"Lee is a highly accomplished leader with commercial expertise in fostering innovation, supporting continuous optimization and driving sales and offers a history of strong performance within the healthcare and diagnostics space," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "With Sera now in the commercial phase following the strong results of our pivotal PRIME study, Lee will play a critical role in expanding adoption and sales of our PreTRM Test and we enthusiastically welcome Lee to our ...

Sera Prognostics (SERA) Q1 2025 Earnings Call May 07, 2025 05:00 PM ET Speaker0 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 toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DeNardo of Capcom Partners for a few introduc ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40606 SERA PROGNOSTICS, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 26-1911522 | | --- | --- | | (State or other jur ...

Exhibit 99.1 "Following the results of our full PRIME pivotal study being publicized we are leveraging them by engaging with key plan providers in focused geographic regions hard hit by premature birth," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "While it will take some time to evolve, we anticipate that Medicaid providers in those areas will see the positive impact PreTRM can make in healthcare cost savings and patient outcomes, furthering adoption of the test." First Quarter 2025 Finan ...

SALT LAKE CITY, May 7, 2025 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the first quarter of 2025 ended March 31, 2025.Recent Highlights: Following release of full Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs ("PRIME") study results meeting primary success ...

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 ...

Sera Prognostics Inc (NASDAQ:SERA) Q4 2024 Earnings Conference Call March 19, 2025 5:00 PM ET Company Participants Peter DeNardo - IR, CapComm Partners Evguenia Lindgardt - President, CEO & Director Austin Aerts - CFO Conference Call Participants Dan Brennan - TD Cowen Margarate Boeye - William Blair Operator Good afternoon, and welcome to the Sera Prognostics Conference Call to review Fourth Quarter Fiscal Year 2024 Results. At this time, all participants are in listen-only mode. We will be facilitating a ...

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].