Sera Prognostics (SERA -0.19%), a diagnostic company specializing in pregnancy risk prediction, reported Q2 2025 results on August 6, 2025. The company’s headline news was a net loss improvement and continued strategic investment toward commercial rollout, despite revenue remaining extremely modest. Revenue (GAAP) was $17,000 in Q2 2025. Net loss (GAAP) was $8.0 million in Q2 2025, improving from a GAAP net loss of $8.3 million in Q2 2024. Earnings per share (EPS) (GAAP) was ($0.16) in Q2 2025. This quarter marked careful expense management, hands-on progress in clinical milestones, and key strategic hires, with management positioning the company for future commercial expansion.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS | ($0.16) | ($0.23) | ($0.25) | 36.0 % |
| Revenue | N/A | $0.05 million | N/A | N/A |
| Research and Development Expense | $3.3 million | $4.4 million | (24.3 %) | |
| Selling, General and Administrative Expense | $6.0 million | $4.9 million | 22.4 % | |
| Net Loss | $8.0 million | $8.3 million | (3.6 %) |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Focus
Sera Prognostics focuses on developing blood tests to assess pregnancy risk, most notably its PreTRM test. This product aims to predict the risk of premature birth, using protein biomarkers detected in blood samples taken during pregnancy. The company leverages a proprietary proteomics and bioinformatics platform, combining advanced mass spectrometry, immunoassays, and a comprehensive biobank for the discovery and validation of new pregnancy-related biomarkers.
The main priority for the business is commercializing the PreTRM test, which has completed substantial clinical trials and is advancing toward broader adoption. Key factors for future success include demonstrating health economic value, obtaining widespread payer reimbursement—including Medicaid coverage—and delivering published, peer-reviewed clinical evidence. The company is also preparing for regulatory shifts and seeking to scale its commercial organization as it transitions into an active commercial phase.
Quarterly Highlights and Notable Developments
During the quarter, Sera Prognostics recorded $17,000 in GAAP revenue in Q2 2025. Total net loss (GAAP) narrowed slightly to $8.0 million in Q2 2025 compared to $8.3 million in Q2 2024. EPS (GAAP) improved to ($0.16) in Q2 2025 from ($0.25) a year ago, supported by a larger base of outstanding shares following recent fundraising efforts.
Research and development expenses (GAAP) fell to $3.3 million in Q2 2025, down from $4.4 million in Q2 2024. The decrease reflects the completion of key clinical work on the PRIME study—an important trial for PreTRM test validation. In contrast, Selling, general, and administrative expenses were $6.0 million in Q2 2025, up from $4.9 million in Q2 2024, as the company expanded its commercial staff and invested in building market awareness ahead of pending PRIME study publication.
Sera Prognostics placed strong emphasis on partnerships and payer engagement, calling out progress with Medicaid plans in two high-preterm birth states and strengthening ties with Elevance Health, a leading insurer. Medicaid accounts for roughly 43% of all births nationally, making it critical for PreTRM test access. Noteworthy activities include the expansion of pilot programs in key states, new commercial hires, targeted educational campaigns that generated approximately 3,000 warm leads among doctors, and collaboration with digital health platforms for patient outreach.
On the regulatory front, the company acknowledged the evolving oversight for laboratory-developed tests, aligning its operations to anticipate possible changes after the July 2024 FDA regulatory updates. No material one-time events or dividend changes were announced, and the PreTRM test remains its sole commercial offering. Sera Prognostics did not provide segment or test volume details during this quarter's release.
Pipeline Products and Commercialization Pathways
The company’s primary revenue engine is the PreTRM test, a blood-based diagnostic focused on predicting preterm birth risk. This test is the only broadly validated, commercially available proteomic assay for this use and holds a unique Current Procedural Terminology (CPT) code from the Centers for Medicare and Medicaid Services, with a listed price of $750 per test.
The company’s research platform has enabled the development of a pipeline targeting additional pregnancy complications, such as preeclampsia and gestational diabetes. However, no pipeline advancements were prominently featured in this quarter's update. Management continues to prioritize market access and payer reimbursement, ramping up Medicaid pilot initiatives and engagement with state agencies. The PRIME study publication remains a clear milestone for influencing adoption and potentially accelerating revenue.
Financial Outlook and Points to Watch
Management did not issue any formal revenue or profit guidance for the upcoming quarters or the remainder of fiscal 2025. Instead, the company reiterated its focus on foundational steps for future growth, emphasizing that cash reserves—$108.5 million as of Q2 2025—are expected to fund operations through 2028 and support the ramp-up of commercial activities.
In the periods ahead, investors will be monitoring progress on Medicaid pilot programs, payer adoption following the PRIME study publication, and potential shifts in regulatory policy that may impact commercial timelines. Future performance hinges on successful guideline inclusion, faster physician adoption, and further evidence of health-economic benefit through published outcomes. SERA does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
