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]

Group 1 - Preterm birth is defined as occurring before 37 weeks of gestation, with a prevalence of 10% in the US [1] - Early preterm births, occurring between 20-34 weeks of gestation, account for 3% of all preterm births [1] - Preterm births are associated with various health implications, although specific details are not provided in the text [1]

A downtrend has been apparent in Sera Prognostics, Inc. (SERA) lately with too much selling pressure. The stock has declined 43.9% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.Here is How to Spot Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicato ...

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]

Summary of Sera Prognostics (SERA) 2025 Conference Call Company Overview - **Company**: Sera Prognostics (SERA) - **Industry**: Diagnostics, specifically focused on preterm birth prediction Key Points and Arguments Preterm Birth Prediction - Current methods for predicting preterm births are limited, primarily relying on previous preterm births and short cervix, which only applies to a small percentage of mothers [1][2] - Approximately 3.6 million mothers give birth annually, with a significant portion being first-time mothers who lack identifiable risk factors for preterm birth [1] Test Approval and Regulation - The preterm test is classified as a lab-developed test (LDT) and is overseen by CAP and CLIA, not the FDA [4] - There is no current risk to commercialization despite potential future FDA oversight of LDTs [6][7] Reimbursement Strategy - Sera Prognostics has partnered with national payer Elevance to facilitate reimbursement, which is expected to expedite coverage compared to typical timelines for diagnostic companies [9][10] - The company has a Medicare code for the test priced at $750, with expectations for both commercial and Medicaid plans to provide coverage [14][10] Market Opportunity - The total addressable market (TAM) for the test is estimated at approximately 3.2 million women annually, representing a multibillion-dollar opportunity [16] - The company plans to target specific states with high rates of preterm births to drive adoption [18] Economic Impact - The test has demonstrated significant cost savings, with estimates showing that screening three to four mothers can save one NICU day, which costs between $4,500 and $20,000 [34][35] - The overall economic burden of preterm births in the U.S. is over $25 billion, with childbirth-related costs representing 27% of all inpatient costs in Medicaid [36] Clinical Utility and Data Collection - The PRIME study showed that the test could keep one out of five babies out of the NICU, generating excitement in the clinical community [31][39] - Sera Prognostics is collecting extensive data on pregnancy-related proteins, with plans to develop additional women's health products [29][30] Sales and Marketing Strategy - The company is expanding its sales force and has appointed a new Chief Commercial Officer to enhance its market presence [22] - Initial efforts will focus on three to five states with high preterm birth rates, leveraging relationships with key opinion leaders and payers [18] Financial Position - Sera Prognostics has raised $57 million, bringing total funding to $215 million, providing a runway until the end of 2028 to reach profitability [23][24] - The annual cash burn rate is between $25 million and $30 million, allowing for strategic growth and marketing efforts [24] Future Catalysts - Upcoming publications detailing the test's efficacy and economic impact are anticipated, along with traction with Medicaid plans [41][42] - The company aims to provide revenue guidance for fiscal 2026 as it gains visibility on volume and market uptake [43] Additional Important Insights - The test's pricing strategy is designed to ensure broad adoption, especially in light of potential Medicaid budget cuts [38] - The clinical community is eager for innovations that can significantly impact preterm birth outcomes, highlighting the test's potential to transform care [39][40]

Sera Prognostics, Inc. (SERA) has been beaten down lately with too much selling pressure. While the stock has lost 30.5% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscil ...

Company Overview - Sera Prognostics is a leading health diagnostics company focused on improving the lives of women and babies through precision pregnancy care [3] - The company's mission is to provide early, pivotal pregnancy information to enhance maternal and newborn health, ultimately reducing healthcare delivery costs [3] - Sera has a robust pipeline of innovative diagnostic tests aimed at early prediction of preterm birth risk and other pregnancy complications [3] Leadership Appointment - Mr. Lee Anderson has been appointed to a leadership role at Sera Prognostics, bringing extensive experience in the biotechnology and diagnostics sector [1] - Anderson previously held significant positions at Genomic Health and Exact Sciences, where he led US Oncology Sales and Global Customer Service, achieving nine consecutive years of revenue growth [1][2] - His role at Biofidelity Inc. as Chief Commercial Officer further enhanced his commercial strategy expertise and market presence [2] PreTRM® Test - 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 [5] - This test analyzes proteins in the blood that are highly predictive of preterm birth, allowing physicians to identify at-risk women between weeks 18 and 20 of pregnancy [5] - The PreTRM® Test enables more informed and personalized clinical decisions based on individual risk assessments [5] Preterm Birth Context - Preterm birth, defined as any birth before 37 weeks' gestation, is the leading cause of illness and death in newborns [4] - Over the last six years, more than one in ten infants in the United States has been born prematurely, leading to significant long-term medical complications [4] - The estimated annual healthcare costs for managing complications related to prematurity in the U.S. were approximately $25 billion in 2016 [4]

This quarterly report represents an earnings surprise of 16.67%. A quarter ago, it was expected that this company would post a loss of $0.23 per share when it actually produced a loss of $0.25, delivering a surprise of -8.70%. Sera Prognostics, Inc. (SERA) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items. There are no easy answers to this key questi ...

Sera Prognostics (SERA) Q1 2025 Earnings Call May 07, 2025 05:00 PM ET Company Participants Peter Denardo - PresidentZhenya Lindgardt - President & CEOAustin Aerts - Chief Financial Officer Conference Call Participants None - AnalystDaniel Brennan - Analyst Operator Good afternoon, and welcome to the SeraPrognostics Conference Call to Review First Quarter Fiscal Year twenty twenty five Results. At this time, all participants are in a listen only mode. We will be facilitating a question and answer session to ...

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $38,000 compared to nil in Q1 2024 [20] - Total operating expenses for Q1 2025 were $9.3 million, slightly up from $9.1 million in the same period last year [20] - Research and development expenses decreased by approximately 9% to $3.3 million due to lower clinical study costs [20] - Selling, general and administrative expenses increased to $5.9 million from $5.4 million year-over-year [21] - Net loss for the quarter was $8.2 million, relatively flat compared to $8.1 million for the same period last year [21] - As of March 31, 2025, the company had cash and equivalents of approximately $114.2 million [21] Business Line Data and Key Metrics Changes - The company is focusing on expanding its commercial presence by adding 5 to 10 full-time employees (FTEs) to enhance its sales force in targeted states [24][25] - The company is ramping up Medicaid plan pilots in states with high rates of premature births [6][10] Market Data and Key Metrics Changes - The company is targeting states with higher premature birth rates than the national average, particularly focusing on Medicaid as a key payer [6][10] - Approximately 43% of all births in the U.S. are paid for by Medicaid, highlighting the importance of this payer in the company's strategy [6] Company Strategy and Development Direction - The company aims to transition from clinical evidence development to commercial growth, with a focus on reimbursement strategies involving commercial insurers, employers, and Medicaid [6][10] - The commercial roadmap includes a geographically focused ecosystem playbook, starting with targeted states and expanding based on success [6][10] - The company plans to build awareness through localized campaigns and partnerships with organizations that reach expectant mothers [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the PRIME study results to generate commercial momentum and influence physician adoption of the preterm test [15][19] - The company recognizes the urgency of addressing rising maternal mortality rates and believes its preterm test can contribute to better health outcomes [16][17] - Management anticipates 2025 will be a pivotal year for commercialization and building a movement for improved maternal care [19][49] Other Important Information - The company is preparing for the publication of the PRIME study results in a peer-reviewed journal, which is expected to enhance its market position [5][19] - The ACOG bulletin update emphasizes risk stratification in prenatal care, aligning with the company's preterm test strategy [30][31] Q&A Session Summary Question: Can you discuss the strategic headcount investments? - The company plans to expand its commercial presence by 5 to 10 FTEs and will monitor progress in targeted states before further expansion [24][25] Question: Any updates on the PRIME study publication? - The company has passed the next milestone in engagement with the target journal but does not have a precise publication date yet [26][27] Question: What was the ACOG bulletin update? - The ACOG bulletin shifted towards tailoring care based on risk stratification, which aligns with the company's preterm test strategy [30][31] Question: How often does ACOG update guidelines? - ACOG updates bulletins every 24 to 48 months, with the relevant bulletin last updated in August 2021 [35] Question: What are the potential outcomes with Medicaid engagement? - The company is excited about Medicaid engagement and is focusing on states that prioritize solutions for preterm birth [41][42]