"Preterm birth is one of the most impactful events we can work to prevent," said Andy Wagner, CEO, Hera Women's Health. "PRIME reinforces Hera's focus on earlier detection, standardized care pathways, and measurable outcomes—so we can reduce avoidable neonatal harm and help families start healthier." Post this Hera views preterm birth as an avoidable high-risk event in many cases: a complication that can often be anticipated earlier, managed proactively, and measured by outcomes that matter to families, he ...

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]

Core Viewpoint - Sera Prognostics Inc. has appointed Dr. Tiffany Inglis as Chief Medical Officer to enhance its leadership in women's health diagnostics, particularly focusing on improving maternal and neonatal health through innovative pregnancy biomarker testing [1][2][3]. Company Overview - Sera Prognostics is dedicated to improving the lives of women and babies through precision pregnancy care, aiming to provide early and pivotal pregnancy information to enhance maternal and neonatal health and reduce healthcare delivery costs [4]. Leadership Appointment - Dr. Tiffany Inglis brings extensive clinical leadership experience from Elevance Health and Carelon Health, where she focused on women's and children's health, improving access to quality care while achieving cost savings [2][3]. - Her clinical expertise and experience with major payer networks position her well to lead Sera's clinical operations during a critical phase, including the upcoming publication of the PRIME study and pilot programs with state Medicaid [3][4]. Product Focus - Sera's PreTRM® Test is a blood-based biomarker test that provides early, accurate, and individualized risk predictions for spontaneous preterm birth in asymptomatic singleton pregnancies, allowing for informed clinical decisions [6][7]. - The test measures proteins in the blood that are highly predictive of preterm birth, enabling identification of at-risk women between 18 and 20 weeks of pregnancy [6][7]. Industry 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 [5]. - The healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion in 2016 [5].