Q2 2024 Aspira Women's Health Inc Earnings Call

August 12, 2024

Operator: Good morning, ladies and gentlemen, and welcome to Aspira's Women's Health Incorporated Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Good morning, ladies and gentlemen, and welcome to as Pirates Women's Health incorporated second 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 you questions.

Operator: 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 are defined under the Private Securities Litigation Reform Act of 1995 and include 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 risk and uncertainties and could differ materially from those anticipated due to the impact of many factors 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.

As a reminder, this call is being recorded today.

Speaker Change: Before we begin I would like to remind everyone that forward looking statements are defined under the private Securities Litigation Reform Act of Max 95 will be made during this call, including statements relating to our spineless expected future performance future business prospects and future events.

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 as pilots.

Speaker Change: Women's helps control the company assumes no obligations to update or supplement any forward looking statements, whether as a result of new information future events or otherwise, except as required by law, but.

Operator: 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 forward-looking statements. At this time, I would like to turn the call over to Nicole Sandford, Chief Executive Officer. Please go ahead.

Speaker Change: Participants are directed to the cautionary notes set forth in today's press release as well as the risk factors set forth in as pilots. Most recent annual report on Form 10-K, and quarterly report on Form 10-Q filed with the SEC for a description.

Speaker Change: Factors that could cause actual results to differ materially from those and disputes and forward looking statements.

Speaker Change: At this time I would like to turn the call over to Nicole Sanford Chief Executive Officer. Please go ahead.

Nicole Sandford: Thank you, operator, and welcome everyone to our second quarter 2024 earnings conference call. With me today is our president, Dr. Sandy Milligan. I will begin with an overview of our strategy, execution, and operations, followed by an update from Sandy on product development. I will then review our financials before opening the call for questions. The most important development for the quarter was the launch of the Longitudinal Mass Monitoring application for Overwatch, following the publication of powerful new data at the beginning of May.

Nicole Sanford: Thank you operator, and welcome everyone to our second quarter of 2024 earnings Conference call.

Dr. Sandy: With me today is our president Dr. Sandy now again I.

Speaker Change: I will begin with an overview of our strategy execution and operations followed by an update comes won't be on product development and will then review our financials before opening the call for questions.

Speaker Change: The most important development for the quarter was the launch of the longitudinal monitoring application for Overwatch following the publication of powerful new data at the beginning of May.

Nicole Sandford: This is the latest development in our effort to expand both the clinical utility and commercial opportunity for our oversweet portfolio of ovarian cancer risk assessment blood tests for women with an inexo mask. The launch of the Longitudinal Monitoring Application means that we have achieved our goal of offering a life-changing suite of blood tests, the first and only tool of its kind available anywhere in the world. This is a major accomplishment and one that we share with the many long-term shareholders who have believed in the company and supported us on this important journey.

Speaker Change: This is the latest development in our effort on both the clinical utility of commercial opportunity for our oldest neat portfolio of ovarian cancer risk assessment.

Speaker Change: For women with Nacco math.

Speaker Change: The launch of a longitudinal monitoring applications means that we have achieved our goal of offering a life changing feed a blood test.

Speaker Change: First and only two of its kind available anywhere in the world.

Speaker Change: This is a major accomplishment and one that we share with the many long term shareholders, who believed in the company and supported US on this important journey.

Nicole Sandford: Let's reflect on the addressable market for our tests over the past few years to set the stage for our future growth. Ova1 Plus, the only test that was commercially available when I joined the company in early 2022, has a total addressable market of between 200,000 and 400,000 tests per year in the United States. We increased that to more than $1.2 million with the launch of the initial assessment application of Overwatch in December of 2022.

Speaker Change: Let's reflect on the Nebraska Bull market broadcast over the past few years.

Speaker Change: Future growth.

Paul: One Paul the only cost that was commercially available when I joined the company in early 2022, our total addressable market of between 200000 and 400000 pets pretty here in the United States, we increased that to more than $1 2 million with the launch of the initial application of a lot in December of 2022.

Nicole Sandford: Now, with the launch of the longitudinal monitoring application this quarter, we believe the total addressable market for our Oversuite tests is between two and four million tests per year. This is a tenfold increase in the revenue potential for the tests that have already been trusted by health care providers more than 200,000 times. It is important to keep the dramatically increased addressable market in mind as we review our performance for the second quarter and look out to the rest of 2024 and beyond.

Speaker Change: Now with the launch of the longitudinal monitoring application. This quarter. We believe the total addressable market for <unk> is between two and 4 million tests per year.

Speaker Change: This is a tenfold increase in the revenue potential for the cats.

Speaker Change: Already been trusted by health care providers more than 200000 times is.

Speaker Change: It is important to keep your dramatically increase the addressable market in mind as we review our performance in the second quarter and look out the rest of 2024 and beyond.

Nicole Sandford: You may recall that we began a refresh of our commercial strategy and program elements in the second half of 2023 with the goal of identifying people, process, and technology enhancements, as well as refining our market messaging to increase both impact and reach. The refresh was completed and fully implemented in the first quarter of 2024.

You may recall that we began the refresh of our commercial strategy and program elements in the second half of 2023 with the goal of identifying people process and technology enhancements as well as refining our marketing messaging to increase scope impact and reach.

Speaker Change: The refresh was completed and fully implemented in the first quarter of 2024 and as a result, I believe we are well positioned to take advantage of the expanded adjustable market car type.

Nicole Sandford: And as a result, I believe we are well positioned to take advantage of the expanded adjustable market for our test. Moreover, the Enhanced Commercial Organization is more efficient and cost-effective than ever, which is critical to our cost containment goals. I'm happy to report that we have seen positive momentum resulting from our refresh efforts, with sequential growth during the first half of 2024. Our total Oversuite test volume in the second quarter hit a new company high water mark of 6,471, with more than 20% of that volume coming from the Overwatch test. We achieved this test volume with 17% fewer full-time field salespeople when compared to the second quarter of 2023.

Speaker Change: Moreover, the enhanced commercial organization is more efficient and cost effective than ever which is critical to our cost containment pools.

Speaker Change: I'm happy to report that we have seen positive momentum, resulting from our refresh efforts with sequential growth during the first half of 2024.

Speaker Change: Our total oversea test volume in the second quarter had a new company high watermark of 6471 with more than 20% of that volume I mean from the Overwatch test.

Speaker Change: We achieved this past volume was 17% fewer full time field salespeople when compared to the second quarter of 2023.

Nicole Sandford: By comparison, we had an average of 16 field salespeople in the first half of this year compared to 21 field salespeople for the same period last year, resulting in an impressive 29% increase in volume for field sales representatives to 769 tests. We added an additional two field sales people in the third quarter and expect the enhanced commercial programs, along with the expanded application of the Overwatch test and the powerful new data published in May, to support rapid success in these territories.

By comparison, we had an average of 16 field sales people in the first half of this year compared to 21 field salespeople for the same period last year, resulting in an impressive 29% increase in volume for field sales representatives to 769 cap.

Speaker Change: We added an additional two field salespeople in the third quarter and expect the enhanced commercial program along with the expanded application of the Overwatch.

Speaker Change: The powerful new data published in May to support rapid success in these territory.

Nicole Sandford: Our primary focus now is to drive adoption of our Oversuite tech portfolio to become the universal standard of care for every woman diagnosed with an anexal mass. There are many important initiatives underway, including working with partners to have our tests added to the protocols for adnexal mass care, which we expect to come together in the third and fourth quarters of this year. Our commercial success and growth also depend on our ability to increase coverage and reimbursement for our Oversuite products, and I'm proud of the progress we have made.

Speaker Change: Our primary focus now is to drive adoption of our oversea test portfolio to become the Universal standard of care for every woman diagnosed within Mexico math.

Speaker Change: There are many important initiatives underway, including working with partners to have our test out the protocols for at Nexon, Mascara, which we expect to come together in the third and fourth quarters of this year.

Speaker Change: Our commercial success and growth also rely on our ability to increase coverage and reimbursement for OSB products and I'm proud of the progress we have made on the commercial plan side, we recently contracted with anthem plans in California, and the northeast States, adding 8 million covered lives, we expect the anthem central in Virginia geographic regions to complete contract.

Nicole Sandford: On the commercial plan side, we recently contracted with Anthem Plans in California and the Northeast states, adding 8 million covered lives. We expect the Anthem Central and Virginia Geographic regions to complete contracting before the end of 2024, which would add an additional 16 million lives. Also of note, we have added Blue Cross Blue Shield of Texas, Blue Cross Blue Shield of Illinois, and Superior Plan Texas so far this year. On the Medicaid side, we added Maryland and Kentucky in the second quarter, bringing the total number of states covering one or more of our OVC tests to nine, including the critical states of California, New York, and Illinois.

Speaker Change: Before the end of 'twenty, 'twenty, four which would add an additional 16 million lives also of note. We have added Blue Cross Blue Shield of Texas across Blue Shield of Illinois, and superior playing Texas, So far this year.

Speaker Change: On the Medicaid side, we added Maryland, you can clock in the second quarter, bringing the total number of states covering one or more of our oversea test Tonight, including the critical States, California, New York and Illinois.

Speaker Change: Medicare and Medicare advantage reimbursement of watches also increased meaningfully in the first half of 'twenty 'twenty four.

Despite these achievements we know we have more to do to convert additional players.

Speaker Change: Study, we published in May was instrumental in helping to screen momentum our way the data clearly demonstrated the benefit of adding overwatch to a physician clinical assessment and women for something within the next one.

Nicole Sandford: We've created a model to help payers quantify the potential savings that can result from a reduction in surgical interventions on low-risk patients if the Overwatch Pass is used. We believe the potential savings, while dependent on circumstances, are both significant and compelling. To further accelerate our reimbursement progress, we have initiated a comprehensive analysis of national, regional, and integrated delivery network payers with the assistance of an experienced third-party consultant. The objective of the project is to gather specific and direct insight regarding the evidence requirements we must meet to support broader coverage and reimbursement for Overwatch.

Speaker Change: We've created a model to help payers quantify the potential savings that can result from a reduction in surgical interventions and lowest patients if the overwatch Pasadena we.

Speaker Change: We believe the potential savings while dependent on circumstances are both significant and compelling.

Speaker Change: To further accelerate our reimbursement progress we have initiated a comprehensive analysis of national regional and integrated delivery network pairs with the assistance of an experienced third party consultants.

Speaker Change: The objective of the project is to gather specific and direct insight regarding evidence requirements, we must meet to support broader coverage and reimbursement for overwatch.

Nicole Sandford: The first phase of the study, which we expect to complete in the third quarter of 2024, consists of interviews with senior stakeholders to identify evidentiary and other gaps we must fill. These findings will be incorporated into a clinical utility study that we expect will help expand commercial coverage for Overwatch and Overwatch Plus, while also informing our market access and reimbursement strategies for future product launches. Now, it is my pleasure to turn the call over to Sandy to talk about product development. Then, I will come back on to discuss our Operating Performance and Balance Sheet position. Sandy?

Speaker Change: The first phase of the study, which we expect to complete in the third quarter of 2024 consists of interviews with senior stakeholders to identify evidentiary another gap.

Speaker Change: No.

Speaker Change: These findings will be incorporated into a clinical utility study that we expect will help expand commercial coverage for overwatch and over one class, while also informing our market access and reimbursement strategies for future product launches.

Speaker Change: Now it is my pleasure to turn the call over to Sandy to talk about product development.

I'll come back on to discuss our operating performance and balance sheet position Sandy.

Sandy Milligan: Thank you, Nicole. In my role as president, my focus continues to be the acceleration of our research and product development program. I'm pleased with the progress we have made in the second quarter, which I'll share with you today. As Nicole mentioned, we announced the publication of two overwatched focused manuscripts in May. Together, these peer-reviewed publications demonstrate the potential for significantly improved physician triaging of malignancies for surgery over their clinical impression alone and support the use of overwatch as an ovarian cancer risk serial assessment tool.

Sandy: Thank you Nicole and my role as President My focus continues to be the acceleration of our research and product development programs and pleased with the progress we have made in the second quarter, which I'll share with you today as.

Speaker Change: As Nicole mentioned, we announced the publication of two Overwatch focused manuscripts and May together. These peer reviewed publications demonstrate the potential for significantly improved physician triaging of malignancies for surgery over their clinical impression alone and supported the use of Overwatch and ovarian.

Speaker Change: Cancer risk serial assessment tool.

Speaker Change: This data demonstrates that overwatch could substantially reduce surgery for low risk patients performed out of concern for malignancy risk, especially for asymptomatic and premenopausal women.

Speaker Change: Indeed, Overwatch may have reduced the number of surgeries in women with low risk of malignancy by 62% in all patients and 77% in premenopausal women with.

Sandy Milligan: With the added feature of serial mass monitoring, BovaWatch can be drawn at provider-specified intervals for active surveillance of an adnexal mass determined by initial clinical assessment as indeterminate or low risk. This is the strongest clinical support for Overwatch and its value proposition for physicians and patients to date. Let me turn now to our product development updates with a brief overview of our progress on EndoCheck, our protein-based test that has been shown to identify certain endometriosis located on the ovary, including endometrioma.

Sandy Milligan: With the added feature of serial mass monitoring, BovaWatch can be drawn at provider-prescribed intervals for active surveillance of an adnexal mass determined by initial clinical assessment as indeterminate or low risk. This is the strongest clinical support for Overwatch and its value proposition for physicians and patients to date. Let me turn now to our product development updates with a brief overview of our progress on EndoCheck, our protein-based test that has been shown to identify certain endometriosis located on the ovary, including endometrioma.

Speaker Change: With the added feature of cereal mass monitoring overwatch can be drawn at provider prescribed interval for active surveillance oven adnexa mass determined by initial clinical assessment, that's indeterminate or low risk. This is the strongest clinical support for overwatch and its value proposition for physicians and patients.

Speaker Change: Date.

Speaker Change: Let me turn now to our product development update with a brief overview of our progress on Endo check our protein based test that has been shown to identify certain endometriosis located on the ovary, including endometrial my.

Sandy Milligan: Following a robust discussion with healthcare providers following our presentation of endocheck data at the Society for Reproductive Investigation Annual Scientific Meeting in February, we believe that the endocheck protein biomarker signature will significantly contribute to a test with a broader endometriosis application, as well as offer insights to improve the understanding of this devastating and complex disease.

Speaker Change: Following a robust discussion with health care providers upon our presentation of Endo check data at the society for reproductive investigation annual scientific meeting in February we believe that the endo check protein biomarker signature will significantly contribute to a test with broader endometriosis application as well as offer insights to improve.

Speaker Change: The understanding of this devastating and complex disease.

Sandy Milligan: We are currently processing nearly 400 samples collected in our endometriosis clinical study and expect to have new data for analysis during the third quarter. With this data in hand, we will have the opportunity to further assess the commercial application of the test and expand our outreach to potential development partners. This may include pharma companies with drug therapies and development that could potentially utilize EndoCheck as a research-focused test to identify or track patient response to drug therapies in ongoing clinical trials.

Speaker Change: We are currently processing nearly 400 samples collected in our endometriosis clinical study and expect to have new data for analysis during the third quarter.

Speaker Change: But this data in hand, we will have the opportunity to further assess the commercial application of the test and expand our outreach to potential development partners.

Speaker Change: This may include pharma companies with drug therapies in development that could potentially utilize endo check as a research focused tests to identify or truck patient response to drug therapies and ongoing clinical trials.

Sandy Milligan: We are also considering how the addition of an endo check score to our Overwatch test report would allow health care providers to assess the risk of both ovarian cancer and endometrioma for women presenting with an index L mass. We believe this may have a positive impact on clinical utility, provider adoption, and pricing of the test. Clearly, we have work to do in deciding how best to proceed with EndoCheck and, for now, have focused the majority of our development resources on our molecular testing portfolio.

Speaker Change: We are also considering how the addition of an endo check score to our Overwatch Test report would allow health care providers to assess the risk of both ovarian cancer and endometrial MA for women presenting with Nextel math.

Speaker Change: We believe this may have a positive impact on clinical utility provider adoption and pricing of the test.

Speaker Change: Clearly we have work to do in deciding how best to proceed with Endo check and for now have focused the majority of our development resources towards our molecular testing portfolio.

Sandy Milligan: With that, let me turn to OVA-MDX, which is being developed in collaboration with the Dana-Farber Cancer Institute. We have completed assay analytical feasibility on an FDA-approved PCR system, a critical milestone that confirms the ability to perform a test that utilizes the microRNA technology discovered by Dana-Farber on a commercially viable diagnostic platform.

Speaker Change: With that let me turn to other MTX, which is being developed in collaboration with the Dana Farber Cancer Institute.

Speaker Change: We have completed assay analytical feasibility on an F. D. A approved PCR system, a critical milestone, which confirms the ability to perform a task that utilizes the micro RNA technology discovered by Dana Farber on a commercially viable diagnostic platform.

Sandy Milligan: Our next phase, which is currently underway, is the design and assay verification process, which we expect to provide additional data on prior to the end of 2024. As we have shared previously, we believe that this test will have the power to improve sensitivity for early stage ovarian cancer, as well as broader detection for various histological subtypes, solidifying our position as the leader in non-invasive ovarian cancer testing for women with adnexal masses. As we complete the development steps for the OVA-MDX program, we will leverage the learnings and experience in developing a microRNA and protein biomarker test into the development of our broad general endometriosis blood test that leverages proteins from endocheck and proprietary microRNAs identified through our research agreement with Dana-Farber. We are working to establish analytical feasibility and the selection of microRNAs and protein candidates as part of the ongoing test design for this broader endometriosis test.

Speaker Change: Our next phase, which is currently underway is the design and assay verification process, which we expect to provide additional data prior to the end of 2024 as.

Speaker Change: As we have shared previously we believe that this test will have the power to improve sensitivity for early stage ovarian cancer as well as broader detection for various histological subtypes solidifying our position as the leader in noninvasive ovarian cancer testing for women with <unk> masses.

Speaker Change: As we complete development steps for the Oba MTX program, we will leverage the learnings and experience and developing a micro RNA and protein biomarker test into the development of our broad general endometriosis blood tests that leverages proteins from Endo check and proprietary micro RNA identified through our research agreement.

Speaker Change: Dana Farber.

Speaker Change: We are working to establish analytical feasibility and the selection of micro RNA and protein candidates as part of the ongoing tests designed this broader endometriosis trial.

Sandy Milligan: Now that the FDA has finalized its rule to regulate lab-developed tests, we are in the process of determining the regulatory pathway and related requirements for our in-development molecular tests for both ovarian cancer and endometriosis. We do not anticipate the new rule to have any impact on our ability to offer our existing products, including the longitudinal testing application of Overwatch, nor do we anticipate the regulation to cause a significant extension of our prior development or launch timelines for the combination microRNA and protein biomarker tests. We continue to focus on identifying non-dilutive sources of funding for our R&D activities, including funding from multiple research grants. Our development related to our in-process molecular tests is groundbreaking.

Speaker Change: Now that the FDA has finalized its rules to regulate lab develop test we are in the process of determining the regulatory pathway and related requirements for are in development molecular tests for both ovarian cancer in endometriosis, we do not anticipate the new role to have any impact on our ability to offer existing.

Speaker Change: <unk> products, including the longitudinal testing application with Overwatch, nor do we anticipate the regulation to cause a significant extension of our prior development or launch timelines for the combination micro RNA and protein biomarker tests.

Speaker Change: We continue to focus on identifying non dilutive sources of funding for our R&D activities, including funding from multiple research grants our development related to our in process molecular test. Our groundbreaking we believed that related research has created new grant opportunities, which we intend to aggressively pursue.

Sandy Milligan: We believe that related research has created new grant opportunities, which we intend to aggressively pursue. In addition, we are waiting for a funding decision on a sizable grant opportunity, which requires confidentiality until such a decision is made. Regardless of the outcome, the application processes have helped us consolidate a compelling and data-driven development and commercialization strategy to bring to potential development partners. Another potential source of non-dilutive funding is through our research biobank, where a recent analysis showed that we have as many as 70,000 serum, plasma, and whole blood samples available for secondary research.

Sandy Milligan: We believe that related research has created new grant opportunities, which we intend to aggressively pursue. In addition, we are waiting for a funding decision on a sizable grant opportunity, which requires confidentiality until such a decision is made. Regardless of the outcome, the application processes have helped us consolidate a compelling and data-driven development and commercialization strategy to bring to potential development partners. Another potential source of non-dilutive funding is through our research biobank, where our recent analysis shows that we have as many as 70,000 serum, plasma, and whole blood samples available for secondary research.

Speaker Change: In addition, we are waiting for a funding decision on a sizable grant opportunity, which requires confidentiality until such decision is de.

Speaker Change: Regardless of the outcome. The application processes has helped us consolidate to a compelling and data driven development and commercialization strategy to bring to potential development partners.

Speaker Change: Another potential source of non dilutive funding is through our research biobank, where our recent analysis showed that we have as many as 70000 serum plasma and whole blood samples available for secondary research in July we executed a number of small material transfer agreements with third parties, who intend to utilize the samples for validation of gynecological.

Sandy Milligan: In July, we executed a number of small material transfer agreements with third parties who intend to utilize the samples for validation of gynecological disease diagnostic tests. We recognized an average selling price of approximately $500 per sample.

Speaker Change: Disease diagnostic test.

Speaker Change: Recognized an average selling price of approximately $500 per sample. This is an important step in establishing a baseline market value for the purchased material and realizing another opportunity for non dilutive cash through sample disposition.

Sandy Milligan: This is an important step in establishing a baseline market value for the purchased material and realizing another opportunity for non-dilutive cash through sample disposition. We also believe that there may be opportunities to work with foundations to identify additional academic and research activities in women's health that could benefit from access to our sample bank. Finding the right path for this initiative is complex and requires a strategic approach, but we have made tremendous progress in 2024. With that, let me now turn it back to Nicole for an update on our financials. Nicole said:

Speaker Change: We also believe that there may be opportunities to work with foundation to identify additional academic and research activities in women's health I could benefit from access to our sample bank finding the right path for this initiative. It is complex and requires a strategic approach that we have made tremendous progress in 2024.

Speaker Change: That let me now turn it back to Nicole for an update and our financial Nicole.

Nicole Sandford: Thank you, Sandy. Oversleet revenue for the second quarter was $2.4 million, a 13% increase sequentially from the first quarter and flat to the second quarter of 2023. Second quarter product volume of 6,471, increased 11% sequentially and 3% year-over-year. Overwatch tax volume contributed significantly to overall growth, increasing 24% sequentially and 48% year-over-year. As I discussed earlier, the contribution of Overwatch to the overall growth is critical, given the tech's large addressable market of between 2 to 4 million tests per year. Our overall average unit price this quarter was $374, a slight increase sequentially compared to $369 in the first quarter, but down 5% from $396 in the second quarter last year.

Nicole Sanford: Thank you Sandy.

Nicole Sanford: Revenue for the second quarter was $2 4, million% to 13% increase sequentially for the first quarter and flat to the second quarter of 2023.

Nicole Sanford: Second quarter product volume.

Nicole Sanford: 471 increased 11% sequentially and 3% year over year.

Nicole Sanford: Overwatch pack volume contributed significantly to overall growth, increasing 24% sequentially and 48% year over year.

Nicole Sanford: As I discussed earlier the contribution of Overwatch to be overall growth is critical given the large addressable market of between two to 4 million tests per year.

Speaker Change: Our overall average unit price this quarter was $374, a slight increase sequentially compared to 369 in the first quarter, but down 5% from 396 in the second quarter last year, it's important to note that our E&P in the prior year reflected an adjustment for a change in estimate required under generally accepted it.

Nicole Sandford: It is important to note that our AUP in the prior year reflected an adjustment for a change in estimate required under generally accepted accounting principles based on actual collections compared to previously recognized revenues. After adjusting for this impact, our second quarter 2023 AUP for all products would have been $381 per test, just over 1% higher than this year. Overall, we are pleased to see Overwatch's AUP converging with Overwatch 1+. Overwatch AUP of $348 in the second quarter reflects a 3% increase sequentially, a 7% increase compared to the second quarter last year, and a 34% increase compared to the first half of 2023. Margins this quarter decreased slightly to 59% compared to 62% last year, as we saw an increase in product costs, including higher shipping costs.

Speaker Change: Accounting principles based on actual collections compared to previously recognized revenues.

Speaker Change: After adjusting for this impact our second quarter 2023, <unk> for all products would have been $381 per test just over 1% higher than this year.

Overall, we are pleased to see Overwatch is a P converging with the old one path.

Speaker Change: I'll watch a P M $348 in the second quarter reflects a 3% increase sequentially.

Speaker Change: 1% increase compared to the second quarter last year, and a 34% increase compared to the first half of 2023.

Speaker Change: Margins this quarter decreased slightly to 59% compared to 62% last year as we saw an increase in product costs, including higher shipping cost.

Nicole Sandford: We are currently exploring options to better control shipping and other costs as we look ahead to 2025. Gross margin for the six months was largely consistent with the prior year. On the operating side, research and development expenses for the quarter increased 37% year over year, as we saw an increase in collaboration costs with our research partner for the molecular test portfolio. This includes reagents and other supplies required to process samples, which must be purchased well in advance of testing. Sales and marketing expenses increased 21% over the second quarter of the prior year, primarily due to an increase in personnel costs with the addition of strategic account leaders, marketing professionals, and inside salespeople.

Speaker Change: We are currently exploring options to better control shipping and other costs. As we look ahead to 2025 gross margin for the six months is largely consistent with the prior year.

Speaker Change: On the operating side research and development expenses for the quarter increased 37% year over year as we saw an increase in collaboration cost with our research partner for the molecular test portfolio.

Speaker Change: Cruise reagents and other supplies required to process samples, which must be purchased well advanced testing.

Nicole Sandford: Sales and marketing expenses increased 21% over the second quarter of the prior year, primarily due to an increase in personnel costs with the addition of strategic account leaders, marketing professionals, and inside salespeople. G&A costs decreased 20% this quarter compared to last year, mainly due to a decrease in personnel and consulting costs.

Speaker Change: Sales and marketing expenses increased 21% over the second quarter of the prior year, primarily due to an increase in personnel costs with the addition of strategic account leaders marketing professionals and inside salespeople.

Nicole Sandford: GNA costs decreased 20 percent this quarter compared to last year, mainly due to a decrease in personnel and consulting costs. During the second quarter, our cash used in operations was $3.7 million, down 16% sequentially and a slight increase of 9% compared to last year. One cause of the increase in cash used over the prior year was related to our decision to pay bonuses to our staff, including a small amount that had been outstanding since 2022. These individuals have dedicated themselves to our mission, and their retention is critical for the achievement of our strategic goals. Our cash as of June 30, 2024, was approximately $962,000.

Speaker Change: G&A costs decreased 20% this quarter compared to last year, mainly due to a decrease in personnel and consulting costs.

Nicole Sandford: During the second quarter, our cash used in operations was $3.7 million, down 16% sequentially and a slight increase of 9% compared to last year. One cause of the increase in cash used over the prior year was related to our decision to pay bonuses to our staff, including a small amount that had been outstanding since 2022. These individuals have dedicated themselves to our mission, and their retention is critical for the achievement of our strategic goals. Our cash as of June 30, 2024, was approximately $962,000.

Speaker Change: During the second quarter, our cash used in operations was $3 7 million down 16% sequentially and a slight increase of 9% compared to last year.

Speaker Change: One cause of the increase in cash used over the prior year was related to our decision to pay bonuses to our fab, including a small amount that had been outstanding since 2022 individuals who have dedicated themselves to our mission and our retention is critical to the achievement of our strategic goals.

Speaker Change: Cash as of June 32024 hour was approximately $962000.

Nicole Sandford: After adjusting for gross proceeds of the subsequent pipe and warrant inducements that were completed in July, our ending cash would have been approximately $5 million. In August, we entered into a new $4.5 million at-the-market facility with H.C. Wainwright. This facility, which will be available to the company following a 60-day standstill under the Warrant Inducement Agreement, replaces a prior arrangement with Cantor Fitzgerald, which had been suspended for some time. We believe H.C. Wainwright offers a better alternative for small-cap companies to this kind of facility for a variety of reasons, including a significantly lower cost of capital.

Speaker Change: After adjusting for gross proceeds of the subsequent pipe and warrant inducements that were completed in July our ending cash would've been approximately $5 million.

Speaker Change: In August we entered into a new $4 5 million aftermarket facility with H C. Wainwright.

Speaker Change: Which will be available to the company. Following a 60 days doing so under the warrant a decent agreement replaces the prior arrangement with Cantor Fitzgerald, which had been suspended for some time, we believe H C. Wainwright offers a better alternative for small cap companies with this kind of a facility for a variety of reasons, including a significantly lower cost of capital.

Nicole Sandford: We are updating our guidance for cash use and operations for 2024 to be between $13 and $14.5 million, down from the $15 to $18 million we guided towards at the beginning of the year. We believe that our in-plate initiatives, including grant funding, sample sales, partnership opportunities, and the availability of our newly executed ATM facility will be sufficient for us to fund operations in the near term. Today, I also announce that Sandy and I have opted to change our base compensation for the remainder of the year. Each of us will be receiving additional equity in exchange for a 20% reduction in cash-based salary. We continue to believe that our stock is significantly undervalued.

Speaker Change: We are updating our guidance for cash used in operations for 2024 to be between 13, and $14 5 million down from the 15 to 18 million, we guided towards at the beginning of the year. We believe that are in play it initiatives, including grant funding sample sale or partnership opportunities and the availability of our newly executed ATM facility will.

Speaker Change: Sufficient for us to fund operations in the near term.

Sandy: Today, we also announced that Sandy and I have opted to change our base compensation for the remainder of the year.

Sandy: Each of us will be receiving additional equity in exchange for a 20% reduction in cash based salary.

Sandy: We continue to believe that our stock is significantly undervalued, we want to be in a position to be rewarded alongside our shareholders. When the capital markets catch up with the company there's lots of potential.

Nicole Sandford: We want to be in a position to be rewarded alongside our shareholders when the capital markets catch up with the company's immense potential. While this year has presented many challenges, we remain steadfastly focused on our mission to improve health outcomes for millions of women while positioning ourselves for long-term success. We have the only blood test on the market for the accurate assessment of the risk of malignancy for all patients that have been diagnosed with an anexal mask, and we are leading the way in the development of non-invasive tests for endometriosis.

Sandy: While this year has presented many challenges we remain steadfastly focused on our mission to improve health outcomes for millions of women, while positioning ourselves for long term success we.

Speaker Change: We have the only blood test on the market for the accurate assessment of the rest of malignancy for all patients that have been diagnosed within electrical math when we are leading the way in the development of noninvasive tests in endometriosis.

Nicole Sandford: I continue to be bullish on our prospects, and I'm proud that we have kept our promises to patients, physicians, and our shareholders to the best of our ability. Before I open for questions, I have an exciting personnel update. This week, the board appointed John Colassi, an experienced financial executive, as our interim chief financial officer, effective August 16th. John brings passion for the mission and decades of experience to the role. He has served in senior level roles, including chief financial officer, chief operating officer, financial strategy, and innovation advisor, as well as founder of several businesses.

Nicole Sandford: I continue to be bullish on our prospects, and I'm proud that we have kept our promises to patients, physicians, and our shareholders to the best of our ability. Before I open for questions, I have an exciting personnel update. This week, the board appointed John Colassi, an experienced financial executive, as our interim chief financial officer, effective August 15th. John brings a passion for the mission and decades of experience to the role. He has served in senior level roles, including chief financial officer, chief operating officer, financial strategy, and innovation advisor, as well as founder of several businesses.

Speaker Change: Continue to be bullish on our prospects I'm proud that we have kept our promise with patients physicians and our shareholders to the best of our ability.

Speaker Change: Before I open for questions I haven't exciting personnel update this week the board appointed John glossy and excluding financial executive as our interim Chief Financial Officer effective August 15th.

Nicole Sandford: John's expertise in solving challenges like those facing Aspira at our critical stage of growth will undoubtedly help to position us for future success. His first priority will be the refinement of our capital and liquidity strategy, as well as expanding our shareholder base. With that, I would now like to open the call for questions. Operator?

Speaker Change: John brings a passion for our mission and decades of experience to the wall disturbed and senior level roles, including Chief Financial Officer, Chief Operating Officer financial strategy, and innovation advisors as well as founder to several businesses.

Speaker Change: John's expertise and solving challenges like those business fireeye at a critical stage of growth will undoubtedly help position us for future success.

Speaker Change: His first priority will be the refinement of our capital and liquidity strategy as well as expanding our shareholder base.

With that I would now like to open the call for questions operator.

Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question key.

Speaker Change: Thank you.

Speaker Change: We will now be conducting a question and answer session.

Operator: You may press star 2 if you would like to remove your questions from the Q&A. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. The first question comes from the line of Ross Osborn with Cantor Fitzgerald.

Speaker Change: If you would like to ask a question. Please press star one on the telephone keypad.

Speaker Change: Confirmation tone will indicate your line is in the question queue.

Speaker Change: Start to if you would like to move your questions from the queue football.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment. Please wanted to poll for questions.

Ross Osborn: Please go ahead. Alright, thanks for taking our questions and congrats on the progress. So starting up on the quarter, really strong volume quarter, would you parse out growth between increasing utilization by existing customers versus attracting new docs to Aspira's portfolio? Hey Ross, thanks for the question. Thanks for joining us. I think it's been pretty consistent across both categories, to be honest with you.

Speaker Change: The first question comes from the line of Ross <unk> with Cantor Fitzgerald. Please go ahead.

Nicole Sandford: So we continue to bring in new providers and continue to see growth in existing provider adoption. Okay, great. That's good to hear. And then regarding your comments around FDA's Eversight versus historical LEDT, realize you don't think the classification is going to impact your current offerings, but do you still plan to submit a watch for FDA approval? And can we walk through that process again? Yeah, sure. Sandy, I don't know if you want to take this.

Alright, thanks for taking our questions and congrats on the progress.

Speaker Change: It's starting up on the quarter I'm really strong volume quarter would you parse out growth between increasing utilization by existing customers versus attracting new docs, that's part of our portfolio.

Speaker Change: Hey, Ross Thanks for the question and thanks for joining I think it's been pretty consistent across both categories to be honest with you. So we continue to bring on new providers and continue to see growth in existing provider adoption.

Ross: That's great that's good to hear and then regarding your comments around.

Speaker Change: Ever site versus historical OTT.

Speaker Change: I realize you don't.

Speaker Change: The classification is going to impact your current offering.

Speaker Change: But do you still plan to submit a whole lot for FDA approval.

Speaker Change: Walk through that process again please.

Speaker Change: Yeah, Sandy I don't know if you want to take that yeah jumped yeah sure absolutely so.

Sandy Milligan: Yeah, jump in. Yeah, sure. Absolutely. So, Ross, we've been considering whether or not to move forward with Overwatch and get it FDA cleared this year, as we initially thought while we were anticipating the LDA regulation, the LDT regulation, to come sometime this year. At this point, we're holding because we do want to accumulate additional clinical utility data before we approach the FDA. So, we're going to leave it as an LDT for now. And as you're probably aware, companies have until – well, we can leave it forever because Overwatch was released before the LDT regulation came into effect.

Ross: Ross, we've been considering whether or not to move forward with overwatch and get it FDA cleared this year as we initially thought while we were anticipating the LTA regulation L. B T regulations come sometime this year at this point, we're holding because we do want to accumulate additional clinical utility data and before we approached the FDA. So we're going to.

Ross: Leave it as an L D T for now and as you're probably aware companies have until well we can leave it forever because overwatch is which released before the LPT regulation came into effect, but if we do want to clear it and we've got the App.

Sandy Milligan: But if we do want to clear it, we've got the opportunity to do so. With the new products, we can release them as an LDT, and then we just have to clear before mid-2028. Okay, perfect. And then lastly, on John Colassi, nice to see the interim appointment. Will he be considered for a full-time hire?

Speaker Change: Opportunity to do so with the new products, we can release as Mel D. G. And then we just have to clear before mid 2028.

Speaker Change: Okay perfect.

John Classy: And then lastly, John Classy nice to see the interim report that well he would be considered for a full time player.

Nicole Sandford: At this point, he's only been brought in as an interim, but certainly, we will keep all of our options open for the long term, as we obviously will need to have a CFO for the long term. Okay, great. Thanks for taking our questions. Thank you. The next question comes from the line of Dookim with Water Tower Research.

Speaker Change: At this point he's only been brought in as an interim but certainly we will keep all of our options open for long term has he obviously will need to have our CFO for a long time.

Speaker Change: Okay, great. Thanks for taking my questions.

Speaker Change: Thank you thanks al.

Speaker Change: Our next question comes from the line of do Kim with water tower to switch. Please go ahead.

Dookim: Please go ahead. Hi, thanks for taking my questions and congrats on the quarter. Just on Overwatch, I just wanted to know how you're thinking about its growth as physicians implement longitudinal monitoring. Do you anticipate more of a steady growth rate, or could we potentially see a step up in growth as the retests occur? Thanks for the question, though.

Dookim: Please go ahead. Hi, thanks for taking my questions and congrats on the quarter. Just on Overwatch, I just wanted to know how you're thinking about its growth as physicians implement longitudinal monitoring. Do you anticipate more of a steady growth rate? Or could we potentially see a step up in growth as the retests occur?

Speaker Change: Hi, Thanks for taking my questions and.

Speaker Change: Congrats on the quarter.

Do Kim: On Overwatch or just wanted to know how you're thinking about its growth.

Speaker Change: <unk> implement longitudinal monitoring do you envision more of like a steady growth rate or could we potentially see a step up in gross adds the retest occur.

Operator: Good morning ladies and gentlemen and welcome to Aspira's Women's Health Incorporated Second 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 are defined under the private securities litigation reform act of 1995, we made during this call, including statements relating to Aspira's expected future performance, future business prospects, and future events or plans.

Nicole Sandford: So, you know, I'm looking at it as, you know, the value proposition for our existing portfolio. A big part of that has been that as we introduce new products, we would be launching them into a warm, warm market, meaning providers that are already familiar with our testing and trust it and have used it in the past. So, you know, I believe that we will see a faster ramp-up for OvalX than we saw when we launched OvalOne Plus.

Nicole Sandford: Thanks for the question, though. So, you know, I'm looking at it as, you know, the value proposition for our existing portfolio. A big part of that has been that as we introduce new products, we will be launching them into a warm, warm market, meaning providers that are already familiar with our testing and trust it and have used it in the past. So, you know, I believe that we will see a faster ramp-up for OvalX than we saw when we launched OvalOne Plus.

Speaker Change: Thanks for the question Joe So you.

Speaker Change: I'm looking at it.

Speaker Change: The value proposition for our existing portfolio.

Speaker Change: Big part of that has been that as we introduce new products, we would be launching them into a warm a warm market, meaning providers that are already familiar with our testing and trusted and have used it in the past. So I believe that we will see.

Operator: 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 risk and uncertainties and could differ materially from those anticipated due to the impact of many factors beyond Aspira's Women's Health Control. The company assumes no obligations to update or supplement any forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Nicole Sandford: But we did see, if you look back over the history, we have seen nice steady growth in OvalOne since it was launched. So I expect it to be at least the same, but I do believe it'll be much faster. Good to know. And just anecdotally, have you gotten any feedback on the level of physician enthusiasm about the publications and for mass monitoring with Overwatch? The reception has actually been very positive.

Speaker Change: Uh huh.

Speaker Change: So ramp up for Overwatch than we saw when we launched a one plus but.

Speaker Change: But we did see if you look back over historical we have seen nice steady growth and over one since it was launched.

Speaker Change: So I expect it to be at least the same but I do believe it'll be much faster.

Nicole Sandford: And just anecdotally, have you gotten any feedback on the level of physician enthusiasm about the publications and for mass monitoring with the Oval Office? The reception has actually been very positive. I believe that since we launched Overwatch, one of the things that providers were really interested in learning more about how it benefits pre- versus post-menopausal women and asymptomatic versus symptomatic women. And in both cases, we were able to provide information that showed the utility of the test for potentially reducing surgical intervention on women with benign masses, so in all of those categories.

Speaker Change: Good to know.

And just.

Speaker Change: And anecdotally have you.

Speaker Change: Gotten any feedback on the level of physician enthusiasm about the fabrication and for mass monitoring with Overwatch.

Speaker Change: The reception has actually been very positive I believe that since we launched Overwatch was one of the things that providers were really interested in learning more about is how it benefits pre versus post menopausal women.

Nicole Sandford: I believe that since we launched Overwatch, one of the things that providers were really interested in learning more about how it benefits pre- versus post-menopausal women and asymptomatic versus symptomatic women. And in both cases, we were able to provide information that showed the utility of the test for potentially reducing surgical intervention on women with benign masses in all of those categories. So for pre-menopausal women, we're clearly maintaining their ovaries as opposed to prophylactically removing them out of fear of malignancy is a really important goal. And also for asymptomatic women, where a mass is identified incidentally through another diagnosis or another kind of Elias. Identification through transvaginal ultrasound or some other method when you're looking for something. Hopefully, that's clear.

Operator: Participants are directed to the cautionary note set forth in today's press release, as well as the risk factor set forth in Aspira's most recent annual report on from 10K and quarterly report on from 10Q, filed with the SEC for a description of factors that could cause actual result to differ materially from those anticipated in forward looking statements.

Speaker Change: Asymptomatic and symptomatic women and in both cases, we were able to provide information that show the utility of the test or potentially reducing surgical intervention on women with benign masses. So in all of those categories. So for premenopausal women, where clearly.

Nicole Sandford: So for premenopausal women, where clearly maintaining their ovaries as opposed to prophylactically removing them out of fear of malignancy is a really important goal. And also for asymptomatic women, where a mass is identified incidentally through another diagnosis or another kind of diagnosis, for example, in Asia. Identification through transvaginal ultrasound or some other when you're looking for something. Hopefully, that's clear.

Nicole Sandford: At the same, I would like to turn the call over to Nicole Sandford, Chief Executive Officer, please go ahead. Thank you, Operator, and welcome everyone to our second quarter of 2024 earning conference call.

Speaker Change: Maintaining their ovaries.

For as opposed to prophylactic lever moving them out of fear of malignancy is a really important goal and also for asymptomatic women who.

And that is identified incidentally through another diagnosis or another another kind of a.

Nicole Sandford: This week's today is our president, Dr. Sandy Milligan. I will begin with an overview of our strategy, execution, and operations, followed by an update from Sandy on product development. I will then review our financials before opening the call for questions.

Speaker Change: Hum identification through transactional ultrasound or some other when youre looking for something else.

Nicole Sandford: But these are two categories where we have heard in the past that doctors really wanted to understand, you know, how Overwatch would help them in those particular populations. And the new data, along with the launch of the longitudinal monitoring application, has been very warmly received as a result, because we've brought forward some additional information that helps them to understand the utility of, Okay, great. That's all great signs.

Nicole Sandford: But these are two categories where we have heard in the past that doctors really wanted to understand, you know, how Overwatch would help them in those particular populations, and the new data, along with the launch of the longitudinal monitoring, application has been very warmly received as a result because we've brought forward some additional information that helps them to understand the utility of the Okay, great. That's all great signs.

Nicole Sandford: The most important development to the quarter was the launch of the longitudinal mass monitoring application for Overwatch, following the publication of powerful new data at the beginning of May. This is the latest development in our effort to expand both the clinical utility and commercial opportunity for our over-sleep portfolio of a very cancer risk assessment blood test for women with an indexal mass. The launch of the longitudinal monitoring application means that we have achieved our goal of offering a life-changing suite of blood test, the first in only tool of its kind available anywhere in the world.

That's clear, but these are two big categories, where we have heard in the past the doctors really wanted to understand how overwatch would help them in those particular population and the new data along with the launch of the longitudinal monitoring.

Speaker Change: Application has been very warmly received as a result, because we brought forward. Some additional information that helps them to understand the utility of the test.

Speaker Change: Okay, Great. That's all great signs thanks for taking my questions.

Speaker Change: Thank you.

Dookim: Thanks for taking my questions. Thank you. Thank you. The next question comes from the line of Laura Seville with Alliance Resource Partners. Please go ahead.

Speaker Change: Thank you next question comes from the line of Laura severe.

Nicole Sandford: This is a major accomplishment and one that we share with the many long-term shareholders who have believed in the company and supported us on this important journey.

Speaker Change: <unk> partners. Please go ahead.

Laura Seville: Hi, thank you for taking the questions and congratulations again on the growth this quarter. So with the longitudinal monitoring feature now implemented in Overwatch, and you also mentioned the potential to add buttoned-up checkscores to Oversuite, what do you see as the next steps, and do you have any current plans to further enhance Oversuite? The next step for, thanks for the question, by the way, next steps for longitudinal monitoring is all about adoption.

Nicole Sandford: Let's reflect on the addressable market for our tests over the past few years to set the stage for our future growth. Over one plus, the only test that was commercially available when I joined the company in early 2022 has a total addressable market of between 200,000 and 400,000 tests per year in the United States. We increased that to more than 1.2 million with the launch of the initial assessment application of Overwatch in December of 2022.

Laura Severe: Hi, Thank you for taking the questions and congratulations again on the growth this quarter.

Laura Severe: But with the longitudinal belonged to two new monitoring fees turned out and sometimes it's the Overwatch and you also mentioned the potential to add and button they'll check sports the oldest suite.

Speaker Change: What do you see here is the next steps and do you have any current plans to further enhance over suite.

Speaker Change: The next steps for Oh, Thanks for the question by the way next steps the longitudinal monitoring it. It's all about adoption. So we're really going back to physicians, who have used one of our oldest sweep has in the past and making sure. They understand the expansion of the test.

Nicole Sandford: Now, with the launch of the longitudinal monitoring application this quarter, we believe the total addressable market for our oversuit test is between 2.4 million tests per year. This is a tenfold increase in the revenue potential for the test that have already been trusted by healthcare providers more than 200,000 times.

Laura Seville: So we're really going back to physicians who have used one of our OvaSuite tests in the past and making sure they understand the expansion of the test for longitudinal monitoring. And in terms of improving OvaSuite or enhancing OvaSuite, we do think there's a possibility, this was actually discussed on that earlier R&D webinar that we held with Dr. Elias, our partner at Bina Farber, Brigham and Women's, actually talked about the benefit that he could see in being able to give the physician an opportunity to rule out ovarian cancer and either rule in or rule out and sort of to be determined with endo-check score endometrioma and bringing to the table an even higher value proposition for a single test.

Speaker Change: Two for longitudinal monitoring and in terms of improving Oh, the suite or enhancing all this week we.

Nicole Sandford: It is important to keep the dramatically increased addressable market in mind as we review our performance for the second quarter and look out to the rest of 2024 and beyond.

Speaker Change: We do think there's a possibility this was actually discussed on my earlier R&D, a webinar that we held.

Nicole Sandford: You may recall that we began a refresh of our commercial strategy and program elements in the second half of 2023, with the goal of identifying people, process, and technology enhancements, as well as refining our market messaging to increase both impact and reach. The refresh was completed and fully implemented in the first quarter of 2024, and as a result I believe we are well positioned to take advantage of the expanded addressable market car test.

Speaker Change: A doctor to ly as our partner at Dana Farber.

Dr. Ly: Regular women's actually talked about the the benefit that he could see in being able to give the physician and opportunity to rule out ovarian cancer and either rule in or rule out and sort of to be determined with the endo check score endometrial Ma.

Nicole Sandford: Moreover, the enhanced commercial organization is more efficient and cost effective than ever, which is critical to our cost containment goals. I'm happy to report that we have seen positive momentum resulting from our refresh efforts with sequential growth during the first half of 2024. Our total oversuit test volume in the second quarter had a new company high water market 6,471, with more than 20% of that volume coming from the Overwatch test. We achieved this test volume with 17% fewer full-time field salespeople compared to the second quarter of 2023.

Dr. Ly: Bringing bringing to the table and even higher value proposition for a single test. So the next step as Sandy mentioned is we are a we're running some additional experiments and unchecked endo check testing on samples and brought in from our.

Nicole Sandford: So the next step, as Sandy mentioned, is we are running some additional experiments and endo-check testing on samples we've brought in from our clinical study and will have additional data in the third quarter to really help us to crystallize a vision for commercializing that product. But certainly, regardless of any decision we make about enhancing Overwatch with the endo-check score, the research that we're doing right now will be very instrumental in the design and development of the endo-MDX. I got it. Lots to look forward to. And then maybe another question for Dr. Milligan. As mentioned in the past, the ongoing research on the digital droplet PCR platform.

Nicole Sandford: So the next step, as Sandy mentioned, is we are running some additional experiments and endo-check testing on samples we've brought in from our clinical study and will have additional data in the third quarter to really help us to crystallize a vision for commercializing that product. But certainly, regardless of any decision we make about enhancing Overwatch with the endo-check score, the research that we're doing right now will be very instrumental in the design and development of the endo-MDX. Got it. Lots to look forward to. And then maybe another question for Dr. Milligan. As mentioned in the past, the ongoing research on the digital droplet PCR platform.

Sandy: Clinical study and we'll have additional data in the third quarter to really help us to crystallized a vision for commercializing that product, but certainly regardless of any decision, we make about it and enhancing overwatch with the endo check score the research that we're doing right now will be there.

Nicole Sandford: By comparison, we had an average of 16 field salespeople in the first half of this year compared to 21 field salespeople for the same period last year. Resulting in an impressive 29% increase in volume for field sales representatives to 769 tests. We added an additional two field salespeople in the third quarter and expect the enhanced commercial programs along with the expanded application of the Overwatch test and the powerful new data published in May to support rapid success in these territories.

Sandy: Instrumental in the design and the development of the handle Mdx test.

Sandy: Yeah.

Sandy: Got it lots to look forward to and then maybe another question for Doctor Milligan. It was mentioned in the past, but ongoing research on the digital PCR and droplet PCR platform. So what is this platform overall encompassed in what are some of the opportunities you see here as well as any other plants on leveraging our commercial.

Sandy Milligan: So what does this platform overall encompass, and what are some of the opportunities you see here, as well as any other plans for leveraging it commercially? So right now, we're just looking at it for our micro RNA. We do think it has an advantage over some of the other platen forms, especially in the throughput in the multivariate sense. For any deep scientific details, I'd need to connect you with our scientist, Todd Pappas, but we are very satisfied to date with the performance that we're seeing on that commercial platform.

Sandy Milligan: So what is this platform overall encompassed, and what are some of the opportunities you see here as well as any other plans on leveraging it commercially? So right now, we're just looking at it for our microRNA. We do think it has an advantage over some of the other platen forms, especially with throughput in the multivariate sense. Any deeper particular scientifically, I'd need to connect you with our scientist, Todd Pappas.

Sandy: Hmm.

Nicole Sandford: Our primary focus now is to drive the adoption of our oversuit test portfolio to become the universal standard of care for every woman diagnosed with a nexel mask. There are many important initiatives on the way, including working with partners to have our test added to the protocols for a nexel mask care, which we expect to come together in the third and fourth quarters of this year.

Doctor Milligan: So right now we're just looking at it for our micro RNA.

Doctor Milligan: We do think it has an advantage over somebody other platinum forms, especially with the throughput and the multivariate sense.

Speaker Change: Any deep particular scientifically I'd need to connect you with our scientists are Todd pepper them, but we are very satisfied to date with our the performance that we're seeing on that commercial platform.

Sandy Milligan: But we are very satisfied to date with the performance that we're seeing on that commercial platform. Got it. Thank you for taking the question. Thank you. A reminder to all the participants that you may press star and 1 to ask a question. The next question comes from the line of Andrew Brackmann with William Blair. Please go ahead. Hi, everyone. This is Maggie on behalf of Andrew.

Nicole Sandford: Our commercial success and growth also rely on our ability to increase coverage and reimbursement for our oversuit products, and I'm proud of the progress we have made. On the commercial plan side, we recently contracted with Anthem plans in California and the Northeast States, adding 8 million covered lives. We expect the Anthem's central and virginity geographic regions to complete contracting before the end of 2024, which would add an additional 16 million lives.

Sandy Milligan: Got it. Thank you for taking the question. Thank you. A reminder to all the participants that you may press star and 1 to ask a question. The next question comes from the line of Andrew Brackmann with William Blair. Please go ahead. Hi, everyone. This is Maggie on behalf of Andrew.

Got it thank you for taking the questions.

Speaker Change: Yeah.

Speaker Change: Thank you.

Speaker Change: To all the participants that do them a press star one to ask a question.

Speaker Change: Next question comes from the line of Andrew Brockman William.

Speaker Change: William Blair. Please go ahead.

Nicole Sandford: Also of note, we have added Ducross Blue Shield of Texas, Ducross Blue Shield of Illinois, and Superior Plan Texas so far this year. On the Medicaid side, we added Maryland and Kentucky in the second quarter, bringing the total number of states covering one and more of our oversuit tests to nine, including the critical states of California, New York, and Illinois.

Speaker Change: Hi, everyone. This is Maggie on for Andrew Thanks for taking our question.

Andrew Brackmann: Thanks for taking our questions. Maybe just to start here, can you give us maybe a little bit more color on how you're thinking about that clinical utility study for Overwatch? Just anything in terms of size, timing, or endpoints that might be helpful to be keeping an eye out for.

Maggie: Maybe just to start here can you give us maybe a little bit more color on how you're thinking about that clinical utility study for Overwatch just anything in terms of size timing or endpoints that might be helpful to be keeping an eye out for.

Nicole Sandford: Medicare and Medicare Advantage reimbursement for overwatches also increased meaningfully in the first half of 2024. Despite these achievements, we know we have more to do to convert additional payers. The study we published in May was instrumental in helping to swing momentum our way. The data clearly demonstrated the benefit of adding overwatch to a physician's clinical assessment in women presenting with a denexal map. We've created a model to help payers quantify the potential savings that can result from a reduction in surgical interventions on low risk patients, if the Overwatch past is used. We believe the potential savings, while dependent on circumstances, are both significant and compelling.

Nicole Sandford: Yeah, so the first phase of the study is to get some additional clarity from the decision makers at the payers about what the gaps are for clinical data that would allow them to move forward with an enhancement to their medical policy for our tests. So we're going to be doing data gathering at the front end that will help to answer some of those questions.

Speaker Change: Yeah. So the first phase hi, Maggie thanks for joining.

Speaker Change: The first phase of the study is to get some additional clarity from the decision makers at the payers.

Speaker Change: About what the gaps are for clinical data that would allow them to move forward with AR and enhancement to their medical policy for our pets. So we're gonna be doing data gathering at the front end that will help to answer some of those questions I'm not I'm not trying to be cagey here, but it.

Nicole Sandford: So I'm not trying to be cagey here, but it is important for us to first find out, you know, what exactly it is that they need to see. Candidly, there's not going to be a single answer. We know that, right? You're dealing with, you know, maybe 50 to 100 different payers in the commercial space. You know, 20 of them matter a lot. Another 20 border matter as well, but maybe not as much as that top.

Speaker Change: It is important for us to first find out what exactly is it that they need to see candidly theres not going to be a single cancer. We know that right you're dealing with you know maybe 50 to 100 different payers in the commercial space 20 of that matter a lot time, another one quarter.

Nicole Sandford: To further accelerate our reimbursement progress, we have initiated a comprehensive analysis of national, regional, and integrated delivery network payers with the assistance of an experienced third-party consultant. The objective of the project is to gather specific and direct insight regarding evidence requirements we must meet to support broader coverage and reimbursement for Overwatch. The first phase of the study, which we expect to complete in the third quarter of 2024, consists of interviews with senior stakeholders to identify evidentiary and other gaps we must sell.

Speaker Change: Or as well, but maybe not as much of that top so now we have to kind of prioritize the views of the larger opportunities for the task in terms of payer input.

Nicole Sandford: These findings will be incorporated into a clinical utility study that we expect will help expand commercial coverage for Overwatch and Overwatch, while also informing our market access and reimbursement strategies for future product launches.

Nicole Sandford: So we have to kind of prioritize the views of the larger opportunities for the test in terms of payer input. So the main objective is to do it quickly so that we can very quickly answer those questions. How long is it going to take for us to gather the data? How much will it take? How much will it cost? And who will likely be responsible?

Speaker Change: So although the main objective is to do it quickly. So that we can very quickly answer those questions. How long is it going to take for us to gather the data how much how long would take how much will it cost.

Speaker Change: And who will who will likely be responsive.

Nicole Sandford: Got it. Thank you. And just with the reduced cash burn guide and recent funding, can you just update us on your thoughts around your ability to further boost the balance sheet? You know, what is your visibility into the non-dilutive financing that you discussed earlier in the call? And then when do you expect to have updates there?

Speaker Change: Got it thank you and just with the reduced cash burn guide in recent funding can you just update us on your thoughts around your ability to further boost the balance sheet. You know what is your visit visibility into non dilutive financing that you discussed earlier.

Sandy Milligan: Now it is my pleasure to turn the call over to Sandy to talk about product development. Then I will come back on to discuss our operating performance and balance sheet position. Sandy?

Sandy Milligan: Thank you, Nicole. In my role as president, my focus continues to be the acceleration of our research and product development program. And please do the progress we have made in the second quarter, which I'll share with you today. As Nicole mentioned, we announced the publication of two Overwatch-focused manuscripts in May. Together, these peer-reviewed publications demonstrate the potential for significantly improved position triaging of malignancies for surgery over their clinical impressional loan and supported the use of Overwatch as an ovarian cancer risk serial assessment tool.

Speaker Change: Earlier in the call and then when you expect to have updates there and then do you view the implied quarterly burn of about 3 million are sustainable going forward, particularly with that product and innovation pipeline you have.

Nicole Sandford: And then, do you view the implied quarterly burn of about $30 million as sustainable going forward, particularly with the product and innovation pipeline? You have it, Sure. So, in terms of non-dilutive financing, we've moved the ball forward quite a bit this quarter in terms of looking at the opportunity to monetize important assets that we have, including the biobank and data. That's something that's taken quite a while to get to the point where it is, which essentially required a full physical inventory and collection of the appropriate legal documents, etc., but also, importantly, looking for the right partners, because this is an opportunity not just to bring in non-dilutive financing but also an opportunity to look for partners that we can sort of lock arms with to either expand our commercial offering, to include other tests, or to look In addition, you know, we've been applying for lots of different grant opportunities, as Sandy mentioned. Many of them require confidentiality throughout the decision-making process, but I can't comment too much on that.

Sure. So in terms of non dilutive financing we've moved the ball forward quite a bit this quarter in terms of looking at the opportunity to monetize them important assets that we have including the biobank.

Speaker Change: And data on.

Speaker Change: That's.

Speaker Change: Something that's taken quite a while to get to the point, where it is which essentially required a full physical inventory and collection of who the appropriate legal documents et cetera, but also importantly, looking for the right partners them. Because this is an opportunity not just to bring in non dilutive financing, but also an opportunity to look for.

Sandy Milligan: This data demonstrates that Overwatch could substantially reduce surgeries for low-risk patients performed out of concern for malignancy risk, especially for asymptomatic and premenopausal women. Indeed, Overwatch may have reduced the number of surgeries in women with low risk of malignancy by 62% in all patients and 77% in premenopausal women. With the added feature of serial mass monitoring, Overwatch can be drawn at provider prescribed intervals for active surveillance of an ad-nextile mass determined by initial clinical assessment as indeterminate or low risk.

Speaker Change: Partners that we can you can sort of lock arms with to either expand our commercial offerings to include other tests or to look for people, who can kind of work and collaborate with us on our development.

Speaker Change: So you know that was an important.

Speaker Change: Very important a few steps forward from this quarter in addition.

Sandy Milligan: This is the strongest clinical support for Overwatch and its value proposition for physicians and patients to date.

Speaker Change: We have been applying to lots of different grant opportunities as and as Sandy mentioned.

Sandy Milligan: Let me turn now to our product development update with a brief overview of our progress on EndoCheck, our protein-based test that has been shown to identify certain endometriosis located on the ovary, including endometrioma. Following a robust discussion with healthcare providers upon our presentation of EndoCheck data at the Society for Reproductive Investigation Annual Scientific Meeting in February, we believe that the EndoCheck protein biomarker signature will significantly contribute to a test with broader endometriosis application, as well as offer insights to improve the understanding of this devastating and complex disease.

Sandy: Many of them require confidentiality talks about the decision making process. So I can't comment too much on that other than to just say, we've just made such great progress on the molecular test portfolio. We're at a point in time, we're going out and asking for additional grant funding makes a lot of sense, a very different place where we're standing.

Nicole Sandford: Other than to just say, we've just made such great progress on the molecular test portfolio. We're at a point in time where going out and asking for additional grant funding makes a lot of sense. A very different place to where we're standing today with that microRNA protein metazata combination of value versus where we've been in the past.

Speaker Change: Today, what that micro Arnie.

Speaker Change: Protein metadata combination of of value versus where we've been in the past. So it makes great sense for us to go out and look for those opportunities.

Nicole Sandford: So, it makes great sense for us to go out and look for those opportunities. Is there a second part of the question that I didn't answer? Oh yeah, keep going, sorry. No, I'm just trying to remember. I think you asked a second question, unless I answered it. No, no, it was just on. Sustainability.

Speaker Change: The second part of the great, but I Didnt answer [laughter], Oh, yeah keep going sorry.

Sandy Milligan: We are currently processing nearly 400 samples collected in our endometriosis clinical study and expect to have new data for analysis during the third quarter. With this data in hand, we will have the opportunity to further assess the commercial application of the test and expand our outreach to potential development partners. This may include pharma companies with drug therapies and development that could potentially utilize Indochec as a research focused test to identify or track patient response to drug therapies and ongoing clinical trials.

Speaker Change: No I'm just trying to remember I think you asked a second question unless I answer that.

Nicole Sandford: Yes, yes, yes. Yes. Yes. So, if you look back over the last two and a half years since I've been in this role, we have reduced our cash burn every quarter, quarter over quarter, year over year. It's the first time in many, many, many quarters where we had a slight increase. And as I mentioned, there were some really specific investments that we made in the second quarter that we believe were worth the increase.

Speaker Change: No no. It was just an oh sustainability, yes, yes, yes, yes, yes, mhm, yes Sophie.

You look back over the last two and a half years, where I've been in this role we have reduced our cash burn.

Speaker Change: Every quarter quarter over quarter year over year. Its the first time in many many many quarters, where we had a slight increase in as I mentioned there were some really specific.

Sandy Milligan: We are also considering how the addition of an Indochec score to our Overwatch test report would also allow health care providers to assess the risk of both ovarian cancer and endometrioma for women presenting with an indexal mass. We believe this may have a positive impact on clinical utility, provider adoption, and pricing of the test. Clearly, we have worked to do in deciding how best to proceed with Indochec and for now have focused the majority of our development resources towards our molecular testing portfolio.

Speaker Change: That means that we need in the second quarter that we believe well worth the.

Speaker Change: The increase in spend but my goal is to continue to reduce that that quarterly burn I have.

Nicole Sandford: But my goal is to continue to reduce that corny burn. I have demonstrated an ability to do that, and I intend to continue to do that with the help of my new CF. Great, thanks so much. Thank you. There are no further questions at this time. I would now like to turn the floor over to Nicole Sandford for closing comments. Well, thank you everyone so much for joining us today. We look forward to continuing our execution and providing another update on our next quarterly earnings call.

Speaker Change: Demonstrated an ability to do that and I intend to continue to do that with the help of my new CFO.

Speaker Change: Great. Thanks, so much.

Speaker Change: Thank you.

Speaker Change: Thank you there are no further questions at this time I would now like to turn the floor over to Nicole San food for closing comments.

Sandy Milligan: With that, let me turn to OVA MDX, which is being developed in collaboration with the Dana Farber Cancer Institute. We have completed assay analytical feasibility on an FDA approved PCR system, a critical milestone which confirms the ability to perform a test that utilizes the microRNA technology discovered by Dana Farber on a commercially viable diagnostic platform. Our next phase, which is currently underway, is the design and assay verification process which we expect to provide additional data prior to the end of 2024.

Speaker Change: Well. Thank you everyone. So much for joining us today, we look forward to continuing our execution and providing another update in our next quarterly earnings call. So thank you everyone.

Nicole Sandford: So, thank you, everyone. Thank you. This concludes our teleconference today. You may disconnect your lines at this time. Thank you for your participation. Dylan Dillon Alex Thank you. Please check out my channel. Thanks for watching, Stephen Hopper, Rita Matrix, Gian Fossaro, Troy Heppner Unmusi's, Student Sora, Ortuni Suhara, Jaclyn Powell, Jasmine Odise, Elizabeth Warren, Andrew Ginchy, El Margaratevo, Cameron Gintron, Victor Rietzner Oliver Fox, Joy That's it for now. If you'd like to see a future Disney film reboot, proactively advertised, tell us at I'd Love to See a Movie by

Speaker Change: Thank you.

Speaker Change: Concludes today's teleconference. You may disconnect your lines at this time, thank you for your participation.

Speaker Change: [music].

Sandy Milligan: As we have shared previously, we believe that this test will have the power to improve sensitivity for early stage ovarian cancer, as well as broader detection for various histological subtypes, solidifying our position as the leader in non-invasive ovarian cancer testing for women with adnexal masses. As we complete development steps for the OVA MDX program, we will leverage the learnings and experience in developing a microRNA and protein biomarker test into the development of our broad general endometriosis blood tests that leverages proteins from Indochec and proprietary microRNAs identified through our research agreement with Dana Farber.

Sandy Milligan: We are working to establish analytical feasibility and the selection of microRNAs and protein candidates as part of the ongoing test design for this broader endometriosis test. Now that the FDA has finalized its role to regulate lab developed tests, we are in the process of determining the regulatory pathway and related requirements for our indevelopment molecular tests for both ovarian cancer and endometriosis. We do not anticipate the new role to have any impact on our ability to offer our existing products, including the longitudinal testing application of OVA watch, nor do we anticipate the regulation to cause a significant extension of our prior development or launch timelines for the combination microRNA and protein biomarker test.

Sandy Milligan: We continue to focus on identifying non dilutive sources of funding for our R&D activities, including funding from multiple research grants. Our development related to our in process molecular tests are groundbreaking. We believe that related research has created new grant opportunities which we intend to aggressively pursue. In addition, we are waiting for a funding decision on a sizable grant opportunity which requires confidentiality until such decision is made. Regardless of the outcome, the application processes have helped us consolidate to a compelling and data driven development and commercialization strategy to bring to potential development partners.

Sandy Milligan: Another potential source of non-dilutive funding is through our research biobank where our recent analysis showed that we have as many as 70,000 serum, plasma and whole blood samples available for secondary research. In July we executed a number of small material transfer agreements with third parties who intend to utilize the samples for validation of gynecological disease diagnostic tests. We recognized an average selling price of approximately $500 per sample. This is an important step and establishing a baseline market value for the purchase material and realizing another opportunity for non-dilutive cash through sample disposition.

Sandy Milligan: We also believe that there may be opportunities to work with foundation to identify additional academic and research activities in women's health that could benefit from access to our sample bank. Finding the right path for this initiative is complex and requires a strategic approach that we have made tremendous progress in 2024.

Nicole Sandford: With that, let me now turn it back to Nicole for an update in our financial Nicole. Thank you Sandy. Over-sleep revenue for the second quarter was 2.4 million, a 13% increase sequentially from the first quarter and black to the second quarter of 2023. Second quarter product volume of 6,471 increased 11% sequentially and 3% year over year. Over-watch test volumes contributed significantly to overall growth, increasing 24% sequentially and 48% year over year.

Nicole Sandford: As I discussed earlier, the contribution of over-watch to the overall growth is critical, given the test large-addressable market of between 2 to 4 million tests per year. Our overall average unit price this quarter was $374, a slight increase sequentially compared to 369 in the first quarter, but down 5% from 396 in the second quarter last year. It is important to note that our AUP and the prior year reflected an adjustment for a change in estimate required under generally accepted accounting principles based on actual collections compared to previously recognized revenues.

Nicole Sandford: After adjusting to this impact, our second quarter 23 AUP for all products would have been $381 per task, is to over 1% higher than this year. Overall, we are pleased to see overwatch's AUP converging with over 1 plus. Overwatch AUP of $348 in the second quarter reflects the 3% increase sequentially as 7% increase compared to the second quarter last year and a 34% increase compared to the first half of 2023. Margin's this quarter decreased slightly to 59% compared to 62% last year, as we saw an increase in product costs, including higher shipping costs.

Nicole Sandford: We are currently exploring options to better control shipping and other costs as we look ahead to 2025. Gross margin for the six months is largely consistent with the prior year. On the operating side, research and development expenses for the quarter increased 37% year over year, as we saw an increase in collaboration costs with our research partner for the molecular task portfolio. This includes reagents and other supplies required to process samples which must be purchased well in advance of testing.

Nicole Sandford: Sales and marketing expenses increase 21% over the second quarter of the prior year, primarily due to an increase in personnel costs for the addition of strategic account leaders, marketing professionals and inside sales people. GNA cost decreased 20% of this quarter compared to last year mainly due to a decrease in post-Nallican folks in cost. During the second quarter are cashews and operations with 3.7 million, down 16% sequentially and a slight increase of 9% compared to last year.

Nicole Sandford: One cause of the increase in cashews over the prior year was related to our decision to pay bonuses to our staff, including a small amount that had been outstanding since 2022. These individuals have dedicated themselves to our mission and the retention is critical for the achievement of our strategic goals. Our cashews of June 30th, 2024 was approximately $962,000. After adjusting for gross proceeds of the subsequent pipe and worn inducements that were completed in July, our ending casch would have been approximately $5 million.

Nicole Sandford: In August, we entered into a new 4.5 million Apple Market facility with H.D. Raybright.

Nicole Sandford: This facility, which will be available to the company following a 60-day stand still under the worn inducement agreement, replaces a prior regional or tantrophic sterile, which had been suspended for some time. We believe H.D. Raybright offers a better alternative for small cap companies for this kind of a facility for a variety of reasons, including a significantly lower cost of capital.

Nicole Sandford: We are updating our values for cashews and operations for 2024 to be between 13 and 14.5 million, down from the 15 to 18 million we guided towards that beginning of the year. We believe that our in-played initiatives, including grant funding, sample sales, a partnership opportunity, and the availability of our newly executed ATM facility, will be sufficient for us to fund operations in the near term.

Nicole Sandford: Today, we also announce that Sandy and I have opted to change our base compensation for the remainder of the year. Each of us will be receiving additional equity in exchange for a 20% reduction in cash-based salary. We continue to believe that our stock is significantly undervalued. We want to be in a position to be rewarded alongside our shareholders when the capital markets catch up with the companies and that's potential. While this year has presented many challenges, we remain steadfastly focused on our mission to improve health outcomes for millions of women while positioning ourselves for long-term success.

Nicole Sandford: We have the only blood cast on the market for the accurate assessment of the risk of malignancy for all patients that have been diagnosed with anorexal mass. When we are leading away in the development of non-invasive pests and endometriosis, I continue to be bullish on our prospects, proud that we have kept our promises to patients, physicians, and our shareholders to the best of our ability.

Nicole Sandford: Before I open for questions, I have an exciting personal update.

Nicole Sandford: This week, the board appointed John Colossi, an experience financial executive as our interim chief financial officer, effective August 15th. John brings a passion for a mission and decades of experience to the role. He has served in senior-level roles, including chief financial officer, chief operating officer, financial strategy, and innovation advisors, as well as founder to several businesses. John's expertise in solving challenges like those facing a spiral at our critical stage of growth will undoubtedly help the position of future success. His first priority will be the retirement of our capital and liquidity strategy, as well as expanding our shareholder base.

Operator: With that, I would now like to open the call for questions. Operator? Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to move your questions from the... Thank you. For participants using speaker equipment, it may be necessary to pick up your handset before blessing the stockies. One moment, please, while we pull for questions.

Ross Osborn: The first question comes from the line of Ross Osborn with Cantor Fitzgerald. Please go ahead. Hi, thanks for taking our questions and I can grasp on the progress.

Nicole Sandford: So starting up on the quarter, really strong volume quarter, would you parcel growth between increasing utilization by existing customers versus attracting the doctor's best fire portfolio? Hey, Ross, thanks for the question. Thanks for joining. I think it's been pretty consistent across both categories to be honest with you. So we continue to bring on new providers and continue to see growth in existing provider adoption. Okay, great.

Unknown Attendee: Let's go to here.

Unknown Attendee: And then regarding your comments around FIA's oversight versus historical LEDT, realize you don't think the classification is going to impact your current offerings, but you still plan to submit a watch or FIA approval, and if we walk through that process again, please. Yeah, sure. I don't know if you want to take that. Yeah, jump in. Sure. Absolutely.

Sandy Milligan: So Ross, we've been considering whether or not to move forward with Overwatch and get it FIA cleared this year, as we initially thought while we were anticipating the LDA regulation. LDT regulations come sometime this year. At this point, we're holding, because we do want to accumulate additional clinical utility data and before we approach the FDA. So we're going to leave it as an LDT for now, and as you're probably aware, companies have until well, we can leave it forever because Overwatch was released before the LDT regulation came to effect, but if we do want to clear it, we've got the opportunity to do so.

Unknown Attendee: With the new products, we can release as an LDT, and then we just have to clear before mid-2028. Okay, perfect.

Unknown Attendee: And then lastly, John Colassi, nice to see the interim appointments.

Nicole Sandford: Will he be considered for a full-time higher? At this point, he's only been brought in as an interim, but certainly we will keep all of our options open for long-term, as we obviously will need to have a CSO for the long-term. Okay, great. Thanks for taking our questions. Thank you.

Unknown Attendee: Next question comes from the line of Dukeim with what totaler to search. Please go ahead.

Unknown Attendee: Hi, thanks for taking my questions and congrats on the quarter. Just on Overwatch, just wanted to know how you're thinking about its growth as physicians implement longitudinal monitoring. Do you envision more like a steady growth rate, or could we potentially see a step up in growth as the retest occur? Thanks for the question, Bill. So, you know, I'm looking at it as the value proposition for our existing portfolio. A big part of that has been that as we introduce new products, we would be launching them into a warm market, meaning providers that are already familiar with our testing and trusted and have used it in the past.

Unknown Attendee: So, you know, I believe that we will see a faster ramp up for Overwatch than we saw probably launched over one plus. But we did see, if you look back over historical, we have seen nice, steady growth in over one since it was launched. So, I expect it to be at least the same, but I do believe it will be much Good to know. And just anecdotally, have you gotten any feedback on the level of physician enthusiasm about the publications and for mass monitoring with Overwatch?

Unknown Attendee: The reception has actually been very positive. I believe that since we launched Overwatch, one of the things that providers were really interested in learning more about is how it benefits pre-versus postmenopausal women and asymptomatic versus symptomatic women. And in both cases, we were able to provide information that show the utility of the test for potentially reducing surgical intervention on women with benign masses. So in all of those categories. So for pre-menopausal women where clearly maintaining their ovaries for as opposed to prophylacically removing them out of fear of pregnancy is a really important goal.

Unknown Attendee: And also for asymptomatic women who a mass is identified incidentally to another diagnosis or another kind of a identification through a trans-vanginal ultrasound or some other one you're looking for something else. Hopefully that's clear. But these are two categories where we have heard in the past that doctors really wanted to understand how Overwatch would help them in those particular populations. And the new data along with the longitudinal monitoring application has been very warmly received as a result because we've brought forward some additional information that helps them to understand the utility of the test. Okay, great. That's all great signs. Thanks for taking my question. Thank you.

Nicole Sandford: Next question comes from the line of Laura Serif with Alliance Resource Partners. Please go ahead. Hi, thank you for taking the questions and congratulations again on the growth of this quarter. Thanks Laura. So with the longitudinal monitoring fee turnout implemented to Overwatch and you also mentioned the potential to add in the end of check scores to oversuit. What do you see here as the next step? And do you have any current plans to further enhance oversuit?

Nicole Sandford: So next step for thanks to the question by the way. Next step to we're really going back to physicians who have used one of our oversuit tests in the past and making sure they understand the expansion of the test for longitudinal monitoring. And in terms of improving oversuit or enhancing oversuit, we do think there's a possibility. This was actually discussed down not earlier R&D webinar that we held with Dr. Elias our partner at being a regular women's actually talked about the benefit that he could see in being able to give to the physician an opportunity to rule out over here in cancer and either rule in or rule out and sort of to be determined with the end of check score and the metrioma and bringing to the table an even higher value proposition for a single test.

Nicole Sandford: So the next step is being mentioned is we are running some additional experiments and check endo-check testing on samples we brought in from our clinical study and we'll have additional data in the third quarter to really help us to crystallize a vision for commercializing that product. But certainly regardless of any decisions we make about enhancing Overwatch with the endo-check score, the research that we're doing right now will be very instrumental in the design and the development of the endo-MDX. Pat. Got it. Looks to look forward to.

Sandy Milligan: And then maybe another question for Dr. Milligan. It was mentioned in the past the ongoing research on the digital PCR, Droslet PCR platform. So what is this platform overall encompass and what are some of the opportunities you see here, as well as any other plans on leveraging it commercially seeking? So right now we're just looking at it for our microRNA. We do think it has an advantage over some of the other platen forums, especially with the throughput in the multivariate sense.

Sandy Milligan: Any deep particular scientifically I'd need to connect you with our scientists, Todd Papis, but we are very satisfied to date with our performance that we're seeing on that commercial platform. Got it. Thank you for taking the question. Thank you.

Operator: A reminder to all the participants that you may press star and want to ask a question.

Maggie: Next question comes from the line of Andrew Brackman with William Blair, please go ahead. Hi, everyone. This is Maggie on for Andrew. Thanks for taking our question. Maybe just to start here, can you give us maybe a little bit more color on how you're thinking about that clinical utility study for Overwatch? Just anything in terms of size, timing, or endpoints that might be helpful to be keeping in our help for? Yeah, so the first phase, hi, Maggie.

Maggie: Thanks for joining. The first phase of the study is to get some additional clarity from the decision makers at the payers about what the gaps are for clinical data that would allow them to move forward with an enhancement to their medical policy card test. We're going to be doing data gathering at the front end that will help to answer some of those questions. I'm not trying to be cagey here, but it is important for us.

Maggie: The first to find out what exactly is it that they need to see. Handedly, there's not going to be a single answer. We know that right here, dealing with maybe 50 to 100 different payers in the commercial space. Maybe 20 of them matter a lot, another 20 quarter matter as well, but maybe not as much as that top. So we have to kind of prioritize the views of the larger opportunities for the test in terms of payer input.

Maggie: So the main objective is to do it quickly so that we can very quickly answer those questions. How long is it going to take for us to gather the data, how long will it take, how much will it cost, and who will likely be responsive?

Nicole Sandford: Got it. Thank you. And just with the reduced cash fund guide and recent funding, can you just update us on your thoughts around your ability to further boost the balance sheet? What is your visibility into non-deluted financing that you discussed earlier in the call and then when you expect to have updates there? And then do you view the implied quarterly burn of about 3 million as sustainable going forward, particularly with the product and innovation pipeline you have?

Nicole Sandford: Sure. So in terms of non-deluded financing, we've moved the ball forward quite a bit this quarter in terms of looking at the opportunity to monetize important assets that we have, including the BioBank and data. That's something that's taking quite a while to get to the point where it is, which essentially required a full physical inventory and collection of the appropriate legal documents, et cetera, but also importantly looking for the right partners, because this is an opportunity not just to bring in non-deluded financing, but also an opportunity to look for partners that we can sort of lock arms with to either expand our commercial offering to include other tests or to look for people who can kind of work and collaborate with us on our development.

Nicole Sandford: So that was an important, very important to see you steps forward from this quarter. In addition, we've been applying to lots of different grant opportunities, as Sandy mentioned, many of them require confidentiality throughout the decision-making process, but I can't comment too much on that. Other than to just say, we've just made such great progress on the molecular test portfolio, we're at a point in time where going out and asking for additional grant funding makes a lot of sense.

Nicole Sandford: Very different place where we're standing today, with that microRNA protein, metadata, combination of value versus where we've been in the past. So it makes great sense for us to go out and look for those opportunities. So the second part of the great, and I didn't answer. Oh, yeah, keep going, sorry. No, I'm just trying to remember. I think you asked the second question, unless I answered it. No, no, it's just on sustainability.

Nicole Sandford: Yes, yes, yes, yes. So if you look back over the last two and a half years where I've been in this role, we have reduced our cash burn every quarter, quarter over quarter year over year. It's the first time in many, many, many quarters where we had a slight increase. And as I mentioned, more or less than really specific investments that we made in the second quarter that we believe were worth the increase in spend. But my goal is to continue to reduce that holy burn. I have demonstrated an ability to do that. And I intend to continue to do that with the help of my new CFO.

Nicole Sandford: Great, thanks so much. Thank you.

Nicole Sandford: There are no further questions at this time. I would now like to turn the floor over to Nicole Sanford for closing comments. Well, thank you, everyone, so much for joining us today. We look forward to continuing our execution and providing another update at our next quarterly earnings call. So thank you, everyone. Thank you. This concludes our today's teleconference. You may disconnect your lines at this time. Thank you for your participation. [inaudible] going to have to go to bed, I'm going to have to go to bed,

Q2 2024 Aspira Women's Health Inc Earnings Call

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