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    SERA
    Earnings call· Jun 2026(Q2 FY26)

    SERA PROGNOSTICS Q2 FY26 earnings call SERA

    Aug 12, 2026 Source

    Executive summary

    Sera Prognostics Q2 FY26 — Illinois Medicaid Coverage and Expanded Payer Engagement

    Sera Prognostics achieved significant milestones in Q2 FY26, securing Illinois Medicaid coverage and expanding payer engagement, validating the PreTRM Test's clinical and economic value. While revenue remains modest and net loss increased, the company is building foundational elements for broad adoption, including clinical validation and commercial execution, with a strong cash position to fund operations through 2029. The focus is now shifting from securing access to driving utilization and implementation in priority markets.

    Highlights

    5

    • Secured Illinois Medicaid coverage legislation, providing access to evidence-based preterm birth risk assessment for 50,000 Medicaid pregnancies annually.

    • Expanded payer engagement to over 20 opportunities across 20+ states, exceeding the initial goal of 15-17 states.

    • Published PRIME data subgroup analysis in first-time mothers, demonstrating a 22% reduction in NICU admissions and a 30% reduction in severe composite neonatal morbidity.

    • Launched the fourth partnership program with a national payer, expanding implementation of PreTRM Test-guided care.

    • Ended the quarter with $80.3 million in cash, cash equivalents, and available-for-sale securities, sufficient to fund the company through 2029.

    Concerns

    4

    • Revenue for the quarter remained modest at $30,000, up from $17,000 in Q2 2025.

    • Net loss for the quarter increased to $9.1 million compared to $8.0 million in Q2 2025.

    • Research and development expenses increased to $3.5 million from $3.3 million in 2025, reflecting restructuring-related costs.

    • Implementation and contracting for newly secured access, such as Illinois Medicaid, is expected to take approximately 6 to 9 months before utilization begins to scale.

    Guidance & targets

    2
    CategoryTargetConfidence
    CE Marking submission
    Full CE marking package submission
    medium materiality
    High
    Commercial programs established
    5 to 7 commercial programs
    medium materiality
    High

    Operational metrics

    17
    Revenue
    $30,000up from $17,000 in Q2 2025
    Q2 FY26

    Revenue for the quarter was $30,000 compared to $17,000 in the second quarter of 2025.

    Operating expenses
    $10 millionup slightly from $9.3 million in the prior year period
    Q2 FY26

    Operating expenses for the quarter were $10 million, up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in evidence generation, regulatory preparation and advocacy activities.

    Research and development expenses
    $3.5 millioncompared to $3.3 million in 2025
    Q2 FY26

    Research and development expenses were $3.5 million compared to $3.3 million in 2025, reflecting restructuring-related costs. We do expect R&D spending to decline in future periods as we continue to focus resources on our commercialization efforts.

    Selling, general and administrative expenses
    $6.5 millionversus $6.0 million in the prior year
    Q2 FY26

    Selling, general and administrative expenses were $6.5 million versus $6.0 million in the prior year, reflecting investments in targeted commercial activities, marketing programs and strategic commercial hires.

    Net loss
    $9.1 millioncompared to a net loss of $8.0 million in the second quarter of 2025
    Q2 FY26

    Net loss for the quarter was $9.1 million compared to a net loss of $8.0 million in the second quarter of 2025.

    Cash, cash equivalents and available-for-sale securities
    $80.3 million
    as of June 30, 2026

    We ended June 30, 2026, with $80.3 million in cash, cash equivalents and available-for-sale securities, which we believe will be sufficient to fund the company across significant adoption and commercial milestones through 2029.

    Payer opportunities
    more than 20exceeded objective of doubling
    Q2 FY26

    We're pleased to report that we have exceeded that objective and are currently engaged with more than 20 payer opportunities across over 20 states.

    Partnership programs launched
    fourth
    Q2 FY26

    This month, we launched our fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer.

    NICU admissions reduction
    22%
    PRIME subgroup analysis

    The findings demonstrated a 22% reduction in NICU admissions, a twofold reduction among newborns following spontaneous preterm birth...

    Severe composite neonatal morbidity reduction
    30%
    PRIME subgroup analysis

    ...and a 30% reduction in severe composite neonatal morbidity.

    Number needed to screen and treat
    28
    PRIME subgroup analysis

    The study also showed a number needed to screen and treat of just 28 patients to prevent 1 NICU admission.

    First-time mothers as % of pregnancies
    40%
    United States

    First-time mothers account for approximately 40% of pregnancies in the United States, making this an important population for broader adoption of biology-based risk assessment.

    Illinois Medicaid eligible births
    50,000
    annually

    So I do not expect a ton of penetration of these 50,000 Medicaid lives in 2026.

    Illinois Medicaid penetration
    1% to 2%
    Year 1 post access (2027)

    So if we look at 2027 as full year 1, looking at the single-digit percentage points would be prudent, so 1% to 2% penetration following year...

    Illinois Medicaid penetration
    2% to 4%
    Year 2 post access (2028)

    ...let's say, 2% to 3%, 2% to 4% and growing that to 5% in year 3 would be commensurate with the benchmarks we've seen.

    Illinois Medicaid penetration
    5%
    Year 3 post access (2029)

    ...and growing that to 5% in year 3 would be commensurate with the benchmarks we've seen.

    Payer policy review process duration
    9 to 12 months
    typical

    With national payers, the process typically takes 9 to 12 months.

    Industry KPIs

    2
    MetricValueDetails
    Launch access metrics50,000pregnancies annually
    Product franchise net sales$30,000USD

    Deals & partnerships

    2
    National payerState-based initiative to expand implementation of PreTRM Test-guided care, supporting quality improvement and maternal health objectives through a value-added benefits framework.

    This month, we launched our fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer. The program is intended to support quality improvement and maternal health objectives through a value-added benefits framework.

    ARPA-HMulti-institutional program focused on developing a novel point-of-care diagnostic to assess fetal hypoxia risk during labor and delivery, with Sera contributing protein biomarker discovery and validation expertise.

    Another highlight this quarter was the start of an ARPA-H-supported collaboration, which provides important validation of our scientific platform and biomarker discovery capabilities. The multi-institutional program is focused on developing a novel point-of-care diagnostic to help clinicians assess fetal hypoxia risk during labor and delivery, with Sera contributing its expertise in protein biomarker discovery and validation.

    Risks & headwinds

    5
    Implementation timeline for new accessNext 6-9 months (from Q2 FY26)

    Approximately 6 to 9 months for implementation and contracting before utilization scales.

    Mitigation: Focus shifts to execution, provider onboarding, workflow integration, champion development, and targeted awareness initiatives.

    Modest revenue in early commercializationCurrent

    $30,000 in Q2 FY26.

    Mitigation: Continued investment in evidence generation, regulatory preparation, advocacy, and building foundational elements for broad adoption.

    Increased net lossCurrent

    $9.1 million in Q2 FY26 compared to $8.0 million in Q2 2025.

    Mitigation: Disciplined cost management, strong cash position ($80.3M) sufficient through 2029.

    R&D spending increase due to restructuringCurrent, but expected to decline in future periods.

    $3.5 million in Q2 FY26 compared to $3.3 million in 2025.

    Mitigation: Expectation for R&D spending to decline as resources focus on commercialization.

    CE Marking submission delayQ3-Q4 FY26

    Submission pushed from mid-year to Q4 2026.

    Mitigation: Additional performance testing on ELISA-based assay platform to derisk execution and strengthen the overall package.

    What to watch in Q3 FY26

    5

    Illinois Medicaid contracting progress

    Next 6-9 months (Q3 FY26 - Q1 FY27)
    CurrentEngaged with Illinois Department of Healthcare and Family Services, managed Medicaid organizations, and provider stakeholders.
    TargetCompletion of contracting with 5 Medicaid plans.

    Why it matters

    Successful contracting is a prerequisite for driving meaningful utilization and volume in Illinois, a key market access win.

    Specifically in Illinois, there are 5 plans. And you can imagine it will take significant effort to reach out and contract in parallel with the 5 payers on all of the Medicaid population in the state. While the first step, the registration and getting provider ID in the state might take from a couple of months up to a year, and we have started it across many states. The contracting timeline is a little bit tighter. So instead of a couple of months to a year, it's typically 6 to 9 months for the step #2, actual contracting for reimbursement with all of the payers.

    Q&A highlights

    6

    What are the specific steps and timeline for Illinois to move from notice to active reimbursement and volume? Which other states are likely to follow Illinois' lead?

    Zhenya outlined three steps: provider registration/in-network contracting (couple months to a year), payer contracting (6-9 months for 5 plans in Illinois), and provider activation/education. She expects minimal penetration in 2026 for Illinois, with 1-2% penetration in 2027 (Year 1), growing to 2-4% in Year 2, and 5% in Year 3, based on benchmarks. Several other states have prioritized preterm birth but their legislative timelines vary. Sera will provide transparency as public signals emerge.

    “So instead of a couple of months to a year, it's typically 6 to 9 months for the step #2, actual contracting for reimbursement with all of the payers.”

    asked by Lauren on for Tycho Peterson, Jefferies · answered by Evguenia Lindgardt

    2 min read6 chapters

    Detailed Narrative

    01

    Illinois Medicaid Coverage

    Sera Prognostics achieved a significant policy milestone with Illinois Medicaid coverage legislation for the PreTRM Test. This provides access for an estimated 50,000 Medicaid pregnancies annually and validates the test's clinical and health economic value. The company has begun engagement with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations, and providers to advance contracting, credentialing, and education, with implementation readiness and contracting expected to take 6-9 months before utilization scales.

    02

    Expanded Payer Engagement

    The company exceeded its goal of doubling payer discussions, now engaging with over 20 payer opportunities across more than 20 states. This expansion is driven by payer referrals and growing market awareness, reflecting broader acceptance of the PreTRM Test's clinical value and economic impact. The focus is shifting from initiating new conversations to advancing implementation, reimbursement readiness, and adoption within high-priority opportunities, with payer policy reviews typically taking 9-12 months for national payers.

    03

    Clinical Evidence Strengthening

    Sera published a PRIME subgroup analysis in first-time mothers, showing a 22% reduction in NICU admissions and a 30% reduction in severe composite neonatal morbidity. This population accounts for 40% of US pregnancies. The company also has a health economics analysis slated for publication in the coming months⏳ and two PRIME-related abstracts accepted for presentation at the SMFM Global Congress in October, further validating the test's value and supporting future guideline inclusion.

    04

    European Strategy Advancement

    The European strategy progressed with expert commentary supporting biomarker-based risk prediction and the convening of an expert advisory board from 9 countries. The PreTRM Test was recognized as the first validated risk prediction tool for expectant mothers. To derisk execution, additional performance testing in the ELISA-based assay platform is being completed, with pre-application activities for CE marking expected in Q3 and full submission in Q4 2026.

    05

    Strategic Partnerships and Awareness

    Sera launched its fourth partnership program, a state-based initiative with a national payer, focused on quality improvement and maternal health objectives. The company also initiated an ARPA-H-supported collaboration for a novel point-of-care diagnostic, leveraging its biomarker discovery expertise. Awareness-building efforts include webinars, podcasts, and scaled digital engagement targeting patients, providers, and advocates, reinforcing the commercialization strategy.

    06

    Financial Position and Outlook

    Revenue for Q2 FY26 was $30,000, up from $17,000 in Q2 FY25, with net loss at $9.1 million compared to $8.0 million in the prior year. The company maintains a strong financial position with $80.3 million in cash, cash equivalents, and available-for-sale securities, which is expected to fund operations through 2029. Testing volumes have increased steadily month-to-month since the PRIME study publication, indicating growing provider awareness and engagement.

    AI-generated summary of the company’s earnings call. Not investment advice.