Sera Prognostics at H.C. Wainwright: PreTRM Test’s Market Push

On Friday, 05 September 2025, Sera Prognostics (NASDAQ:SERA) presented at the H.C. Wainwright 27th Annual Global Investment Conference. CEO Zhenya Lindgardt outlined the company’s strategy to reduce preterm births through its PreTRM test. While the company is well-funded and focused on commercialization, challenges remain in expanding adoption and proving economic benefits to healthcare systems.

Key Takeaways

• Sera Prognostics is focusing on the commercialization of the PreTRM test to address preterm birth.
• The company holds $110 million in cash reserves with an annual operating budget of $30 million.
• Clinical studies show the PreTRM test significantly reduces NICU admissions and healthcare costs.
• Sera Prognostics is targeting six states with Medicaid and commercial plans for initial test adoption.
• Partnerships with digital education channels aim to raise awareness among physicians and expectant mothers.

Financial Results

Sera Prognostics reported a strong financial position with approximately $110 million in cash reserves. The company’s annual operating budget is set at $30 million, allowing for strategic investments in commercialization efforts. The financial stability supports their focus on reducing the $25 billion annual cost of preterm births to the U.S. healthcare system.

Operational Updates

The PreTRM test, which measures biomarkers IGFBP4 and SHBG, is designed to predict the risk of spontaneous preterm births. Clinical validations, such as the AVERT and PRIME studies, demonstrate the test’s effectiveness in reducing NICU admissions by 22% and NICU stay lengths by 8%. The company is actively engaging with payers and Medicaid directors to highlight these benefits.

Commercialization Strategy

Sera Prognostics is concentrating its efforts on six target states, leveraging an expanded sales force and Access Team. By partnering with key opinion leaders and state Medicaid directors, the company aims to demonstrate the test’s clinical and economic value. A pilot program with Medicaid plans is underway to showcase the test’s impact on public health.

Future Outlook

The company’s health economic model suggests that the PreTRM test can achieve a breakeven point within a year by reducing healthcare costs. Sera Prognostics is partnering with Everyday Health to educate first-time mothers and physicians about the test and the risks of preterm birth. This educational initiative is expected to further drive test adoption and awareness.

For a detailed understanding of the conference call, readers are encouraged to refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Vivian, Analyst on the Corporate Access team, HC Wainwright: Hello everyone, and thank you for joining HC Wainwright’s 27th Annual Global Investment Conference. My name is Vivian, and I’m an analyst on the Corporate Access team. HC Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 19 publishing senior analysts and over 650 companies covered across all sectors. If you would like more information, please visit our website at hcwco.com. As a reminder, please reference your online conference portal that provides your individual links to your meetings and all company sessions. With that, I would like to introduce Zhenya Lindgardt, the Chief Executive Officer of Sera Prognostics.

Zhenya Lindgardt, Chief Executive Officer, Sera Prognostics: Vivian, thank you so much, and everyone, thank you for joining. I’m excited to share with you today where we are at Sera Prognostics in our commercialization efforts of our PreTRM Test on our mission to reduce the burden of preterm birth across the globe. First, our bold ambition is to deploy our findings and breakthrough research in proteomics and advanced analytics to provide holistic and pivotal insights about the pregnancy to providers and expectant mothers to improve health for moms and babies, as well as improve economics of healthcare delivery, specifically in pregnancy. To double-click on what challenge we’re addressing, one in 10 babies are born too soon. Premature birth is defined as birth before 37 weeks of gestation. Full term is defined as birth within weeks 37 to 40. The earliest born babies, sometimes before 28 weeks, have the most healthcare complications.

Unfortunately, trends are not going in the right direction. Today, babies have a higher chance, newborns specifically, going into NICU after birth than 10 years ago. The United States has a D rating on where we stand as a society compared to other countries across the globe on health of our newborns and moms and outcomes in childbirth. We at Sera Prognostics, the pregnancy company, developed a solution to deploy personalized screening for risk for preterm birth and are excited to share it with clinicians across the globe. PreTRM Test is the only clinically validated test available to screen for risks of spontaneous premature birth and verified by many clinical studies that I will talk about today. We are poised for a major inflection point in our commercialization.

We’re unique in that we are very well funded through the next three to four years, through about $110 million in cash we hold and about $30 million annual operating budget. We’re about to publish our pivotal PRIME data in a reputable journal coming soon and are excited to share about the progress we’ve had recently in launching our commercialization in selected states with Medicaid and commercial plans to show what the test can do on the ground for public health in places that need it the most. We have a huge opportunity in front of us addressing the cost of about $25 billion annually that prematurity costs the U.S. healthcare system. Let me share more about the challenge, the solution, and more detail about our commercial progress.

The key challenge with preterm birth in the United States and beyond is the ability to identify which pregnancies are the ones to pay the most attention to that could result in preterm birth. Unfortunately, not only there haven’t been that many reliable indicators that could give clinicians a heads up that the pregnancy may end up in prematurity, but also the trends have been going in the wrong direction. In the last ten years, according to March of Dimes statistics, preterm birth in the United States increased. It’s actually a double-digit compound growth rate. In total, from 9.4% in 2013 to 10.4% in 2023, percent of newborns born preterm. The implications of preterm birth are dire. Some payers and employers call very premature babies, so-called million-dollar babies, because the cost of childbirth and the stay in the NICU is enormous.

If you average it out for extremely premature babies born before 28 weeks, their NICU stay could be three or four months. The cost of a NICU day in the United States averages around $4,500 per day, but for the earliest born, it could be as high as $20,000. Unfortunately, for those earliest borns, even survival is uncertain. It’s about a 50/50 chance whether the baby makes it if the baby is born very early or before 28 weeks of gestation. The baby also will likely encounter lifelong implications on the health, with respiratory, cardiovascular, sometimes neurological issues, and an increased rate of infections. Not only do we have to, as a healthcare system, look at the dire healthcare outcomes, implications for the baby and the family, but also for the healthcare system, because the cost of the birth itself could be in hundreds of thousands of dollars.

Here we show the average delivery cost around $350,000, but could be in the millions. The lifetime cost is many tens of times higher than the costs of healthcare for over a lifetime for a full-term baby. When we look at specifically the first seven years of life, the healthcare cost of the earliest born is seven times higher than a full-term baby. The cost of birth itself is about 18 to 20 times higher. Of course, it’s a range, as I mentioned, could be much, much higher. Not only do we need to address the health implications of prematurity, but also it makes sense for us to do from a healthcare economics perspective. As I mentioned, the critical challenge that the healthcare community needs to address is that the majority of the likely preterm births are missed at screening.

If you look on the right, 100% of expectant mothers, about 80% or more, are missed by traditional guideline-based screening methods, which are only two. The prior preterm birth, which is only available as history for second, third, fourth, and beyond time moms, and not available for about 40% of pregnancies, which are first-time moms. The second screening method, which is measuring the length of the cervix throughout the pregnancy. Very few moms end up getting identified by this method. All in all, the sensitivity of the screening method of prior preterm birth and short cervix identifies only about 20% of expectant mothers that will give birth prematurely. 80% of those who will go into spontaneous preterm labor are missed.

This is where we see an enormous opportunity to deploy our breakthrough technology to identify and share with the clinicians and the mom herself the higher risk for spontaneous preterm birth to give the physician and mom a chance to potentially prevent it. Not only the majority of the moms are missed, but the communication about the risks of preterm birth is lacking. Only 20% of moms hear about the risks of preterm birth in her conversations with the clinician, specifically in the first appointment. That’s when the mom needs to start thinking about what are the risks in her pregnancy. What is it that we’ve discovered and how can it help in the identification of spontaneous preterm birth? We focus our work on the science of proteomics and developing blood tests using proteomics to identify risks for preterm birth.

Proteomics is a science that measures the levels of proteins circulating in pregnant moms’ blood to identify where there could be things going wrong. Specifically, in our PreTRM Test, we measure two biomarkers we’ve identified in the last decades of research as ones that can highlight risks of spontaneous premature delivery. These proteins are IGFBP4 and SHBG. Let me tell you a little bit about them. First is the insulin-like growth factor binding protein 4. It specifically has been known to show the effectiveness of nutrient delivery from placenta to the fetus, among many things it works on in the body during pregnancy. The second one is the sex hormone binding globulin, which, among many things, signals potential inflammatory processes happening during the pregnancy. The ratio between these two proteins could highlight the likelihood of spontaneous preterm birth.

Our test is able to take the ratio between these two proteins and highlight whether or not the risk for the mom is higher than an average pregnant woman for spontaneous preterm birth, even if she lacks any other evident risk factors. The PreTRM Test is conducted during weeks 18 to 20 of pregnancy, typically in the second trimester when the mom comes into her first ultrasound appointment to take a look at the baby. It very conveniently integrates into the standard of care of pregnancy. The specimen, when the blood draw takes place, gets shipped to our lab in Salt Lake City, Utah, which is CLIA certified and CAP accredited, and we deliver the results to the physician within three to five days.

Our results form shows very clearly whether the mom is at higher risk or not at higher risk for preterm birth and specifically can be used for the physicians to communicate to mom that the pregnancy could be at risk for spontaneous preterm birth, longer hospital length of stay for the baby, and severe health outcomes for the baby in case of prematurity. Most recently, we developed a robust portfolio of clinical evidence to show how effective PreTRM screening tests could be in managing pregnancy for clinicians.

On the left, we’ve deployed a lot of our developed evidence, 11+ publications, a 20,000-strong blood bank of blood samples through all of our clinical research that we use ongoingly to improve our predictive algorithms, the diverse data set that we developed across our clinical evidence, and an increasingly global data set with data we already have not only in North America but also Europe, Asia, and Africa. We use advanced mass spectrometry to measure over 300+ proteins that occur in pregnant blood during pregnancy. Last but not least, we’ve been investing in artificial intelligence and machine learning to improve our algorithms.

Using all of these assets, we are continuously improving the predictive power of PreTRM tests to ensure we’re able to predict as early as possible the risk of spontaneous preterm birth and allow for that shared decision-making to happen between the physician and the patient on how to address that specific pregnancy and, over time, reduce healthcare costs for the whole system. As I mentioned before, the PreTRM Test is the only clinically validated test available for early prediction of premature birth. We validated it with a large study conducted in 2026 with over 5,500 pregnancies that participated in our research and development of the predictor that shows how the ratio between the two proteins I talked about could be a strong marker for the predictive power of the test of spontaneous preterm birth.

This validation publication was chosen as Editor’s Choice in the leading journal of the American Journal of Obstetrics and Gynecology. Since then, we’ve been investing consistently in a number of clinical utility studies that show what the outcomes for health of the baby could be by screening pregnant moms with PreTRM Tests and deploying an intervention bundle. Specifically today, I want to talk about two studies that were recently completed: AVERT and PRIME. AVERT is a study that was completed in 2023 and was published in July of 2024 in Diagnostics Journal and was featured on the cover page of that issue of July 2024 Diagnostics Magazine. The second study, PRIME, was completed in December 2024 and was conducted across the whole of the United States with 19 sites and was presented at the Society for Maternal Fetal Medicine Conference last January.

The abstract is available in the Pregnancy Journal, the leading journal of the Society for Maternal and Fetal Medicine that deals with highest-risk pregnancies. The studies showed that the PreTRM Test is an incredibly effective alternative to traditional methods for screening for preterm birth. One of the ways to measure efficiency and effectiveness of a screening method is a metric called the number needed to screen. For example, when we look at the number of mothers that needed to be screened to spot and avoid one NICU admission, it is as low as only 40 moms. When we compare that metric with traditional methods like transvaginal ultrasound cervical length measurement and progesterone treatment to prevent NICU admission, which requires 150 moms to be screened, the Sera Prognostics preterm risk screening test only requires 40. It is three times or more so more efficient than the traditional method.

When we look at the number needed to screen to save one NICU day, it is just four moms that are needed to be screened with the PreTRM Test from the AVERT study in order to avoid one NICU day. Now let me tell you a little bit about the pivotal trial we just finished, the results of which were presented in January. We had spectacular partners, 19 sites that participated in the study with us to enroll and analyze over 5,000 patients. Let me remind you, the study was stopped at the interim for efficacy. Because the results reached the intended outcomes, we were able to start analyzing the results sooner for all of the moms that were already enrolled in the study.

We use the same healthcare outcomes as endpoints for both AVERT and PRIME studies, and they included neonatal health as measured by the index of neonatal morbidity and mortality that combined a whole host of conditions that unfortunately are the result of prematurity to show that over 20% fewer conditions occur for babies that are born prematurely when screened with the PreTRM Test, and the intervention group is treated with an intervention bundle. The second key result is the decrease in NICU admissions. There was a fantastic result of 22% avoidance of NICU admissions in the PRIME study and a very impressive 8% further reduction in the length of stay in the NICU for the babies who did make it to NICU. We did also observe an increase in gestation of the babies.

Specifically, the odds of delivery before 35 weeks, the earliest borns, were decreased by more than a third, 35%. Last but not least, the cost savings from screening low-risk pregnancies with the PreTRM Test showed that only four women need to be screened in order to avoid one NICU day stay. The intervention bundle that we tested in both the PRIME and AVERT studies was recommended by experts in the Society of Maternal and Fetal Medicine, and they included three interventions: very low-dose aspirin, 81 milligrams administered daily; vaginal progesterone administered daily; and last but not least, weekly nurse phone calls. Using the results that we just shared, we’re excited to enter the new stage of commercialization.

Taking all of the clinical validation and evidence we’ve generated, we are aiming for targeted adoption in selected states to ensure that we can show the clinical community and public health agencies what the screening test can do by screening all of the lower risk or not evident for higher risk pregnancies in the clinic. With that evidence, we’re looking forward to informing the guideline inclusion and payer coverage. Specifically, we are focusing on three key initiatives. Number one, we’ve expanded our sales force and staff to ensure robust commercialization. Specifically, we hired a sales force to focus on six target states and are running programs within each of these states to support them with sales reps and Medical Science Liaisons. We also staffed an Access Team to make sure that we are working closely with the payers to ensure reimbursement in those target states.

Specifically, we offered public and private payers the opportunity to use the test and see how the results impact the health outcomes of the babies and, of course, the healthcare costs. We’re excited to say that we have terrific traction in about four states out of six targeted and good awareness even beyond those initial states and launched one Medicaid plan pilot to show how much it can do for public health in that state. We’re really focused on a flywheel of ecosystem awareness building by working with key opinion leaders in the states that are in the leading delivery institutions there to educate all of the OBGYNs and clinicians taking care of the patients in that state.

We’re also partnering with all of the payers and the state Medicaid Director to build awareness of the data that we’ve seen in our clinical trials and working to show how it can help reduce prematurity and the NICU stay burden for the state where we are screening the moms with the PreTRM Test and the physicians are deploying the intervention bundle. Specifically, what’s most exciting to both commercial and public health plans is the opportunity to reduce healthcare costs without reducing benefits. What you see here is the health economic model that our Data Science Team built in partnership with our partner payers to show that the breakeven for deploying the test and testing low-risk moms that are pregnant could show a breakeven within a year. We’re presenting this data at the ISPOR Europe Conference later this fall.

In order to drive adoption and awareness building across both physicians and moms, we are partnering with digital education channels both for physicians and for moms. Here, I’m highlighting in particular a partnership with Everyday Health, which reaches about 93% of first-time moms. We want to make sure that moms know about this test and, importantly, know about the risks of preterm birth so that we can educate both the clinicians and the moms and start driving adoption of this test across the community. Of course, our leadership team is growing, and we’re excited to have world-class experts across the industry helping us. We have our work cut out for us. We need to educate providers, empower moms to help babies be born healthier and stay in the hospital less time. We’re looking forward to helping the community deliver healthier babies.

Thank you so much, and look forward to all of your questions.

Vivian, Analyst on the Corporate Access team, HC Wainwright: Thank you, Zhenya, for leading a productive and informative presentation on behalf of Sera Prognostics. We appreciate the time that went into putting this together, and are grateful for the team’s presence at our conference this year.

Zhenya Lindgardt, Chief Executive Officer, Sera Prognostics: Thank you so much. Thank you for having me here.

Vivian, Analyst on the Corporate Access team, HC Wainwright: Of course, thank you.

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