Prognostics, Inc. . . . . . . Prognostics, Inc. . . . . . . Good afternoon, ladies and gentlemen, and welcome to CERA Prognostics Second Quarter 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. 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.

Thank you, Operator.

Welcome to SARA Prognostics' second quarter 2026 earnings conference call. Earlier today, SARA 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 SARA.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. The second quarter was marked by significant wins across key drivers of long-term adoption for preterm test-guided care. During the quarter, we expanded commercial engagement 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 preterm test-guided care and reinforce our confidence in a 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 healthcare affordability initiatives. Illinois provides an excellent example of the effectiveness of our commercialization strategy. Illinois was not originally included in the state supporting our peer 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 preterm tests, 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 preterm test guided care within existing maternal health programs. This month, we launched our fourth partnership program, expanding implementation of preterm 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 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 preterm 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 three categories. They are 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, championed development and targeted awareness initiatives where 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. A 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 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 preterm 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 preterm 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 preterm 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 two-fold 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. They also remain on track for publication of our health economics analysis in the coming months. This work will further quantify the economic impact of preterm 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 PRIAM 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 preterm 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 SARA 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 SARA while maintaining our primary focus on the successful commercialization of preterm 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 Erie. We also participated in a Medscape Hear from Her podcast, featuring our team and Prime Investigator Dr. Molly 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 200 times 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 OBGYN, 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 on ultimately the adoption of evidence-based care. 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 in the 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 preterm 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 third quarter with submission of our full CE marking package to conclude in the fourth quarter of this year. Finally, we continue 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 peer engagement, saw an important Medicaid policy milestone in Illinois, strengthened our clinical evidence-based 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.

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.

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 touchstone 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 more, please, for your first question. First question comes from Tycho Peterson from Jefferies. Please, go ahead.

This is Lauren. I'm 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 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.

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 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 I.D. 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, typically six to nine months for the step number two, 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 OBGYNs are affiliated with hospitals, we typically focus on major institutions who hold MSM opinion leaders among their staff and work with them to have events and programs to ensure quick OBGYN onboarding and test and intervention bundle adoption. These three steps are typical to convert access like what we've achieved in Illinois to actual meaningful volume. So 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. 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're moving through evaluation and decision-making on reimbursing preterm tests and funding preterm prevention priorities in their states.

Great, thank you. That was helpful, Culler. 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? Thanks.

Thank you for that 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 two 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 two 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?

Yes, great. Thank you so much.

Thank you.

Your next question comes from Dan Redden from TD Cohen. 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, you know, across the programs, how we should think about those developing meetings? Like, what are the program directors looking for? When will you share info? And then, you know, what happens at the end of the program? Like, 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. 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 preterm 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?

Yep, 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's in place, Could you walk us through, like, you know, you talked about 50,000 eligible births in the press release. Like, over the first, say, three years, I mean, is 10%, 15%? Like, what's the way you think about when, you know, when everything's set in Illinois, like, 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. 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 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. 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 one, two, and three post access. We learned that one or two percent is good, two to three percent is outstanding, and five percent is frequently not achieved until year three. 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 school year one, looking at the single digit percentage points would be prudent, so one to two percent penetration, following year, let's say two to three, two to four, and growing that to 5% in year three 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?

Yeah, that's great. And maybe I'll just ask one more. So the engagement with 20 payers across 20 states, how do we think about the path to Africa converting those opportunities into reimbursement?

Yeah. 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 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 the 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 state.

Good stuff. Yeah, that was great. Thank you. I'll get back in the queue. Thank you.

Thank you. Next question comes from Bill Bonello from Craig Hallam. 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 SNFM 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 subanalysis on the first time moms. This is exactly the kind of activity that ensures that the Bulletin 234, 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 two. That is the biggest update we're 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 preterm test effectiveness to put it out into the community so that the data can be included in the guidelines review when the time comes.

Thanks, that's helpful. And then just in terms of the oral presentation upcoming at the FM, 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's data that was published, indeed, the new data that just came out. Okay.

That's very helpful. Thank you.

Thank you so much, Bill.

Thank you. And your next question comes from Matt Leroux from Blair, William Blair. Please, go ahead.

Great afternoon. Just one for me, which is on C.E. McCain. targeting fourth quarter now or I guess by year end for submission versus mid-year. 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 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 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. 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'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 C-mark as soon as possible.

Okay, that's all from me. Thank you.

Thank you so much, Matt.

Thank you. As a reminder, if you wish to ask a question, please press star 1. 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 second half 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.