Sera Prognostics (SERA) Corporate presentation summary

Market need and problem

• Preterm birth rates in the US have risen from 9.4% to 10.4% between 2013 and 2024, with NICU admissions increasing from 8.7% to 9.8% between 2016 and 2023.

• Preterm births account for 61% of neonatal costs for in-hospital deliveries, with extremely premature births costing up to $344,355 per delivery and 7x higher healthcare costs over 7 years.

• Traditional screening methods fail to identify 81% of women who will experience preterm birth, and only 20% of pregnant mothers receive information on preterm labor risk at their first prenatal appointment.

Solution and product overview

• The PreTRM test is a blood-based, proteomics-driven diagnostic that predicts spontaneous preterm birth risk early in pregnancy.

• It measures specific protein biomarkers (IGFBP4 and SHBG) associated with preterm birth, discovered in partnership with 13 universities and medical institutions.

• The test integrates seamlessly into prenatal care workflows, with results delivered in about five days from a CLIA-certified, CAP-accredited lab.

Clinical validation and evidence

• PreTRM is the only clinically validated test for early prediction of premature birth, verified by 8 independent clinical studies and supported by 11+ published studies.

• The PRIME randomized controlled trial (n=5,018) showed 20% fewer NICU admissions, 56% and 32% reductions in births before 32 and 35 weeks, and a 20% reduction in neonatal morbidity odds.

• Each day of gestational age gained among the earliest 10% of births was prolonged by 4.5 days on average.