Strong cash runway and cost-reduction plan
Cash, cash equivalents and available-for-sale securities of $86.8 million at March 31, 2026; company expects to reduce base operating expenses by nearly $10 million annually, extending runway and management believes cash is sufficient to fund operations through 2029.
Commercial and payer engagement momentum
Launched a third partnership program in Q1 (now 2 live programs plus the new one) with plans to stand up ~one program per quarter; engaged in active discussions with 13 payers across 15 states (up from 10 payers in 13 states prior quarter), pursuing a focused market approach to drive implementation and pull-through.
Awareness and media traction
Broad media and outreach efforts including a SHE MD podcast episode featuring Hailey Bieber that surpassed 0.5 million views; additional targeted podcast and media appearances planned to drive patient and provider awareness and advocacy.
Scientific publications and evidence building
Full PRIME study published; European expert commentary published in the Journal of Maternal Fetal and Neonatal Medicine (March); PREPARE survey accepted for publication; multiple PRIME sub-analyses planned in 2026 including a health economic study and Medicaid outcomes to strengthen clinical and economic case for adoption.
Regulatory progress in Europe
On track for a midyear CE Marking dossier submission and constructive engagement with European regulators and clinical stakeholders, advancing commercialization readiness in Europe.
Strategic shift to commercialization
Company realigned resources from R&D/clinical operations toward commercialization, payer engagement and market access; R&D expense declined to $3.0 million in Q1 2026 (from $3.3 million in Q1 2025, ~9.1% decrease), reflecting transition toward revenue-driving activities.