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DATE

Wednesday, May 6, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • President and Chief Executive Officer — Zhenya Lindgardt
  • Chief Financial Officer — Austin Eretz

TAKEAWAYS

  • Revenue -- $14 thousand, declining from $38 thousand, attributed to "the timing and nature of Sera Prognostics (SERA 3.72%)'s geographically targeted commercialization strategy."
  • Operating Expenses -- $9.4 million, a slight increase from $9.3 million.
  • R&D Expenses -- $3 million, decreasing from $3.3 million as resources shift from clinical studies to commercialization efforts.
  • Selling, General, and Administrative Expenses -- $6.3 million, compared to $5.9 million, reflecting increases tied to commercial initiatives and strategic hiring.
  • Net Loss -- $8.4 million, versus $8.2 million previously.
  • Cash, Cash Equivalents, and Available-for-Sale Securities -- $86.8 million as of March 31, 2026.
  • Annualized Operating Expense Reduction -- Management expects operating expenses to decrease by nearly $10 million annually, with most impact realized from 2027.
  • Commercial Program Launches -- Third partnership program launched, targeting over 350 providers in three states and expanding access to the PreTRM test.
  • Payer Engagement -- Active discussions now with 13 payers across 15 states, up from 10 payers in 13 states.
  • Cash Runway Guidance -- Management expects cash resources are "sufficient to fund our operating expenses and capital expenditure requirements through 2029."
  • Guideline, Regulatory, and Advocacy Milestones -- Submission of CE marking dossier in Europe remains on track for midyear; continued progress on U.S. advocacy, including physician and patient-led engagement with Medicaid programs.

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RISKS

  • Austin Eretz said, "revenue in 2026 could remain modest and uneven," indicating delays in revenue growth due to the time required for reimbursement-driven adoption and program implementation.

SUMMARY

During the call, management spotlighted a strategic pivot with capital deployment shifting from research and development to commercialization, immediately impacting expense focus and operating leverage. Executives announced steady expansion of the payer pipeline and highlighted a consistent plan to launch one commercial program per quarter to build reimbursement-access density. Company leadership confirmed ongoing multi-state Medicaid engagement and outlined grassroots advocacy initiatives involving physician and patient outreach to support broader coverage. European growth efforts were emphasized with CE marking dossier submission planned and stakeholder alignment reinforcing regional readiness. Management asserted the company's financial position, projecting sufficient cash to fully execute their adoption strategy through 2029 without seeking incremental capital.

  • Lindgardt said, "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," describing an integrated approach to commercial expansion.
  • Executives cited market feedback and PRIME study completion as rationales for realigning resource allocation from internal R&D to external partnership-driven development.
  • Management acknowledged that reporting test volume metrics will be deferred until internal data demonstrates consistent upward trends, noting that low single-digit thousand annual volume estimates are not unreasonable.
  • Lindgardt stated that successful program launches require about three months of execution per site to embed PreTRM testing and related workflow integration with providers and payers.

INDUSTRY GLOSSARY

  • PreTRM: A proprietary blood-based biomarker test developed by Sera Prognostics to assess the risk of spontaneous preterm birth in asymptomatic singleton pregnancies.
  • PRIME Study: A large, multi-year clinical trial sponsored by Sera Prognostics evaluating the clinical utility and outcomes of the PreTRM test in preterm birth risk management.
  • CE marking: A European Union regulatory certification indicating a product's compliance with EU safety, health, and environmental requirements, necessary for marketing medical devices in Europe.

Full Conference Call Transcript

Genya Lyngard, President and CEO, and Austin Eretz, 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 have not had a chance to review our quarterly earnings release, it can be found on our website at ferra.com. This call can be heard live via webcast at sarah.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 Zhenya Lindgardt.

Zhenya Lindgardt: Thank you, Jennifer, and thank you, everyone, for joining us today. Given that we reported full year results just over six weeks ago, I will focus my remarks on several key developments that continue to advance our commercial strategy and expand access to preterm. 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 healthcare 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 preterm’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 preterm 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 SheMD podcast featured an interview with Haley Bieber, discussing her pregnancy and the preterm test, which she received under the care of Doctor Aliyah Abadi, SheMD cohost, and Sarah Gaston. This generated a high level of awareness of preterm, given Haley's global visibility and social following, along with a subsequent People magazine exclusive interview. The episode surpassed half a million views and continues to drive awareness. Following that, we engaged with CMD 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 Prognostics, Inc., the clinical evidence from PRIME, and how the preterm test needs broad awareness and should be considered as future standard of care. The episode discusses Doctor Ali Abadi's experience with preterm 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's Hear From Her, the Women in Healthcare Leadership Podcast, engaging in conversation with podcast host Gilena Spiropoulos and Doctor Molly McDonald, the 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 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 preterm. This program is expected to reach over 350 providers across three states, expanding our clinical footprint and advancing earlier intervention for at-risk pregnancies.

Beyond these established programs, we are working 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 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 preterm. 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 fail 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 PREPARED 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 subanalyses 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 are 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 for 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 at-risk populations. To date, we have 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 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 our 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 twelve 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 have discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption.

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. With that, I will now turn the call over to Austin Eretz for the financial results.

Austin Eretz: Thanks, Zhenya, and good afternoon, everyone. Revenue for the quarter was $14 thousand compared to $38 thousand in 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 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 2025.

We ended 03/31/2026 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 Zhenya 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. We will now open the call for questions. Operator?

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 touch-tone 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.

Analyst: Hey, team. This is Lauren on for Tycho. A few from me. First, on the partner program, could we get a little bit of 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 that is going to look like for the next couple of quarters? And then second, for the new reps, I think you have 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 are targeting for the second half of the year for these reps? Thanks.

Zhenya Lindgardt: 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 can 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 have learned over the last couple of years that it takes a few months to iron out how the patients who test for 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—this is why one a quarter, roughly—and we are right on track with that with another launch this quarter.

We first select how the test will get paid for, engage on reimbursement, then with the payers 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 into their workflow and delivery of the intervention bundle. That is critical for fast recruitment and delivery of the test to the participant, which, of course, in turn gives the results to both payers and providers faster. It is in all of the partners' interests in these programs to prepare well so that we can get to revenue for us and impact faster for them. 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 is a fair bit of follow-up with other payers in the state that have the Medicaid plans, who are starting to also reach out and want to participate. We are excited to report that our pipeline of payers that we are engaged with is growing steadily from 10 payers in 13 states we reported last quarter to 13 payers in 15 states.

We are still sticking to our target states, but what we are seeing happen is the payers that we are 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 expanding with these payers into other regions. That is why we are pacing it one a quarter, roughly, and you can certainly anticipate us announcing one per quarter.

Of course, we will 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 we, with the payers, select large-volume institutions so that we can get the density of test ordering after we get reimbursement to go faster and the pull-through to pick up. For about once a quarter to give us three months to execute on the launch of the program. Does that answer the first part of your question?

Analyst: Yeah, that is helpful color. Thank you.

Zhenya Lindgardt: Perfect. And then the second question: of course, rep productivity is critical. Our chief commercial officer and our head of sales, that is exactly how they engage with Austin and me on our forecasting—on the number of reps and the number of tests per month per rep that is anticipated—so that we can goal the reps and drive toward steady progress. We are cautiously optimistic, but we want to watch it for another few quarters. We are seeing these metrics move. The question behind the question probably is when are you going to report on some of these metrics?

Let us see the steady progress on them internally first, and as soon as we see the steady up and up, we will start reporting on this.

Operator: Next question. Your next question comes from Dan Brennan from TD Cowen. Please go ahead.

Dan Brennan: Great. Thank you. Thanks for the questions. Maybe first one: you both talked about the shift to a more direct commercial effort, maybe pulling back some resources on the R&D side to extend the cash runway. What prompted the shift? It kind of makes sense logically, but I am just wondering if there is feedback in the market about timing, how long it is going to take, or if this is in discussion with the board. Just maybe a little color behind it.

Zhenya Lindgardt: Dan, thank you for the question. It is a very logical one. There are actually two root causes that drove that happening now. First, of course, as you know, the R&D and clinical operations efforts—both of these groups—were incredibly focused on PRIME, and that was a seven-year effort, if you can believe it, with very heavy resourcing devoted to that. As we are shifting towards now publishing as much as possible, with a couple of dozen publications in the pipeline from our data, we realized that we need less capacity specifically for our preterm birth product R&D and clinical operations capacity.

Of course, we have a pipeline of other products that we are working on, but we had inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests. What you are seeing as the first impetus is the less demand on R&D and clinical operations capacity internally, and the second one is the demand externally to continue developing the tests. As soon as we lock in these partnerships, we will communicate all of those to you.

You can imagine our R&D proteomics platform is a great asset, with a biobank of thousands and perhaps a couple of tens of thousands of samples, which will allow us to support other diagnostic and screening tests in pregnancy, perhaps also support therapeutics or screening for drug interventions in pregnancy. You can imagine that is a strategic move, as well as simply less demand internally for now until we pick up, in this collaborative model, on other assets. That is the answer on the R&D side. Does it help?

Dan Brennan: Yep. Yeah, that helps. Yep. No. Very logical. Maybe just a couple other quick ones. Just on the—previously, you talked about low single-digit thousand volumes this year. Is that still on track? Or how should we think about that?

Zhenya Lindgardt: Dan, I did not hear you quite well. A low single-digit—

Dan Brennan: Volumes for 2026. I think in the past—

Zhenya Lindgardt: I got you. Yeah. That is not unreasonable.

Dan Brennan: That is not unreasonable?

Zhenya Lindgardt: That is not unreasonable. As you know, we do not report the volume of orders, but it is certainly not an unreasonable number to be thinking about. Given your question, Dan, and our conversations, of course, as soon as we see steadiness we will start reporting on it. But yes, that assumption is not unreasonable.

Dan Brennan: Got it. And then maybe just on the first Medicaid program that began a little over a year ago—when can you see that program turn into a positive coverage decision, do you think?

Zhenya Lindgardt: Great question. I think when we announced it, I believe I even talked through the timeline. For that particular program, we believe it took us about six months to stand it up with EMR integration and all of the provider setup to provide care management for the patients. Actually, that set of collaborators are now piloting a tool with us that allows the providers to deliver care management a lot more efficiently with weekly symptom check tooling. We are looking forward to reporting on how that goes because that is something that will remove a significant barrier in terms of taking the OBGYN nursing capacity from the office for that care management.

So it took us six months to do that.