#USA #Salt Lake City #Sera Prognostics #Maternal Health #PreTRM

Sera Prognostics Reports First Quarter Financial Results for 2026

Sera Prognostics Inc., recognized as The Pregnancy Company® and traded on Nasdaq under the ticker SERA, has officially released its financial results for the first quarter ending March 31, 2026. The company's primary focus remains on enhancing maternal and neonatal health through innovative pregnancy biomarkers, and they have made significant strides in this arena.

Key Highlights from the First Quarter

Sera Prognostics’ first quarter was marked by a number of notable achievements:

1. Landmark Clinical Trial: The results from the landmark PRIME randomized trial involving 5,018 women have demonstrated that the PreTRM® test can significantly reduce early preterm births. Specifically, the test showed a 56% reduction in births before 32 weeks and a 32% decrease in births before 35 weeks. Additionally, the study revealed a 20% reduction in both NICU admissions and neonatal morbidity. It was found that one NICU day can be saved for every 4.2 patients screened, emphasizing the test's efficacy.

2. Expanded Evidence Base: Two peer-reviewed publications have further established the European evidence base for Sera’s tests. One of the noteworthy studies from the PREPARE survey assessed preterm birth awareness and education across five countries. This research indicated a significant gap between perceived risk and actual understanding, which the PreTRM® test can address effectively.

3. Commercial Partnerships: Sera has launched its third partnership program aimed at enhancing physician education and access to the PreTRM test, targeting over 350 providers across three states. Furthermore, discussions are ongoing with 13 payers across 15 states to broaden the test's accessibility and acceptance.

4. Active Engagement at Medical Meetings: The company's presence at major medical gatherings such as the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting and the Society of Maternal-Fetal Medicine (SMFM) Annual Meeting has facilitated valuable interactions with clinicians and specialists, enhancing awareness and understanding of the PreTRM test.

5. Advancing Towards CE Marking: Sera is making substantial progress in preparing its regulatory dossier for CE marking, aimed for a mid-year submission, with ongoing validation activities continuing in Europe.

Financial Overview

Financial results from the first quarter of 2026 show mixed outcomes:

• - Revenue: The company reported revenue of $14,000, a decline from $38,000 in the same period in 2025.
• - Operating Expenses: With total operating expenses reaching $9.4 million (compared to $9.3 million in Q1 2025), the company is strategically managing its investments to ensure sustainability. Research and development expenses totaled $3.0 million while general and administrative costs were $6.3 million.
• - Net Loss: The company recorded a net loss of $8.4 million, slightly increasing from $8.2 million in the previous year. As of March 31, 2026, Sera holds approximately $86.8 million in cash and equivalents, providing a solid cash runway through 2029.

Looking Ahead

Sera Prognostics is committed to evolving its operations from a clinical stage to a commercially driven organization. This transition involves redirecting investments towards commercialization while maintaining financial stability.

President and CEO Zhenya Lindgardt expressed enthusiasm about the company's direction, stating, “Our focus is to enhance clinician awareness while evolving into a commercially driven entity.” He highlighted the importance of expanding the clinical foundation into commercially viable strategies, bolstered by peer-reviewed validations and increased clinician engagement.

The company is also set to partake in numerous upcoming investor conferences, where key organizational figures will engage in discussions about the company’s future directions and operational strategies.

In summary, Sera Prognostics is steadily making progress in both clinical and commercial domains, with a clear path toward impacting maternal and neonatal health significantly.