Sera Prognostics, Inc. Q1 FY2026 Earnings Call

Ladies and gentlemen, welcome to Sera Prognostics' First Quarter 2026 Financial Results Conference Call. Please be advised that this call is being recorded today, Wednesday, May 6, 2026. I will now turn the call over to our first speaker today, Jennifer Zibuda, Investor Relations. Please go ahead.

Thank you, operator. Welcome to Sera Prognostics' First Quarter Fiscal Year 2026 Earnings Conference Call. At the close of market today, Sera Prognostics released its financial results for the quarter ended March 31, 2026. Presenting for the company today will be Evguenia Lindgardt, President and CEO; and Austin Aerts, our CFO. During the call, we will review the financial results we released today, after which we will host a question-and-answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at sera.com. This call can be heard live via webcast at sera.com, and a recording will be archived in the Investors section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results and market trends and opportunities. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from those expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward-looking statements. I will now turn the call over to Evguenia.

Thank you, Jennifer, and thank you, everyone, for joining us today. Given that we reported full year results just over six weeks ago, I'll focus my remarks on several key developments that continue to advance our commercial strategy and expand access to PreTRM. Following the publication of the full PRIME study results in January, our primary focus in the first quarter was building awareness with both clinicians and broader stakeholders. Our education and outreach efforts were designed to broaden understanding of preterm birth risk and prevention, including among audiences that are difficult to reach through traditional health care channels. From a provider engagement standpoint, we maintained a strong presence across key clinical forums, including the SMFM Annual Meeting in February, and more recently, the ACOG Annual Clinical and Scientific Meeting. At SMFM, we highlighted key clinical evidence and engaged directly with maternal fetal medicine specialists on PreTRM's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss PRIME study outcomes. At ACOG, we built on that momentum with a targeted product theater that showcased both the PRIME data and practical implementation strategies, underscoring how PreTRM can be seamlessly integrated into routine clinical care. We have been featured in several targeted podcasts this year, which complements our presence at medical meetings and extends our reach. In March, the SHE MD podcast featured an interview with Hailey Bieber discussing her pregnancy and the PreTRM test, which she received under the care of Dr. Aliabadi, SHE MD co-host and Sera's customer. This generated a high level of awareness of PreTRM, given Hailey's global visibility and social following along with a subsequent People magazine exclusive interview. The episode surpassed 0.5 million views and continues to drive awareness. Following that, we engaged SHE MD to record a new podcast episode releasing May 14 to coincide with National Women's Health Week. This interview will feature a conversation on the science behind Sera, the clinical evidence from PRIME and how the PreTRM test needs broad awareness and should be considered as a future standard of care. The episode discusses Dr. Aliabadi's experience with PreTRM tests over the last few years and the value of prevention and evidence-based risk identification. We hope you will all tune in next week. As we look ahead, we will also be featured on Medscape Hear From Her, the Women in Healthcare Leadership podcast, engaging in conversation with the podcast host, Jelena Spyropoulos and Dr. Mollie McDonald, Maternal & Fetal Medicine Specialist at St. David's Women's Center in Austin, Texas. The episode dives into the realities of preterm birth, the need for proper intervention and what can be done to help patients. Together, these media efforts continue to drive awareness across patients and providers, policymakers and payers who play an important role in improving pregnancy outcomes. Turning to our commercial progress. Our efforts during the quarter remained focused on building sustainable access points and referral pathways that 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 PreTRM. 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 base supporting PreTRM. 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 PreTRM approach with existing European health care 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 health care 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 economic 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. Preterm 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 PreTRM 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 midyear submission of our CE Marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisory 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 a 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 PreTRM. 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 are seeing and confident that the foundation we are laying will support meaningful long-term pull-through. With that, I'll turn the call over to Austin.

Thanks, Evguenia, 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 Evguenia 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.

Your question comes from Tycho Peterson from Jefferies.

This is Lauren on for Tycho. A few from me. First on the partner program: could we get a little more color on the profile of the third partner and how it compares to the first two? And then in terms of the required cadence throughout the rest of the year to hit the goal of five to seven partner programs, what will that look like for the next couple of quarters? Second, for the new reps, you've talked about before how it could take a couple of quarters to see density of adoption and increased productivity. Are you measuring anything in terms of tests per rep per month or other KPIs that you're targeting for the second half of the year for these reps?

Lauren, thank you so much for the questions. On the programs, indeed, very exciting. The way we planned our pipeline of potential programs is to launch roughly one a quarter to make sure that we swarm the organization and stand them up well. Each program typically is a combination of a payer and provider groups to ensure that the pull-through can happen on the ground in the offices quickly. We've learned over the last couple of years that it takes a few months to iron out how the patients who test as higher risk of preterm birth get cared for by the physician offices with the intervention bundle. So we make it as seamlessly integrated into the workflow of those offices as possible. For us, each of these programs— that's why one a quarter roughly — and we're right on track with that with another launch this quarter. We first select how the test will get paid for, engage on reimbursement with the payers, then figure out what is the set of providers that are going to partner with us to adopt the test and get them ready for seamless integration to their workflow and delivery of the intervention bundle. That is critical for fast recruitment and delivery of the test to the participant, which in turn gives the results to both payers and providers faster. So it's in all of the partners' interest in these programs to prepare well to get to revenue for us and impact for them faster. For many programs, we are engaged deeply with the state as well. On a quarterly basis, we report out the progress of the programs to the state Medicaid agencies, and these are usually public forums where other payers are present. Another reason why one a quarter is because there's a fair bit of follow-up with other payers in the state that have Medicaid plans who are starting to also reach out and want to participate. We're excited to report that our pipeline of payers that we're engaged with is growing steadily from 10 payers in 13 states, which we reported last quarter, to 13 payers in 15 states. We're still sticking to our target states. What we're seeing happen is the payers that we're running the program with now for six to nine months are introducing us to other parts of their organization that cover plans in other states, which is exactly what we were hoping for and expands these programs into other regions. So that's why we're pacing it roughly one a quarter, and you can certainly anticipate us announcing one per quarter. Of course, we'll go faster if we can go faster, but I described the activities so that you get a feel for what an undertaking it is to stand up these pretty substantial provider institutions who partner with us, obviously because, with the payers, we select large-volume institutions so that we can get density of test ordering after we get reimbursement to go faster and the pull-through to be clear. About once a quarter gives us three months to execute on the launch of the program. Does that answer the first part of your question?

Yes, that's helpful color.

Perfect. And then the second question, of course, rep productivity is critical. Our Chief Commercial Officer and our Head of Sales engage with Austin and me on forecasting the number of reps and the number of tests per month per rep that is anticipated so that we can size the reps and drive toward steady progress. We're cautiously optimistic, but we want to watch it for another few quarters. We are seeing these metrics move. The question behind the question is likely when we're going to report some of these metrics. Let us see steady progress on them internally first. As soon as we see sustained improvement, we will start reporting on them.

Your next question comes from Dan Brennan from TD Cowen.

Maybe first one: you both talked about the shift to a more direct commercial effort and pulling back some resources on the R&D side to extend the cash runway. What prompted the shift? Was this based on market feedback, timing expectations, or discussions with the Board? Any color would be helpful.

Dan, thank you for the question. There are two root causes that drove this shift now. First, the R&D and clinical operations efforts were incredibly focused on PRIME, which was a seven-year effort with heavy resourcing devoted to it. As we shift toward publishing as much as possible — we have a couple dozen publications in the pipeline from our data — we realized that we need less internal capacity specifically for PreTRM R&D and ClinOps. Second, we have inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests. Our proteomics platform and biobank of thousands, possibly tens of thousands, of samples is an asset that can support other diagnostic and screening tests in pregnancy and potentially support therapeutic screening for drug interventions in pregnancy. So part of the impetus is less internal demand on R&D and ClinOps right now and part is external demand to collaborate. As we lock in partnerships, we'll communicate those. So it's both a strategic move and a response to current capacity and external opportunity. Does that help?

Yes, that helps. Maybe just a couple other quick ones. You previously talked about low single-digit thousand volumes this year. Is that still on track? How should we think about volumes for 2026?

Dan, I didn't hear you quite well at first, but low single-digit thousands for 2026 is not unreasonable. We don't report order volume, but it's certainly not an unreasonable number to be thinking about. As soon as we see steadiness in volume metrics internally, we'll start reporting on them. For now, that assumption is not unreasonable.

Got it. And on the first Medicaid program that began a little over a year ago, when could that program potentially turn into a positive coverage decision?

Great question. When we announced it, I laid out the timeline for that particular program. It took about six months to stand up with EMR integration and provider setup to provide care management for patients. The collaborators are now piloting a digital tool with us that allows providers to deliver care management more efficiently with weekly symptom-check tooling, which should reduce OB/GYN nursing capacity constraints. For the timeline: it will take about nine to 12 months to fully recruit the program, about four to five months for patients to deliver on a rolling basis, then a couple of months to collect outcome data such as NICU admissions and infant weight. Then we take it to the state. The state is already engaged with us on what coverage would mean and why it is needed. We're mobilizing clinical advocates in that state and executing our letter writing campaign asking providers to write to the state Medicaid program to advocate for payment. The tactical timeline nets out to about two years to a decision for the state, with plus or minus a quarter or two. It could go faster or slower depending on data complexity — for example, in some states the baby is assigned to a different Medicaid plan at birth, which requires data matching. For that program, we expect probably beginning of 2027 to bring the decision and results. We'll report on that when available. Does that help?

Yes, that helps a lot.

There are no further questions at this time. I will now turn the call over to Evguenia Lindgardt, President and CEO. Please continue.

Thank you so much, operator. In summary, we're building the medical, reimbursement and advocacy foundations necessary for commercialization and guideline inclusion efforts, and the engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead. Thank you so much, everyone, for your time today, and we look forward to continuing to share our progress steadily each quarter.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.