Sera Prognostics Q2 Earnings Call Highlights

Key Points

• Revenue remained modest at $30,000 in Q2, up from $17,000 a year earlier, while the net loss widened to $9.1 million. Sera ended the quarter with $80.3 million in cash and said its capital should fund operations through major milestones into 2029.
• Illinois Medicaid implementation is underway following legislation requiring coverage of prescribed proteomic tests and related care management. However, registration and contracting may take months, with substantial penetration of the estimated 50,000 eligible pregnancies not expected until after 2026.
• Sera expanded its payer pipeline to more than 20 opportunities across over 20 states and continued advancing clinical and regulatory plans. The company reported favorable PRIME subgroup results, including reduced NICU admissions, and expects to submit its European CE-marking package in Q4 2026.

Sera Prognostics NASDAQ: SERA reported modest second-quarter revenue while outlining progress in payer engagement, Illinois Medicaid policy, clinical evidence and European regulatory preparations for its PreTRM Test-guided care platform.

Revenue for the quarter ended June 30 was $30,000, compared with $17,000 in the second quarter of 2025. Chief Financial Officer Austin Aerts said the revenue level reflected the timing of the company’s geographically focused commercialization strategy and its ongoing efforts to build awareness following publication of the PRIME study. He added that testing volumes have increased month to month since the study’s publication earlier this year.

The company reported a net loss of $9.1 million, compared with a net loss of $8 million a year earlier. Operating expenses rose to $10 million from $9.3 million. Research and development expense was $3.5 million, compared with $3.3 million in the prior-year period, while selling, general and administrative expense increased to $6.5 million from $6 million.

Sera ended the quarter with $80.3 million in cash equivalents and available-for-sale securities. Aerts said the company believes its capital position will fund operations through significant adoption and commercial milestones through 2029. He also said R&D spending is expected to decline in future periods as Sera directs resources toward commercialization.

Illinois Medicaid Legislation Moves to Implementation

President and Chief Executive Officer Zhenya Lindgardt highlighted Illinois legislation requiring the state Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage spontaneous preterm birth risk, along with associated care-management services and interventions that have demonstrated improved outcomes.

Lindgardt said Sera has begun working with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations and providers. The company is pursuing contracting, credentialing, provider education, workflow integration and implementation readiness across eligible Medicaid and commercially insured populations.

During the question-and-answer session, Lindgardt described three primary steps from coverage to utilization:

• Registering as a provider in the state and obtaining in-network status with payers.
• Contracting with the state’s payers, including five Medicaid plans in Illinois.
• Activating providers through education, clinical champions and integration with major institutions and maternal-fetal medicine specialists.

She said provider registration can take from several months to as long as a year, while payer contracting typically takes six to nine months. Sera does not expect substantial penetration of Illinois’ estimated 50,000 eligible Medicaid pregnancies during 2026.

Looking to 2027 as a full first year following access, Lindgardt said a 1% to 2% penetration rate would be prudent based on benchmarks from other diagnostic and screening tests. She cited 2% to 4% penetration in a second year and approximately 5% in a third year as comparable benchmarks, while stating that Sera aims to outperform them.

Payer Pipeline Expands Beyond Initial Targets

Sera said it launched its fourth partnership program during the quarter, a state-based initiative with a national payer designed to support quality improvement and maternal health objectives through a value-added benefits framework. The company remains on track toward its objective of establishing five to seven commercial programs.

At the beginning of 2026, Sera had targeted doubling its payer discussions across 15 to 17 states. Lindgardt said the company has exceeded that goal and is now engaged in more than 20 payer opportunities across more than 20 states, aided by payer referrals and market awareness.

Management said its payer opportunities fall into three broad groups: policy reviews, programs or value-based arrangements in selected geographies, and arrangements involving employer customers or provider groups. Lindgardt noted that national payer policy reviews typically take nine to 12 months, though individual payers do not publicly disclose their review timelines.

The company said its focus in the second half of 2026 will shift toward implementation, reimbursement readiness and adoption among its highest-priority opportunities. Management said market-access initiatives can require roughly six to nine months of implementation and contracting before testing utilization begins to scale, and it expects many current opportunities could contribute more meaningfully as the company approaches early 2027.

Clinical Evidence and Regulatory Work Continue

In July, Sera published a PRIME subgroup analysis focused on first-time mothers. According to Lindgardt, the analysis showed a 22% reduction in neonatal intensive care unit admissions, a twofold reduction in NICU admissions among newborns following spontaneous preterm birth, and a 30% reduction in severe composite neonatal morbidity. The study also reported a number needed to screen and treat of 28 to prevent one NICU admission.

First-time mothers represent approximately 40% of U.S. pregnancies, the company said. Sera expects to publish a health economics analysis in the coming months to further quantify the economic impact of PreTRM Test-guided care.

Two PRIME-related abstracts were accepted for presentation at the Society for Maternal-Fetal Medicine Global Congress in October. One, focused on first-time-mother outcomes, was selected for oral presentation. A second abstract on the economic impact of screen-guided interventions was selected among top poster presentations. Lindgardt clarified that the oral presentation will cover data already published in July rather than new data.

Sera also began an ARPA-H-supported collaboration involving development of a point-of-care diagnostic intended to help clinicians assess fetal hypoxia risk during labor and delivery. The company is contributing protein biomarker discovery and validation capabilities to the multi-institutional program.

In Europe, Sera convened an advisory board with experts representing nine countries and cited published European commentary supporting biomarker-based risk prediction and prevention approaches. The company said it elected to conduct additional performance testing on its ELISA-based assay platform before its CE-marking submission, including work related to sample stability during transport to the laboratory. Sera expects pre-application activities to begin in the third quarter and plans to submit its full CE-marking package in the fourth quarter.

About Sera Prognostics (NASDAQ:SERA)

Sera Prognostics, Inc is a precision medicine company focused on improving pregnancy outcomes through proteomic testing. The company's flagship product, the PreTRM™ test, is a blood-based assay designed to assess a woman's risk of delivering prematurely by measuring specific protein biomarkers in maternal serum. By identifying patients at elevated risk for spontaneous preterm birth, Sera Prognostics aims to enable earlier interventions and tailored care plans that can reduce the incidence of neonatal complications associated with early delivery.

Since its founding in 2014 and subsequent initial public offering in 2020, Sera Prognostics has worked closely with clinical research networks and obstetric care providers across the United States to validate the clinical performance of its PreTRM test.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.

Continue following MarketBeat

Add MarketBeat as your preferred source on Google to see our latest stories in your feed.

Add As Preferred Source