Sera Prognostics announced that the findings of its Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes (PRIME) study have been accepted for publication in a peer‑reviewed medical journal. The study, the largest of its kind, demonstrated that the company’s PreTRM blood‑based biomarker test can predict spontaneous preterm birth with high accuracy and can reduce neonatal intensive care unit admissions by about 20%, translating into significant health‑economic benefits.
The acceptance follows a podium presentation of the study abstract at the Society for Maternal‑Fetal Medicine’s annual meeting earlier in 2025. Management said the full manuscript will be shared at upcoming medical conferences and through events with research analysts once the journal publishes the paper. The publication is a key step toward broader clinical adoption and payer reimbursement, providing independent validation of the test’s predictive accuracy and cost‑effectiveness.
However, the announcement comes at a time when Sera Prognostics is grappling with persistent financial challenges. In the third quarter of 2025, the company reported a net loss of $7.8 million, a slight improvement from $7.9 million a year earlier, and revenue of $16,000, down from $29,000 in Q3 2024. The revenue miss was driven by a sharp decline in test sales, reflecting the company’s ongoing transition from clinical trials to commercial deployment and the need to secure payer contracts.
Management explained that research and development expenses fell in Q3 2025 compared with the prior year because the company completed the PRIME study and is shifting resources toward commercialization. In contrast, selling, general, and administrative costs rose as the company invested in targeted commercial activities and strategic hiring to accelerate market entry. The company’s cash position remains strong, with approximately $102.4 million in cash and equivalents as of September 30 2025, expected to fund operations through 2028.
Despite the revenue shortfall, executives highlighted progress on payer engagement. President and CEO Zhenya Lindgardt noted that the PRIME study data are driving meaningful conversations with managed Medicaid programs and other payers across thirteen states, including a pilot launch in Nevada. Chief Medical Officer Dr. Tiffany Inglis emphasized that the test’s 20% reduction in NICU admissions is expected to lower costs for both providers and payers, reinforcing the case for reimbursement.
Investors reacted to the Q3 2025 earnings report with concern over the revenue miss, highlighting the challenges of scaling the PreTRM test and securing widespread reimbursement. Analysts noted that while earnings beat expectations by $0.04 per share, the revenue miss underscored the need for continued commercial traction and payer agreements.
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