Sera Prognostics(SERA) - 2024 Q4 - Annual Results

Preterm Birth Statistics and Impact - The Preterm Birth rate in the U.S. rose to 10.4% in 2023, with 34.2% of newborn deaths attributed to preterm birth[10]. - The average cost to manage complications of prematurity in 2016 was $64,815 per preterm birth, which is estimated to be 10 times higher than costs associated with full-term births[16]. - The lifetime costs associated with preterm birth are significantly higher, accounting for 61% of neonatal care expenditures for in-hospital deliveries[16]. PreTRM Test and Its Efficacy - The PreTRM® test is highly predictive of spontaneous preterm birth, validated through three independent studies involving 5,501 patients across 11 centers[22]. - The PreTRM Test is designed to screen women without obvious risk factors for preterm birth, providing a single probability score for preterm birth risk[25]. - The PreTRM testing process integrates seamlessly into women's health clinics, with results delivered in an average of five days from a CLIA-certified lab[24]. - The PreTRM Test utilizes precise mass spectrometry measurements of proteins to generate a risk score based on blood drawn at 18-20 weeks of gestation[20]. AVERT and PRIME Studies Outcomes - The AVERT PRETERM Trial demonstrated that the PreTRM test-and-treat strategy reduced neonatal hospital length of stay by an average of one week[37]. - Severe neonatal morbidity and mortality rates were significantly reduced by 18% in the prospective arm compared to the historical arm in the AVERT study[41]. - The AVERT study demonstrated statistically significant reductions in neonatal length of stay (NNLOS) and neonatal morbidity/mortality (NMI) in both the modified intention-to-treat (mITT) and intention-to-treat (ITT) populations[46]. - The average hospital stay for babies born before 32 weeks gestation was reduced from 40 days to 12 days with the PreTRM intervention[48]. - The intervention group showed a 25% lower odds of adverse outcomes on the Neonatal Morbidity Index (NMI) compared to the control group, with an Odds Ratio (OR) of 0.75[61]. - NICU admissions were reduced by 22%, with an adjusted rate of 0.78 for the intervention group[69]. - The pooled effect size from the PRIME and AVERT studies indicated a 22% decrease in odds of NMI[82]. Cost Savings and Economic Impact - Annual cost savings from interventions amounted to$ 14.8 million, with 10,750 NICU days reduced, resulting in cost offsets of $53.75 million[88]. - The number needed to screen (NNS) to prevent one NICU day is 3.7[88]. - The number of patients needed to screen to reduce neonatal length of stay by one day was calculated to be between 3 and 4[47]. Company Strategy and Future Plans - Sera's cash position is projected to extend well into 2027, supporting the goal of reaching a significant revenue inflection point[101]. - The company has an annual operating spend of less than$ 30 million, allowing for aggressive commercialization efforts[101]. - Planned milestones include publications, commercialization, reimbursement guidelines, and additional evidence gathering[95]. - The focus is on building physician awareness and payer demand to drive coverage and reimbursement for the PreTRM test[97]. - Engagement with health economics campaigns and early adopter programs is underway to promote the PreTRM test[97]. - The company aims to educate providers and empower mothers while advancing science and improving care[105]. - Leadership includes experienced professionals from various sectors, enhancing the company's strategic direction[102].