after a standard review process that spanned more than two years. This approval is required for lab-developed tests to ensure compliance with New York State's clinical laboratory regulatory standards and is the result of a rigorous process to assess procedures for maintaining lab quality and risk management. By any measure, this is a major development. Not only does this open access to one of the nation's largest healthcare markets, the approval of Overwatch solidifies our position as a mature diagnostic company capable of developing innovative algorithmic tests that can achieve New York State approval. Following the approval, we moved quickly to expand our commercial distribution partnership with BioReference Labs, adding Overwatch to its test compendium. The BioReference sales team, has been distributing over one plus since 2022 and will now introduce Overwatch to the company's ordering physicians. BioReference operates 10 laboratory facilities around the country, is in network with the largest health plans in the United States and serves over 19 million patients annually. Now let's shift gears to innovation. Of course, the most important development for the quarter was the announcement that Aspire received a $10 million federal award intended to fund the completion of our in-development multi-marker blood test to aid in the detection of endometriosis. This test, which has been rebranded EndoInform, will rely on a powerful AI-enabled algorithm that combines protein and microRNA biomarkers and patient data and leverages technology like that embedded in our ovarian cancer risk assessment blood test. In addition to funding, the award provides for access to a team of world-class subject matter experts and advisors to support the successful completion and commercial launch of the test before the end of the two-year contract term. This is an incredible achievement and validation of Aspira's capabilities. We have worked tirelessly to advance endometriosis diagnostic research for many years, but our strong scientific foundation alone would not have resulted in our success. We believe the intense focus on operational excellence and the rebuilding of our commercial capabilities over the past year were also instrumental in our selection from among the more than 1,700 submissions. Today, I'm happy to share that the team has made substantial progress against the first milestone and has submitted the deliverables and other required information related to its completion to ARPA-H, the agency responsible for overseeing the award. While it is difficult to predict the time it will take for the materials to be reviewed and payment to be processed, we expect to receive the first payment of $2 million before the end of the year. The R&D team continues its progress towards the second milestone, which we intend to complete in the first quarter of 2025. The announcement of the award has led to many incredible opportunities to expand our reach as a company. We hosted a press conference in our Connecticut offices with U.S. Representative Rosa DeLauro and Connecticut State Representative Jillian Gilchrist, and we're recognized by Senator Chris Murphy's office as the Connecticut Innovator of the Month for November, highlighting our continued commitment to innovation in women's health. We intend to leverage the attention received from the ARPA-H award to our greatest advantage and time the launch of a completely redesigned website and aggressive social media strategy with the award announcement. Now it is my pleasure to turn the call over to Dr. Sandra Milligan, We'll continue the update on product strategy. Sandy? Thank you, Nicole.

Following up with more detail, as Nicole mentioned, we have secured a $10 million award from ARPA-H to fund the development of EndoInform, our non-invasive multiomic diagnostic blood test for women suspected of having endometriosis. ARPA-H and Aspira are aligned on the criticality of focused investment in EndoInform with a goal of launching the diagnostic within the two-year funding timeframe. Along with this honor of being an award recipient, Aspira was named a spoke member of the Investor Catalyst Hub, led by the ARPA program director, VentureWell. This membership provides us with access to a vast network of nearly 600 members from key organizations across the private, public, and nonprofit sectors. The driving principle for the Investor Catalyst Hub is to speed the transition of innovative ideas into practical, accessible and promising solutions by connecting institutions with relevant capabilities from incubators, accelerators, and venture investors to clinical researchers, academic institutions, and commercialization resources. As our EndoINFORM project progresses, we plan to leverage our membership to gain insight, connection, and collaboration to accelerate its development and commercialization. This $10 million award from ARPA-H provides crucial support to complete development and commercialization of endoINFORM. The funding milestones agreed to with ARPA-H are not time-based, but rather are built on the cross-divisional activities that are required mileposts for stage-appropriate investment. We provided a detailed overview of the award and its impact on our overall product development strategy on an R&D Investor Day presentation in October. At that time, we stated that we had made a strategic decision to incorporate our prior endometriosis protein research into the development of EndoInform, and, as a result, the launch of EndoCheck as a standalone endometrioma protein test has been deprioritized. We are making solid progress on the EndoInform clinical study, with nearly 500 samples collected so far and several new clinical sites added. The ARPA-H funding will accelerate the expansion of the clinical study, and we are also exploring options for purchasing additional samples to meet the required numbers for launch. We remain focused on advancing both endoinform and ova-inform as quickly as possible based on the scientific progress and funding allocation. Importantly, capabilities and infrastructure built through the ARPA-H support of the endoinform project will also support the ongoing development of ova-inform. creating efficiencies and resources across both initiatives. This funding supports the construction of our molecular laboratory, which will support the EndoInform launch and the commercialization of OvaInform. Recently, we collaborated with physicians and scientists of the Dana-Farber Cancer Institute, Brigham and Women's Hospital, Medical University of Ludd's, and the Harvard Medical School to publish a scientific paper in the Gynecologic Oncology Journal, providing further evidence that the addition of microRNA and metadata to our existing protein assay significantly improves sensitivity and specificity for the detection of early-stage ovarian cancer. More specifically, we found that serum microRNA and protein biomarkers are complementary in estimating the risk of malignancy of an ovarian mass. An integrated model with proteins, microRNA, and metadata offers the most accurate classification performance. And the addition of microRNA improves sensitivity and specificity for identification of early-stage ovarian cancer. We shared more details about our development pipeline and the next steps for EndoInform and OvaInform during the R&D Day presentation, and I encourage you to access the replay on our Investor Relations page of our website. With that, let me now turn it over to John for an update on our financials. John?

Thank you, Sandy. Let me begin with the review of our third quarter 2024 financial results. Ovisuite revenue for the third quarter of 2024 was $2.3 million, a 2% increase from $2.2 million of the same period last year and a slight decrease from $2.4 million in the second quarter of 2024. The number of Ovisuite tests performed increased 4% for the third quarter of 2024 compared to 5,783 tests in the same period last year. This growth of test volume was primarily driven by Overwatch, which increased 27% year-over-year for the quarter. As Nicole discussed earlier, our growth for the quarter was negatively impacted by severe weather, especially Hurricane Helene that devastated several of our major markets in Florida, Georgia, South Carolina, North Carolina, and Tennessee in September. Our average unit price was $376 for the third quarter of 2024, compared to $383 in the third quarter of 2023. The Overwatch average unit price increased 4% to $360 for the third quarter of 2024, compared to $347 in the same period last year. Overwatch test volume now makes up 22% of the total Oversuite test volume for the third quarter of 2024, compared to the 18% of the total for the same period last year, contributing to a modest decrease in AUP. Our gross margins for the third quarter of 2024 improved to 60%, compared to 59% for the third quarter of 2023. Research and development expenses for the quarter decreased by $90,000, or 9%, compared to the same period in 2023, as we deferred some spending while the ARPA-H award process was ongoing. We expect research and development expenses to increase over the fourth quarter of 2024 as we focus on accelerating our endo-informed development plan in connection with the ARPA-H award. Sales and marketing expenses for the quarter increased by $441,000, or 26%, compared to the same period in 2023, due to personnel costs for additional field sales representatives and the costs associated with the launch of a new corporate website. For the nine months ending September 30th, 2024, sales and marketing expenses increased by just 2% compared to the same period in 2023. General and administrative expenses for the quarter decreased by $675,000, or 25%, compared to the same period in 2023. For the nine months ended September 30, 2024, general and administrative expenses decreased by $1.8 million, or 19%, compared to the same period in 2023. Decreases for both periods are related to reductions in personnel costs, and in professional and legal fees. Our cash used in operating activities in the third quarter of 2024 was $2.9 million, down 12% compared to cash used in operating activities of $3.3 million in the third quarter of 2023. This is the first time since the launch of our OVA1 Plus test that we used less than $3 million in operating cash in a quarter. Cash in restricted cash as of September 30th, 2024 was $2.1 million, down from $2.9 million as of December 31st, 2023. In September, we entered into an at-the-market offering agreement with HC Wainwright, targeting aggregate gross proceeds of up to $4.5 million. We reiterate our guidance for cash used in operations in 2024 to be less than $14.5 million. The company has filed for an extension to November 19th, 2024 for filing its form 10Q where the quarter ended September 30th, 2024. The extension is needed to complete the accounting where the warrant inducement transaction entered into on July 31st, 2024. This is a complex accounting matter that simply requires additional time for consideration. However, I do not believe the accounting conclusion will have any impact on reported cash or any other financial information provided in our press release. I will now turn the call back over to Nicole. Nicole?

Thank you, John. Aspire remains steadfastly focused on its mission to improve health outcomes for millions of women while positioning ourselves for long-term success. We are proud of what we have accomplished so far this year, and thank you for the continued support of our shareholders. With that, I would like to now open the call for questions. As was mentioned previously, we will be taking questions using our online platform. If you have a question, please click on the question button at the bottom of your screen. If you have joined by phone and you have a question, please email it to investors at AspiraWH.com.

Thanks, everyone.

So this is Sandy, and while some of the questions come in, let me answer the first one in the queue. So that question is, Sandy, why do you think Aspira's endometriosis proposal was chosen by ARPA-H out of the 1,700 submissions? So when I reflect on our experience in applying for the ARPA-H award, it was intensely competitive. I think the reason why we were selected as a winner was because we offer a complete package from development to commercialization with a track history for our over suite. So I do believe that ARPA-H for the larger awards, such as the $10 million, really wanted to see a proposed solution make it all the way to the finish line. So I do think that that is one of the critical points, not just our science, not just our development capabilities, but also our commercialization capabilities that made us stand out.

Okay, I'm just looking at the questions right now.

So here is a question. Can we provide a range of estimated timelines for OVA-INFORM and ENDO-INFORM development to commercialization? Will it likely take the full two years of ARPA-H funding for ENDO-INFORM? So we have contracted with ARPA-H for a full two years of funding. We are driving as hard as we can, and the outside date would be the full two years. But we are moving as quickly as we can and are optimistic that we can accelerate the development to come under that two years. For OVA-INFORM, we are continuing along the development process, but of course we need to allocate the capital investment for appropriate stage gate progression, but we are still developing OVA-INFORM at this point. Let's see. An additional question regarding Endo-INFORM, any thoughts on possible partnering with a company creating endometriosis therapies in the future, and how would I describe the current overall partnership environment? This is an excellent question, and it certainly is in line of the way that we envision future partnerships. Right now, we're focused with the ARPA grant in moving EndoInform across the line as a diagnostic, but as we commercialize it and gather additional data from patients, we will look to a longitudinal diagnostic, a prognostic diagnostic, and a predictive diagnostic, which is what you're alluding to. In order to have a predictive diagnostic, wherein we can predict the response of or monitor the response of a certain endometriosis therapy, we will be required to partner with an endometriosis innovation therapeutic company. How would I describe the current overall partnership environment? I think it's positive. I'm hoping that with the surge of interest in women's health, that we will see additional investment by innovator drug companies in that space, which will basically increase the opportunities for us.

And let me just refresh real fast. Okay. Sorry, it's a new system.

Okay. So I think that's all the questions that I can answer this morning.

And on behalf of the entire executive team, thank you for joining us today. and we will look forward to finishing the year strong. Thank you very much.

Thank you. This does conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.