5/6/2026

speaker
Xenia Lingard
President and CEO

we expect to support our long-term volume and revenue. Adding to our two live programs, we launched our third partnership program during the quarter, further expanding education and access to preterm. This program is expected to reach over 350 providers across three states, expanding our clinical footprint and advancing earlier identification and intervention for at-risk pregnancies. Beyond these established programs, we are contracting with additional partners and expect to provide more detail as these initiatives transition from contracting into live implementation. In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships with a focused set of target markets. We believe this concentrated approach is more effective in driving meaningful implementation and adoption than pursuing broader but less integrated engagement. Across all of these efforts, our priorities remain execution, reimbursement, physician awareness, clinical integration, and provider adoption. We view these steps as foundational to broader coverage and scale over time. In addition to reimbursement, we are making steady progress in our efforts to drive guideline inclusion while continuing to expand the evidence-based supporting preterms. As discussed in our year-end call, European expert commentary on the prime trial was published in the Journal of Maternal, Fetal, and Neonatal Medicine in March. The authors emphasized that current preterm birth prevention strategies failed to identify the majority of women who ultimately deliver preterm and highlighted the alignment of the preterm approach with existing European healthcare systems. Also in March, results from the PREPARE survey were accepted for publication in the Journal of Women's Health. This survey examined preterm birth awareness and risk perception among women across five European countries and identified a meaningful gap between perceived awareness and actionable understanding, reinforcing the need for earlier and more standardized risk communication. We look forward to the formal publication expected in May. Together, these publications support our stakeholder engagement efforts in Europe and underscore the global relevance of risk-based preterm birth prevention as healthcare systems increasingly emphasize prevention, education, and cost-effective maternal care. Looking ahead, we remain on track to publish several additional prime sub-analyses in 2026, including a highly anticipated health economics study, Medicaid population outcomes of the prime study, and a focused analysis of first-time moms further strengthening the clinical and economic foundation for adoption. During the quarter, we also continued to advance our advocacy strategy. Pre-term birth is not only a clinical challenge, but a public health and policy issue. We're engaging with stakeholders across multiple states to monitor and, where appropriate, support legislative initiatives and policy discussions focused on earlier identification and prevention, particularly in Medicaid and value-based care settings. We also recently launched a targeted letter-writing campaign designed to encourage physicians and patients to engage with state Medicaid programs on reimbursement for the preterm test. The initiative is intended to amplify, at the local level, the existing clinical voice calling for access for its risk populations. To date, we've seen encouraging participation, with multiple letters submitted across several states reflecting growing physician advocacy and awareness. We believe these grassroots efforts will play an important role in advancing broader coverage discussions over time. Through these efforts, we continue to build awareness and alignment well in advance of formal coverage decisions and to help policymakers understand both the clinical and the economic burden of preterm birth. We view advocacy as an important complement to our commercial and scientific strategies. In Europe, we continue to make progress towards commercialization readiness. We remain on track for a mid-year submission of our CE marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisor group continues to reinforce alignment around clinical utility, evidence requirements, and implementation considerations. On capital deployment, we have completed the next phase of our evolution from a clinical stage company to a commercial organization driven to secure reimbursement and revenue. Following comprehensive business review, We realigned resources, identified significant operational efficiencies, and streamlined R&D and G&A functions. We are prioritizing investments in payer engagement, market access, and clinical adoption of preterm. As part of this realignment, we are intentionally shifting capital away from R&D and clinical operations towards commercial and medical activities that directly support access and adoption. Over time, this results in a meaningfully higher proportion of our operating spend focused on commercialization and medical engagement, with R&D becoming a smaller share of our overall expense base as we move into 2027 and beyond. These actions are expected to reduce our base operating expenses by nearly 10 million annually, while enhancing our ability to focus capital on commercialization efforts. At this new operating level, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029. By extending our runway by an additional year, we have positioned the company to capitalize on meaningful growth expected over the next 12 months and to achieve key access and commercialization milestones in the years to come. To wrap up, the first quarter was characterized by awareness building and intentional positioning, expanding access points, strengthening referral pathways, advancing advocacy efforts, and continuing to build the scientific foundation necessary for long-term adoption. Everything we've discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption. And while these adoption cycles take time, we remain encouraged by the level of engagement we're seeing and confident that the foundation we're laying will support meaningful long-term pull through. With that, I'll turn the call over to Austin.

speaker
Austin
Chief Financial Officer

Thanks, Jenya, and good afternoon, everyone. Revenue for the quarter was $14,000 compared to $38,000 in the first quarter of 2025. As expected, revenue in the quarter remained modest, reflecting the timing and nature of our geographically targeted commercialization strategy and our ongoing effort to build advocacy and awareness following the prime publication. Operating expenses for the quarter were $9.4 million, up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in evidence generation, regulatory preparation, and advocacy activities. As discussed following our business review, we expect to reduce our operating expense base by nearly $10 million on an annualized basis. The benefit in 2026 will be limited due to the phasing of activities and related charges, with the majority of the savings expected to be realized in 2027 and beyond. Research and development expenses were $3.0 million compared to $3.3 million in 2025. With the prime study now published, R&D expenses will continue to decrease as we focus resources on activities that more directly drive commercialization and awareness building. Selling general and administrative expenses were $6.3 million versus $5.9 million in the prior year, reflecting our transition from clinical stage investments toward targeted commercial initiatives and strategic headcount. Net loss for the quarter was $8.4 million compared to a net loss of $8.2 million in the first quarter of 2025. We ended March 31, 2026 with $86.8 million in cash, cash equivalents, and available for sale securities. Based on our measured commercialization strategy and a more sustainable cost base resulting from the activities discussed earlier, we believe our capital resources will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As Jenny outlined, our strategy prioritizes building durable prerequisites for adoption. From a financial perspective, that means revenue in 2026 could remain modest and uneven as we continue pushing reimbursement, awareness and advocacy campaigns, and as programs move from setup to implementation, with increasing pull-through anticipated later in the year and into 2027. In summary, the first quarter reflects continued financial discipline alongside steady progress in laying the groundwork for broader adoption. We remain focused on execution as these initiatives mature. With that, let's open the line for questions. Operator?

speaker
Operator

Thank you, ladies and gentlemen. We will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. Please be advised to ask one question and one follow-up. Your question comes from Tycho Peterson from Jefferies. Please go ahead.

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