Good morning, everyone, and thank you for joining day three of the H.C. Wainwright twenty-sixth Annual Global Investment Conference 2024. My name is Daniel Smith, and I'm an H.C. Wainwright Equity Research Associate in Biotechnology. With that said, let me introduce our presenter for the session. I'd like to welcome Ms. Zhenya Lindgardt, President and CEO of Sera Prognostics, a global leader in high-value women's health diagnostics. Sera is traded on the Nasdaq under the ticker S-E-R-A. The floor is yours. Thank you so much, and good morning, everyone. I'm really excited to share an update where we've been and where we're going in, innovating pregnancy care in this country and globally. Sera Prognostics focuses on innovating how pregnancy risk complications are screened for and addressed in pregnancy care. It's an enormous problem in the United States and globally. One out of ten babies are born too soon and contribute to about 1/3 of newborn death. We are talking about saving babies' lives. Unfortunately, March of Dimes gives the United States a grade of D+ in pregnancy care for preterm birth. It is a full-blown crisis. Importantly, it's critical to know that it's avoidable. We can lessen the burden of preterm birth with the use of Sera Prognostics products. The burden of preterm birth is uneven across the country. If you look at the map here, there are states that are particularly hard hit, and while on average, preterm birth affects one out of ten women who are pregnant and delivering, some populations, like Black women, have double the rate of preterm birth than others, like Caucasian women. It's really critical for us as society to address this problem. It's not only carrying devastating health complications that could be lifelong and burden on the families, but also for the cost of healthcare in the ecosystem. It's about $25 billion per year in this country for preterm birth cost, across 3.6 million births per year in the United States. Majority of the cost is hitting for the babies that are born earliest, below 35 weeks. Of course, that's where a lot of the health complications are, and sometimes babies stay in the NICU for months at a time if they're born before 32-28 weeks. So for us to address the health complications and the economics of the problem, we really need to identify those who will be born the earliest and will be born before 37 weeks, the definition of preterm birth. We have developed a solution with proteomics, a technology that is mass spectrometry-based, that looks at the proteins secreted by placenta, that identifies the health of placental function, the organ that is developed for the particular pregnancy and it mediates the exchange between mother's body and the demands of the fetus. Specifically, we've launched a PreTRM test that is administered between weeks 18 and 21 of pregnancy to healthy and asymptomatic singleton pregnancies. This test is really to screen for spontaneous preterm birth, and preterm birth that will occur without warning. In today's guidelines, there are only a few risk factors that can point to the risk of preterm birth. One is short cervix. Fewer than 2% of women in this country have that condition when they're pregnant, or going into pregnancy, and history of preterm birth. Neither of these are particularly reliable predictors of preterm birth, but those are the ones that we have available in the guidelines. Now there is another solution, PreTRM screening test. Out of 3.6 million pregnancies in the United States, 3.2 million should be screened for preterm birth, because half of preterm birth occurs without any warning. The weeks 18-21, when the draw occurs, are conveniently overlapping with the first ultrasound for the second trimester of pregnancy. So it's very easy for OB-GYNs and the maternal- fetal medicine specialists to combine the blood draw and the test administration with already scheduled routine care visit for the expectant mother. Importantly, many women who give birth don't even present their pregnancy to the obstetrician until the second trimester. So we believe this is a perfect time to administer the test, and if the woman screens for higher risk for preterm birth, administer an intervention bundle. We analyze the tests on our machines in Salt Lake City and provide the results to the physician in three to five days. If the woman screens for higher risk for preterm birth, the intervention bundle we tested extensively in clinical trials is very simple. It's daily low-dose aspirin, 81 mg, vaginal progesterone administered daily, and a weekly structured nurse calls for care management. The impacts of delaying early delivery are enormous. Not only they improve the health of the baby who is born later in gestation, they also therefore reduce the need for long stay in the hospital or in the NICU. I mentioned our extensive research. I will not go through every paper that we've published, but I will highlight the latest one that just made the cover of the Diagnostics journal in July, called AVERT. This study was able to compare the control group and the active arm of the study, where we screened the women for higher risk for preterm birth and administered the intervention bundled I walked through, and saw incredible impact on both extension of gestation, reduction of length of stay, and improvement on health of the babies. We saw across the cohort, a week-long reduction in neonatal hospital stay in tested expectant mothers. Additionally, we saw an incredible improvement in the health of the babies. So 18% reduction in a composite index called neonatal mortality and morbidity index, that shows reduction of incidence of respiratory distress syndrome, and many other severe complications of preterm birth in babies by 18%. We saw extension of gestation for those earliest born. If you recall, that's where a majority of the costs of preterm birth and healthcare complications for the baby occur by very impactful two and a half weeks. For those earliest born, born before 32 weeks, we saved a month in a NICU, 28 days, almost a month in a NICU. So for those parents who've seen preterm birth and experienced three or four months in the hospital, being able to take their baby home a month earlier is incredible. Of course, for the payer and the government in our country, 40% of babies get born on Medicaid, saving nearly a month in the NICU. Cost of a day in the NICU ranges between $4,000-$20,000. It's an incredibly important opportunity for not only improving health, but also saving cost. Most recently, we had a very exciting announcement in December of last year that our pivotal trial, called PRIME, the abbreviation of this very long name, was halted at the recommendation of DSMB at the interim point for success. We're very excited because we are seeing the same endpoints we've measured as I just presented in AVERT, laying out the success of extending gestation, improving health of the babies at birth, and therefore reducing the length of stay in the hospital and the NICU for the baby, demonstrating the economic savings and incredible health impact. I haven't even started talking about the impact on maternal health, because as you can imagine, if the baby gets born healthier later, the health impact for the mom is significant as well. It's really exciting, for us to publish this data and to showcase, in the coming months, the results. In addition to health outcomes from PRIME study, we will update what happened economic with economic savings. What we already have publicly available is from our partner, Elevance, formerly known as Anthem, who has modeled for over 40,000 of their members, applying test and treat strategy to their member population. And to summarize a lot of text on this slide, we've seen $1,600 savings of cost of care per member tested. So this incredible opportunity to screen healthy, otherwise healthy mothers, where the payer cannot foresee a $1 million-$2 million cost of a severe preterm birth baby that will occur spontaneously in many mothers. Identify it, apply treatment, and realize the savings within six months of getting the test. So what is next for us? As we share the results of the PRIME study, we're really excited to publish the PRIME study, to publish the economic impact that Elevance will publish on specifically the Elevance patients that were in the PRIME study, so that you can see not just modeled economic results, but also actual observed results. We're going to be putting our foot on the commercialization pedal and driving the next inflection point in the revenue in 2025. Our strategy will be very focused on selecting some of the hardest-hit states in the United States and driving density of adoption of the test to show the full potential of the test. In order to do that, we will team up with the opinion leaders that have participated in our trials, are believers and early adopters of the test, and they will drive the OB-GYN community to start screening their expectant mothers that otherwise are asymptomatic and healthy in order to identify those at higher risk and refer them to maternal- fetal medicine specialists and administer treatment. For us to be able to show not only the health outcomes case to the payers and to the communities, but also to the payers, the economic case for Medicaid and for commercial payers will be incredibly powerful. We can achieve that only if we show at scale, in a particular geographic area, how powerful it will be to screen and identify those mothers. Of course, using that data, over the next year in selected states, we will take that business case to other states and to showcase to providers big systems that deliver tens of thousands of babies in order to change their care protocols, and of course, go together to the payers locally to achieve reimbursement. We've got some exciting payers who are already very engaged with us, like Elevance, as well as several others regional that we hope to achieve reimbursement in the coming months and years. Of course, we will be looking to change fundamentally the practice of prenatal care in this country and to change the guidelines to include the use of PreTRM test to screen asymptomatic, healthy singleton pregnancies that don't have other risk factors pointing to the potential of preterm birth. And last, of course, we'll be engaging with the new regulators. As I'm sure you've heard, we, as an LDT, laboratory developed test, which used to be overseen by CLIA and New York State, still are, but FDA will be putting higher regulation on our field, and we're really excited to engage with FDA. While the tests are grandfathered for commercialization today, if they're approved in New York State, we think with our broad evidence portfolio, it will be an advantage for us in this space to go ahead and comply. And I welcome higher regulation, because if FDA approved, of course, it will be a big advantage for getting reimbursement for the test. So we're really excited. The whole team is looking forward to the next milestones and executing on them. We've got a very experienced leadership team and look forward to updating all of you on what comes next in the remaining months of 2024 and 2025. I'm happy to take any questions. Awesome. Even though it's kind of black, so we take... But are you-- Yes, it's a great question, and probably a hundred million dollar question, at least, maybe hundreds. We have a PLA code for CMS for $750. We don't talk about pricing otherwise. Of course, we want to make it accessible. We have a patient access program that, depending on income, if the mother can pay for the test herself, we'll offer up to 90% discount, you know, for the test. And we are going to offer self-pay for the test in order to broaden access. I don't know if you knew, but in over 30% of rural counties in the United States, there's no hospital-grade obstetric care. So for those because of shortage of staff in obstetric care. So for those mothers in particular, they need to know if they need to be near a NICU because they are at higher risk for preterm birth. Sometimes if something does go wrong in those pregnancies, it goes really wrong because they cannot get to a NICU quickly or to a hospital quickly. So that's why we're pushing on different availability across channels of this test: self-pay, through employers, through physicians' offices, and through payer coverage. So the cost to the commercial payer, to the physician through the office, to the individual, of course, will range depending on the contract we have. But we're looking to make it as accessible as possible. In terms of COGS, you know, cost could be cost to the patient, as well as cost for us to produce and recover, we've made great strides this year by implementing an updated LC-MS technology on how to process the test and analyze the results, and we'll realize up to 60% reduction in our cost to deliver the result, so we're really poised for scaling and look forward to starting to contract next year for the test. As a matter of fact, you know, as soon as we start signing the contracts, we'll try and make the early successes public so that you can see the uptake. But it's really exciting how much the maternal-fetal medicine specialists that have participated in studies with us believe in the test. They want to make the test available to everyone in their practice. How do we lobby? Which is the second part of your question. We have a really broad advisory board of maternal-fetal medicine specialists, and in this country, there are two guideline-setting bodies: ACOG, American College of Obstetricians and Gynecologists, and Maternal-Fetal Medicine Society, SMFM. And, of course, those physicians, MFMs, who treat higher-risk mothers are really on board with us and have been incredibly helpful rallying their community around this test. They talk about this test as a breakthrough they haven't seen in decades. So we're looking forward to leveraging their buy-in to go to guideline-setting bodies, to go to payers with us and make sure that this happens. I do think the current administration's TMaH program, I don't know how many of you have heard about it. It's about $500 million this administration set aside for improvement of maternal care. It will be granted for 10 years to 15 states to experiment with innovative modes of care, like our test. We can really be part of the solution. They will also support risk stratification tools, innovative care delivery specialists like doulas and midwives, as well as patient-physician shared decision-making tools, like PreTRM test, to ensure that mothers comply with the treatment protocol. Of course, when they see a blood test, it's a lot easier to convince a mom to take a pill every day than if you just say, "You know what? You might be at higher risk for preterm birth." But if you're otherwise healthy, it's gonna be harder. So that's why we think that a test is going to be really helpful in prevention. Yes? What are you guys doing on the sales and marketing, and then function too? A lot of important campaigns. So number one, through platforms like Doximity, we're going to run a really broad education campaign to reach 80%-90% of physicians in this country with AVERT and PRIME study results. We think that's incredibly important for the physicians to quickly understand how effective this test and treat strategy is. We will not forget the moms either. We will do a broad media push. We're actually airing on Viewpoint program with Dennis Quaid on prime television in October, and again, an Empowered program with Meg Ryan in January. So that is going to help create the surround sound because, of course, OB-GYNs are also consumers, and we want them to see it from multiple directions. There is a huge social media push. Of course, we will work with societies at the upcoming spring meetings. There's three of them: SMFM in January, SRI in March, and ACOG in May. That is going to be incredibly important. We will be at least in one of these meetings to present it to the community and really drive the effort. We do think that this state-specific push, where we partner with the provider and the payer, payers, in the community to achieve density of adoption, because I do want to showcase how important it is to screen a broad swath of women, because, of course, payers will say, "How can we stratify and not apply it to the 80% of women? But let's just do first-time moms, or let's do some other, maybe only Medicaid moms." But it's really important to screen as many as we can because, again, there are no other symptoms, and this can happen to anyone. It is truly a no-brainer, and that's why we want to get it into clinics, demonstrate, publish the economic results, show again and again in real world, clinic by clinic, here's what they achieved in terms of NICU day savings. Go to states, have the state Medicaid director present at the state Medicaid conference what they were able to achieve. This will be really our strategy, where individual voices should carry nationwide and have conversations state by state. Yeah. [audio distortion] 18-21. I'll tell you exactly why. We heard because so many babies are born on Medicaid, the Medicaid population presents later in the pregnancy. We didn't want to make the window too early. It needs to be early enough for the treatment bundle to make a big difference. [audio distortion] You know, it's, yeah. So it's actually. We want a healthy baby, and in the first trimester, there are other risks to pregnancy. One out of three pregnancies in this country have a major complication, one out of two, that includes miscarriage. So in the first trimester, you want to make sure that the pregnancy viability is there, and then in trimester two, you start addressing potential complications. So that's why we thought this is a sweet spot. Most pregnancies, by second trimester, identify that a woman is pregnant, and therefore, physicians are ready to really start potential treatment if it's at higher risk for preterm birth. Fantastic conversation. I love the questions. Sorry for running over. No. Thank you so much.