Sera Prognostics (SERA) Piper Sandler 36th Annual Healthcare Conference summary

Company background and product overview

• Developed a biomarker-based blood test, PreTRM, to predict preterm birth risk in pregnancy using protein mapping data collected over 17 years.

• PreTRM is a finger prick test, available online or in physician offices, with results delivered within five days.

• The test identifies higher risk for preterm birth, using a threshold set at twice the average risk, simplifying results for clinical use.

Clinical evidence and outcomes

• AVERT study showed an 18% reduction in adverse outcomes for babies, with significant extension of gestation and reduced NICU stays.

• Babies born before 32 weeks saw a 28-day reduction in hospital stay under the intervention protocol.

• PRIME pivotal trial, run across 19 centers with over 5,000 patients, was stopped early for success and will be presented at a major conference.

• Consistent positive results across three major trials (PREVENT, AVERT, PRIME) support the test's efficacy.

Market need and adoption challenges

• Preterm birth rates have increased from 9.4% to 10.4% over the past decade, with significant healthcare costs and disparities, especially among Black mothers.

• Traditional risk factors miss over half of preterm births, making broad screening valuable.

• Physician adoption is cautious, pending strong randomized clinical trial evidence and guideline inclusion.