Sera Prognostics, Inc. (SERA): History, Ownership, Mission, How It Works & Makes Money

Sera Prognostics, Inc. (SERA): History, Ownership, Mission, How It Works & Makes Money

US | Healthcare | Medical - Diagnostics & Research | NASDAQ

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When you look at Sera Prognostics, Inc. (SERA), the question isn't just about their PreTRM® Test, but how a diagnostics company with a trailing twelve-month revenue of only about $95,000 as of September 30, 2025, can aim to disrupt a market where annual US healthcare costs for prematurity complications alone are estimated to be over $25 billion; that's the scale of the problem they're tackling. You're seeing minimal sales right now, but the real story is the balance sheet: they secured a cash runway of roughly $102.4 million, which is defintely enough to fund operations through 2028, giving them time to execute their market strategy. So, how is this small-cap biotech, with 31.28% of its stock owned by institutional investors, planning to convert its science into revenue by targeting the 50% market opportunity represented by Medicaid, especially after launching its first pilot in Nevada?

Sera Prognostics, Inc. (SERA) History

You're looking for the foundational story behind Sera Prognostics, Inc., and that starts with a core scientific problem: the inability to reliably predict spontaneous premature birth. The company's history is a classic biotech narrative, moving from university-licensed intellectual property and venture capital funding to a public offering, all anchored by a singular, high-impact diagnostic product, the PreTRM Test.

The trajectory shows a deliberate, evidence-based approach, prioritizing clinical validation-culminating in the pivotal PRIME study results in 2025-over rapid commercial scale. This is a long-game play, and its financial health, as of late 2025, reflects that continued investment in market-shaping data.

Given Company's Founding Timeline

Year established

Sera Prognostics was established in 2008.

Original location

The company is headquartered in Salt Lake City, Utah. The original technology was licensed from Brigham Young University and the University of Utah.

Founding team members

The company was founded by the venture firm UpStart Life Science Capital. The core scientific co-founders who developed the proteomic methods for biomarker discovery were:

  • Dr. M. Sean Esplin
  • Dr. Steven W. Graves

Initial capital/funding

While founded in 2008, the first major institutional capital event was a $19.3 million Series A financing in November 2011, led by InterWest Partners, Domain Associates, and Catalyst Health Ventures. This funding was specifically earmarked to complete the multi-center Proteomic Assessment of Preterm Risk (PAPR) clinical trial.

Given Company's Evolution Milestones

Year Key Event Significance
2008 Company founded and licensed core technology. Established the foundation for the PreTRM test using serum proteomics.
2011 Secured $19.3 million Series A funding and appointed Dr. Gregory C. Critchfield as CEO. Validated investor confidence and brought in seasoned diagnostics leadership to drive clinical trials and commercialization strategy.
2021 (May) Announced multi-year commercial partnership with Anthem, Inc. Secured a major commercial win, making the PreTRM Test available to members of the nation's second-largest health insurer, validating the test's economic and clinical value.
2021 (July) Initial Public Offering (IPO) on Nasdaq (SERA). Raised approximately $75.0 million in gross proceeds at $16.00 per share, providing capital for commercial expansion and further research.
2025 (Jan) PRIME study topline results presented. Pivotal clinical data showed a 25% reduction in neonatal morbidity and mortality index (NMI), meeting a primary success criterion and providing the crucial evidence needed for broader payer adoption.
2025 (Feb) Completed a public follow-on offering. Raised $57.5 million, extending the cash runway through 2028 and funding the expansion of commercial efforts in selected US geographies and preparation for European Union expansion.
2025 (Oct) Named Dr. Tiffany Inglis Chief Medical Officer. Strengthened the executive team with a focus on clinical strategy and payer engagement following the successful PRIME study results.
2025 (Nov) PRIME study findings accepted for peer-reviewed publication. The final step in scientific validation, which is defintely critical for securing broad medical guideline inclusion and comprehensive reimbursement.

Given Company's Transformative Moments

The company's evolution has been shaped by two key transformative decisions: the focus on a robust clinical trial strategy and strategic capital raises tied to commercial milestones.

The most significant moment was the commitment to the Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal OutcoMEs (PRIME) study. This was a massive undertaking, but the positive results-showing a 25% reduction in NMI-fundamentally changed the commercial conversation from a diagnostic test to an intervention that saves lives and money. That's the difference between a niche lab test and a market-shaping standard of care.

  • Shifting from Science to Scale: The 2021 commercial partnership with Anthem, Inc. was transformative because it signaled the market's acceptance of the PreTRM Test's value proposition, moving the company from a research-focused entity to a commercial one.
  • Capitalizing on Validation: The $57.5 million public offering in February 2025, immediately following the positive PRIME study data, was a smart, opportunistic move. It extended the cash runway to 2028, allowing management to pursue the slow, complex process of getting Medicaid coverage in all 50 states, which represents about half of the total addressable market.
  • Focusing on Health Economics: The Q3 2025 results show the company is still in the investment phase, reporting only $16,000 in revenue, but a manageable net loss of $7.8 million. The real value is the $102.4 million in cash and equivalents as of September 30, 2025, which funds the commercial build-out and payer negotiations based on the PRIME data. This is a land-and-expand strategy, where the data is the weapon.

If you want to understand the long-term strategic intent, especially around patient outcomes and cost-saving, you should review the Mission Statement, Vision, & Core Values of Sera Prognostics, Inc. (SERA).

Sera Prognostics, Inc. (SERA) Ownership Structure

Understanding who owns Sera Prognostics, Inc. (SERA) shows you where the decision-making power sits, which is crucial for mapping future strategy and risk. The company is primarily controlled by institutional investors, but insiders still hold a meaningful stake, aligning their interests with the long-term success of the PreTRM test.

Given Company's Current Status

Sera Prognostics is a publicly traded company, listed on the Nasdaq Stock Market under the ticker symbol SERA. As of November 2025, its market capitalization stands at approximately $120.80 million. This public status means its financials and ownership are transparent, but it also subjects the company to the volatility and reporting demands of the public market.

The company is still in its early commercialization phase, focusing on driving adoption of its PreTRM test, a blood-based biomarker test that predicts the risk of spontaneous premature delivery. For example, their third quarter 2025 revenue was only $16,000, which is a tiny number, but they are focused on securing broad payer coverage, not volume yet. Importantly, the company reported a strong balance sheet with approximately $102.4 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2025, which they believe will fund operations through 2028. That's a defintely solid runway for a diagnostics firm.

Given Company's Ownership Breakdown

The ownership structure is heavily weighted toward professional money managers, which is typical for a biotech or diagnostics company that requires significant capital for research and commercialization. Institutional holders, like Baker Bros. Advisors LP and Whetstone Capital Advisors LLC, hold the majority of the stock, indicating a belief in the long-term value of the underlying technology.

Shareholder Type Ownership, % Notes
Institutions 64.96% Includes major investors like Baker Bros. Advisors LP (14.82%) and Elevance Health, Inc. (5.936%).
Retail/Public 24.24% Calculated as the remaining float held by individual investors and non-institutional entities.
Insiders 10.8% Includes the leadership team and board members, demonstrating significant skin in the game.

Given Company's Leadership

The executive team is a blend of seasoned healthcare and technology veterans, bringing the right mix of clinical, commercial, and financial expertise needed to scale a precision medicine product. The focus is clearly on commercialization and market access following the positive clinical study results.

  • Zhenya Lindgardt: President and Chief Executive Officer (CEO). She brings nearly two decades of experience from Boston Consulting Group (BCG) and executive leadership at Uber Technologies, Inc., focusing on scaling new businesses.
  • Austin Aerts: Chief Financial Officer (CFO). He manages the fiscal strategy, which is critical given the current focus on cash management and commercial investment.
  • Dr. Tiffany Inglis: Chief Medical Officer (CMO), appointed in October 2025. She is an accomplished OB/GYN with prior leadership roles at Elevance Health, which is a key payer perspective for the company.
  • Lee Anderson: Chief Commercial Officer (CCO), appointed in May 2025, tasked with driving sales and market penetration.
  • Chuck Hyde: Head of Market Access, appointed in July 2025, focusing on securing payer reimbursement, which is the biggest hurdle for adoption.

The team's recent additions, especially in commercial and medical affairs, signal a strategic pivot from pure research to aggressive market adoption. You can learn more about the strategic direction in the Mission Statement, Vision, & Core Values of Sera Prognostics, Inc. (SERA).

Sera Prognostics, Inc. (SERA) Mission and Values

Sera Prognostics, Inc. is fundamentally driven by a dual purpose: advancing precision pregnancy care to improve outcomes for mothers and newborns, and simultaneously generating significant healthcare cost savings. This mission is the cultural bedrock that guides their strategy, even as they ramp up commercialization efforts.

You can see the commitment when you look at their Q3 2025 financials, where they still spent $3.3 million on Research and Development (R&D) to advance their science, even with revenue at only $16,000 for the quarter, reflecting a long-term, mission-first investment strategy.

Given Company's Core Purpose

Official mission statement

The company's mission is direct and impactful. It's all about getting critical information to doctors and patients early on, so they can act before complications arise. This focus on early, pivotal pregnancy information is designed to improve health outcomes and reduce the financial burden on the healthcare system.

  • Provide early, pivotal pregnancy information to improve the health of mothers and newborns.
  • Result in reductions in the costs of healthcare delivery.

Vision statement

Sera Prognostics, Inc. doesn't just want to be a player; they aim to be a market leader in a niche that desperately needs innovation. Their vision is about global leadership in women's health diagnostics, taking a holistic approach to care while making the economics work for everyone.

  • Become a global leader in high-value women's health diagnostics.
  • Deliver pivotal information to providers and patients for better health.
  • Improve the economics of healthcare delivery simultaneously.

Core Values (Value-Driven Operating Principles)

While the company emphasizes its 'Value-Driven Operating Principles,' the core purpose is consistently articulated as a dedication to one major problem: preterm birth. This dedication is the lens through which they view all operations, from R&D to commercialization.

  • Dedication to improving maternal and neonatal health through precision pregnancy care.
  • Focus on innovation, particularly in developing novel diagnostic technologies like the PreTRM test.
  • Commitment to addressing the problem of preterm birth, which affects more than one in ten infants in the United States.

Here's the quick math on their runway: as of September 30, 2025, the company held approximately $102.4 million in cash and equivalents, which they expect to fund operations through 2028, showing a defintely long-term commitment to their core purpose despite current low revenue. You can read more about their ethos here: Mission Statement, Vision, & Core Values of Sera Prognostics, Inc. (SERA).

Given Company slogan/tagline

The company's official tagline is simple and clear, positioning them as the definitive resource in their field.

  • The Pregnancy Company®

Sera Prognostics, Inc. (SERA) How It Works

Sera Prognostics operates as a precision medicine company, using its proprietary proteomics and bioinformatics platform to develop and commercialize blood-based diagnostic tests that predict a pregnant woman's individualized risk for various complications, enabling earlier clinical intervention.

The core value proposition is simple: provide doctors with pivotal, early-stage risk information to improve maternal and neonatal outcomes and, consequently, drive down the significant healthcare costs associated with conditions like preterm birth.

Sera Prognostics, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
PreTRM Test for Risk Management Healthcare Providers, Payers, Asymptomatic Singleton Pregnancies (18-20 weeks gestation) Only broadly validated, commercially available blood test for spontaneous preterm birth risk. Measures two specific proteins (IBP4 and SHBG) to provide an individualized risk score. The pivotal PRIME study showed a 20% reduction in NICU admissions when the test was used to guide targeted care.
LikeMine Platform Mothers/Patients, Clinicians A data platform that draws on millions of U.S. pregnancies to offer comparison reports, like the complimentary Complications Summary Report, showing outcomes for women with similar profiles. Helps patients navigate their pregnancy with confidence.

Sera Prognostics, Inc.'s Operational Framework

The company's operations are currently laser-focused on commercialization and market access, shifting from a heavy research and development (R&D) phase following the completion of the pivotal PRIME study.

Here's the quick math on the current burn: for the third quarter of 2025, total operating expenses were $9.0 million, while revenue was only $16,000. The net loss for that quarter was $7.8 million, but the company's cash and equivalents of approximately $102.4 million as of September 30, 2025, are expected to fund operations through 2028.

The value creation process hinges on a few core steps:

  • Biomarker Discovery: Using a proprietary proteomics and bioinformatics platform to identify and validate protein biomarkers in maternal blood that are predictive of adverse pregnancy outcomes.
  • Test Processing: A single blood draw is processed exclusively at the Sera Prognostics Clinical Laboratory in Salt Lake City, Utah, using liquid chromatography-mass spectrometry to measure the diagnostic proteins.
  • Risk Reporting: A proprietary algorithm uses the protein abundances and the patient's pre-pregnancy Body Mass Index (BMI) to generate a qualitative risk prediction, which is reported to the physician.
  • Payer Adoption: Commercial efforts center on demonstrating the health economic benefits of the PreTRM Test to secure broad coverage, particularly with Medicaid, which represents roughly half of the total addressable market. They are actively enrolling patients in a Medicaid pilot in Nevada and engaging with payers across thirteen states.

The entire operation is built to convert complex proteomic data into an actionable clinical decision point. You can read more about the company's long-term goals here: Mission Statement, Vision, & Core Values of Sera Prognostics, Inc. (SERA).

Sera Prognostics, Inc.'s Strategic Advantages

The company's market success is defintely tied to its first-mover advantage and the high barrier to entry in clinical diagnostics.

  • First-in-Class Validation: The PreTRM Test is the only broadly validated, commercially available blood-based biomarker test for spontaneous preterm birth risk in asymptomatic singleton pregnancies. This is a huge head start.
  • Proprietary Biobank and Platform: The company owns an extensive proprietary biobank of samples and clinical data, which is a critical asset for discovering and validating new diagnostic tests for other pipeline conditions like preeclampsia and stillbirth.
  • Pivotal Clinical Evidence: The successful completion and publication of the full PRIME study results provide compelling, real-world data showing a significant clinical benefit-specifically, a 20% reduction in NICU admissions when the test is used to guide care. This evidence is crucial for driving payer reimbursement decisions.
  • Targeted Commercial Strategy: By focusing on Medicaid and other payers in high-risk states, and backing their pitch with health economics data, they are directly addressing the largest cost-drivers and market segments for preterm birth.

Sera Prognostics, Inc. (SERA) How It Makes Money

Sera Prognostics, Inc. primarily generates revenue by commercializing its proprietary proteomic blood test, the PreTRM Test, which assesses a pregnant woman's risk of spontaneous preterm birth. The core of the business model is securing broad reimbursement coverage from third-party payers, including commercial insurers and government programs like Medicaid, to drive test adoption and scale. Exploring Sera Prognostics, Inc. (SERA) Investor Profile: Who's Buying and Why?

Sera Prognostics, Inc. Revenue Breakdown

As of the 2025 fiscal year, the company's revenue is nascent and almost entirely dependent on a single product, reflecting its early-stage commercialization efforts following key clinical study results.

Revenue Stream % of Total Growth Trend
PreTRM Test Sales (Diagnostic Services) ~100% Increasing (from near-zero base)
Other (Research/Grants) <1% Stable/Irregular

For the nine months ended September 30, 2025, total revenue reached approximately $71,000, a notable increase from the prior year's period, though still minimal as the company focuses on establishing payer coverage. The most recent quarter, Q3 2025, saw revenue of only $16,000, which was a decrease from the same quarter in 2024. This shows the revenue stream is still highly volatile. The entire business hinges on getting the PreTRM Test covered widely.

Business Economics

The economic engine of Sera Prognostics is built on a high-value diagnostic test that aims to deliver significant cost savings to the healthcare system by reducing the incidence of expensive neonatal intensive care unit (NICU) admissions. The company's primary strategy is to prove the test's health economic benefits to payers.

  • Pricing Anchor: The Centers for Medicare & Medicaid Services (CMS) set a payment rate for the PreTRM Test (CPT code 0247U) at $750.00, which acts as a benchmark for negotiations with other commercial and governmental payers.
  • Payer Focus: The company is heavily focused on Medicaid, which represents about half of the total addressable market in the US. They are actively pursuing adoption, including an inaugural Medicaid pilot program in Nevada, which resulted in an initial $100,000 deferred revenue prepayment as of September 30, 2025.
  • Value Proposition: The core value is shifting care from expensive reactive treatment to proactive intervention. Early data presented in 2025 suggests the test-and-treat paradigm can lead to a 20% reduction in NICU admissions, a massive cost-saver for payers.
  • Cost Structure: The company operates with a high fixed cost for research, development, and commercial infrastructure, leading to substantial operating losses as test volume remains low.

Sera Prognostics, Inc. Financial Performance

The company's financial performance in 2025 reflects a pre-commercial stage enterprise with significant cash burn, prioritizing market access and clinical evidence over immediate revenue. This is defintely a high-risk, high-reward profile.

  • Total Revenue (9M 2025): Revenue for the first nine months of 2025 totaled approximately $71,000. This is a minimal figure, indicating that broad commercial reimbursement has not yet materialized.
  • Net Loss (Q3 2025): The net loss for the third quarter of 2025 was approximately $7.8 million, a slight improvement from the prior year's quarter, but still a significant cash outlay.
  • Operating Expenses (Q3 2025): Total operating expenses for Q3 2025 were $9.0 million. Selling, General, and Administrative (SG&A) expenses were $5.7 million, reflecting the investment in commercial activities and strategic headcount to drive future growth.
  • Cash Runway: As of September 30, 2025, the company maintained a strong cash position with approximately $102.4 million in cash, cash equivalents, and available-for-sale securities. Management projects this capital is sufficient to fund operations through significant commercial milestones until 2028. Here's the quick math: with a quarterly net loss around $7.8 million, the cash position provides a runway of over three years, which is critical for a company navigating the slow process of payer adoption.

Sera Prognostics, Inc. (SERA) Market Position & Future Outlook

Sera Prognostics, Inc. is fundamentally a development-stage diagnostics company with a near-term outlook entirely dependent on commercializing its PreTRM Test, a predictive blood test for spontaneous preterm birth. The company is currently a niche player in the massive maternal-fetal health market, with estimated full-year 2025 sales of only around $244,800, but it possesses a unique, validated product that could be a game-changer if it achieves broad payer coverage and clinical adoption. You need to focus on payer decisions, because that's the only thing that moves the needle right now.

Competitive Landscape

In the broader maternal-fetal diagnostics market, Sera Prognostics competes not just with direct preterm birth tests (which are few) but with large-scale non-invasive prenatal testing (NIPT) providers and clinical lab giants. The company's current market share in the overall $12.26 Billion global Fetal Monitoring, Diagnostics, and Predictive Tests Market in 2025 is negligible, but its true competition lies in securing the 'standard of care' position for preterm birth risk assessment.

Company Market Share, % (Sub-Segment Est.) Key Advantage
Sera Prognostics, Inc. <0.1% Only broadly validated, blood-based test for spontaneous preterm birth risk.
Natera 25% (NIPT Market Est.) Dominant scale and established reimbursement for Non-Invasive Prenatal Testing (NIPT).
LabCorp (Laboratory Corporation of America Holdings) 15% (Clinical Lab Services Est.) Vast national clinical laboratory network and established payer contracts.

Opportunities & Challenges

The company's strategic focus is on converting its strong clinical data into commercial traction, but this requires overcoming significant financial hurdles. The Q3 2025 net loss was $7.8 million, which highlights the need for rapid revenue growth.

Opportunities Risks
Publication of PRIME study results to drive clinical guideline changes. Limited current revenue (Q3 2025 revenue was only $16,000).
Expansion of Medicaid coverage, which represents approximately 50% of the total addressable market. Uncertainty of converting pilot programs (like the Nevada Medicaid pilot) into broad, recurring reimbursement.
Leveraging the PreTRM Test's demonstrated 20% reduction in NICU admissions to prove cost-effectiveness to payers. Regulatory risk, including potential changes to FDA regulation of laboratory-developed tests (LDTs).

Industry Position

Sera Prognostics is positioned as a first-mover in the precision pregnancy care sub-segment, specifically for preterm birth risk prediction, which is a significant and costly unmet need in the US healthcare system. While the company's current market capitalization of $122.5 million positions it as a niche player, its value is tied to its intellectual property and clinical validation.

  • Owns the only broadly validated, commercially available blood-based biomarker test for spontaneous preterm birth risk.
  • Cash position of approximately $102.4 million as of September 30, 2025, provides a runway through 2028 to pursue commercial milestones.
  • Shifted focus from R&D to commercialization, with Q3 2025 R&D expenses decreasing to $3.3 million as the pivotal PRIME study concluded.
  • Adoption hinges on moving beyond the lab-developed test (LDT) model to securing national payer coverage, which is a slow, methodical process.

To get a deeper understanding of the company's financial stability and capital structure, you should read our full breakdown: Breaking Down Sera Prognostics, Inc. (SERA) Financial Health: Key Insights for Investors. Defintely check the cash burn rate against the expected revenue ramp-up.

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