Financial Data and Key Metrics Changes - Net revenue for the second quarter of fiscal year 2025 was $17 million, down from $24 million in the same quarter of 2024 [18] - Total operating expenses remained flat at $9.3 million compared to the previous year [18] - Research and development expenses decreased by approximately 24% to $3.3 million from $4.4 million due to lower clinical study costs [18] - Selling, general and administrative expenses increased to $6 million from $4.9 million as the company invests in targeted commercial activities [18] - Net loss for the quarter was $8 million, slightly improved from $8.3 million in the prior year [18] - As of June 30, 2025, the company had cash and cash equivalents of approximately $108.5 million, expected to fund operations through significant adoption and commercial milestones until 2028 [18] Business Line Data and Key Metrics Changes - The company is focusing on commercial strategies and tactics to enhance market awareness through data generation, particularly with the PRIME study results [5][6] - The company plans to publish additional data on health economic benefits and subpopulation analysis to support its reimbursement strategy [6][7] Market Data and Key Metrics Changes - The company is targeting Medicaid plan pilots in states with above-average premature birth rates, with hopes to sign two to four pilot programs in the coming months [9][10] - The company is also expanding its commercial reach in Europe, particularly in the UK, France, and Germany, where there is a recognized unmet need for preterm birth risk assessment [15][16] Company Strategy and Development Direction - The company aims to build market awareness and revenue through strategic partnerships and by enhancing its commercial team [12][13] - The transition of the preterm test from mass spectrometry to an immunoassay is part of the strategy to facilitate market entry in Europe [16][17] - The company is focused on generating evidence that meets regulatory standards for approval and reimbursement in Europe [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming publication of the PRIME study results and the potential impact on reimbursement strategies [6][25] - The company is actively engaging with healthcare provider organizations and opinion leaders to drive clinical utilization of its tests [9][10] - Management highlighted the importance of the upcoming medical conferences for sharing data and increasing awareness among clinicians [13][14] Other Important Information - The company has made key strategic leadership hires to enhance its commercial capabilities, including a new Chief Commercial Officer and head of market access [11][12] - The company plans to report on key commercialization performance indicators in the coming quarters [15] Q&A Session Summary Question: Can you discuss the milestones in your commercial efforts since adding Lee? - Management noted that Lee has emphasized the test's role in augmenting care protocols and has focused on expanding the commercial team with experienced sales leaders [22][23] Question: What is the rationale for expanding into the EU market? - Management explained that European opinion leaders encouraged the company to expand, and they plan to partner with local entities to minimize costs [29][30] Question: How many sales representatives have been hired, and how will Medicaid coverage affect hiring? - Management indicated that they currently have a 10% sales force and are prepared to hire more as reimbursement traction is achieved in targeted states [31][32] Question: Any updates on feedback regarding the ACOG bulletin? - Management highlighted the positive shift in ACOG's approach towards tailored care pathways, which aligns with the company's objectives [34][36]

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 June 30, 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 juri ...

Salt Lake City – August 6, 2025 – 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 second quarter of 2025 ended June 30, 2025. Second Quarter and Recent Highlights: • Ongoing progress in engaging Medicaid plans in targeted states with prior PreTRM clinical study experience. Notable traction in two particular states with abov ...

SALT LAKE CITY, Aug. 6, 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 second quarter of 2025 ended June 30, 2025.Second Quarter and Recent Highlights: Ongoing progress in engaging Medicaid plans in targeted states with prior PreTRM clinical study experience. Notable traction in two particular states w ...

{ WE AT SERA AIM TO CHANGE PREGNANCY CARE } In order to transform the experience into one with fewer uncertainties ©2025 Sera Prognostics, Inc. All rights reserved. PreTRM, Sera Prognostics and their logos are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States. ARE BORN TOO SOON1 Preterm birth contributes to 34.2% Safe Harbor Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements ...

SALT LAKE CITY, July 29, 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 that it will report second quarter fiscal year 2025 financial results on Wednesday, August 6, 2025, after the close of the market. The Company will host a corresponding conference call and live webcast to discuss operational highlights, financial results an ...

Preterm birth is defined as occurring before 37 weeks of gestation, and it has a US prevalence of 10% . Three percent of preterm births are early preterm, between 20-34 weeks gestation. As shown below, preterm births are associatedAnalyst’s Disclosure:I/we have a beneficial long position in the shares of SERA either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I h ...

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 ...

SALT LAKE CITY, May 29, 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 that members of the Sera team will participate in the following upcoming investor conferences:William Blair 45th Annual Growth Stock ConferenceDate: June 3 – 5, 20251X1 Meetings OnlyDoug Fisher, M.D., Strategic Advisor to Sera and former Chief Business Offic ...

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]