Preterm Birth Challenge - Preterm birth affects 1 in 10 babies[9], contributing to 342% of newborn deaths[9, 14] - The US preterm birth rate increased from 94% to 104% between 2013 and 2023[11] - In 2016, the average cost to manage complications of prematurity in the US was $64,815 per preterm birth[17] - Preterm births account for 61% of neonatal costs for in-hospital deliveries[17] - 50% of women who deliver prematurely have no known risk factors[22] PreTRM Test & AVERT Trial - The PreTRM test is designed to screen women without obvious risk factors for preterm birth, using a blood draw between 18 and 20 6/7 weeks of gestation[32, 34] - The AVERT PRETERM Trial demonstrated that the PreTRM test-and-treat strategy reduced neonatal hospital length of stay by 7 days[57] - The AVERT study showed an 18% reduction in severe neonatal morbidity and mortality with the PreTRM test-and-treat strategy[59, 60] PRIME Trial Results - The PRIME trial (2025) showed that the odds of adverse outcomes on the Neonatal Morbidity Index (NMI) scale were 25% lower in the intervention group compared to the control group (Odds Ratio 075)[90, 93] - The PRIME trial also indicated that infants in the intervention group had an 18% lower risk of prolonged hospital stays (Hazard Ratio 082) when focusing on the 10% with the longest stays[98] - In the full analysis set and intent-to-treat population of the PRIME trial, there was a 20% reduction in odds of NMI and a 22% reduction in odds of NICU admissions[103] Meta-Analysis of PRIME and AVERT - A meta-analysis of the AVERT and PRIME trials demonstrated a 22% decreased risk of prolonged hospital stay[113] - The meta-analysis also showed a 22% decreased odds of Neonatal Morbidity and Mortality (NMI)[120] Economic Value - With 5 million covered lives, the annual cost savings from PreTRM is $148 million, or $296 per covered life, with 39,773 pregnancies eligible and screened[128] - The PreTRM test shows powerful results, with the Number Needed to Screen (NNS) to prevent one NICU day demonstrated in the PRIME and AVERT study to be 3-4[125]

Financial Data and Key Metrics Changes - For Q3 2022, the company reported revenue of $87,000, a significant increase from $23,000 in Q3 2021, indicating a year-over-year growth [31] - Total operating expenses rose to $11.3 million from $9.5 million in the same period last year, with R&D expenses increasing to $4.2 million from $2.1 million due to higher laboratory operations and clinical study costs [32] - The net loss for Q3 2022 was $10.7 million, compared to $9.9 million in Q3 2021, while cash and cash equivalents stood at approximately $111.2 million as of September 30, 2022, providing a runway into 2026 [35] Business Line Data and Key Metrics Changes - The company is focusing on early adopter systems, particularly integrated delivery networks (IDNs), to establish revenue while reducing financial burdens for customers [11][12] - The collaboration with Banner Health aims to make the preterm test available to over 300,000 members, reflecting a strategic move to penetrate the market effectively [13][17] Market Data and Key Metrics Changes - The company is targeting a significant market, with approximately 42% of births occurring in Medicaid patients, which represents a large potential customer base for the preterm test [66] - The U.S. birth rate is approximately 12 per 1,000 individuals, providing a framework for estimating the number of pregnancies that could be candidates for the preterm test [72] Company Strategy and Development Direction - The company aims to establish a new paradigm in maternal and neonatal care through its preterm test, which is designed to improve health outcomes and reduce healthcare costs [9][10] - There is a strong emphasis on addressing healthcare disparities, particularly among underserved populations, by ensuring access to the preterm test for Medicaid patients [22][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about revenue growth accelerating in 2023 as commercialization efforts with early adopter systems take effect [36] - The company is confident in its ability to manage costs while increasing testing volume, anticipating lower cash burn over time [36] Other Important Information - The company has successfully validated a new ambient temperature blood collection transport system for preterm testing, which is expected to facilitate sample collection and reduce costs [30][84] - The PRIME Study, a multicenter trial, is on track to provide interim data in 2023, which is crucial for future growth and adoption of the preterm test [27][49] Q&A Session Summary Question: Insurer Conversations and Contracts - Management noted that some groups are eager to implement the preterm test, while others are waiting for additional clinical data from the PRIME study [40][43] Question: Hiring Pace and Cash Preservation - The company is balancing hiring with the need to preserve cash, focusing on regions and systems that show adoption potential [45][46] Question: PRIME Study Execution and Timeline Risks - Management confirmed that they are on track to meet enrollment goals for the PRIME study, despite challenges posed by COVID-19 [48][49] Question: Revenue Progression in 2023 - Management indicated that while they are cautious about projections, they expect revenue growth as they penetrate integrated delivery systems [53][55] Question: Managed Medicaid Plans and Data Requirements - Management stated that they do not anticipate a two-year wait post-PRIME readout to enter managed Medicaid plans, as interest is already present [67] Question: Physician Education and Test Ordering - Management highlighted the importance of providing physicians with the tools to follow up with patients who have positive tests, addressing workflow integration [69] Question: Interest from Peers and Market Trends - Management observed increased interest from self-insured employers in offering advanced pregnancy benefits, driven by competition for talent [78] Question: Enrollment in PRIME Study - Management confirmed that they are on track to meet the target enrollment for the PRIME study, which is essential for the interim look [80]