Preterm birth prediction

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Sera Prognostics (SERA) Earnings Call Presentation
2025-08-06 20:00
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]