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Investor releaseQuarter not tagged2026-08-19Sera (SERA) Q2 2026 Earnings Call Transcript
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Sera (SERA) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 5 p.m. ET Head of Investor Relations - Jennifer Zibuda President and Chief Executive Officer - Evguenia Lindgardt Chief Financial Officer - Austin Aerts Operator: Good afternoon, ladies and gentlemen, and welcome to Sera Prognostics Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Wednesday, August 12, 2026. I would now like to turn the conference over to Jennifer Zibuda, Head of Investor Relations. Please go ahead. Jennifer Zibuda: Thank you, operator. Welcome to Sera Prognostics Second Quarter 2026 Earnings Conference Call. Earlier today, Sera reported financial results for the quarter ended June 30, 2026. Joining me on today's call are Zhenya Lindgardt, President and Chief Executive Officer; and Austin Aerts, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. A copy of today's earnings release can be found in the Investors section of our website at sera.com, and a replay of this webcast will also be available. Before we begin, please note that today's discussion will include projections or forward-looking statements around events and circumstances that have not yet occurred, including regarding our business, future financial results and performance and market opportunities. These statements are based on our current expectations and are subject to risk factors and uncertainties that could cause actual results to differ materially and adversely from these expectations and forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent Forms 10-K, 10-Q and 8-K for important information regarding these risk factors. With that, I will turn the call over to Zhenya. Evguenia Lindgardt: Thank you, Jennifer, and thanks to everyone for joining us this afternoon. The second quarter was marked by significant wins across key drivers of long-term adoption for PreTRM Test-guided care. During the quarter, we expanded commercial engagement through the launch of the fourth partnership program and increased payer activity across our target geographies. An important policy milestone was unlocked with Illinois Medicaid coverage legislation, which provides access to evidence-based preterm birth risk assessment for tens of thousands of Medicaid pregnancies…Read full documentShow less
Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 5 p.m. ET Head of Investor Relations - Jennifer Zibuda President and Chief Executive Officer - Evguenia Lindgardt Chief Financial Officer - Austin Aerts Operator: Good afternoon, ladies and gentlemen, and welcome to Sera Prognostics Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Wednesday, August 12, 2026. I would now like to turn the conference over to Jennifer Zibuda, Head of Investor Relations. Please go ahead. Jennifer Zibuda: Thank you, operator. Welcome to Sera Prognostics Second Quarter 2026 Earnings Conference Call. Earlier today, Sera reported financial results for the quarter ended June 30, 2026. Joining me on today's call are Zhenya Lindgardt, President and Chief Executive Officer; and Austin Aerts, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. A copy of today's earnings release can be found in the Investors section of our website at sera.com, and a replay of this webcast will also be available. Before we begin, please note that today's discussion will include projections or forward-looking statements around events and circumstances that have not yet occurred, including regarding our business, future financial results and performance and market opportunities. These statements are based on our current expectations and are subject to risk factors and uncertainties that could cause actual results to differ materially and adversely from these expectations and forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent Forms 10-K, 10-Q and 8-K for important information regarding these risk factors. With that, I will turn the call over to Zhenya. Evguenia Lindgardt: Thank you, Jennifer, and thanks to everyone for joining us this afternoon. The second quarter was marked by significant wins across key drivers of long-term adoption for PreTRM Test-guided care. During the quarter, we expanded commercial engagement through the launch of the fourth partnership program and increased payer activity across our target geographies. An important policy milestone was unlocked with Illinois Medicaid coverage legislation, which provides access to evidence-based preterm birth risk assessment for tens of thousands of Medicaid pregnancies annually. We also strengthened our clinical evidence base through publication of PRIME data in first-time mothers, demonstrating significant reductions in NICU admissions and severe neonatal morbidity reductions, while continuing to advance our European regulatory, and commercialization efforts. Taken together, these achievements reflect increasing alignment among stakeholders around the potential value of PreTRM Test-guided care and reinforce our confidence in the long-term opportunity ahead. We continue to expand payer discussions across the country as we execute our geographically focused commercialization strategy. Opportunities to expand access are being driven through engagements with payers, state agencies and legislators in markets where maternal health outcomes, Medicaid priorities and policy momentum create favorable conditions for converting market access into adoption. These conversations increasingly center not only on the clinical benefits of earlier risk identification, but also on the potential to improve outcomes, reduce the economic burden of preterm birth and support broader health care affordability initiatives. Illinois provides an excellent example of the effectiveness of our commercialization strategy. Illinois was not originally included in the states supporting our payer engagement objectives for 2026, yet through increased awareness among providers, policymakers, maternal health advocates and payers the state emerged as one of the most active opportunities in our pipeline. While many stakeholders contributed to the legislative outcome, we believe growing recognition of preterm birth as a significant public health challenge and increased awareness of evidence-based solutions like PreTRM Test helped create the momentum that led to statewide Medicaid coverage legislation. Importantly, this illustrates how our strategy extends beyond traditional payer contracting. By combining evidence generation, policy engagement, provider advocacy and awareness building activities, we're cultivating an ecosystem from which the conditions necessary for broader market utilization can organically emerge. We're also advancing discussions around innovative implementation models designed to integrate PreTRM Test-guided care within existing maternal health programs. This month, we launched our fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer. The program is intended to support quality improvement and maternal health objectives through a value-added benefits framework. Importantly, we remain on track towards our goal of establishing 5 to 7 commercial programs as we continue to expand our footprint in targeted geographies. At the beginning of the year, we set a goal of doubling the number of payer discussions across 15 to 17 states during 2026. We're pleased to report that we have exceeded that objective and are currently engaged with more than 20 payer opportunities across over 20 states. Importantly, this expansion into new opportunities is driven through payer referrals and growing market awareness, leading existing payer contacts to introduce us to affiliated plans and decision-makers in other states and expanding our pipeline more rapidly than anticipated. We believe this reflects broader acceptance of both the clinical value and health economic impact of PreTRM Test-guided care and reinforces the effectiveness of our focused commercialization strategy. As we move through the second half of the year, our emphasis will shift from initiating new conversations to advancing implementation, reimbursement readiness and adoption within our highest priority opportunities. We believe the market access progress achieved this year has significantly expanded our commercialization pipeline. Today, our opportunities broadly fall into 3 categories: payer engagement and evaluation, implementation preparation and contracting, and continued provider activation in markets where access has already been secured. Each of these 3 stages represents a step forward in converting access into clinical uptake and testing volume increase. In many cases, opportunities that have secured access enter an implementation and contracting period that can take approximately 6 to 9 months before utilization begins to scale. As opportunities progress through this commercialization pathway, our focus shifts from securing access to driving utilization. Through provider onboarding, workflow integration, champion development and targeted awareness initiatives, we're building a repeatable model designed to translate market access into testing volume and revenue growth over time. We believe the breadth and maturity of our pipeline position many of these opportunities to contribute meaningfully as we progress towards early 2027. One of the most significant developments during the quarter was the passage of landmark legislation in Illinois. The new law requires the state's Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage the risk of spontaneous preterm birth, along with associated care management services and interventions that have demonstrated improved outcomes. We believe the legislation represents an important milestone for maternal health care and validates that earlier identification and management of preterm birth risk can improve outcomes while addressing significant health care costs. We have already begun engagement with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations and provider stakeholders across the state. Over the coming quarters, we will work towards contracting, credentialing, provider education, workflow integration and implementation readiness. With coverage established, attention turns to execution. Illinois is now progressing through the next phase of our commercialization playbook, which we refer to as implementation readiness and contracting. We are advancing contracting and provider onboarding activities to support integration of PreTRM Test-guided care across both Medicaid and commercially insured populations eligible for testing. As the first state to formally recognize the clinical and health economic value of PreTRM Test-guided care, we believe Illinois can serve as a blueprint for similar initiatives nationwide. Evidence generation remains the cornerstone of our strategy, and we continue to strengthen our already substantial body of clinical and economic data supporting PreTRM guided care. In July, we published a prime subgroup analysis focused on first-time mothers, a population for which traditional risk assessment tools have limited predictive value. The findings demonstrated a 22% reduction in NICU admissions, a twofold reduction among newborns following spontaneous preterm birth and a 30% reduction in severe composite neonatal morbidity. The study also showed a number needed to screen and treat of just 28 patients to prevent 1 NICU admission. First-time mothers account for approximately 40% of pregnancies in the United States, making this an important population for broader adoption of biology-based risk assessment. We also remain on track for publication of our health economics analysis in the coming months. This work will further quantify the economic impact of PreTRM Test-guided care and will be an important component of payer and reimbursement discussions. We were also pleased that 2 PRIME-related abstracts were accepted for presentation at the Society for Maternal-Fetal Medicine Global Congress in October. One abstract was selected as an oral presentation and focuses on outcome in first-time mothers. The second was recognized among the top poster presentations and highlights the economic impact of screen guided interventions using our biomarker platform. These selections represent important external validation from the maternal fetal medicine community, and reflects growing recognition of both the clinical and economic value demonstrated in the PRIME trial. Importantly, our pathway towards future guideline inclusion remains straightforward. continue publishing high-quality evidence, expand collaboration with a broader network of key opinion leaders who are exploring the PRIME data set and generate new clinical and economic publications that further strengthen the evidence supporting PreTRM Test-guided care. Another highlight this quarter was the start of an ARPA-H-supported collaboration, which provides important validation of our scientific platform and biomarker discovery capabilities. The multi-institutional program is focused on developing a novel point-of-care diagnostic to help clinicians assess fetal hypoxia risk during labor and delivery, with Sera contributing its expertise in protein biomarker discovery and validation. More broadly, partnerships, grants and collaborative research programs are an important component of our innovation strategy. These relationships allow us to advance our pipeline, expand our scientific leadership position and pursue new opportunities with limited incremental investment from Sera, while maintaining our primary focus on the successful commercialization of PreTRM Test-guided care. We believe this collaborative approach enables us to create long-term pipeline value without diverting material resources from our core commercial priorities. Building awareness is a critical pillar of our commercialization strategy. In Q2, we advanced our thought leadership and educational initiatives with an on-demand webinar titled, Improving Outcomes of Preterm Birth, featuring Dr. Tiffany Inglis, and PRIME lead investigator, Dr. Brian Iriye. We also participated in a Medscape Hear From Her podcast, featuring our team and PRIME investigator, Dr. Mollie McDonnold. Importantly, we continue to execute these initiatives with a disciplined approach to spending, leveraging scalable digital platforms and third-party partnerships to maximize reach and impact. We also scaled digital and social engagement to reach patients, providers and maternal health advocates. Here's why this matters to our broader strategy. Preterm birth is one of the most common serious pregnancy complications, yet most women remain unaware of it until it affects them personally. Over the course of a pregnancy, women spend roughly 200x more time on social media than with their provider. That's where awareness can begin. When patients learn to ask about preterm birth risk, they raise it with their OB/GYN, and this is one of the ways that physician behavior can follow. Our consumer efforts reinforce rather than compete with our provider and payer strategies. Similar approaches have proven effective across diagnostics and health care innovation, helping drive awareness, access and ultimately the adoption of evidence-based care. While still early, the initiatives in Illinois, partnerships with providers and payers and the education and awareness for patients and providers are demonstrating their potential to accelerate provider integration into clinical practice and payer coverage, driving improved access is a fully integrated part of our commercialization strategy. Our European strategy also advanced during this quarter. European expert commentary supporting the role of biomarker-based risk prediction and biology-driven prevention strategies was published, and we convened a European expert advisory board representing 9 countries. Participants recognized the PreTRM Test as the first validated risk prediction tool for expectant mothers and affirmed the potential role of biology-driven prevention strategies across European health care systems. To support the strongest possible regulatory submission, we have elected to complete additional performance testing in our ELISA-based assay platform, a decision we believe strengthens the overall package while reducing execution risk. We expect pre-application activities to commence in the third quarter with submission of our full CE marking package to conclude in the fourth quarter of this year. Finally, we continued strengthening our leadership team and governance structure. During this quarter, we added key leadership capabilities in marketing and payer strategy while also welcoming Mark Capone to our Board. These additions further enhance our ability to execute against our commercial and strategic priorities. In summary, the second quarter demonstrated meaningful progress across the key drivers of market uptake. We expanded payer engagement, saw an important Medicaid policy milestone in Illinois, strengthened our clinical evidence base, advanced our European strategy and continued building awareness among providers and patients. While we remain in the early stages of commercialization, we believe these achievements further strengthen the foundation for future adoption and long-term growth. With that, I'll turn the call over to Austin to review our second quarter financial results. Austin Aerts: Thanks, Zhenya, and good afternoon, everyone. Revenue for the quarter was $30,000 compared to $17,000 in the second 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. Importantly, though, we are encouraged by the traction we see across the business. Since publication of the PRIME study earlier this year, testing volumes have increased steadily month-to-month, reflecting growing provider awareness and engagement. Operating expenses for the quarter were $10 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. Research and development expenses were $3.5 million compared to $3.3 million in 2025, reflecting restructuring-related costs. We do expect R&D spending to decline in future periods as we continue to focus resources on our commercialization efforts. Selling, general and administrative expenses were $6.5 million versus $6.0 million in the prior year, reflecting investments in targeted commercial activities, marketing programs and strategic commercial hires. Net loss for the quarter was $9.1 million compared to a net loss of $8.0 million in the second quarter of 2025. We ended June 30, 2026, with $80.3 million in cash, cash equivalents and available-for-sale securities, which we believe will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As we continue to build the foundational elements necessary for broad adoption, including reimbursement progress, clinical validation and commercial execution, and with testing volumes continuing to increase, we believe the company is entering the second half of the year with strong momentum and a solid financial position. With that, operator, let's open the line for questions. Operator: [Operator Instructions] First question comes from Tycho Peterson from Jefferies. Unknown Analyst: This is Lauren on for Tycho. Congrats again on securing Illinois in the quarter. Maybe just one question around that. Like what are the specific steps to move from provider notice to active reimbursement for individual claims and kind of what that ramp looks like? And then given your presence in first wave states, which of these geographies is likely to follow the Illinois mandate? And then I have a follow-up. Evguenia Lindgardt: Wonderful. Good to hear your voice, Lauren. Thank you for the question. It's a great opportunity for me to recap on the important sequence of steps that need to be put in place in order to start driving meaningful utilization and volume in any state where we secure access. So first steps have to do with provider registration in the state and getting into network with the payers. Step #2 is understanding the end contracting with all of the payers present. Specifically in Illinois, there are 5 plans. And you can imagine it will take significant effort to reach out and contract in parallel with the 5 payers on all of the Medicaid population in the state. While the first step, the registration and getting provider ID in the state might take from a couple of months up to a year, and we have started it across many states. The contracting timeline is a little bit tighter. So instead of a couple of months to a year, it's typically 6 to 9 months for the step #2, actual contracting for reimbursement with all of the payers. And then the third is provider activation and reaching out sometimes alongside the payer to ensure all of the providers are on board that we activate the champions to educate the provider community since a lot of OB/GYNs are affiliated with hospitals, we typically focus on major institutions who hold MFM opinion leaders among their staff and work with them to have events and programs to ensure quick OB/GYN onboarding and test and intervention bundle adoption. So these 3 steps are typical to convert access like what we've achieved in Illinois to actual meaningful volume. So that's your -- the first half of the question. Second half is in which other states are likely to follow. There are several other states we believe are close and have prioritized preterm birth as one of their health care priorities to focus on in their communities that allocate health care budget towards such priorities. The time line here is different, though, state by state. So while some states may have prioritized the preterm birth reimbursement higher, their legislative session does not start for another few months. So what I promise we will do is provide greater transparency as we see public signals from the states that they are moving through evaluation and decision-making on reimbursing preterm test and funding preterm prevention priorities in their state. Unknown Analyst: Great. That was helpful color. And then just the second one around the SMFM meeting in October. I guess, how will your presence and the nature of your conversations differ this year versus last year now that PRIME and some of the sub-analyses are out there? Evguenia Lindgardt: Thank you for the question. So first of all, the dialogue and the depth of dialogue and the tenor of the dialogue has shifted dramatically. With the PRIME data out there, we went from communicating the basics of clinical utility and the major endpoint results into much deeper conversations around the biology, the literature expectation of all of the biomarker pathways and how PRIME study and the 2 studies AVERT and PREVENT before the PRIME study came out, showed the same results and very much validated what literature expected SHBG and IBP4 biomarkers to show. And what this signals to me is that the clinical community very quickly passed through the -- does this test work? Into, of course, it works because it validates a lot of what literature said about these 2 biomarkers before and starting to ask questions on what other conditions does the test enrich for. So a lot of our discussions with opinion leaders are starting to focus on those topics. And that's actually tremendously exciting because it confirms that the validation stage and the convincing stage is almost over, and now we're moving towards the acceptance and implementation and adoption question. Does that help? Operator: Your next question comes from Daniel Brennan from TD Cowen. Daniel Brennan: Maybe first one, just on the 4 programs that you've signed, could you just remind us about across the programs, how we should think about those developing, meaning like what are the program directors looking for when will you share info and then what happens at the end of the program? Like what would be a success? Evguenia Lindgardt: Great. Dan, thank you so much for the question. Different program directors and typically, we work directly with the Chief Medical Officers for either the plan or the state or employer or provider network for these programs. And their goals typically differ in size and scope, but they typically have to do with showing that we're able to replicate the tremendously successful outcomes from our clinical trials in real life in their patient population. That's very typical. And with this latest program that just launched, it's very typical. This national payer took the quality metrics that they're accountable for to the state and knowing that PreTRM Test has the opportunity to impact their achievement. would like to see in the program population us moving the needle on those metrics. And the spectrum of flavors that these programs take may include value-based care. Some partners look at what will be the outcomes and how much value is created and others really focus on just clinical outcomes. Does this help? Operator: Yes. That's good. Maybe back to the first question in terms of -- I know Austin was talking a lot about as you guys migrate your focus maybe towards more -- start to think about more execution, delivery of volumes. But from the first question, obviously, on the Illinois, given the steps that have to occur in terms of activation outreach and whatnot, it sounds like really the impact there could be more '28 than '27, it feels like. So correct me if I'm wrong there. But assuming it's more '28 when everything is in place, could you walk us through like you talked about 50,000 eligible births in the press release, like over the first, say, 3 years, I mean, is 10%, 15%? Like what's the way you think about when everything is set in Illinois, like how you might be able to ramp that 50,000 opportunity? Evguenia Lindgardt: Great question, Dan, and thank you for cutting right to the chase on penetration percentages, which we often think about internally, how quickly can we ramp those. We -- so using the steps that I described in the conversation in the question earlier, we are in the midst of contracting with payers. So that is step number one. In parallel, of course, engaging with all the providers to educate them and running awareness campaigns. So that is step number one. But I would say from July 1, when reimbursement took place, and we ramped our team immediately on the ground, do take the first 6 months for the contracting, and if I can call it, awareness building. So I do not expect a ton of penetration of these 50,000 Medicaid lives in 2026. Then when we looked at the benchmarks of how other leading diagnostic and screening tests performed as far as penetration in years 1, 2 and 3 post access, we learned that 1% or 2% is good, 2% to 3% is outstanding and 5% is frequently not achieved until year 3. So we'd like to outperform -- but I would imagine that following that benchmark is at the least we are aiming to achieve. So if we look at 2027 as full year 1, looking at the single-digit percentage points would be prudent, so 1% to 2% penetration following year, let's say, 2% to 3%, 2% to 4% and growing that to 5% in year 3 would be commensurate with the benchmarks we've seen. But of course, we'll keep you posted and talk a lot about how Illinois is going because that trajectory and that ramp will show you what we can do in other states once access is achieved there. Does this help? Daniel Brennan: Yes. No, that's great. And maybe I'll just ask one more. So the engagement with 20 payers across 20 states, like what's the -- how do we think about the path there for converting those opportunities in reimbursement? Evguenia Lindgardt: Yes. So I mentioned that engagement follows a pretty typical pathway after the introductory call and getting everybody familiar with the data. The second step usually is the triage on the payer side. Are they going to put us through their policy review? Are they going to take a path of thinking about a program together in any particular geography or exploration of a value-based arrangement or a conversation around partnering with one of their customers, let's say, an employer or a provider. So with these 20 payers plus across 20-plus states, the segments fall into these 3 categories. There is a swath of payers where we are being taken through the policy review process. With national payers, the process typically takes 9 to 12 months. None of the payers make it transparent how long their policy review process takes. But typically, once that process concludes, there is a definitive decision for now on where does our product fall in their reimbursement schedule. The second segment is where they chose to let's do something together like you, Sarah are doing in XYZ state with such and such payer. We would like to do something similar. So we're discussing which states, which geographies would be valuable to them. And payers typically look at both where the need is the highest for the patients, where the cost of care is the highest and where they have an opportunity to win new business. So specifically on Medicaid, they're looking to achieve quality metrics required by Medicaid, leveraging the test. And we've got quite a few payers thinking about which locations we might want to run a program or they might want to implement the test first. And third set of payers, the engagement is around, okay, well, let's look for a set of customers that would be excited to implement this or a set of providers where the implementation could take place efficiently and they could see real time how quickly we're able to drive results. So if that helps, that's a quick segmentation for lack of a better term of the landscape of payer engagement across the states. Operator: Next question comes from Bill Bonello from Craig-Hallum. William Bonello: Just a question on any updated thoughts in terms of guidelines? Evguenia Lindgardt: Bill, thank you for the question. We are working diligently on the strategy we laid out in our previous calls, namely, as you know, ACOG and SMFM are facing a long list of priorities of topics that need guideline updates, and they prioritize the topics that need to be updated based on the literature that has come out recently with new information that may change the guidelines. So both societies advised us to publish, publish, publish. That's why we've doubled down, not let up after PRIME publication, but doubled down and increased our resources to look at the PRIME data set, expand the set of opinion leaders to engage them to look at our PRIME data set together and continue publishing as much as we possibly can in the near future. And that's why we were highlighting the publication of sub-analysis on the first-time moms -- this is exactly the kind of activity that ensures that the bulletin 2,3,4, which is where update of the guidelines will be most immediate for us is on our priority list and the community received incredibly warmly the analyses that we are conducting. And we've got a pipeline of another half a dozen that will come out in the coming year or 2. So that is the biggest update. We are executing on the ask from both societies to mine the treasure trove of the PRIME data set and publish as much as possible about the PreTRM Test effectiveness to put it out into the community so that data can be included in the guidelines review when the time comes. William Bonello: That's helpful. And then just in terms of the oral presentation upcoming at the SMFM, what -- is that going to be new data that above and beyond what was published in July? Or is the presentation essentially of a recap of what was published? Evguenia Lindgardt: It's data that was published, indeed, the new data that just came out. Operator: And your next question comes from Matt Larew from Blair -- William Blair. Matthew Larew: Just one for me, which is on CE Marking. Things targeting fourth quarter now or I guess, by year-end for submission versus midyear. I think you mentioned some additional data that was asked for. Just kind of curious, was that after convening the Advisory Board, was that data they suggested might augment your package? Or was it a feedback in terms of addressing any specific shortcomings in the package? Just kind of curious what led to that decision and if you're still -- I guess, kind of what the confidence is to get it by the end of the year? Evguenia Lindgardt: Thank you so much, Matt. No, it did not come out from the Advisory Board. It was our internal team's recommendation and actually it had to do with looking at the stability of the samples as they travel to the lab for analysis and a couple of other things. So to derisk execution, as I mentioned, it would be good to be extra sure given you've heard the heat waves, you've heard that we are pursuing ELISA, and there's a slightly different pathway in Europe that we're taking from the blood draw to the lab where it's analyzed. So that's been the driver, not the Advisory Board. We are working with great consultants, regulatory consultants and are very happy with all of the regulatory interactions and remain on track to get to our CE mark as soon as possible. Operator: [Operator Instructions] There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt for her closing remarks. Please continue. Evguenia Lindgardt: Thank you so much, everyone, for your time today. With growing market access, clinical evidence and encouraging commercial indicators, we believe the business is building meaningful momentum as we move through the second half of 2026, and we look forward to updating you on our progress in another quarter. Thank you so much. Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect your lines. Have a good day. Before you buy stock in Sera Prognostics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Sera Prognostics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Sera (SERA) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-13Sera Prognostics Inc (SERA) (Q2 2026) Earnings Call Highlights: Payer Momentum Builds with ...
GuruFocus.com
Sera Prognostics Inc (SERA) (Q2 2026) Earnings Call Highlights: Payer Momentum Builds with ...
This article first appeared on GuruFocus. Revenue: $30,000 for Q2 2026, compared to $17,000 in Q2 2025. Operating Expenses: $10 million for the quarter, up slightly from $9.3 million in the prior year period. R&D Expenses: $3.5 million, compared to $3.3 million in 2025, reflecting restructuring-related costs. SG&A Expenses: $6.5 million, versus $6.0 million in the prior year, reflecting investments in targeted commercial activities and marketing programs. Net Loss: $9.1 million for the quarter, compared to a net loss of $8.0 million in Q2 2025. Cash Position: $80.3 million in cash equivalents and available-for-sale securities as of June 30, 2026, expected to fund operations through 2029. Warning! GuruFocus has detected 5 Warning Signs with SERA. Is SERA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Sera Prognostics Inc (NASDAQ:SERA) achieved a major policy milestone with Illinois Medicaid coverage legislation, providing access to its preterm birth test for tens of thousands of pregnancies annually. The company exceeded its goal for payer engagement, now in discussions with more than 20 payers across over 20 states, driven by referrals and growing market awareness. A new subgroup analysis of the PRIME trial published in July showed a 22% reduction in NICU admissions and a 30% reduction in severe neonatal morbidity in first-time mothers. Sera Prognostics Inc (NASDAQ:SERA) launched its fourth partnership program with a national payer, expanding the implementation of its test-guided care and remaining on track to establish five to seven commercial programs. The company's cash position of $80.3 million is expected to fund operations through significant adoption and commercial milestones into 2029. Sera Prognostics Inc (NASDAQ:SERA) is advancing its European strategy, with a CE marking submission for its LISA-based assay platform expected in the fourth quarter of 2026. Revenue remains minimal at $30,000 for the quarter, reflecting the early stage of commercialization and the lengthy process of converting market access into testing volume. The timeline for meaningful revenue contribution from the Illinois Medicaid legislation is expected to be slow, with penetration rates of only 1-2% projected for the first full year. T…Read full documentShow less
This article first appeared on GuruFocus. Revenue: $30,000 for Q2 2026, compared to $17,000 in Q2 2025. Operating Expenses: $10 million for the quarter, up slightly from $9.3 million in the prior year period. R&D Expenses: $3.5 million, compared to $3.3 million in 2025, reflecting restructuring-related costs. SG&A Expenses: $6.5 million, versus $6.0 million in the prior year, reflecting investments in targeted commercial activities and marketing programs. Net Loss: $9.1 million for the quarter, compared to a net loss of $8.0 million in Q2 2025. Cash Position: $80.3 million in cash equivalents and available-for-sale securities as of June 30, 2026, expected to fund operations through 2029. Warning! GuruFocus has detected 5 Warning Signs with SERA. Is SERA fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Sera Prognostics Inc (NASDAQ:SERA) achieved a major policy milestone with Illinois Medicaid coverage legislation, providing access to its preterm birth test for tens of thousands of pregnancies annually. The company exceeded its goal for payer engagement, now in discussions with more than 20 payers across over 20 states, driven by referrals and growing market awareness. A new subgroup analysis of the PRIME trial published in July showed a 22% reduction in NICU admissions and a 30% reduction in severe neonatal morbidity in first-time mothers. Sera Prognostics Inc (NASDAQ:SERA) launched its fourth partnership program with a national payer, expanding the implementation of its test-guided care and remaining on track to establish five to seven commercial programs. The company's cash position of $80.3 million is expected to fund operations through significant adoption and commercial milestones into 2029. Sera Prognostics Inc (NASDAQ:SERA) is advancing its European strategy, with a CE marking submission for its LISA-based assay platform expected in the fourth quarter of 2026. Revenue remains minimal at $30,000 for the quarter, reflecting the early stage of commercialization and the lengthy process of converting market access into testing volume. The timeline for meaningful revenue contribution from the Illinois Medicaid legislation is expected to be slow, with penetration rates of only 1-2% projected for the first full year. The company's net loss widened to $9.1 million in Q2 2026, up from $8.0 million in the same period last year. The CE marking submission for Europe has been delayed to the fourth quarter of 2026 due to the need for additional performance testing, pushing back potential European market entry. The process of converting payer discussions into active contracts and reimbursement is lengthy, with policy reviews taking 9-12 months and implementation periods of 6-9 months before utilization scales. Sera Prognostics Inc (NASDAQ:SERA) faces a significant execution challenge in Illinois, requiring contracting with five separate managed Medicaid organizations and extensive provider onboarding before volumes can ramp. Q: What are the specific steps to move from provider notice to active reimbursement for individual claims in Illinois, and which geographies are likely to follow the Illinois mandate? A: Zhenya Lindgardt, President and CEO, outlined a three-step process: first, provider registration and getting in-network with payers, which can take from a couple of months up to a year; second, contracting with all payers present (five plans in Illinois), typically taking six to nine months; and third, provider activation and education, focusing on major institutions with MFM opinion leaders. She noted several other states have prioritized preterm birth as a healthcare focus, but timelines vary by state legislative sessions, and the company will provide transparency as public signals emerge. Q: Given the steps required for activation in Illinois, when might the impact be felt, and what is the expected penetration ramp for the 50,000 eligible births? A: Zhenya Lindgardt, President and CEO, stated that the first six months post-reimbursement (from July 1st) will focus on contracting and awareness building, so minimal penetration is expected in 2026. Based on benchmarks from other diagnostic tests, she projected 1-2% penetration in year one (2027), 2-4% in year two, and up to 5% in year three, noting the company aims to outperform these benchmarks. Q: How should we think about the development of the four partnership programs signed, and what would define success? A: Zhenya Lindgardt, President and CEO, explained that program directors (typically Chief Medical Officers) aim to replicate the successful outcomes from clinical trials in real-life patient populations. The latest program with a national payer focuses on quality metrics the payer is accountable for to the state. Programs vary in structure, with some focusing on value-based care and outcomes, while others focus purely on clinical outcomes. Q: With engagement across 20 payers in over 20 states, what is the path for converting these opportunities into reimbursement? A: Zhenya Lindgardt, President and CEO, segmented the payer engagement into three categories: (1) payers undergoing policy review, which typically takes 9-12 months for national payers and concludes with a definitive decision; (2) payers interested in launching partnership programs in specific geographies, particularly for Medicaid quality metrics; and (3) payers exploring implementation with specific customers or providers to demonstrate real-time results. Q: What are the updated thoughts on guideline inclusion, and will the upcoming SMFM oral presentation feature new data? A: Zhenya Lindgardt, President and CEO, stated the company is executing on advice from ACOG and SMFM to publish as much data as possible from the PRIME dataset, with a pipeline of additional analyses coming in the next year or two. Regarding the SMFM presentation, she confirmed it will feature the already-published data on first-time mothers, not new data. Q: What led to the decision to delay the CE marking submission to Q4, and was it related to feedback from the European advisory board? A: Zhenya Lindgardt, President and CEO, clarified the decision was internal, not from the advisory board. The delay is due to additional performance testing on the ELISA-based assay platform, specifically regarding sample stability during transport to the lab for analysis. This is intended to de-risk execution and strengthen the overall regulatory package, with the company remaining on track for submission by year-end. Q: How has the dialogue with the clinical community changed now that PRIME data is published, and what will the SMFM presence look like? A: Zhenya Lindgardt, President and CEO, noted the dialogue has shifted dramatically from basic clinical utility to deeper conversations about biology, biomarker pathways, and validation of SHBG and IBP-4 biomarkers. The clinical community has moved past "does this test work" to asking what other conditions the test enriches for, signaling a transition from validation to acceptance and implementation. Q: Can you provide more detail on the financial results for the quarter and the company's cash position? A: Austin Aerts, CFO, reported revenue of $30,000 for Q2 2026, up from $17,000 in Q2 2025. Operating expenses were $10 million, up slightly from $9.3 million, with R&D at $3.5 million and SG&A at $6.5 million. Net loss was $9.1 million, compared to $8.0 million in the prior year. The company ended with $80.3 million in cash, sufficient to fund operations through 2029. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-13Sera Prognostics, Inc. Q2 2026 Earnings Call Summary
Moby
Sera Prognostics, Inc. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured landmark Illinois Medicaid coverage legislation, validating the clinical and economic value of PreTRM Test-guided care for tens of thousands of annual pregnancies. Exceeded 2026 payer engagement goals by doubling discussions to over 20 opportunities across more than 20 states, driven largely by organic payer referrals and market awareness. Launched the fourth partnership program as a state-based initiative with a national payer, focusing on quality improvement and maternal health objectives through a value-added benefits framework. Strengthened the clinical evidence base with a PRIME subgroup analysis showing a 22% reduction in NICU admissions and a 30% reduction in severe neonatal morbidity for first-time mothers. Shifted commercial focus from initiating new conversations to advancing implementation readiness, reimbursement contracting, and provider activation in high-priority markets. Advanced the European strategy by convening a nine-country expert advisory board and electing to perform additional ELISA-based assay testing to de-risk the upcoming CE marking submission. Maintained a disciplined cost structure while investing in targeted commercial hires and marketing programs to support the transition from evidence generation to clinical uptake. Anticipates a 6 to 9-month implementation and contracting period for new market access wins before utilization and testing volumes begin to scale meaningfully. Targets the establishment of 5 to 7 total commercial programs in 2026 to expand the geographic footprint in high-priority maternal health markets. Expects to submit the full CE marking package for European regulatory approval in the fourth quarter of 2026 following pre-application activities in Q3. Projects that current cash reserves of $80.3 million will be sufficient to fund operations and reach significant adoption milestones through 2029. Focuses future guideline inclusion efforts on a 'publish, publish, publish' strategy, with approximately half a dozen additional PRIME data analyses planned for the coming year or two. Elected to delay the European CE marking submission from mid-year to Q4 to complete additional performance testing on sample stability and the ELISA platform. Reported a slight in…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Secured landmark Illinois Medicaid coverage legislation, validating the clinical and economic value of PreTRM Test-guided care for tens of thousands of annual pregnancies. Exceeded 2026 payer engagement goals by doubling discussions to over 20 opportunities across more than 20 states, driven largely by organic payer referrals and market awareness. Launched the fourth partnership program as a state-based initiative with a national payer, focusing on quality improvement and maternal health objectives through a value-added benefits framework. Strengthened the clinical evidence base with a PRIME subgroup analysis showing a 22% reduction in NICU admissions and a 30% reduction in severe neonatal morbidity for first-time mothers. Shifted commercial focus from initiating new conversations to advancing implementation readiness, reimbursement contracting, and provider activation in high-priority markets. Advanced the European strategy by convening a nine-country expert advisory board and electing to perform additional ELISA-based assay testing to de-risk the upcoming CE marking submission. Maintained a disciplined cost structure while investing in targeted commercial hires and marketing programs to support the transition from evidence generation to clinical uptake. Anticipates a 6 to 9-month implementation and contracting period for new market access wins before utilization and testing volumes begin to scale meaningfully. Targets the establishment of 5 to 7 total commercial programs in 2026 to expand the geographic footprint in high-priority maternal health markets. Expects to submit the full CE marking package for European regulatory approval in the fourth quarter of 2026 following pre-application activities in Q3. Projects that current cash reserves of $80.3 million will be sufficient to fund operations and reach significant adoption milestones through 2029. Focuses future guideline inclusion efforts on a 'publish, publish, publish' strategy, with approximately half a dozen additional PRIME data analyses planned for the coming year or two. Elected to delay the European CE marking submission from mid-year to Q4 to complete additional performance testing on sample stability and the ELISA platform. Reported a slight increase in operating expenses to $10 million, primarily due to restructuring-related costs and strategic investments in marketing and payer strategy leadership. Identified Illinois as a blueprint for future state-level initiatives, despite the state not being part of the original 2026 priority list, demonstrating the impact of organic policy momentum. Noted that R&D spending is expected to decline in future periods as resources are reallocated toward commercialization and market adoption efforts. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management outlined a three-step process: provider registration, contracting with five separate Medicaid plans (taking 6-9 months), and provider activation through hospital systems. Stated that 2026 will focus on contracting and awareness, with 2027 serving as 'Year 1' for meaningful volume penetration. Projected conservative penetration targets of 1% to 2% in the first year, growing to 5% by the third year, consistent with diagnostic industry benchmarks. Management noted the conversation with opinion leaders has moved past 'does the test work?' to deeper discussions on biomarker biology and implementation. The clinical community is now exploring what other conditions the test might enrich for, signaling a transition from validation to adoption. Engagement is segmented into three paths: formal policy reviews (typically 9-12 months), collaborative pilot programs, and targeted implementation with specific employers or providers. Payers are prioritizing geographies where maternal care costs are highest and where they need to meet specific Medicaid quality metrics. The decision to delay was internal rather than driven by advisory board feedback, focusing on ensuring sample stability during transport to the lab. Management emphasized that the extra testing is intended to 'de-risk execution' for the ELISA-based platform in the European market.
Investor releaseQuarter not tagged2026-08-13Sera Prognostics Q2 Earnings Call Highlights
MarketBeat
Sera Prognostics Q2 Earnings Call Highlights
Interested in Sera Prognostics, Inc.? Here are five stocks we like better. Revenue remained modest at $30,000 in Q2, up from $17,000 a year earlier, while the net loss widened to $9.1 million. Sera ended the quarter with $80.3 million in cash and said its capital should fund operations through major milestones into 2029. Illinois Medicaid implementation is underway following legislation requiring coverage of prescribed proteomic tests and related care management. However, registration and contracting may take months, with substantial penetration of the estimated 50,000 eligible pregnancies not expected until after 2026. Sera expanded its payer pipeline to more than 20 opportunities across over 20 states and continued advancing clinical and regulatory plans. The company reported favorable PRIME subgroup results, including reduced NICU admissions, and expects to submit its European CE-marking package in Q4 2026. Sera Prognostics (NASDAQ:SERA) reported modest second-quarter revenue while outlining progress in payer engagement, Illinois Medicaid policy, clinical evidence and European regulatory preparations for its PreTRM Test-guided care platform. Revenue for the quarter ended June 30 was $30,000, compared with $17,000 in the second quarter of 2025. Chief Financial Officer Austin Aerts said the revenue level reflected the timing of the company’s geographically focused commercialization strategy and its ongoing efforts to build awareness following publication of the PRIME study. He added that testing volumes have increased month to month since the study’s publication earlier this year. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The company reported a net loss of $9.1 million, compared with a net loss of $8 million a year earlier. Operating expenses rose to $10 million from $9.3 million. Research and development expense was $3.5 million, compared with $3.3 million in the prior-year period, while selling, general and administrative expense increased to $6.5 million from $6 million. Sera ended the quarter with $80.3 million in cash equivalents and available-for-sale securities. Aerts said the company believes its capital position will fund operations through significant adoption and commercial milestones through 2029. He also said R&D spending is expected to decline in future periods as Sera directs resources toward commercialization. → AST Spac…Read full documentShow less
Interested in Sera Prognostics, Inc.? Here are five stocks we like better. Revenue remained modest at $30,000 in Q2, up from $17,000 a year earlier, while the net loss widened to $9.1 million. Sera ended the quarter with $80.3 million in cash and said its capital should fund operations through major milestones into 2029. Illinois Medicaid implementation is underway following legislation requiring coverage of prescribed proteomic tests and related care management. However, registration and contracting may take months, with substantial penetration of the estimated 50,000 eligible pregnancies not expected until after 2026. Sera expanded its payer pipeline to more than 20 opportunities across over 20 states and continued advancing clinical and regulatory plans. The company reported favorable PRIME subgroup results, including reduced NICU admissions, and expects to submit its European CE-marking package in Q4 2026. Sera Prognostics (NASDAQ:SERA) reported modest second-quarter revenue while outlining progress in payer engagement, Illinois Medicaid policy, clinical evidence and European regulatory preparations for its PreTRM Test-guided care platform. Revenue for the quarter ended June 30 was $30,000, compared with $17,000 in the second quarter of 2025. Chief Financial Officer Austin Aerts said the revenue level reflected the timing of the company’s geographically focused commercialization strategy and its ongoing efforts to build awareness following publication of the PRIME study. He added that testing volumes have increased month to month since the study’s publication earlier this year. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The company reported a net loss of $9.1 million, compared with a net loss of $8 million a year earlier. Operating expenses rose to $10 million from $9.3 million. Research and development expense was $3.5 million, compared with $3.3 million in the prior-year period, while selling, general and administrative expense increased to $6.5 million from $6 million. Sera ended the quarter with $80.3 million in cash equivalents and available-for-sale securities. Aerts said the company believes its capital position will fund operations through significant adoption and commercial milestones through 2029. He also said R&D spending is expected to decline in future periods as Sera directs resources toward commercialization. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be President and Chief Executive Officer Zhenya Lindgardt highlighted Illinois legislation requiring the state Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage spontaneous preterm birth risk, along with associated care-management services and interventions that have demonstrated improved outcomes. Lindgardt said Sera has begun working with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations and providers. The company is pursuing contracting, credentialing, provider education, workflow integration and implementation readiness across eligible Medicaid and commercially insured populations. → First Solar’s Profit Engine Faces a New Policy Test in Washington During the question-and-answer session, Lindgardt described three primary steps from coverage to utilization: Registering as a provider in the state and obtaining in-network status with payers. Contracting with the state’s payers, including five Medicaid plans in Illinois. Activating providers through education, clinical champions and integration with major institutions and maternal-fetal medicine specialists. She said provider registration can take from several months to as long as a year, while payer contracting typically takes six to nine months. Sera does not expect substantial penetration of Illinois’ estimated 50,000 eligible Medicaid pregnancies during 2026. Looking to 2027 as a full first year following access, Lindgardt said a 1% to 2% penetration rate would be prudent based on benchmarks from other diagnostic and screening tests. She cited 2% to 4% penetration in a second year and approximately 5% in a third year as comparable benchmarks, while stating that Sera aims to outperform them. Sera said it launched its fourth partnership program during the quarter, a state-based initiative with a national payer designed to support quality improvement and maternal health objectives through a value-added benefits framework. The company remains on track toward its objective of establishing five to seven commercial programs. At the beginning of 2026, Sera had targeted doubling its payer discussions across 15 to 17 states. Lindgardt said the company has exceeded that goal and is now engaged in more than 20 payer opportunities across more than 20 states, aided by payer referrals and market awareness. Management said its payer opportunities fall into three broad groups: policy reviews, programs or value-based arrangements in selected geographies, and arrangements involving employer customers or provider groups. Lindgardt noted that national payer policy reviews typically take nine to 12 months, though individual payers do not publicly disclose their review timelines. The company said its focus in the second half of 2026 will shift toward implementation, reimbursement readiness and adoption among its highest-priority opportunities. Management said market-access initiatives can require roughly six to nine months of implementation and contracting before testing utilization begins to scale, and it expects many current opportunities could contribute more meaningfully as the company approaches early 2027. In July, Sera published a PRIME subgroup analysis focused on first-time mothers. According to Lindgardt, the analysis showed a 22% reduction in neonatal intensive care unit admissions, a twofold reduction in NICU admissions among newborns following spontaneous preterm birth, and a 30% reduction in severe composite neonatal morbidity. The study also reported a number needed to screen and treat of 28 to prevent one NICU admission. First-time mothers represent approximately 40% of U.S. pregnancies, the company said. Sera expects to publish a health economics analysis in the coming months to further quantify the economic impact of PreTRM Test-guided care. Two PRIME-related abstracts were accepted for presentation at the Society for Maternal-Fetal Medicine Global Congress in October. One, focused on first-time-mother outcomes, was selected for oral presentation. A second abstract on the economic impact of screen-guided interventions was selected among top poster presentations. Lindgardt clarified that the oral presentation will cover data already published in July rather than new data. Sera also began an ARPA-H-supported collaboration involving development of a point-of-care diagnostic intended to help clinicians assess fetal hypoxia risk during labor and delivery. The company is contributing protein biomarker discovery and validation capabilities to the multi-institutional program. In Europe, Sera convened an advisory board with experts representing nine countries and cited published European commentary supporting biomarker-based risk prediction and prevention approaches. The company said it elected to conduct additional performance testing on its ELISA-based assay platform before its CE-marking submission, including work related to sample stability during transport to the laboratory. Sera expects pre-application activities to begin in the third quarter and plans to submit its full CE-marking package in the fourth quarter. Sera Prognostics, Inc is a precision medicine company focused on improving pregnancy outcomes through proteomic testing. The company's flagship product, the PreTRM™ test, is a blood-based assay designed to assess a woman's risk of delivering prematurely by measuring specific protein biomarkers in maternal serum. By identifying patients at elevated risk for spontaneous preterm birth, Sera Prognostics aims to enable earlier interventions and tailored care plans that can reduce the incidence of neonatal complications associated with early delivery. Since its founding in 2014 and subsequent initial public offering in 2020, Sera Prognostics has worked closely with clinical research networks and obstetric care providers across the United States to validate the clinical performance of its PreTRM test. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Sera Prognostics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-12SERA PROGNOSTICS REPORTS SECOND QUARTER 2026 FINANCIAL RESULTS
PR Newswire
SERA PROGNOSTICS REPORTS SECOND QUARTER 2026 FINANCIAL RESULTS
SALT LAKE CITY, Aug. 12, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the second quarter ended June 30, 2026. Key Second Quarter and Recent Highlights: Advanced Commercial Adoption Strategy with Fourth Partnership Program Launch: In August 2026, we launched fourth partnership program, expanding implementation of PreTRM® Test-guided care through a state-based initiative with a national payer. We also exceeded our 2026 payer engagement objective, with active discussions now spanning more than 20 payer opportunities across over 20 states, and are increasingly focused on advancing implementation, reimbursement readiness, and adoption within priority markets. Illinois Medicaid Coverage Mandate Expands Access to PreTRM-Test: In June 2026, Illinois enacted legislation (Public Act 104-0470, Section 5-54) requiring Medicaid coverage and reimbursement for prescribed proteomic blood tests used to identify spontaneous preterm birth risk and associated interventions. In July, the Illinois Department of Healthcare and Family Services published a Provider Notice confirming the coverage of biomarker testing to include assessing risk of preterm birth in pregnant individuals. The Department also confirmed for providers that coverage applies to all Medicaid pregnancies in Illinois, representing approximately 50,000 annual Medicaid births. Scientific Recognition Highlights New Clinical and Economic PRIME Data: Two abstracts from the PRIME randomized controlled trial were accepted for presentation at the Society for Maternal-Fetal Medicine (SMFM) Global Congress 2026, reflecting continued external validation of our growing clinical evidence base. Advanced European Regulatory and Commercial Readiness: European expert commentary published supporting the role of biomarker-based risk prediction and biology-driven prevention strategies in addressing preterm birth, the convening of a European Expert Advisory Board representing nine countries, and completion of additional ELISA-based assay performance testing strengthened our CE marking submission package, with pre-application activities expected to commence in the third quarter and submission to conclude in the fourth quarter of 20…Read full documentShow less
SALT LAKE CITY, Aug. 12, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the second quarter ended June 30, 2026. Key Second Quarter and Recent Highlights: Advanced Commercial Adoption Strategy with Fourth Partnership Program Launch: In August 2026, we launched fourth partnership program, expanding implementation of PreTRM® Test-guided care through a state-based initiative with a national payer. We also exceeded our 2026 payer engagement objective, with active discussions now spanning more than 20 payer opportunities across over 20 states, and are increasingly focused on advancing implementation, reimbursement readiness, and adoption within priority markets. Illinois Medicaid Coverage Mandate Expands Access to PreTRM-Test: In June 2026, Illinois enacted legislation (Public Act 104-0470, Section 5-54) requiring Medicaid coverage and reimbursement for prescribed proteomic blood tests used to identify spontaneous preterm birth risk and associated interventions. In July, the Illinois Department of Healthcare and Family Services published a Provider Notice confirming the coverage of biomarker testing to include assessing risk of preterm birth in pregnant individuals. The Department also confirmed for providers that coverage applies to all Medicaid pregnancies in Illinois, representing approximately 50,000 annual Medicaid births. Scientific Recognition Highlights New Clinical and Economic PRIME Data: Two abstracts from the PRIME randomized controlled trial were accepted for presentation at the Society for Maternal-Fetal Medicine (SMFM) Global Congress 2026, reflecting continued external validation of our growing clinical evidence base. Advanced European Regulatory and Commercial Readiness: European expert commentary published supporting the role of biomarker-based risk prediction and biology-driven prevention strategies in addressing preterm birth, the convening of a European Expert Advisory Board representing nine countries, and completion of additional ELISA-based assay performance testing strengthened our CE marking submission package, with pre-application activities expected to commence in the third quarter and submission to conclude in the fourth quarter of 2026. Publication Demonstrates Clinical and Health Economic Value in First-Time Pregnancies: In July 2026, a PRIME study subgroup analysis was published in The Journal of Maternal-Fetal & Neonatal Medicine demonstrating that PreTRM test-guided care reduced NICU admissions by 22% among first-time mothers, including a two-fold reduction among newborns following spontaneous preterm birth, while reducing severe composite neonatal morbidity by 30%. The analysis also demonstrated strong screening efficiency, with only 28 first-time pregnancies needing to be screened and treated to prevent one NICU admission. Strengthened Leadership Team and Board to Support Commercial Growth: Expanded commercial leadership capabilities in marketing and payer and government strategy and appointed healthcare diagnostics veteran Mark Capone to the Board of Directors, adding deep expertise in diagnostics commercialization, reimbursement, and scaling innovative healthcare businesses. Maintained Strong Balance Sheet: Ended the quarter with approximately $80.3 million in cash, cash equivalents and available-for-sale securities that the Company believes will fund operations through significant adoption and commercialization milestones through 2029. "During the second quarter, we continued to build momentum across the key drivers of long-term adoption, including payer engagement, policy advancement, clinical evidence generation, and organizational strength," said Zhenya Lindgardt, President and Chief Executive Officer of Sera Prognostics. "The launch of our fourth partnership program, progress in payer engagement, the new Illinois Medicaid coverage law, the publication of compelling PRIME data in first-time mothers, and growing recognition from the maternal-fetal medicine community reinforce our belief that precision, biology-driven pregnancy care can improve outcomes for mothers and babies while creating meaningful value for healthcare systems. While we remain in the early stages of market development, we have been encouraged by the steady month-to-month increase in testing volume following publication of the PRIME study, which we believe reflects growing provider awareness and adoption." Second Quarter 2026 Financial Results Second quarter 2026 revenue was $30,000 compared to $17,000 for the second quarter of 2025. Total operating expenses were $10.0 million, compared to $9.3 million for the same period in 2025. Research and development expenses for the second quarter of 2026 were $3.5 million, compared to $3.3 million in the prior-year period, reflecting restructuring-related costs; R&D spending expected to decline in future periods. Selling, general and administrative expenses for the second quarter of 2026 were $6.5 million, compared to $6.0 million for the prior-year period, reflecting investments in commercial execution, marketing programs and strategic hires. Net loss for the quarter was $9.1 million, compared to $8.0 million for the second quarter of 2025. Conference Call Information Sera Prognostics will host a corresponding conference call and live webcast today to discuss second quarter 2026 financial results and recent business highlights at 5:00 p.m. Eastern Time. Individuals interested in listening to the conference call may do so by dialing the following: US domestic callers: (800) 836-8184 International callers: (646) 357-8785 Webcast Registration Link: https://app.webinar.net/O2ldBxvpPmE Live audio of the webcast will be available online from the Investors page of the Company's website at www.sera.com. The webcast will be archived on the Investors page and will be available for one year. About Sera Prognostics, Inc. Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah. About Preterm Birth Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, marking the longest stretch of the lowest grade in Report Card history. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016. About the PreTRM® Test The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM® Test is ordered by a medical professional. Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries. Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the date and time and content of the Company's quarterly earnings release and conference call; availability of the live audio of the conference call on the Company's website; advancing implementation, reimbursement readiness, and adoption within priority markets; approximately 50,000 annual Medicaid births in Illinois; presentation of two abstracts from the PRIME randomized controlled trial at the SMFM Global Congress 2026; submission of the Company's CE marking package in the fourth quarter of 2026; current cash funding operations through significant adoption and commercialization milestones through 2029; growing provider awareness and adoption; and the Company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. Contacts:Investor ContactJennifer Zibuda, Head of Investor [email protected]+1 (801) 396-8043 Media ContactNicole Kaplan at Allison [email protected]+1 (847) 721-6033 View original content to download multimedia:https://www.prnewswire.com/news-releases/sera-prognostics-reports-second-quarter-2026-financial-results-302848881.html
TranscriptFY2026 Q22026-08-12FY2026 Q2 earnings call transcript
Earnings source - 60 paragraphs
FY2026 Q2 earnings call transcript
Thank you, operator. Welcome to Sera Prognostics Q2 2026 Earnings Conference Call. Earlier today, Sera reported financial results for the quarter ended June 30, 2026. Joining me on today's call are Zhenya Lindgardt, President and Chief Executive Officer, and Austin Aerts, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. A copy of today's earnings release can be found in the Investors section of our website at sera.com, and a replay of this webcast will also be available. Before we begin, please note that today's discussion will include projections or forward-looking statements around events and circumstances that have not yet occurred, including regarding our business, future financial results and performance, and market opportunities.
These statements are based on our current expectations and are subject to risk factors and uncertainties that could cause actual results to differ materially and adversely from these expectations and forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent Forms 10-K, 10-Q, and 8-K, for important information regarding these risk factors. With that, I will turn the call over to Zhenya.
Thank you, Jennifer, and thanks to everyone for joining us this afternoon. Q2 was marked by significant wins across key drivers of long-term adoption for PreTRM Test-guided care. During the quarter, we expanded commercial engagements through the launch of the fourth partnership program and increased payer activity across our targeted geographies. An important policy milestone was unlocked with Illinois Medicaid coverage legislation, which provides access to evidence-based preterm birth risk assessment for tens of thousands of Medicaid pregnancies annually. We also strengthened our clinical evidence base through publication of PRIME data in first-time mothers, demonstrating significant reductions in NICU admissions and severe neonatal morbidity reductions while continuing to advance our European regulatory and commercialization efforts. Taken together, these achievements reflect increasing alignment among stakeholders around the potential value of PreTRM Test-guided care and reinforce our confidence in the long-term opportunity ahead.
We continue to expand payer discussions across the country as we execute our geographically focused commercialization strategy. Opportunities to expand access are being driven through engagement with payers, state agencies, and legislators in markets where maternal health outcomes, Medicaid priorities, and policy momentum create favorable conditions for converting market access into adoption. These conversations increasingly center not only on the clinical benefits of earlier risk identification, but also on the potential to improve outcomes, reduce the economic burden of preterm birth, and support broader healthcare affordability initiatives. Illinois provides an excellent example of the effectiveness of our commercialization strategy. Illinois was not originally included in the states supporting our payer engagement objectives for 2026. Yet, through increased awareness among providers, policymakers, maternal health advocates, and payers, the state emerged as one of the most active opportunities in our pipeline.
While many stakeholders contributed to the legislative outcome, we believe growing recognition of preterm birth as a significant public health challenge and increased awareness of evidence-based solutions like PreTRM Test help create the momentum that led to statewide Medicaid coverage legislation. Importantly, this illustrates how our strategy extends beyond traditional payer contracting. By combining evidence generation, policy engagement, provider advocacy, and awareness-building activities, we're cultivating an ecosystem from which the conditions necessary for broader market utilization can organically emerge. We're also advancing discussions around innovative implementation models designed to integrate PreTRM Test-guided care within existing maternal health programs. This month, we launched our fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer. The program is intended to support quality improvement and maternal health objectives through a value-added benefits framework.
Importantly, we remain on track towards our goal of establishing five to seven commercial programs as we continue to expand our footprint in targeted geographies. At the beginning of the year, we set a goal of doubling the number of payer discussions across 15 to 17 states during 2026. We're pleased to report that we have exceeded that objective and are currently engaged with more than 20 payer opportunities across over 20 states. Importantly, this expansion into new opportunities is driven through payer referrals and growing market awareness, leading existing payer contacts to introduce us to affiliated plans and decision-makers in other states and expanding our pipeline more rapidly than anticipated. We believe this reflects broader acceptance of both the clinical value and health economic impact of PreTRM Test-guided care and reinforces the effectiveness of our focused commercialization strategy.
As we move through the H2 of the year, our emphasis will shift from initiating new conversations to advancing implementation, reimbursement readiness, and adoption within our highest priority opportunities. We believe the market access progress achieved this year has significantly expanded our commercialization pipeline. Today, our opportunities broadly fall into three categories: payer engagement and evaluation, implementation preparation and contracting, and continued provider activation in markets where access has already been secured. Each of these three stages represents a step forward in converting access into clinical uptake and testing volume increase. In many cases, opportunities that have secured access enter an implementation and contracting period that can take approximately six to nine months before utilization begins to scale. As opportunities progress through this commercialization pathway, our focus shifts from securing access to driving utilization.
Through provider onboarding, workflow integration, champion development, and targeted awareness initiatives, we're building a repeatable model designed to translate market access into testing volume and revenue growth over time. We believe the breadth and maturity of our pipeline position many of these opportunities to contribute meaningfully as we progress towards early 2027. One of the most significant developments during the quarter was the passage of landmark legislation in Illinois. The new law requires the state's Medicaid program to provide coverage and reimbursement for prescribed proteomic blood tests used to identify and manage the risk of spontaneous preterm birth, along with associated care management services and interventions that have demonstrated improved outcomes. We believe the legislation represents an important milestone for maternal healthcare and validates that earlier identification and management of preterm birth risk can improve outcomes while addressing significant healthcare costs.
We have already begun engagement with the Illinois Department of Healthcare and Family Services, managed Medicaid organizations, and provider stakeholders across the state. Over the coming quarters, we will work towards contracting, credentialing, provider education, workflow integration, and implementation readiness. With coverage established, attention turns to execution. Illinois is now progressing through the next phase of our commercialization playbook, which we refer to as implementation readiness and contracting. We are advancing contracting and provider onboarding activities to support integration of PreTRM Test-guided care across both Medicaid and commercially insured populations eligible for testing.
As the first state to formally recognize the clinical and health economic value of PreTRM Test-guided care, we believe Illinois can serve as a blueprint for similar initiatives nationwide. Evidence generation remains the cornerstone of our strategy, and we continue to strengthen our already substantial body of clinical and economic data supporting PreTRM Test-guided care.
In July, we published a PRIME subgroup analysis focused on first-time mothers, a population for which traditional risk assessment tools have limited predictive value. The findings demonstrated a 22% reduction in NICU admissions, a twofold reduction among newborns following spontaneous preterm birth, and a 30% reduction in severe composite neonatal morbidity. The study also showed a number needed to screen and treat of just 28 patients to prevent one NICU admission. First-time mothers account for approximately 40% of pregnancies in the United States, making this an important population for broader adoption of biology-based risk assessment. We also remain on track for publication of our health economics analysis in the coming months. This work will further quantify the economic impact of PreTRM Test-guided care and will be an important component of payer and reimbursement discussions.
We were also pleased that two PRIME-related abstracts were accepted for presentation at the Society for Maternal-Fetal Medicine Global Congress in October. One abstract was selected as an oral presentation and focuses on outcomes in first-time mothers. The second was recognized among the top poster presentations and highlights the economic impact of screen-guided interventions using our biomarker platform. These selections represent important external validation from the maternal fetal medicine community and reflect growing recognition of both the clinical and economic value demonstrated in the PRIME trial. Importantly, our pathway towards future guideline inclusion remains straightforward. Continue publishing high-quality evidence, expand collaboration with a broader network of key opinion leaders who are exploring the PRIME dataset, and generate new clinical and economic publications that further strengthen the evidence supporting PreTRM Test-guided care.
Another highlight this quarter was the start of an ARPA-H supported collaboration, which provides important validation of our scientific platform and biomarker discovery capabilities. The multi-institutional program is focused on developing a novel point-of-care diagnostic to help clinicians assess fetal hypoxia risk during labor and delivery, with Sera contributing its expertise in protein biomarker discovery and validation. More broadly, partnerships, grants, and collaborative research programs are an important component of our innovation strategy. These relationships allow us to advance our pipeline, expand our scientific leadership position, and pursue new opportunities with limited incremental investment from Sera while maintaining our primary focus on the successful commercialization of PreTRM Test-guided care. We believe this collaborative approach enables us to create long-term pipeline value without diverting material resources from our core commercial priorities. Building awareness is a critical pillar of our commercialization strategy.
In Q2, we advanced our thought leadership and educational initiatives with an on-demand webinar titled Improving Outcomes of Preterm Birth, featuring Dr. Tiffany Inglis and PRIME lead investigator Dr. Brian Iriye. We also participated in a Medscape Hear from Her podcast featuring our team and PRIME investigator, Dr. Mollie McDonald. Importantly, we continue to execute these initiatives with a disciplined approach to spending, leveraging scalable digital platforms and third-party partnerships to maximize reach and impact. We also scaled digital and social engagement to reach patients, providers, and maternal health advocates. Here's why this matters to our broader strategy. Preterm birth is one of the most common serious pregnancy complications, yet most women remain unaware of it until it affects them personally. Over the course of a pregnancy, women spend roughly 200x more time on social media than with their provider. That's where awareness can begin.
When patients learn to ask about preterm birth risk, they raise it with their OB-GYN, and this is one of the ways that physician behavior can follow. Our consumer efforts reinforce rather than compete with our provider and payer strategies. Similar approaches have proven effective across diagnostics and healthcare innovation, helping drive awareness, access, and ultimately the adoption of evidence-based care. While still early, the initiatives in Illinois, partnerships with providers and payers, and the education and awareness for patients and providers are demonstrating their potential to accelerate provider integration into clinical practice and payer coverage. Driving improved access is a fully integrated part of our commercialization strategy. Our European strategy also advanced during this quarter. European expert commentary supporting the role of biomarker-based risk prediction and biology-driven prevention strategies was published, and we convened a European expert advisory board representing nine countries.
Participants recognized the PreTRM test as the first validated risk prediction tool for expectant mothers and affirmed the potential role of biology-driven prevention strategies across European healthcare systems. To support the strongest possible regulatory submission, we have elected to complete additional performance testing in our ELISA-based assay platform, a decision we believe strengthens the overall package while reducing execution risk. We expect pre-application activities to commence in the Q3, with submission of our full CE marking package to conclude in the Q4 of this year. Finally, we continued strengthening our leadership team and governance structure. During this quarter, we added key leadership capabilities in marketing and payer strategy, while also welcoming Mark Capone to our board. These additions further enhance our ability to execute against our commercial and strategic priorities. In summary, Q2 demonstrated meaningful progress across the key drivers of market uptake.
We expanded payer engagement, saw an important Medicaid policy milestone in Illinois, strengthened our clinical evidence base, advanced our European strategy, and continued building awareness among providers and patients. While we remain in the early stages of commercialization, we believe these achievements further strengthen the foundation for future adoption and long-term growth. With that, I'll turn the call over to Austin to review our Q2 financial results.
Thanks, Zhenya, and good afternoon, everyone. Revenue for the quarter was $30,000 compared to $17,000 in the Q2 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. Importantly, though, we are encouraged by the traction we see across the business. Since publication of the PRIME study earlier this year, testing volumes have increased steadily month-to-month, reflecting growing provider awareness and engagement. Operating expenses for the quarter were $10 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. Research and development expenses were $3.5 million compared to $3.3 million in 2025, reflecting restructuring related costs.
We do expect R&D spending to decline in future periods as we continue to focus resources on our commercialization efforts. Selling, general, and administrative expenses were $6.5 million versus $6.0 million in the prior year, reflecting investments in targeted commercial activities, marketing programs, and strategic commercial hires. Net loss for the quarter was $9.1 million, compared to a net loss of $8.0 million in the Q2 of 2025. We ended June 30, 2026, with $80.3 million in cash equivalents, and available-for-sale securities, which we believe will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As we continue to build the foundational elements necessary for broad adoption, including reimbursement progress, clinical validation, and commercial execution, and with testing volumes continuing to increase, we believe the company is entering the H2 of the year with strong momentum and a solid financial position.
With that, operator, let's open the line for questions.
Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have any question, please press the star followed by the 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 two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. First question comes from Tycho Peterson from Jefferies. Please go ahead.
Team, this is Lauren on for Tycho. Thanks for taking the question. Congrats again on securing Illinois in the quarter. Maybe just one question around that. What are the specific steps to move from provider notice to active reimbursement for individual claims and what that ramp looks like? Given your presence in first wave states, which of these geographies is likely to follow the Illinois mandate? Then I have a follow-up.
Good to hear your voice, Lauren. Thank you for the question. It's a great opportunity for me to recap on the important sequence of steps that need to be put in place in order to start driving meaningful utilization and volume in any state where we secure access. First steps have to do with provider registration in the state and getting into network with the payers.
Step number two is understanding and contracting with all of the payers present. Specifically in Illinois, there are five plans, and you can imagine it will take significant effort to reach out and contract in parallel with the five payers on all of the Medicaid population in the state. While the first step, the registration and getting provider ID in the state, might take from a couple of months up to a year, and we have started it across many states. The contracting timeline is a little bit tighter. Instead of a couple of months to a year, it's typically six to nine months for the step number two, actual contracting for reimbursement with all of the payers.
The third is provider activation and reaching out, sometimes alongside the payer, to ensure all of the providers are on board, that we activate the champions to educate the provider community. Since a lot of OB-GYNs are affiliated with hospitals, we typically focus on major institutions who hold MFM opinion leaders among their staff and work with them to have events and programs to ensure quick OB-GYN onboarding and PreTRM Test and intervention bundle adoption. These three steps are typical to convert access, like what we've achieved in Illinois, to actual meaningful volume. That's the first half of the question. Second half is in which other states are likely to follow. There are several other states we believe are close and have prioritized preterm birth as one of their healthcare priorities to focus on in their committees that allocate healthcare budget towards such priorities.
The timeline here is different, though, state by state. While some states may have prioritized the preterm birth reimbursement higher, their legislative session does not start for another few months. What I promise we will do is provide greater transparency as we see public signals from the states that they're moving through evaluation and decision-making on reimbursing PreTRM Test and funding preterm prevention priorities in their state.
Great, thank you. That was helpful color. Then just the second one around the SMFM meeting in October. I guess, how will your presence and the nature of your conversations differ this year versus last year now that PRIME and some of the sub-analyses are out there? Thanks.
Thank you for that question. First of all, the dialogue and the depth of dialogue and the tenor of the dialogue has shifted dramatically. With the PRIME data out there, we went from communicating the basics of clinical utility and the major endpoint results into much deeper conversations around the biology, the literature expectation of all of the biomarker pathways, and how PRIME study and the two studies of PREVENT-PTB trial before the PRIME study came out showed the same results and very much validated what literature expected SHBG and IGFBP4 biomarkers to show. What this signals to me is that the clinical community very quickly passed through the, "Does this test work?" into, "Of course, it works," because it validates a lot of what literature said about these two biomarkers before, and starting to ask questions on what other conditions does the test enrich for.
A lot of our discussions with opinion leaders are starting to focus on those topics. That's actually tremendously exciting because it confirms that the validation stage and the convincing stage is almost over, and now we're moving towards the acceptance and implementation and adoption question. Does that help?
Yes. Great. Thank you so much.
Thank you. Your next question comes from Dan Brennan from TD Cowen. Please go ahead.
Great. Thank you for the questions. Maybe first one, just on the four programs that you've signed, could you just remind us about across the programs, how we should think about those developing? Meaning, what are the program directors looking for? When will you share info? What happens at the end of the program? What would be a success?
Great. Hi, Dan. Thank you so much for the question. Different program directors and, typically, we work directly with chief medical officers for either the plan or the state or employer or provider network for these programs. Their goals typically differ in size and scope, but they typically have to do with showing that we're able to replicate the tremendously successful outcomes from our clinical trials in real life in their patient population. That's very typical, and with this latest program that just launched, it's very typical. This national payer took the quality metrics that they're accountable for to the state and knowing that PreTRM Test has the opportunity to impact their achievement, would like to see in the program population, us moving the needle on those metrics.
The spectrum of flavors that these programs take may include value-based care. Some partners look at what will be the outcomes and how much value is created, and others really focus on just clinical outcomes. Does this help?
Yep, no, that is good. Maybe back to the first question in terms of, I know Austin was talking a lot about as you guys migrate your focus, maybe start to think about more execution delivery of volumes. But from the first question, obviously, on the Illinois, given the steps that have to occur in terms of activation outreach and whatnot, it sounds like really the impact there could be more 2028 than 2027, it feels like. Correct me if I am wrong there, but assuming it is more 2028 when everything is in place, could you walk us through, you talked about 50,000 eligible births in the press release. Over the first, say, three years, is 10%, 15%? What is the way you think about when everything is set in Illinois, how you might be able to ramp that 50,000 opportunity?
Great question, Dan, and thank you for cutting right to the chase on penetration percentages, which we often think about internally, how quickly can we ramp those. Using the steps that I described in the conversation in the question earlier, we are in the midst of contracting with payers. That is step number one. In parallel, of course, engaging with all the providers to educate them and running awareness campaigns. That is step number one, but I would say from July 1st, when reimbursement took place, and we ramped our team immediately on the ground, do take the first six months for the contracting and if I can call it awareness building. I do not expect a ton of penetration of these 50,000 Medicaid lives in 2026.
When we looked at the benchmarks of how other leading diagnostic and screening tests performed as far as penetration in years one, two, and three post-access, we learned that 1% or 2% is good, 2% to 3% is outstanding, and 5% is frequently not achieved until year three. We would like to outperform, but I would imagine that following that benchmark is at the least we are aiming to achieve. If we look at 2027 as full year one, looking at the single-digit percentage points would be prudent. So 1% to 2% penetration. Following year, let us say 2% to 3%, 2% to 4%, and growing that to 5% in year three would be commensurate with the benchmarks we have seen.
Of course, we will keep you posted and talk a lot about how Illinois is going because that trajectory and that ramp will show you what we can do in other states once access is achieved there. Does this help?
Yeah. No, that's great. And maybe I'll just ask one more. The engagement with 20 payers across 20 states, how do we think about the path there for converting those opportunities into reimbursement?
I mentioned that engagement follows a pretty typical pathway after the introductory call and getting everybody familiar with the data. The second step usually is the triage on the payer side. Are they going to put us through their policy review? Are they going to take a path of thinking about a program together in any particular geography, or exploration of a value-based arrangement, or a conversation around partnering with one of their customers, let's say an employer or a provider? With these 20 payers plus across 20+ states, the segments fall into these three categories. There is a swath of payers where we are being taken through the policy review process. With national payers, the process typically takes 9 to 12 months. None of the payers make it transparent how long their policy review process takes.
But typically, once that process concludes, there is a definitive decision for now on where does our product fall in their reimbursement schedule. The second segment is where they chose to, let's do something together, like you, Sera, are doing in XYZ state with such and such payer. We would like to do something similar, so we're discussing which states, which geographies would be valuable to them. And payers typically look at both where the need is the highest for the patients, where the cost of care is the highest, and where they have an opportunity to win new business. Specifically on Medicaid, they're looking to achieve quality metrics required by Medicaid, leveraging the test. And we've got quite a few payers thinking about which locations we might want to run a program, or they might want to implement the test first.
And third set of payers, the engagement is around, okay, well, let's look for a set of customers that would be excited to implement this, or a set of providers where the implementation could take place efficiently, and they could see real-time how quickly we're able to drive results. So if that helps, that's a quick segmentation, for lack of a better term, of the landscape of payer engagement across the state.
Good stuff. Yeah, that was great. Thank you. I will get back in the queue.
Thank you.
Thank you. Next question comes from Bill Bonello from Craig-Hallum. Please go ahead.
Hey, guys. Thanks a lot. Just a question on any updated thoughts in terms of guidelines.
Hi, Bill. Thank you for the question. We are working diligently on the strategy we laid out in our previous calls. Namely, as you know, ACOG and SMFM are facing a long list of priorities of topics that need guideline updates. They prioritize the topics that need to be updated based on the literature that has come out recently with new information that may change the guidelines. So both societies advised us to publish, publish. That is why we have doubled down, not let up after PRIME publication, but doubled down and increased our resources to look at the PRIME dataset, expand the set of opinion leaders to engage them to look at our PRIME dataset together and continue publishing as much as we possibly can in the near future. That is why we were highlighting the publication of sub-analysis on the first-time moms.
This is exactly the kind of activity that ensures that the ACOG Practice Bulletin 234, which is where update of the guidelines will be most immediate for us, is on our priority list. The community received incredibly warmly the analyses that we are conducting. We have got a pipeline of another half a dozen that will come out in the coming year or two. So that is the biggest update. We are executing on the ask from both societies to mine the treasure trove of the PRIME dataset and publish as much as possible about the PreTRM Test effectiveness to put it out into the community so that that data can be included in the guidelines review when the time comes.
Thanks. That is helpful. Then just in terms of the oral presentation upcoming at the SMFM, is that going to be new data above and beyond what was published in July? Or is the presentation essentially a recap of what was published?
It is data that was published, indeed. The new data that just came out.
Okay. Good. That is very helpful. Thank you.
Thank you so much, Bill Bonello.
Thank you. Your next question comes from Matt Larew from William Blair. Please go ahead.
Great afternoon. Just one for me, which is on CE marking. I think targeting fourth quarter now or I guess by year-end for submission versus mid-year. I think you mentioned some additional data that was asked for. Just curious, was that after convening the advisory board, was that data they suggested might augment your package, or was it a feedback in terms of addressing any specific shortcomings in the package? Just curious what led to that decision and if you are still, I guess, what the confidence is to getting it in by the end of the year.
Thank you so much, Matt. No, it did not come out from the advisory board. It was our internal team's recommendation, and actually, it had to do with looking at the stability of the samples as they travel to the lab for analysis, and a couple of other things. So to de-risk execution, as I mentioned, it would be good to be extra sure given you've heard the heat waves, you've heard that we're pursuing ELISA, and there's a slightly different pathway in Europe that we're taking from the blood draw to the lab where it's analyzed. So that's been the driver, not the advisory board. We are working with great consultants, regulatory consultants, and are very happy with all of the regulatory interactions and remain on track to get to our CE marking as soon as possible.
Okay, that's all for me. Thank you.
Thank you so much, Matt.
Thank you. As a reminder, if you wish to ask a question, please press star one. There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt for her closing remark. Please continue.
Thank you so much, everyone, for your time today. With growing market access, clinical evidence, and encouraging commercial indicators, we believe the business is building meaningful momentum as we move through the H2 of 2026, and we look forward to updating you on our progress in another quarter. Thank you so much.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect your lines. Have a good day.
Investor releaseQuarter not tagged2026-08-06Viatris (VTRS) Beats Q2 Earnings and Revenue Estimates
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Viatris (VTRS) Beats Q2 Earnings and Revenue Estimates
Viatris (VTRS) came out with quarterly earnings of $0.69 per share, beating the Zacks Consensus Estimate of $0.62 per share. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +11.29%. A quarter ago, it was expected that this generic drugmaker would post earnings of $0.52 per share when it actually produced earnings of $0.59, delivering a surprise of +13.46%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Viatris, which belongs to the Zacks Medical Services industry, posted revenues of $3.76 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.19%. This compares to year-ago revenues of $3.58 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Viatris shares have added about 41.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Viatris has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Viatris was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It wil…Read full documentShow less
Viatris (VTRS) came out with quarterly earnings of $0.69 per share, beating the Zacks Consensus Estimate of $0.62 per share. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +11.29%. A quarter ago, it was expected that this generic drugmaker would post earnings of $0.52 per share when it actually produced earnings of $0.59, delivering a surprise of +13.46%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Viatris, which belongs to the Zacks Medical Services industry, posted revenues of $3.76 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.19%. This compares to year-ago revenues of $3.58 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Viatris shares have added about 41.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While Viatris has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Viatris was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.65 on $3.82 billion in revenues for the coming quarter and $2.46 on $14.74 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Services is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Sera Prognostics, Inc. (SERA), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +12.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Sera Prognostics, Inc.'s revenues are expected to be $0.13 million, up 550% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Viatris Inc. (VTRS) : Free Stock Analysis Report Sera Prognostics, Inc. (SERA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-05Earnings To Watch: Sera Prognostics Inc (SERA) Q2 2026 -- GF Value Sees 22% Downside
GuruFocus.com
Earnings To Watch: Sera Prognostics Inc (SERA) Q2 2026 -- GF Value Sees 22% Downside
This article first appeared on GuruFocus. Sera Prognostics Inc (NASDAQ:SERA) is set to release its Q2 2026 earnings on Aug 6, 2026. The consensus estimate for Q2 2026 revenue is 0.06 million, and the earnings are expected to come in at -0.16 per share. The full year 2026's revenue is expected to be $0.35 million and the earnings are expected to be $-0.66 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 5 Warning Signs with SERA. Is SERA fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Sera Prognostics Inc (NASDAQ:SERA) have declined from $0.48 million to $0.35 million for the full year 2026 and from $3.31 million to $2.68 million for 2027. Meanwhile, earnings estimates have increased from $-0.68 per share to $-0.66 per share for the full year 2026 and from $-0.61 per share to $-0.56 per share for 2027 over the same period. In the previous quarter of 2026-03-31, Sera Prognostics Inc's (NASDAQ:SERA) actual revenue was $0.01 million, which missed analysts' revenue expectations of $0.08 million by -82.5%. Sera Prognostics Inc's (NASDAQ:SERA) actual earnings were $-0.17 per share, which met analysts' earnings expectations. After releasing the results, Sera Prognostics Inc (NASDAQ:SERA) was up by 6.08% in one day. Based on the one-year price targets offered by 2 analysts, the average target price for Sera Prognostics Inc (NASDAQ:SERA) is $5.50 with a high estimate of $6.00 and a low estimate of $5.00. The average target implies an upside of 184.97% from the current price of $1.93. Based on GuruFocus estimates, the estimated GF Value for Sera Prognostics Inc (NASDAQ:SERA) in one year is $1.51, suggesting a downside of -21.76% from the current price of $1.93. Based on the consensus recommendation from 4 brokerage firms, Sera Prognostics Inc's (NASDAQ:SERA) average brokerage recommendation is currently 1.50, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Investor releaseQuarter not tagged2026-07-29SERA PROGNOSTICS ANNOUNCES CONFERENCE CALL AND WEBCAST OF SECOND QUARTER FISCAL YEAR 2026 FINANCIAL RESULTS ON AUGUST 12, 2026
PR Newswire
SERA PROGNOSTICS ANNOUNCES CONFERENCE CALL AND WEBCAST OF SECOND QUARTER FISCAL YEAR 2026 FINANCIAL RESULTS ON AUGUST 12, 2026
SALT LAKE CITY, July 29, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced it will report second quarter fiscal year 2026 financial results on Wednesday August 12, 2026, after the close of the market. The Company will host a corresponding conference call and live webcast to discuss operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. A press release outlining the financial results and highlights will be publicly distributed before the call. Conference Call Details: US domestic callers: (800) 836-8184 International callers: (646) 357-8785 Webcast Registration Link: https://app.webinar.net/O2ldBxvpPmE Live audio of the webcast will be available online from the Investors page of the Company's website at www.sera.com. The webcast will be archived on the Investors page and will be available for one year. About Sera Prognostics, Inc. Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah. About Preterm Birth Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, marking the longest stretch of the lowest grade in Report Card history. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate sig…Read full documentShow less
SALT LAKE CITY, July 29, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced it will report second quarter fiscal year 2026 financial results on Wednesday August 12, 2026, after the close of the market. The Company will host a corresponding conference call and live webcast to discuss operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. A press release outlining the financial results and highlights will be publicly distributed before the call. Conference Call Details: US domestic callers: (800) 836-8184 International callers: (646) 357-8785 Webcast Registration Link: https://app.webinar.net/O2ldBxvpPmE Live audio of the webcast will be available online from the Investors page of the Company's website at www.sera.com. The webcast will be archived on the Investors page and will be available for one year. About Sera Prognostics, Inc. Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah. About Preterm Birth Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, marking the longest stretch of the lowest grade in Report Card history. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016. About the PreTRM® Test The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM® Test is ordered by a medical professional. Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries. Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the date, time and content of the Company's quarterly earnings release and conference call; availability of the live audio of the conference call on the Company's website; and the Company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. Investor ContactJennifer Zibuda, Head of Investor [email protected]+1 (801) 396-8043 View original content to download multimedia:https://www.prnewswire.com/news-releases/sera-prognostics-announces-conference-call-and-webcast-of-second-quarter-fiscal-year-2026-financial-results-on-august-12-2026-302837088.html
Investor releaseQuarter not tagged2026-05-07SERA PROGNOSTICS REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS
PR Newswire
SERA PROGNOSTICS REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS
SALT LAKE CITY, May 6, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the first quarter ended March 31, 2026. Key First Quarter and Recent Highlights: Published Landmark PRIME Randomized Trial: Study in 5,018 women showing the PreTRM® test reduced early preterm births (–56% <32 weeks; –32% <35 weeks), NICU admissions (–20%), and neonatal morbidity (-20%), with one NICU day saved per 4.2 patients screened. Expanded European Evidence Base with Two Peer-Reviewed Publications: PREPARE Survey Accepted for Publication in The Journal of Women's Health: In March, results from the Pregnancy Research on European Women's Preterm Birth Awareness, Risk and Education (PREPARE) survey were accepted for publication evaluating preterm birth awareness, risk perception, and education across five countries. Findings identified a meaningful gap between perceived awareness and actionable understanding of preterm birth risk, underscoring the need for earlier and more standardized risk communication, an area PreTRM® testing is designed to address. The live publication is expected in May. European Expert Commentary on the PRIME Trial Published in The Journal of Maternal-Fetal & Neonatal Medicine: In March, expert commentary highlighted that current European preterm birth prevention strategies fail to identify most women who deliver preterm. They recognized that the PreTRM approach better aligns with existing European healthcare systems. Commercial Progress: Launched third partnership program expanding physician education and access to PreTRM. This program is expected to reach over 350 providers across three states. In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships within a focused set of target markets. Strong Presence Across Key Medical Meetings: American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in May: Participation included a dedicated product theater and targeted engagement with clinicians to discuss evidence generation and clinical implementation of PreTRM. Society of Maternal-Fetal Medicine (SMFM) Annual Meeting in February: Highlighted key clin…Read full documentShow less
SALT LAKE CITY, May 6, 2026 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the first quarter ended March 31, 2026. Key First Quarter and Recent Highlights: Published Landmark PRIME Randomized Trial: Study in 5,018 women showing the PreTRM® test reduced early preterm births (–56% <32 weeks; –32% <35 weeks), NICU admissions (–20%), and neonatal morbidity (-20%), with one NICU day saved per 4.2 patients screened. Expanded European Evidence Base with Two Peer-Reviewed Publications: PREPARE Survey Accepted for Publication in The Journal of Women's Health: In March, results from the Pregnancy Research on European Women's Preterm Birth Awareness, Risk and Education (PREPARE) survey were accepted for publication evaluating preterm birth awareness, risk perception, and education across five countries. Findings identified a meaningful gap between perceived awareness and actionable understanding of preterm birth risk, underscoring the need for earlier and more standardized risk communication, an area PreTRM® testing is designed to address. The live publication is expected in May. European Expert Commentary on the PRIME Trial Published in The Journal of Maternal-Fetal & Neonatal Medicine: In March, expert commentary highlighted that current European preterm birth prevention strategies fail to identify most women who deliver preterm. They recognized that the PreTRM approach better aligns with existing European healthcare systems. Commercial Progress: Launched third partnership program expanding physician education and access to PreTRM. This program is expected to reach over 350 providers across three states. In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships within a focused set of target markets. Strong Presence Across Key Medical Meetings: American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting in May: Participation included a dedicated product theater and targeted engagement with clinicians to discuss evidence generation and clinical implementation of PreTRM. Society of Maternal-Fetal Medicine (SMFM) Annual Meeting in February: Highlighted key clinical evidence from PRIME study and engaged with maternal-fetal medicine specialists on PreTRM's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss the PRIME study outcomes. Continued Progress in Europe: Advancing toward CE marking with regulatory dossier preparation on track for mid‑year submission. Commercial readiness efforts are supported by ongoing clinical validation activities and engagement with European clinical and advisory stakeholders. Cash Runway Extended Through 2029: As part of the final phase of our transition from a clinical to a commercial organization, we completed a comprehensive business review to redirect investment from clinical activities toward commercialization and rightsized our operating model, resulting in a sustainable cost structure to support the company across significant adoption and commercialization milestones through 2029. "In the first quarter, our primary focus was building awareness with clinicians and the broader stakeholder community as we continue the evolution from clinical stage to a commercial driven organization," said Zhenya Lindgardt, President and CEO of Sera Prognostics. "We made meaningful progress translating our expanding clinical foundation into commercial readiness, supported by growing peer reviewed validation in Europe, increasing clinician engagement, expanded education and access through the launch of our third partnership program, and active discussions with 13 payers across 15 states. Our strong presence at SMFM and ACOG and continued progress toward CE marking underscore our focus on scaling in high‑value markets and driving adoption of the PreTRM® test." "During the quarter, we advanced into the next phase of our evolution as a commercial organization through a comprehensive business review. As discussed in prior quarters, we redirected investment from clinical spend toward reimbursement driven commercialization while maintaining a sustainable cost structure," said Austin Aerts, Chief Financial Officer of Sera Prognostics. "These actions extended our cash runway by approximately one year, through 2029, providing the financial flexibility to fund the company through key adoption and commercial milestones." Upcoming Investor Conferences Company management will participate in the following investor conferences. When a fireside chat is scheduled a live webcast will be accessible through the Investors section of the Company's website for approximately 30 days following each conference. RBC Capital Markets Global Healthcare Conference May 19-20, 2026 in New York: Zhenya Lindgardt, President & CEO will host one-on-one meetings on Tuesday, May 19. Jefferies Global Healthcare Conference June 2-4, 2026 in New York: Zhenya Lindgardt, President and CEO, and Dr. Tiffany Inglis, Chief Medical Officer, will participate in a fireside chat on Wednesday June 3, at 9:20am ET and host one-on-one meetings. William Blair 46th Annual Growth Stock Conference June 2-4 in Chicago: Austin Aerts, Chief Financial Officer, and Jay Boniface, Chief Scientific Officer, will host one-on-one meetings on Wednesday June 3. First Quarter 2026 Financial Results First quarter 2026 revenue was $14,000 compared to $38,000 for the first quarter of 2025. Total operating expenses were $9.4 million, compared to $9.3 million for the same period in 2025. Research and development expenses for the first quarter of 2026 were $3.0 million, compared to $3.3 million for the first quarter of 2025. Selling, general and administrative expenses for the first quarter of 2026 were $6.3 million, compared to $5.9 million for the prior-year period as Sera continued to carefully invest in targeted commercial activities and strategic headcount additions, while building market awareness following the publication of PRIME study data. Net loss for the quarter was $8.4 million, compared to $8.2 million for the first quarter of 2025 as the Company continued its focus on managing our capital resources ahead of expected revenue expansion in the future. As of March 31, 2026, the Company had cash, cash equivalents, and available-for-sale securities of approximately $86.8 million, which Sera expects to fund the company across significant adoption and commercial milestones through 2029. Conference Call Information Sera Prognostics will host a corresponding conference call and live webcast today to discuss first quarter 2026 operational highlights, financial results and key topics at 5:00 p.m. Eastern Time. Individuals interested in listening to the conference call may do so by dialing the following: US domestic callers: (800) 836-8184 International callers: (646) 357-8785 Webcast Registration Link: https://app.webinar.net/voeWlGmwyd6 Live audio of the webcast will be available online from the Investors page of the Company's website at www.sera.com. The webcast will be archived on the Investors page and will be available for one year. About Sera Prognostics, Inc. Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® Test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is headquartered in Salt Lake City, Utah. About Preterm Birth Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, making the longest stretch of the lowest grade in Report Card history. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016. About the PreTRM® Test The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® Test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® Test permits physicians to identify, during the weeks 18 through 20 of pregnancy, which women are at increased risk for preterm birth and its complications, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM® Test is ordered by a medical professional. Sera, Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc. in the United States and/or other countries. Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the date and time and content of the Company's quarterly earnings release and conference call; availability of the live audio of the conference call on the Company's website; the Company's third partnership program expanding physician education and access to PreTRM and reaching over 350 providers across three states; advancing toward CE marking with regulatory dossier preparation on track for mid‑year submission; a sustainable cost structure and funding the Company across significant adoption and commercialization milestones through 2029; translating the Company's expanding clinical foundation into commercial readiness, increasing clinician engagement, and expanded education and access; scaling in high value markets and driving adoption of the PreTRM® test; extending the Company's cash runway by approximately one year, through 2029; providing the financial flexibility to fund the Company through key adoption and commercial milestones; expected revenue expansion in the future; the Company's attendance at, Company leadership's availability for one-on-one meetings at, and the availability of webcasts from the RBC Capital Markets Global Healthcare Conference May 19-20, 2026 in New York, the Jefferies Global Healthcare Conference June 2-4, 2026 in New York, and the William Blair 46th Annual Growth Stock Conference June 2-4 in Chicago; and the Company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM Test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM Test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM Test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law. Contacts: Investor Contact Jennifer Zibuda, Head of Investor Relations [email protected] +1 (801) 396-8043 Media Contact Nicole Kaplan at Allison Worldwide [email protected] +1 (847) 721-6033 View original content to download multimedia:https://www.prnewswire.com/news-releases/sera-prognostics-reports-first-quarter-2026-financial-results-302764424.html
Investor releaseQuarter not tagged2026-05-07Sera Prognostics, Inc. Q1 2026 Earnings Call Summary
Moby
Sera Prognostics, Inc. Q1 2026 Earnings Call Summary
Management is pivoting the organization from a clinical-stage focus to a commercial-first entity following the completion of the multi-year PRIME study. Performance attribution for the quarter reflects a deliberate focus on building awareness and advocacy rather than immediate volume, with revenue remaining modest at $14,000. The company is leveraging high-visibility media features, such as the SHE MD podcast where Hailey Bieber discussed her personal experience with the PreTRM test, to drive patient and provider awareness. Strategic positioning is centered on a 'concentrated approach' to payer engagement, focusing on 13 payers across 15 states to ensure deep integration rather than broad, shallow coverage. Operational context includes a significant realignment of resources, shifting capital away from R&D and clinical operations toward commercial and medical activities that support market access. Management highlighted the launch of a third partnership program reaching 350 providers, emphasizing that these programs serve as blueprints for seamless clinical integration of the PreTRM test. The company expects to reduce its base operating expenses by approximately $10 million annually, with the majority of the savings realized in 2027 and beyond. Existing cash and equivalents are projected to fund operations through 2029, extending the previous runway by one year due to disciplined cost management. Management anticipates a cadence of launching approximately one new partnership program per quarter to ensure high-quality implementation and pull-through. Revenue for 2026 is expected to remain modest and uneven, with more significant pull-through anticipated in late 2026 and into 2027 as programs mature. Key upcoming milestones include a midyear CE Marking dossier submission for European commercialization and the publication of PRIME sub-analyses, including health economic data. A comprehensive business review led to streamlined R&D and G&A functions, reflecting the transition away from heavy PRIME-related clinical spending. Management noted that R&D will become a smaller share of overall expense as the company explores a collaborative model for its proteomics platform with external partners. The company launched a targeted letter-writing campaign to mobilize physician advocacy for state Medicaid reimbursement, addressing the risk of slow policy adoption. European…Read full documentShow less
Management is pivoting the organization from a clinical-stage focus to a commercial-first entity following the completion of the multi-year PRIME study. Performance attribution for the quarter reflects a deliberate focus on building awareness and advocacy rather than immediate volume, with revenue remaining modest at $14,000. The company is leveraging high-visibility media features, such as the SHE MD podcast where Hailey Bieber discussed her personal experience with the PreTRM test, to drive patient and provider awareness. Strategic positioning is centered on a 'concentrated approach' to payer engagement, focusing on 13 payers across 15 states to ensure deep integration rather than broad, shallow coverage. Operational context includes a significant realignment of resources, shifting capital away from R&D and clinical operations toward commercial and medical activities that support market access. Management highlighted the launch of a third partnership program reaching 350 providers, emphasizing that these programs serve as blueprints for seamless clinical integration of the PreTRM test. The company expects to reduce its base operating expenses by approximately $10 million annually, with the majority of the savings realized in 2027 and beyond. Existing cash and equivalents are projected to fund operations through 2029, extending the previous runway by one year due to disciplined cost management. Management anticipates a cadence of launching approximately one new partnership program per quarter to ensure high-quality implementation and pull-through. Revenue for 2026 is expected to remain modest and uneven, with more significant pull-through anticipated in late 2026 and into 2027 as programs mature. Key upcoming milestones include a midyear CE Marking dossier submission for European commercialization and the publication of PRIME sub-analyses, including health economic data. A comprehensive business review led to streamlined R&D and G&A functions, reflecting the transition away from heavy PRIME-related clinical spending. Management noted that R&D will become a smaller share of overall expense as the company explores a collaborative model for its proteomics platform with external partners. The company launched a targeted letter-writing campaign to mobilize physician advocacy for state Medicaid reimbursement, addressing the risk of slow policy adoption. European market entry is being supported by new publications highlighting the gap between preterm birth awareness and actionable understanding among patients. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management targets launching roughly one program per quarter to allow for deep integration with payer and provider workflows. Programs are specifically designed to include large-volume institutions to ensure density of test ordering once reimbursement is secured. The shift is driven by the completion of the 7-year PRIME study effort and a strategic move to monetize the proteomics platform through external partnerships. This realignment allows the company to focus internal resources on market access while maintaining a pipeline through collaborative R&D. A typical program takes approximately 2 years from setup to a state decision, involving 6 months for setup, 12 months for recruitment, and several months for outcome data collection. Management expects results from the first major Medicaid program to drive decision-making by the beginning of 2027. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.
Investor releaseQuarter not tagged2026-05-07Sera Prognostics Q1 Earnings Call Highlights
MarketBeat
Sera Prognostics Q1 Earnings Call Highlights
Sera is pushing a targeted commercial strategy to build clinician and consumer awareness and create access pathways, launching partnership programs that will reach >350 providers across three states and engaging with 13 payers in 15 states to drive reimbursement and adoption of its PreTRM test. Clinical and regulatory momentum continues: full PRIME results and related commentaries have been published, PREPARE survey results accepted, additional PRIME sub-analyses are planned for 2026, and a CE marking dossier for Europe is targeted for mid-year submission. Financially, Q1 revenue was negligible at $14,000 with a net loss of $8.4 million, but the company ended the quarter with $86.8 million in cash and believes its capital will fund operations through 2029, aided by a resource realignment expected to cut base operating expenses by nearly $10 million annually (with most savings realizing in 2027+). Interested in Sera Prognostics, Inc.? Here are five stocks we like better. Sera Prognostics (NASDAQ:SERA) reported first-quarter fiscal 2026 results and highlighted what management described as continued progress toward expanding awareness, access, and reimbursement pathways for its PreTRM test following publication of the full PRIME Study results in January. President and CEO Zhenya Lindgardt said the company’s first-quarter focus was “building awareness with both clinicians and broader stakeholders,” including efforts to reach audiences outside traditional healthcare channels. Lindgardt pointed to continued engagement at clinical meetings, including the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting in February and the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? At SMFM, the company presented clinical evidence and discussed PRIME outcomes with specialists and SMFM leadership, Lindgardt said. At ACOG, Sera hosted a product theater focused on PRIME data and “practical implementation strategies,” with an emphasis on integrating PreTRM into routine care. Lindgardt also outlined media efforts aimed at raising awareness. She cited an interview on the SHE MD Podcast featuring Hailey Bieber discussing her pregnancy and the PreTRM test, which Lindgardt said generated significant visibility and was followed by a People magazine exclusive. Lindgard…Read full documentShow less
Sera is pushing a targeted commercial strategy to build clinician and consumer awareness and create access pathways, launching partnership programs that will reach >350 providers across three states and engaging with 13 payers in 15 states to drive reimbursement and adoption of its PreTRM test. Clinical and regulatory momentum continues: full PRIME results and related commentaries have been published, PREPARE survey results accepted, additional PRIME sub-analyses are planned for 2026, and a CE marking dossier for Europe is targeted for mid-year submission. Financially, Q1 revenue was negligible at $14,000 with a net loss of $8.4 million, but the company ended the quarter with $86.8 million in cash and believes its capital will fund operations through 2029, aided by a resource realignment expected to cut base operating expenses by nearly $10 million annually (with most savings realizing in 2027+). Interested in Sera Prognostics, Inc.? Here are five stocks we like better. Sera Prognostics (NASDAQ:SERA) reported first-quarter fiscal 2026 results and highlighted what management described as continued progress toward expanding awareness, access, and reimbursement pathways for its PreTRM test following publication of the full PRIME Study results in January. President and CEO Zhenya Lindgardt said the company’s first-quarter focus was “building awareness with both clinicians and broader stakeholders,” including efforts to reach audiences outside traditional healthcare channels. Lindgardt pointed to continued engagement at clinical meetings, including the Society for Maternal-Fetal Medicine (SMFM) Annual Meeting in February and the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? At SMFM, the company presented clinical evidence and discussed PRIME outcomes with specialists and SMFM leadership, Lindgardt said. At ACOG, Sera hosted a product theater focused on PRIME data and “practical implementation strategies,” with an emphasis on integrating PreTRM into routine care. Lindgardt also outlined media efforts aimed at raising awareness. She cited an interview on the SHE MD Podcast featuring Hailey Bieber discussing her pregnancy and the PreTRM test, which Lindgardt said generated significant visibility and was followed by a People magazine exclusive. Lindgardt said the episode surpassed half a million views, and she noted a new SHE MD episode was recorded for release May 14 to coincide with National Women’s Health Week. She also said Sera will be featured on Medscape’s “Hear From Her: The Women in Healthcare Leadership Podcast,” in a discussion focused on preterm birth and interventions. → A Prada Payday: Is AMC Back in Style? On commercial execution, Lindgardt said Sera’s efforts remain focused on creating “sustainable access points and referral pathways” to support longer-term volume and revenue. During the quarter, the company launched its third partnership program, which Lindgardt said is expected to reach more than 350 providers across three states. She added that Sera is contracting with additional partners and intends to provide more detail as programs transition from contracting to implementation. Lindgardt said the company was in active discussions with 13 payers across 15 states, describing it as a targeted approach designed to drive “meaningful implementation and adoption.” She said priorities include execution, reimbursement, physician awareness, clinical integration, and provider adoption. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Alongside commercialization efforts, Lindgardt said Sera continues to pursue guideline inclusion and broaden the evidence base for PreTRM. She noted European expert commentary on the PRIME trial was published in The Journal of Maternal-Fetal & Neonatal Medicine in March. According to Lindgardt, the authors emphasized that current prevention strategies fail to identify many women who ultimately deliver preterm and highlighted alignment of the PreTRM approach with European healthcare systems. Lindgardt also said results from the PREPARE survey were accepted for publication in the Journal of Women’s Health. She described the survey as examining awareness and risk perception across five European countries, concluding there is a gap between perceived awareness and actionable understanding. Formal publication is expected in May, she said. Looking ahead, Lindgardt said the company expects to publish additional PRIME sub-analyses in 2026, including: A health economics study Medicaid population outcomes from PRIME An analysis focused on first-time mothers Lindgardt framed preterm birth as a “public health and policy issue” and said the company is engaging with stakeholders across multiple states, particularly around Medicaid and value-based care settings. She said Sera recently launched a letter-writing campaign to encourage physicians and patients to engage with state Medicaid programs regarding reimbursement for PreTRM, and she described early participation as “encouraging,” with multiple letters submitted across several states. In Europe, Lindgardt said Sera is progressing toward commercialization readiness and remains on track for a mid-year submission of its CE marking dossier. She said discussions with regulators and clinical stakeholders have been constructive, and she cited ongoing engagement with the company’s European advisor group around clinical utility, evidence requirements, and implementation considerations. Chief Financial Officer Austin Aerts reported first-quarter revenue of $14,000, compared with $38,000 in the first quarter of 2025. Aerts said results were consistent with expectations, reflecting the company’s “geographically targeted commercialization strategy” and its ongoing advocacy and awareness building following PRIME’s publication. Operating expenses totaled $9.4 million, compared with $9.3 million in the prior-year quarter. Aerts said this reflected disciplined cost management while investing in evidence generation, regulatory preparation, and advocacy. Research and development expense was $3.0 million, down from $3.3 million a year earlier, which Aerts attributed in part to the PRIME study now being published. Selling, general and administrative expense increased to $6.3 million from $5.9 million, reflecting the transition “toward targeted commercial initiatives and strategic headcount,” he said. Net loss was $8.4 million, compared with a net loss of $8.2 million in the first quarter of 2025. Sera ended the quarter with $86.8 million in cash, cash equivalents, and available-for-sale securities. Aerts said the company believes its capital resources are sufficient to fund operations and capital expenditures through 2029, citing a more sustainable cost base and its measured commercialization strategy. Management also discussed resource realignment. Lindgardt said Sera had “realigned resources” and streamlined R&D and G&A functions, shifting capital away from R&D and clinical operations toward payer engagement, market access, and adoption-focused activities. She said these actions are expected to reduce base operating expenses by nearly $10 million annually, though Aerts noted the benefit in 2026 would be limited due to phasing and related charges, with most savings expected in 2027 and beyond. During the Q&A, Lindgardt described the cadence of partner program launches as “roughly one a quarter,” emphasizing the operational work required to stand up programs, including reimbursement discussions, provider onboarding, and workflow integration for both testing and the intervention bundle. She also said the payer engagement pipeline expanded from “10 payers in 13 states” previously to 13 payers in 15 states, as payer organizations introduce Sera to other regions. Asked about sales productivity metrics, Lindgardt said management tracks “the number of tests per month per rep,” adding that the company is seeing metrics “move” but wants to observe steadier internal progress before publicly reporting those metrics. On volumes, Lindgardt said an analyst’s characterization of “low single-digit thousand” test volumes in 2026 was “not unreasonable,” while reiterating that Sera does not currently report order volume. Discussing timing for Medicaid coverage decisions, Lindgardt described an estimated “about two years” decision timeline for a specific state program, with variability depending on data collection and administrative complexity. She said the company expects to bring program results toward a decision point beginning in 2027. Sera Prognostics, Inc is a precision medicine company focused on improving pregnancy outcomes through proteomic testing. The company's flagship product, the PreTRM™ test, is a blood-based assay designed to assess a woman's risk of delivering prematurely by measuring specific protein biomarkers in maternal serum. By identifying patients at elevated risk for spontaneous preterm birth, Sera Prognostics aims to enable earlier interventions and tailored care plans that can reduce the incidence of neonatal complications associated with early delivery. Since its founding in 2014 and subsequent initial public offering in 2020, Sera Prognostics has worked closely with clinical research networks and obstetric care providers across the United States to validate the clinical performance of its PreTRM test. The article "Sera Prognostics Q1 Earnings Call Highlights" was originally published by MarketBeat.

