Core Insights - Sera Prognostics Inc. will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, highlighting the company's latest achievements [1] - The company focuses on improving maternal and neonatal health through innovative pregnancy biomarker information [1][3] Company Overview - Sera Prognostics is dedicated to enhancing the lives of women and babies via precision pregnancy care, aiming to provide early pregnancy information to improve health outcomes and reduce healthcare costs [3] - The company has a robust pipeline of diagnostic tests, particularly the PreTRM® Test, which predicts the risk of spontaneous premature delivery [3][5] Preterm Birth Context - Preterm birth, defined as any birth before 37 weeks' gestation, is a leading cause of illness and death in newborns, with over 10% of infants born prematurely in the U.S. for the last six years [4] - The annual healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion in 2016 [4] PreTRM® Test Details - The PreTRM® Test is the only broadly validated blood-based biomarker test that provides early and accurate risk predictions for spontaneous preterm birth in asymptomatic singleton pregnancies [5] - This test allows physicians to identify women at increased risk for preterm birth between weeks 18 and 20 of pregnancy, facilitating personalized clinical decisions [5]

Core Insights - Sera Prognostics Inc. reported a revenue of $17,000 for Q2 2025, a decrease from $24,000 in Q2 2024, while total operating expenses remained flat at $9.3 million [4][6] - The company is focusing on commercial momentum following the completion of its pivotal PRIME study, which is expected to enhance engagement with managed Medicaid and other organizations [3][9] - The net loss for the quarter was $8.0 million, slightly improved from $8.3 million in the same period last year, with cash reserves of approximately $108.5 million expected to support operations through 2028 [6][15] Financial Performance - Revenue for Q2 2025 was $17,000, down from $24,000 in Q2 2024 [4] - Total operating expenses were $9.3 million, consistent with the previous year [4] - Research and development expenses decreased by approximately 24% to $3.3 million, attributed to lower clinical study costs [4] - Selling, general, and administrative expenses increased to $6.0 million from $4.9 million, reflecting investments in commercial activities [5] - The net loss for the quarter was $8.0 million, compared to $8.3 million a year ago [6] Strategic Initiatives - The company is engaging Medicaid plans in targeted states, particularly those with high premature birth rates, to capitalize on commercial opportunities [9] - Sera Prognostics plans to publish full results of the PRIME study this year, along with additional data on health economic benefits and expected cost savings [9] - Recent leadership appointments aim to strengthen the company's commercial capabilities and investor relations [9] Product Overview - The PreTRM® Test is a blood-based biomarker test that predicts the risk of spontaneous preterm birth, allowing for earlier interventions [12] - The test is designed to provide individualized risk assessments during weeks 18 to 20 of pregnancy, enabling personalized clinical decisions [12]

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]

Company Overview - Sera Prognostics Inc. is focused on improving maternal and neonatal health through innovative pregnancy biomarker information [3] - The company aims to provide early pregnancy information to enhance the health of mothers and newborns, thereby reducing healthcare delivery costs [3] - Sera Prognostics is headquartered in Salt Lake City, Utah [3] Financial Results Announcement - The company will report its second quarter fiscal year 2025 financial results on August 6, 2025, after market close [1] - A conference call and live webcast will be held at 5:00 p.m. Eastern Time to discuss operational highlights and financial results [1][2] - A press release detailing the financial results will be distributed before the call [1] PreTRM® Test - The PreTRM® Test is a blood-based biomarker test that predicts the risk of spontaneous preterm birth in asymptomatic singleton pregnancies [5] - It measures proteins in the blood that are highly predictive of preterm birth, allowing for early identification of at-risk women [5] - The test enables personalized clinical decisions based on individual risk during weeks 18 to 20 of pregnancy [5] Preterm Birth Context - Preterm birth, defined as birth before 37 weeks' gestation, is the leading cause of illness and death in newborns [4] - Over the last five years, more than 10% of infants in the U.S. have been born prematurely [4] - The annual healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion in 2016 [4]

Core Insights - Sera Prognostics Inc. is focused on enhancing maternal and neonatal health through innovative pregnancy biomarker information [4] - The company will participate in two upcoming investor conferences, the William Blair 45th Annual Growth Stock Conference and the Jefferies Global Healthcare Conference, both taking place from June 3 to June 5, 2025 [1][2] Company Overview - Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care [4] - The company's mission is to provide early, pivotal pregnancy information to enhance the health of mothers and newborns, aiming to reduce healthcare delivery costs [4] - Sera has a robust pipeline of innovative diagnostic tests, particularly focused on early prediction of preterm birth risk and other pregnancy complications [4] Preterm Birth Context - Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns [5] - The March of Dimes Report Card indicates that over one in ten infants in the U.S. has been born prematurely for the last six consecutive years [5] - The annual healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion for 2016 [5] PreTRM® Test Details - The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides early, accurate, and individualized risk predictions for spontaneous preterm birth in asymptomatic singleton pregnancies [6] - This test measures and analyzes proteins in the blood that are highly predictive of preterm birth, allowing physicians to identify women at increased risk during weeks 18 through 20 of pregnancy [6] - The PreTRM® Test enables more informed, personalized clinical decisions based on each woman's individual risk [6]

Company Overview - Sera Prognostics Inc. is focused on improving maternal and neonatal health through innovative pregnancy biomarker information [3] - The company aims to provide early pregnancy information to enhance the health of mothers and newborns, thereby reducing healthcare delivery costs [3] - Sera Prognostics is headquartered in Salt Lake City, Utah [3] Financial Results Announcement - The company will report its first quarter fiscal year 2025 financial results on May 7, 2025, after market close [1] - A conference call and live webcast will be held at 5:00 p.m. Eastern Time to discuss operational highlights and financial results [1][2] - A press release with financial results will be distributed before the call [1] PreTRM® Test - The PreTRM® Test is a blood-based biomarker test that predicts the risk of spontaneous preterm birth in asymptomatic singleton pregnancies [5] - It measures proteins in the blood that are highly predictive of preterm birth, allowing for early identification of at-risk women [5] - The test enables personalized clinical decisions based on individual risk during weeks 18 to 20 of pregnancy [5] Preterm Birth Context - Preterm birth is defined as any birth before 37 weeks' gestation and is a leading cause of illness and death in newborns [4] - Over the last five years, more than 10% of infants in the U.S. have been born prematurely [4] - The annual healthcare costs for managing complications of prematurity in the U.S. were estimated at approximately $25 billion in 2016 [4]