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]

Sera Prognostics (SERA) Q4 2024 Earnings Call March 20, 2025 12:49 AM ET Company Participants Peter Denardo - PresidentZhenya Lindgardt - President & CEOAustin Aerts - Chief Financial OfficerDaniel Brennan - Managing Director Conference Call Participants Maggie Boeye - Equity Research Analyst Operator Good afternoon and welcome to the Serra Prognostics Conference Call to review Factor Fiscal Year twenty twenty four Results. At this time, all participants are in listen only mode. We will be facilitating a qu ...

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $24,000, down from $41,000 in Q4 2023 [32] - Total operating expenses for Q4 were $9.4 million, up 6% from $8.9 million in the same period last year [32] - Net loss for the quarter was $8.6 million compared to $7.9 million for the same period a year ago [32] - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were approximately $68.2 million [33] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $3.1 million from $3.9 million in Q4 2023, primarily due to reduced expenses related to the PRIME study [32] - Selling, general, and administrative expenses increased to $6.3 million from $5.0 million in Q4 2023, driven by spending on commercial activities [32] Market Data and Key Metrics Changes - The U.S. received a D+ grade from the March of Dimes for high preterm birth rates, indicating a significant market need for solutions [22] - Medicaid covers approximately 43% of births in the U.S., representing a substantial opportunity for the company to reduce costs for public health agencies [24] Company Strategy and Development Direction - The company aims to leverage the results of the PRIME study to drive awareness and adoption of its PreTRM test, focusing on building its evidence portfolio and seeking reimbursement [19][20] - Plans include expanding commercial operations in the U.S. and exploring international opportunities, particularly in Europe [20][26] - The company is focused on generating real-world evidence to support the adoption of its test and treat strategy [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Medicaid to adopt the PreTRM test more quickly due to the current focus on cost reduction and improving clinical outcomes [51] - The company anticipates a pivotal year in 2025 for engagement with key stakeholders and adoption of its test following the publication of the PRIME study [35] Other Important Information - The company raised $57.5 million through a public follow-on offering to expand its commercial operations and secure a cash runway through 2028 [34] - The company is working on two products from its pipeline, targeting launches in the second half of 2025 [76] Q&A Session Summary Question: Can you elaborate on the three tenants of your plan to get into guidelines? - Management discussed plans for publishing more information, providing real-world evidence, and driving clinical community adoption to support the PreTRM test [40][41][46] Question: What are your plans regarding Medicaid and its coverage of the test? - Management highlighted the significant opportunity with Medicaid, emphasizing the potential for cost savings and the importance of focusing on states with high preterm birth rates [48][50][52] Question: How do you view the timeline for getting into guidelines? - Management indicated that while it is difficult to predict, there is potential for updates to guidelines within the next one to three years, especially with the upcoming publication of the PRIME study [61][62] Question: What is the expected cash runway based on current operating plans? - Management stated that the cash runway extends into 2028, with operating expenses projected between $30 million to $35 million for the year [64] Question: What are the commercial investments planned for 2025? - Management outlined plans to build a sales organization, enhance medical liaison efforts, and optimize the revenue cycle to drive adoption of the PreTRM test [70][73]

Sera Prognostics, Inc. (SERA) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.23. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.70%. A quarter ago, it was expected that this company would post a loss of $0.22 per share when it actually produced a loss of $0.24, delivering a surprise of -9.09%.Over the last four quarters, the company has n ...

Financial Performance and Projections - The company incurred a net loss of $36.2 million for the year ended December 31, 2023, and an accumulated deficit of $279.8 million as of the same date[278]. - The company expects to continue incurring losses for the foreseeable future as it invests in increasing adoption and reimbursement for the PreTRM test[278]. - The company anticipates significant costs related to the development and commercialization of new tests and services, necessitating additional capital through equity or debt financing[281]. - The financial condition of the company may be adversely affected by fluctuations in quarterly and annual results, impacting stock value[289]. - The company has significant net operating loss carryforwards of approximately $239.6 million, with $70.3 million beginning to expire in 2028[348]. Revenue Sources and Risks - Substantially all revenues are derived from the PreTRM test, with ongoing reliance on a limited number of direct customers, exposing the company to customer concentration risk[275][279]. - A significant portion of the company's revenue and cash flows is expected to come from a limited number of direct customers, including Elevance Health, exposing it to customer concentration risk[301]. - The company derives substantially all of its revenues from the PreTRM test and plans to establish reimbursement by collaborating with payers to demonstrate health and economic benefits[296]. - Third-party payers currently do not reimburse for the PreTRM test, and negative coverage determinations may impact future revenue generation[279]. - The average reimbursement rate for the PreTRM test is priced at $750 as of November 2021, but there is uncertainty regarding future reimbursement rates and coverage[360]. Sales and Marketing Challenges - The company has faced challenges in maintaining effective sales and marketing capabilities, which are crucial for the commercialization of the PreTRM test[275]. - The company has limited experience in sales and marketing, which may hinder its ability to commercialize the PreTRM test effectively[302]. - The company may face challenges in maintaining and growing effective sales and marketing capabilities, which are essential for the commercialization of the PreTRM test[302]. Competition and Market Acceptance - The company faces intense competition in the life sciences industry, particularly in molecular diagnostics and proteomics, which may impact its ability to sustain revenues and achieve profitability[307]. - The success of the PreTRM test depends on broad scientific and market acceptance, which is uncertain due to various factors including competition and reimbursement challenges[298]. Regulatory and Compliance Risks - The company is subject to stringent regulatory requirements, including CLIA certification, which is necessary for billing federal and state health care programs[395]. - Noncompliance with federal and state laboratory licensing requirements could result in the loss of the ability to perform tests, adversely affecting business operations[395]. - The FDA's final rule on Laboratory Developed Tests (LDTs) will phase in over four years, with high-risk tests needing premarket approval by the 3.5-year mark[405]. - Increased regulatory burdens under the FDA's final rule may lead to higher costs and potential legal actions for noncompliance[413]. - The company is subject to HIPAA regulations, requiring it to implement safeguards for protected health information (PHI)[421]. Operational and Supply Chain Risks - The company relies on third-party suppliers for laboratory instruments and materials, which poses risks if these suppliers are disrupted[275]. - The company relies on third parties for specimen collection and delivery services, and disruptions in these services could harm business operations and reputation[333]. - The company must scale operations and attract skilled employees to meet growing test volumes, which may lead to increased operational costs[338]. Data Privacy and Cybersecurity - The evolving regulatory framework for data privacy and security may lead to inconsistent interpretations and increased compliance costs for the company[430]. - Cybersecurity incidents could result in unauthorized access to sensitive information, leading to potential legal claims and significant reputational damage[432]. - The company's insurance coverage may not be adequate to mitigate liabilities arising from privacy and security practices, posing additional financial risks[447]. Strategic and Growth Considerations - The company is evaluating international expansion, initially focusing on Europe, to increase revenues from the PreTRM test[296]. - The company may engage in strategic transactions that could disrupt operations and dilute stockholder value[343]. - The company's growth may strain its operating and financial systems, leading to escalated operating costs and challenges in managing expanding operations[340]. Legal and Legislative Risks - The company may face substantial penalties and reputational damage if it or its contractors violate healthcare laws, with potential civil and criminal fines for violations[452]. - Investigative demands from governmental agencies could result in civil or criminal proceedings, substantial fines, and additional compliance obligations[461]. - Future health care initiatives and legislative changes may adversely affect the company's test volumes and overall financial condition[385].

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].

Core Insights - Sera Prognostics Inc. announced the appointment of Jeff Elliott to its Board of Directors, effective March 20, 2025, while Ryan Trimble will retire on June 30, 2025, after 14 years with the company [1][2] - The company is focused on improving maternal and neonatal health through innovative pregnancy biomarker information, particularly with its PreTRM® test [1][4] Company Developments - Jeff Elliott brings extensive experience in corporate strategy, business operations, and commercializing molecular diagnostics, which will aid Sera in leveraging recent PRIME study results for market building [2][3] - Ryan Trimble expressed confidence in the company's direction and the successful completion of the PRIME study, indicating a strong foundation for future growth [3] Product Information - Sera Prognostics specializes in precision pregnancy care, aiming to reduce healthcare delivery costs through early prediction of preterm birth risk and other pregnancy complications [4] - The PreTRM® Test is a validated blood-based biomarker test that predicts the risk of spontaneous preterm birth, allowing for personalized clinical decisions [7]

Core Viewpoint - Sera Prognostics Inc. reported its financial results for Q4 and full year 2024, highlighting a decrease in revenue and net loss, while emphasizing progress in its PRIME study and recent fundraising efforts to support its mission in maternal and neonatal health [1][3]. Financial Results Summary Fourth Quarter 2024 - Revenue for Q4 2024 was $24,000, down from $41,000 in Q4 2023 [4]. - Total operating expenses increased to $9.4 million, a 6% rise from $8.9 million in Q4 2023 [4]. - Research and development expenses were $3.1 million, a decrease of approximately 19% compared to Q4 2023 [5]. - Selling, general and administrative expenses rose to $6.3 million from $5.0 million in Q4 2023, driven by increased spending on commercial activities [5]. - The net loss for the quarter was $8.6 million, compared to $7.9 million in the prior-year quarter [5]. Full Year 2024 - Total revenue for the full year 2024 was $77,000, down from $306,000 in 2023 [6]. - Total operating expenses decreased to $36.7 million from $40.1 million in 2023 [6]. - Research and development expenses for 2024 were $14.7 million, down from $15.2 million in 2023 [8]. - Selling, general and administrative expenses for 2024 were $21.9 million, significantly reduced from $24.7 million in 2023 [8]. - The net loss for 2024 was $32.9 million, down from $36.2 million in 2023 [8]. PRIME Study Results - The PRIME study demonstrated a 25% reduction in neonatal morbidity and mortality index (NMI) and an 18% reduction in neonatal length of hospital stay among the modified intent-to-treat population [7]. - A broader intent-to-treat population showed a 20% reduction in NMI and a 22% reduction in NICU admissions [7]. Fundraising and Future Plans - The company raised $57.5 million through a public follow-on offering in February 2025, extending its cash runway through 2028 [7][9]. - Proceeds will be used to expand commercial efforts in selected U.S. geographies, partner with payers and providers, and prepare for expansion in the European Union [7]. Company Overview - Sera Prognostics is focused on improving maternal and neonatal health through innovative pregnancy biomarker information [1][11]. - The PreTRM® Test is a key product that provides early risk prediction for spontaneous preterm birth, enabling proactive interventions [11][13].

Core Insights - Sera Prognostics Inc. will report its fourth quarter and full year 2024 financial results on March 19, 2025, after market close, followed by a conference call to discuss operational highlights and financial results [1] - The company focuses on improving maternal and neonatal health through innovative pregnancy biomarker information [1][3] - Sera Prognostics is dedicated to providing early pregnancy information to reduce healthcare delivery costs and has a robust pipeline of diagnostic tests [3] Company Overview - Sera Prognostics is a leading health diagnostics company headquartered in Salt Lake City, Utah, specializing in precision pregnancy care [3] - The company's mission is to enhance the health of mothers and newborns, particularly through the PreTRM® Test, which predicts the risk of spontaneous premature delivery [3][5] - The PreTRM® Test is the only broadly validated blood-based biomarker test for early risk prediction of preterm birth in asymptomatic singleton pregnancies [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 five 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]

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, pivotal 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] Product Information - The PreTRM® Test is a blood-based biomarker test that predicts the risk of spontaneous preterm birth in asymptomatic singleton pregnancies [5] - This test analyzes proteins in the blood that are highly predictive of preterm birth, allowing for early identification of women at increased risk during weeks 18 to 20 of pregnancy [5] - The PreTRM® Test enables more informed and personalized clinical decisions based on individual risk [5] Industry 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 five years, more than one in ten infants in the United States has been born prematurely [4] - The annual healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion for 2016 [4]