Sera Prognostics Q1 Earnings Call Highlights

Key Points

• Sera is pushing a targeted commercial strategy to build clinician and consumer awareness and create access pathways, launching partnership programs that will reach >350 providers across three states and engaging with 13 payers in 15 states to drive reimbursement and adoption of its PreTRM test.
• Clinical and regulatory momentum continues: full PRIME results and related commentaries have been published, PREPARE survey results accepted, additional PRIME sub-analyses are planned for 2026, and a CE marking dossier for Europe is targeted for mid-year submission.
• Financially, Q1 revenue was negligible at $14,000 with a net loss of $8.4 million, but the company ended the quarter with $86.8 million in cash and believes its capital will fund operations through 2029, aided by a resource realignment expected to cut base operating expenses by nearly $10 million annually (with most savings realizing in 2027+).

Sera Prognostics NASDAQ: SERA reported first-quarter fiscal 2026 results and highlighted what management described as continued progress toward expanding awareness, access, and reimbursement pathways for its PreTRM test following publication of the full PRIME Study results in January.

Commercial strategy centered on awareness, access points, and payer engagement

President and CEO Zhenya Lindgardt said the company’s first-quarter focus was “building awareness with both clinicians and broader stakeholders,” including efforts to reach audiences outside traditional healthcare channels. Lindgardt pointed to continued engagement at clinical meetings, including the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting in February and the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.

At SMFM, the company presented clinical evidence and discussed PRIME outcomes with specialists and SMFM leadership, Lindgardt said. At ACOG, Sera hosted a product theater focused on PRIME data and “practical implementation strategies,” with an emphasis on integrating PreTRM into routine care.

Lindgardt also outlined media efforts aimed at raising awareness. She cited an interview on the SHE MD Podcast featuring Hailey Bieber discussing her pregnancy and the PreTRM test, which Lindgardt said generated significant visibility and was followed by a People magazine exclusive. Lindgardt said the episode surpassed half a million views, and she noted a new SHE MD episode was recorded for release May 14 to coincide with National Women’s Health Week. She also said Sera will be featured on Medscape’s “Hear From Her: The Women in Healthcare Leadership Podcast,” in a discussion focused on preterm birth and interventions.

On commercial execution, Lindgardt said Sera’s efforts remain focused on creating “sustainable access points and referral pathways” to support longer-term volume and revenue. During the quarter, the company launched its third partnership program, which Lindgardt said is expected to reach more than 350 providers across three states. She added that Sera is contracting with additional partners and intends to provide more detail as programs transition from contracting to implementation.

Lindgardt said the company was in active discussions with 13 payers across 15 states, describing it as a targeted approach designed to drive “meaningful implementation and adoption.” She said priorities include execution, reimbursement, physician awareness, clinical integration, and provider adoption.

Evidence generation and guideline efforts continue

Alongside commercialization efforts, Lindgardt said Sera continues to pursue guideline inclusion and broaden the evidence base for PreTRM. She noted European expert commentary on the PRIME trial was published in The Journal of Maternal-Fetal & Neonatal Medicine in March. According to Lindgardt, the authors emphasized that current prevention strategies fail to identify many women who ultimately deliver preterm and highlighted alignment of the PreTRM approach with European healthcare systems.

Lindgardt also said results from the PREPARE survey were accepted for publication in the Journal of Women’s Health. She described the survey as examining awareness and risk perception across five European countries, concluding there is a gap between perceived awareness and actionable understanding. Formal publication is expected in May, she said.

Looking ahead, Lindgardt said the company expects to publish additional PRIME sub-analyses in 2026, including:

• A health economics study
• Medicaid population outcomes from PRIME
• An analysis focused on first-time mothers

Advocacy and policy engagement, including Medicaid reimbursement outreach

Lindgardt framed preterm birth as a “public health and policy issue” and said the company is engaging with stakeholders across multiple states, particularly around Medicaid and value-based care settings. She said Sera recently launched a letter-writing campaign to encourage physicians and patients to engage with state Medicaid programs regarding reimbursement for PreTRM, and she described early participation as “encouraging,” with multiple letters submitted across several states.

Europe: CE marking dossier targeted for mid-year submission

In Europe, Lindgardt said Sera is progressing toward commercialization readiness and remains on track for a mid-year submission of its CE marking dossier. She said discussions with regulators and clinical stakeholders have been constructive, and she cited ongoing engagement with the company’s European advisor group around clinical utility, evidence requirements, and implementation considerations.

Financial results: modest revenue, disciplined spending, and runway extended to 2029

Chief Financial Officer Austin Aerts reported first-quarter revenue of $14,000, compared with $38,000 in the first quarter of 2025. Aerts said results were consistent with expectations, reflecting the company’s “geographically targeted commercialization strategy” and its ongoing advocacy and awareness building following PRIME’s publication.

Operating expenses totaled $9.4 million, compared with $9.3 million in the prior-year quarter. Aerts said this reflected disciplined cost management while investing in evidence generation, regulatory preparation, and advocacy. Research and development expense was $3.0 million, down from $3.3 million a year earlier, which Aerts attributed in part to the PRIME study now being published. Selling, general and administrative expense increased to $6.3 million from $5.9 million, reflecting the transition “toward targeted commercial initiatives and strategic headcount,” he said.

Net loss was $8.4 million, compared with a net loss of $8.2 million in the first quarter of 2025. Sera ended the quarter with $86.8 million in cash, cash equivalents, and available-for-sale securities. Aerts said the company believes its capital resources are sufficient to fund operations and capital expenditures through 2029, citing a more sustainable cost base and its measured commercialization strategy.

Management also discussed resource realignment. Lindgardt said Sera had “realigned resources” and streamlined R&D and G&A functions, shifting capital away from R&D and clinical operations toward payer engagement, market access, and adoption-focused activities. She said these actions are expected to reduce base operating expenses by nearly $10 million annually, though Aerts noted the benefit in 2026 would be limited due to phasing and related charges, with most savings expected in 2027 and beyond.

During the Q&A, Lindgardt described the cadence of partner program launches as “roughly one a quarter,” emphasizing the operational work required to stand up programs, including reimbursement discussions, provider onboarding, and workflow integration for both testing and the intervention bundle. She also said the payer engagement pipeline expanded from “10 payers in 13 states” previously to 13 payers in 15 states, as payer organizations introduce Sera to other regions.

Asked about sales productivity metrics, Lindgardt said management tracks “the number of tests per month per rep,” adding that the company is seeing metrics “move” but wants to observe steadier internal progress before publicly reporting those metrics.

On volumes, Lindgardt said an analyst’s characterization of “low single-digit thousand” test volumes in 2026 was “not unreasonable,” while reiterating that Sera does not currently report order volume.

Discussing timing for Medicaid coverage decisions, Lindgardt described an estimated “about two years” decision timeline for a specific state program, with variability depending on data collection and administrative complexity. She said the company expects to bring program results toward a decision point beginning in 2027.

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.

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