Core Insights - Sera Prognostics, Inc. will present at the TD Cowen 46th Annual Health Care Conference on March 2, 2026, focusing on its achievements in maternal and neonatal health [1] - The company specializes in innovative pregnancy biomarker information, particularly through its PreTRM® Test, which predicts the risk of spontaneous preterm birth [1] Company Overview - Sera Prognostics is dedicated to improving maternal and neonatal health through precision pregnancy care [1] - The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test for early risk prediction of spontaneous preterm birth [1] 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 [1] - The 2025 March of Dimes Report Card indicates that the U.S. has received a D+ grade for preterm birth for four consecutive years, marking the longest stretch of the lowest grade in history [1] - The annual healthcare costs for managing complications of prematurity in the U.S. were estimated at approximately $25 billion for 2016 [1] PreTRM® Test Details - The PreTRM Test measures proteins in the blood that are highly predictive of preterm birth, allowing for individualized risk assessment during weeks 18 to 20 of pregnancy [1] - This test enables physicians to make informed clinical decisions based on each woman's individual risk [1]

Core Insights - Preterm birth is viewed as an avoidable high-risk event that can be anticipated and managed proactively, with a focus on earlier detection and standardized care pathways to reduce neonatal harm [1][3] - The PRIME trial demonstrated that a screen-guided approach can significantly reduce NICU admissions and improve neonatal outcomes, emphasizing the importance of proactive, outcomes-driven maternity care [2][3] Company Overview - Hera Women's Health is a national collaborative focused on providing advanced, personalized care for women, emphasizing data-driven, outcome-oriented practices [4] - The company aims to enhance healthcare outcomes by facilitating collaboration between Obstetrics and Maternal Fetal Medicine providers through evidence-based protocols and technology [4] PRIME Trial Findings - The PRIME trial involved 5018 participants across 19 sites and showed a 20% reduction in the composite neonatal morbidity/mortality index and shorter neonatal hospital stays [5] - The screen-guided approach resulted in fewer NICU admissions (10.2% vs 12.8%) and a total of 58 fewer NICU admissions and 545 fewer NICU days in the screen-guided arm [5] Competitive Advantage - Hera Women's Health has achieved a 25% reduction in preterm births and a 40% reduction in cesarean deliveries compared to regional competitors, highlighting its effective approach to maternity care [3]

Core Viewpoint - Sera Prognostics, Inc. (SERA) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Company Performance and Outlook - The upgrade in Sera Prognostics' rating indicates an improvement in the company's underlying business, which is expected to positively influence its stock price [5][10]. - The Zacks Consensus Estimate for Sera Prognostics has increased by 6.8% over the past three months, with an expected earnings per share of -$0.68 for the fiscal year ending December 2025, showing no year-over-year change [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7][9]. - Sera Prognostics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Insights - The PRIME study, a significant research initiative on preterm birth, has been accepted for publication in a peer-reviewed journal, following its presentation at a medical conference earlier this year [1][2] - Sera Prognostics, Inc. focuses on enhancing maternal and neonatal health through innovative pregnancy biomarker information [1][3] Company Overview - Sera Prognostics is a health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care [3] - The company's PreTRM Test is the only broadly validated, commercially available blood-based biomarker test for early risk prediction of spontaneous preterm birth [4] Product Details - The PreTRM Test analyzes proteins in the blood to predict preterm birth risk in asymptomatic singleton pregnancies, allowing for informed clinical decisions [4] - The test is ordered by medical professionals and provides risk assessments during weeks 18 to 20 of pregnancy [4]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Viewpoint - Sera Prognostics, Inc. reported a quarterly loss of $0.16 per share, which was better than the Zacks Consensus Estimate of a loss of $0.19, indicating an earnings surprise of +15.79% [1] Group 1: Earnings Performance - The company has surpassed consensus EPS estimates three times over the last four quarters [2] - The quarterly revenue was $0.02 million, missing the Zacks Consensus Estimate by 75.39%, compared to $0.03 million in the same quarter last year [2] - The stock has lost approximately 61.7% since the beginning of the year, while the S&P 500 has gained 16.5% [3] Group 2: Future Outlook - The future performance of Sera Prognostics' stock will depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.19 on revenues of $0.1 million, and for the current fiscal year, it is -$0.73 on revenues of $0.12 million [7] Group 3: Industry Context - The Medical Services industry, to which Sera Prognostics belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, which may impact the stock's performance [8]

Financial Data and Key Metrics Changes - Net revenue for Q3 2025 was $16,000, a decrease from $29,000 in the same period last year [17] - Total operating expenses for the quarter were $9.0 million, slightly up from $8.9 million in Q3 2024 [17] - Research and development expenses decreased to $3.3 million from $3.5 million, attributed to lower clinical study costs [17] - Selling, general, and administrative expenses increased to $5.7 million from $5.4 million, reflecting investments in commercial activities [18] - Net loss for the quarter was $7.8 million, down from $7.9 million in Q3 2024 [18] - Cash, cash equivalents, and available-for-sale securities totaled approximately $102.4 million as of September 30, 2025 [18] Business Line Data and Key Metrics Changes - The company is focusing on the PreTRM test adoption, with significant progress in commercialization efforts [4][6] - The first Medicaid pilot program in Nevada is actively enrolling patients, indicating initial traction in the market [7][12] Market Data and Key Metrics Changes - The company is targeting six initial states, representing approximately 33% of U.S. births and 35% of Medicaid births annually [8] - Engagement with 10 payers across 13 states is underway, indicating a diverse mix of national and regional opportunities [12] Company Strategy and Development Direction - The company is executing a geographically focused strategy to enhance coverage, physician education, and patient awareness [4] - A two-prong approach is being utilized for commercialization: targeting state engagement and payer-driven adoption through pilots [9][10] - The company aims to establish the PreTRM test as a standard of care for preterm birth risk [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial momentum and the potential for significant growth opportunities [18] - The timeline for guideline inclusion is estimated to be 24-36 months post-publication of the PRIME study results [31] Other Important Information - The company plans to publish full results of the PRIME study in a peer-reviewed journal by the end of the year [5] - Key leadership appointments have been made to strengthen the team and drive the adoption of the PreTRM test [14][15] Q&A Session Summary Question: Progress on Medicaid pilots and timeline for additional pilots - Management confirmed they are on track with one pilot launched and another in contracting, with discussions ongoing for additional pilots [22] Question: Economics of the Nevada pilot and payment structure - The pilot size is expected to be a few hundred patients, with discussions for value-based healthcare arrangements ongoing [24] Question: Timing of PRIME publication and additional data - Management is confident the publication will be out before year-end and will provide new insights upon release [27][29] Question: Pathway to guideline inclusion and focus areas - The timeline for guideline inclusion remains 24-36 months, with a focus on geographic adoption and broader engagement with payers and providers [31][32] Question: Organizational readiness post-PRIME publication - The company has prepared for the publication with plans for payer engagement and dissemination of information to clinicians [38]

Clinical Trials and Biomarker Development - The PreTRM test is the only broadly validated, commercially available blood-based biomarker test to predict the risk of preterm birth, providing accurate predictions during weeks 18 through 20 of gestation [88]. - The AVERT PRETERM TRIAL showed an 18% reduction in severe neonatal morbidity and mortality, and a 7-day reduction in mean neonatal hospital length of stay for at-risk neonates [89]. - The PRIME study indicated a 25% reduction in neonatal morbidity and mortality and an 18% reduction in neonatal hospital length of stay for approximately 10% of babies who stay beyond standard delivery days [91]. - The company is actively developing additional biomarker tests, including one for more accurate delivery date predictions, currently in early market testing [101]. Financial Performance - The company reported net losses of $7.8 million and $7.9 million for the three months ended September 30, 2025 and 2024, respectively, and $24.0 million and $24.3 million for the nine months ended September 30, 2025 and 2024, respectively [104]. - Revenue for the three months ended September 30, 2025, was $16,000, a decrease of $13,000 (44.83%) compared to $29,000 in 2024 [116]. - For the nine months ended September 30, 2025, revenue increased by $18,000 (33.96%) to $71,000 from $53,000 in 2024 [122]. - Total operating expenses for the same period were $8,996,000, an increase of $105,000 (1.18%) from $8,891,000 in 2024 [116]. - Total operating expenses for the nine months ended September 30, 2025, were $27,621,000, an increase of $356,000 (1.31%) from $27,265,000 in 2024 [122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $19,503,000, compared to $7,929,000 in 2024 [132]. - As of September 30, 2025, the company had cash, cash equivalents, and available-for-sale securities totaling $102.4 million, with an accumulated deficit of $303.8 million [127]. Operational Strategy and Future Outlook - The company completed a public offering in February 2025, resulting in approximately $53.6 million in net proceeds after deducting underwriting discounts and commissions [103]. - The company plans to expand its commercial team, having recently hired a Chief Commercial Officer and field sales representatives in strategic geographies [100]. - The company believes its cash runway is sufficient to operate through 2028 based on existing plans, while continuing to monitor operating expenses [105]. - The company aims to secure contracts with private and governmental payers using positive data from clinical studies to generate material revenues [106]. - The company expects research and development expenses to decrease in 2026 compared to 2025 as it shifts capital allocation toward revenue-generating activities [109]. - Selling and marketing expenses are anticipated to increase in Q4 2025 and further in 2026 due to investments in commercialization activities for the PreTRM test [110]. - The company expects significant additional operating losses and negative cash flows due to commercialization activities for the PreTRM test and other pipeline products [136]. - The company currently has no credit facility or committed sources of capital, and future funding requirements will depend on various factors including sales from the PreTRM test [137]. - Existing cash and cash equivalents are expected to fund operating expenses and capital expenditures for at least the next 12 months [138]. Market and Economic Factors - A hypothetical 100 basis point increase in interest rates would have resulted in a decrease of $0.8 million in the market value of available-for-sale debt securities as of September 30, 2025 [148]. - The company does not regularly incur expenses in foreign currencies, and exchange rate fluctuations have not materially affected results to date [149]. - Inflation has not had a material effect on results, but ongoing inflation could increase costs of labor and supplies, adversely affecting business operations [150].

Financial Performance - Third quarter 2025 revenue was $16,000, a decrease from $29,000 in the same quarter of 2024[6] - Total operating expenses for Q3 2025 were $9.0 million, slightly up from $8.9 million in Q3 2024[6] - The net loss for Q3 2025 was $7.8 million, a slight improvement from a net loss of $7.9 million in Q3 2024[9] Expenses Breakdown - Research and development expenses decreased to $3.3 million in Q3 2025 from $3.5 million in Q3 2024, reflecting lower clinical study costs[7] - Selling, general and administrative expenses rose to $5.7 million in Q3 2025, compared to $5.4 million in the prior-year period[8] Cash Position - As of September 30, 2025, the company had cash, cash equivalents, and available-for-sale securities totaling approximately $102.4 million[9] Market Opportunities - The company is advancing discussions with managed Medicaid plans covering 33% of U.S. births and 35% of Medicaid births annually, indicating a significant commercial opportunity[3] Product Impact - The PreTRM Test is associated with a 20% reduction in NICU admissions, highlighting its potential impact on maternal and neonatal outcomes[5] - The company is on track to publish full results of the PRIME study this year, which will include health economic benefits and expected cost-saving benefits of the PreTRM Test[4] Leadership Changes - Sera Prognostics has strengthened its leadership team with the appointment of Dr. Tiffany Inglis as Chief Medical Officer and Marisol Urbano as Head of Commercial Operations[4]

Core Insights - Sera Prognostics Inc. will report its third quarter fiscal year 2025 financial results on November 13, 2025, followed by a conference call to discuss operational highlights and financial results [1][2] Company Overview - Sera Prognostics is dedicated to improving maternal and neonatal health through innovative pregnancy biomarker information, aiming to reduce healthcare delivery costs [3] - The company has a robust pipeline of diagnostic tests focused on early prediction of preterm birth risk and other pregnancy complications [3] - The PreTRM® Test is a key product that provides individualized risk predictions for spontaneous preterm birth, allowing for proactive interventions [5] Industry Context - Preterm birth, defined as any birth before 37 weeks' gestation, is the 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]