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Sera Prognostics (SERA) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 12, 2026

Source: earnings call transcript

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

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

Deals & partnerships

National payer State-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-H Multi-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

Implementation timeline for new access Next 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 commercialization Current

$30,000 in Q2 FY26.

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

Increased net loss Current

$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 restructuring Current, 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 delay Q3-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

Illinois Medicaid contracting progress

Next 6-9 months (Q3 FY26 - Q1 FY27)
Current Engaged with Illinois Department of Healthcare and Family Services, managed Medicaid organizations, and provider stakeholders.
Target Completion 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.

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Q&A highlights

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 read 6 chapters

Detailed narrative

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.

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.