PreTRM Trial Cuts Early Preterm Births 56%, Sera Extends Cash Runway to 2029
Sera Prognostics reported Q1 revenue of $14,000 (vs. $38,000), with expenses of $9.4 million and R&D spend of $3.0 million. Landmark PRIME trial showed PreTRM cut early preterm births by 56% (<32 weeks), NICU admissions by 20% and morbidity by 20%, and the company extended its cash runway to 2029.
1. First Quarter Results
Sera Prognostics posted first‐quarter revenue of $14,000 compared with $38,000 in the prior year period, while total operating expenses rose slightly to $9.4 million from $9.3 million. Research and development costs decreased to $3.0 million from $3.3 million as the company shifted resources toward commercial activities.
2. PRIME Trial Outcomes
The landmark PRIME randomized trial in 5,018 women demonstrated that the PreTRM test reduced early preterm births by 56% before 32 weeks and by 32% before 35 weeks. Additionally, NICU admissions and neonatal morbidity each declined by 20%, with one NICU day saved for every 4.2 patients screened.
3. Commercial and Regulatory Progress
Sera launched its third partnership program, reaching over 350 providers across three states, and is in active discussions with 13 payers in 15 states to expand reimbursement. In Europe, two peer-reviewed publications were accepted and the company is on track to submit its CE marking dossier by mid-year, supported by ongoing clinical validation.
4. Cash Runway Extension
A comprehensive business review redirected investment from clinical trials to commercialization, rightsizing the operating model. These measures extended the company’s cash runway through 2029, providing funding flexibility for key adoption and commercialization milestones.