NASDAQ:SERA Sera Prognostics Q3 2024 Earnings Report $2.88 -0.03 (-1.03%) As of 12:52 PM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast Sera Prognostics EPS ResultsActual EPS-$0.24Consensus EPS -$0.22Beat/MissMissed by -$0.02One Year Ago EPS-$0.23Sera Prognostics Revenue ResultsActual Revenue$0.03 millionExpected Revenue$0.09 millionBeat/MissMissed by -$60.00 thousandYoY Revenue GrowthN/ASera Prognostics Announcement DetailsQuarterQ3 2024Date11/6/2024TimeAfter Market ClosesConference Call DateWednesday, November 6, 2024Conference Call Time5:00PM ETUpcoming EarningsSera Prognostics' Q1 2025 earnings is scheduled for Wednesday, May 14, 2025, with a conference call scheduled on Wednesday, May 7, 2025 at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Sera Prognostics Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 6, 2024 ShareLink copied to clipboard.There are 5 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Sarah Prognostics Conference Call to review Third Quarter Fiscal Year 20 24 Results. At this time, all participants are in a listen only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, the call is being recorded for replay purposes. I would now like to turn the call over to Peter Donardo of CAPCOM Partners for a few introductory comments. Speaker 100:00:30Thank you, operator. Good afternoon, everyone. Welcome to Serra Prognostic's 3rd quarter fiscal year 2024 earnings conference call. At the close of the market today, Serra Prognostic released its financial results for the quarter ended September 30, 2024. Presenting for the company today will be Zhenya Lingard, President and CEO and Austin Ayers, our CFO. Speaker 100:00:53During the call, we will review the financial results we released today, after which we will host a question and answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.com and a recording will be archived in the Investors section of our website. Please note that some of the information presented today may contain projections or other forward looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results and market trends and opportunities. These statements are based on management's current expectations and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. Speaker 100:01:41We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10 ks, its quarterly reports on Form 10 Q and its current reports on Form 8 ks. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward looking statements. As a reminder, a webcast replay of this call will be available on the Investors section of our website. I will now turn the call over to Zhenya, Theraprognostics' President and CEO. Zhenya? Speaker 200:02:19Thank you so much, Peter, and good afternoon, everyone. We're solidly executing our plan for the year to support increases and test adoption and revenue. This plan, which we've communicated previously, focuses on publication of our clinical trial results, building awareness of preterm birth screening risks and sera solutions, increasing payer coverage, making it easier to access our test, putting scalability in place to harness that growth. Once established, these prerequisites are expected to be the engine of our growth, fueled by the critical need we can and will fulfill in improving maternal health care outcomes for mothers and babies. Following the publication of our positive AVERT preterm trial results on the front cover of the July issue of the international peer reviewed journal Diagnostics, we are eagerly pursuing publication of PRIME results. Speaker 200:03:13As we discussed last quarter, we are now seeking publication of these results in the key pregnancy and maternal health conferences in the spring and a manuscript submission to a high quality peer reviewed journal. The AVERT publication solidly demonstrated that the health risks of babies can be improved in asymptomatic pregnant mothers without typical risk factors. We believe publication of the final PRIME clinical study results could prove even more compelling in supporting the benefits of our preterm test coupled with a 10th and treat program. We locked our database a few weeks ago and are actively working towards publication and abstract submissions. We will update you as more news becomes available on our progress. Speaker 200:03:59While we await this further evidence to become available, we've made progress towards other prerequisites that are required to grow our business commercially. Before I lay out updates to our commercialization progress, I'd like to take a moment to detail how significant the health care problem is that we are addressing and how it represents a huge opportunity for Thera to affect positive change. 1 in 10 babies is born prematurely in the United States and that is increasing. In fact, a recent CDC study found the rate to have risen 12% between 2014 2022. However, most Americans, about 71% are unaware that the rates of infant mortality are higher in the U. Speaker 200:04:41S. Than in other developed countries. Furthermore, 60% don't know that the U. S. Has the highest rate of maternal mortality among such developed countries and about 1 in 4 Americans incorrectly believe it does not. Speaker 200:04:55This shows the extent of the clinical problem and lack of awareness among consumers. And we can do better, certainly for one of the most innovative and advanced countries in the world. Toward that end, we can truly make a difference through education, awareness and Sarah's unique technology to solve this growing problem. We have doubled down on engaging all of our key stakeholders. For example, we've enlisted expert consulting advice on the best strategies and tactics to reach payers through preparing strong evidence in our ongoing dialogue with payers. Speaker 200:05:31As I mentioned on our last call, we've initiated and are continuing education programs with the leading platform for U. S. Medical professionals with more than 80% of United States doctors and 50% of nurse practitioners and physician assistants as members. The first campaign had great engagement across a series of 3 targeted e mails. The first e mail had an open rate of 9% the second, 48% and the 3rd and final, 70%. Speaker 200:06:01If you know anything about e mail marketing, these were stellar results and show that our message is resonating and was effective. Armed with the AVERT publication, we began a second campaign on this platform around mid October. And after just a few days, the data indicated that 9% of our targeted contacts were deeply engaged. We believe these types of campaigns will be a key component of physician demand generation going forward. Beyond reaching out to physicians to create broad awareness, including among consumers, we also have now activated our TV campaign with programs Viewpoint with Dennis Quaid and EMPowered with MedRyan. Speaker 200:06:42These programs are expected to be distributed to public television stations in all 50 states and in over 84,000,000 homes via MSNBC, CNBC, CNN or similar networks broadly supporting Sarah's goal of informing the public about our preterm test and how it can drive improved pregnancy outcomes. Adding to this, we have been executing social media and email campaigns to broaden our product visibility to build adoption across our defined sales channels. Effective October 1, we made the preterm test available for order from our website for home delivery of the collection kit, where expectant mothers can use our new ambient whole blood collection kit and mail it to Sarah's lab. Following the confirmation of the order by a physician, patients will receive the results to be discussed with their health care provider. Time Magazine highlighted this broadened access to the preterm test we made available through the CERA website in October and we're pleased with that exposure in this broadly distributed publication. Speaker 200:07:50Complementing this is, of course, our awareness campaign to encourage consumers to ask their physician about the test or to seek it out on their own via our website patient portal. We've already received a lot of interest following making preterm available for ordering online. In comparison to last year in September, our preterm.com site saw a 2 27% traffic increase. We are excited by the channel opportunity it presents, and we have implemented patient access programs that we believe will enable more mothers to get the test. Beyond these implemented programs in the commercial front, while exercising great care in where we're spending money on staff and technical growth activities, we have selectively strengthened our capabilities and revenue cycle, sales and marketing, market access, regulatory staff members. Speaker 200:08:49This is the result of bringing on a few key hires and consultants focused on enabling future growth. Furthering our strategy to build relationship with women who are pregnant or planning to become pregnant, we've shared with you before our plans to launch an education tool, which leverages predictive analytics to inform expectant mothers about risk factors of preterm birth. I'm pleased to note that this tool is now in beta testing. It is a website where women can explore informative reports based on the data from millions of pregnancy experiences and glean personalized insights into pregnancies like theirs. This will not only educate the likelihood of outcomes based on different pregnancy characteristics, but also establish awareness of Thera product offerings and roles Thera solutions can play in leading positive change in addressing birth health risks. Speaker 200:09:42We believe these predictive analytics tools could have a standalone value as a product, but also maybe a powerful digital front door to our biomarker testing products. We will continue to develop our time to birth products and with multiple offerings for pregnant moms, this portfolio will allow us to generate multiple journeys to Sarah's solutions for pregnant moms. Let me now take a moment to discuss care guidelines, which are an essential part of delivering the benefits of preterm to identify mothers at risk and addressing riskier pregnancies through better informed care. The development of guidelines takes time. For example, in the case of American College of Obstetrics and Gynecologists or ACOG, their development of clinical practice guidelines is a process that typically spans 24 to 36 months from initial topic selection to final publication. Speaker 200:10:34So we've spent considerable time reviewing past guideline changes to prepare for meetings with stakeholders and policymakers next year. This has been well informed by consultants and key experts and we're convening the right groups and focusing on what matters the most, the quality of our evidence and data. When PRIME results are published paired with the awareness campaigns we've already launched and more in the pipeline, we believe we will be fully ready to further engage with the medical community in helping set the guidelines and standards of care necessary to support healthier babies among those at risk. Hand in hand with making progress towards care guidelines is making sure that we continue to have solid quality and rigor in our testing and lab processing from a regulatory standpoint. As many of you know, the FDA published its final rule on laboratory developed tests in late April. Speaker 200:11:28This rule has already seen some legal challenges by various parties. While the outcome of this may not be known until at least the Q1 of next year, we have been taking steps to ensure preterm remains compliant. As a result, we have expanded Sarah's expertise to prepare for engagement with regulatory authorities and are confident in our prior quality controls and reliability of test outcomes. In summary, to date, this has been a very busy year for FASERRA with successful execution of our stated goals thus far to back our growth plans. There is more to be done, but we are pleased with our progress and fortifying our commercial organization to ramp revenue when all necessary prerequisites for growth are aligned and we are ready to expand sales and shareholder value. Speaker 200:12:21Now, I'll turn the call over to Austin for a finance update. Speaker 300:12:25Thanks, Sanya, and good afternoon, everyone. Let me review our financial results for the quarter. Afterward, I'll briefly touch on our view of managing operating expenses, while investing where we need to such that once our prerequisites have been achieved, we can begin accelerating towards revenue growth. Net revenue for the Q3 of 2024 was $29,000 compared to $42,000 for the same period a year ago. Our plan for the year has called for making very careful, cost effective and select investments that we believe will drive commercial sales to a higher magnitude in future quarters and this quarterly revenue level reflects that plan accordingly. Speaker 300:13:03With that in mind, total operating expenses for the Q3 of $8,900,000 were up 8% from $8,200,000 for the same period a year ago. Net loss for the quarter was up 10% to $7,900,000 compared to $7,200,000 for the Q3 of 2023. About 2 thirds of the increased operating costs and net loss year over year was due to an increase in non cash stock compensation expense due to our higher stock price. Adjusting for this, our cost and net loss were relatively flat year over year with only a modest 3% increase. Research and development expenses were $3,500,000 and approximately flat with the Q3 of 2023. Speaker 300:13:46Selling, general and administrative expenses for the Q3 were $5,400,000 and up from $4,600,000 for the same period a year ago due primarily to our selected investment in anticipated growth drivers, costs associated with filing our shelf registration and increased stock compensation expense. As of September 30, 2024, the company had cash, cash equivalents and available for sale securities of approximately $74,300,000 In 2024, our gross cash expense is expected to be less than $30,000,000 with many of our expenses focused on evidence generation, building foundations for scalability and awareness, making select investments in market broadening opportunities, enhancing some of our commercial capabilities and product development. As we begin planning for the year ahead, we are targeting gross cash expenses to remain under that threshold, while we begin allocating more towards commercial activity than in 2024. Therefore, with the projected year end cash balance of approximately $68,000,000 we believe we have cash into 2027 before assuming any future revenues. Operator, we can now open the call for questions. Operator00:14:53Thank you. Ladies and gentlemen, we will now begin the question and answer Andrew Brackman from William Blair. Please go ahead. Speaker 400:15:27Great. Good afternoon. Thanks for taking the questions. Hi, Genia. Hi, Austin. Speaker 400:15:31Maybe on your comments related to sort of the timing precedent here for guidelines. First, could you maybe just clarify your timeline expectations here for preterm? And I guess secondly, I know a lot is not in your control with respect to these guideline bodies actually moving it through their own processes. But can you maybe sort of talk about the levers that are in your control how you're ensuring to make that process go smoothly and hopefully quickly? Speaker 200:16:00Definitely. Thank you so much for your question, Andrew. Good to hear you. ACOG frequently looks at other guideline bodies, for example, in this case, Society For Maternal and Fetal Medicine, SMSM to inform their position. And there is an existing ACOG bulletin with guidelines. Speaker 200:16:27So they will not be developing it from white space, de novo. It would be a consideration for an update, which frequently starts with a commentary letter on a publication. That would be the first meaningful milestone to look out for. Society For Maternal Fetal Medicine typically comments on 20, 30 publications a year. We are excited about PRIME results and we of course will be eagerly waiting to see the reaction of the society to our results as the first green shoot. Speaker 200:17:11The common next milestones would include practice advisory or a practice bulletin. Those usually come later as the questions from the community to the society come up on what is the position of the society on care guidelines of this innovation. We think again, we don't have a crystal ball unfortunately, but we think that that will come in time. But of course, it will start with a key milestone, prime peer reviewed publication. Until that event, we don't expect any significant signals from the societies, SMFM or ACOG. Speaker 200:18:04We should also consider and are developing strategies for other USPS task force for example and we'll keep the community updated on our progress towards these. Overall, the number one lever is the quality of our data, Andrew, to your question what can we control. And that's why we invested so much in our pivotal PRIME study to make sure that the quality of that evidence, the quality of the analytical methods, the input we got and the work of the PIs in that study will speak for itself to the guideline setting body influencers. Speaker 400:18:52Terrific. And then I just want to go back to your comments sort of around your discussion or ongoing discussions with payers. Maybe just sort of talk to us about this at a high level. I guess from your perspective, what gets them across the finish line here? Will it be prime results? Speaker 400:19:10Will it be something else? It seems to me that this is a test that sort of makes common sense for them to bring under coverage. So in your view, what sort of gets them to move there? Thanks. Speaker 200:19:22Absolutely. Program Minimum is a quality peer reviewed publication, which Prime will be and of course coupled with AVERT, it will be really strong evidence base for the potential of preterm test and treat program. 2nd, of course, is the economic modeling. Here, we're very fortunate to have a few tools to make available for payers. Number 1, of course, is Elavance modeling of their own population that delivered results published results of $1600 of savings per member tested on about 40,000 members they've modeled. Speaker 200:20:06Our partners, ELEVANCE, will also be modeling economic impact on the PRIME study subjects that were elavance members and that will be additional evidence that will absolutely be considered by all the other payers reviewing the preterm test for coverage. We also put together a model we'll make available as we begin discussions with all of the payers where they can put in their own cost of care and members' characteristics so that they can see what covering preterm tests can do for their cost of care reductions and cost savings, as well as the potential to improve care in some of their Medicaid plans. So those two key levers will be absolutely essential. And as you can imagine, we're working very hard on a great peer reviewed publication of PRIME. And as I described, we have a really strong economic evidence to put in front of payers. Speaker 200:21:12With that, I think there will be particular payers and we are happy to talk more about that next quarter that will jump on the opportunity for cost of care savings early. Others will follow. It will be a process over many years, but we hope that that process will start robustly post prime publication. Speaker 400:21:37Perfect. Thanks for taking the question. Speaker 200:21:40Thanks for the question, Andrew. Operator00:22:31There are no further questions at this time. I'd now like to turn the call over to Zhenya Lindgaard for final closing comments. Speaker 200:22:40Thank you, operator. Thank you so much everyone for attending our call today. We look forward to the expected publication of our pivotal PRIME clinical study results and continuing to propel our company towards commercial success. Although we have plenty of work to do in the final weeks of 2024, this has been a great year for Cerro Prognostics and we thank our shareholders for their support. I'll now turn it back over to the operator to conclude the call. Speaker 200:23:05Operator?Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallSera Prognostics Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Sera Prognostics Earnings HeadlinesSera Prognostics Announces Conference Call and Webcast of First Quarter Fiscal Year 2025 Financial Results on May 7, 2025April 24, 2025 | prnewswire.comSera Prognostics: Initiating With Hold, Potential Of PreTRM Test, But Uncertain Commercial TimelineApril 15, 2025 | seekingalpha.comSilicon Valley Gold RushA new technology has sparked a modern-day gold rush in Silicon Valley. OpenAI’s Sam Altman invested $375M. Bill Gates has backed four companies in this space. The World Economic Forum calls it “the most exciting human discovery since fire.” Whitney Tilson believes this trend could mint a new class of wealthy investors—and he’s sharing one stock to watch now, for free.May 5, 2025 | Stansberry Research (Ad)Sera Prognostics Earnings Call: Balancing Success and ChallengesMarch 21, 2025 | tipranks.comSera Prognostics, Inc.: Sera Prognostics Reports Fourth Quarter 2024 Financial ResultsMarch 21, 2025 | finanznachrichten.deEarnings call transcript: Sera Prognostics Q4 2024 sees revenue drop, stock risesMarch 21, 2025 | uk.investing.comSee More Sera Prognostics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Sera Prognostics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Sera Prognostics and other key companies, straight to your email. Email Address About Sera PrognosticsSera Prognostics (NASDAQ:SERA), a women's health diagnostic company, discovers, develops, and commercializes biomarker tests for improving pregnancy outcomes in the United States. The company develops PreTRM test, a blood-based biomarker test to predict the risk of spontaneous preterm birth in singleton pregnancies. It is also developing a portfolio of product candidates for various pregnancy-related conditions, including preterm birth, preeclampsia, molecular time-to-birth, predictive analytics, gestational diabetes mellitus, fetal growth restriction, stillbirth, and postpartum depression. The company was incorporated in 2008 and is headquartered in Salt Lake City, Utah.View Sera Prognostics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback Plan Upcoming Earnings American Electric Power (5/6/2025)Advanced Micro Devices (5/6/2025)Marriott International (5/6/2025)Constellation Energy (5/6/2025)Arista Networks (5/6/2025)Brookfield Asset Management (5/6/2025)Duke Energy (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Ferrari (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 5 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Sarah Prognostics Conference Call to review Third Quarter Fiscal Year 20 24 Results. At this time, all participants are in a listen only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, the call is being recorded for replay purposes. I would now like to turn the call over to Peter Donardo of CAPCOM Partners for a few introductory comments. Speaker 100:00:30Thank you, operator. Good afternoon, everyone. Welcome to Serra Prognostic's 3rd quarter fiscal year 2024 earnings conference call. At the close of the market today, Serra Prognostic released its financial results for the quarter ended September 30, 2024. Presenting for the company today will be Zhenya Lingard, President and CEO and Austin Ayers, our CFO. Speaker 100:00:53During the call, we will review the financial results we released today, after which we will host a question and answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.com and a recording will be archived in the Investors section of our website. Please note that some of the information presented today may contain projections or other forward looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results and market trends and opportunities. These statements are based on management's current expectations and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. Speaker 100:01:41We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10 ks, its quarterly reports on Form 10 Q and its current reports on Form 8 ks. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward looking statements. As a reminder, a webcast replay of this call will be available on the Investors section of our website. I will now turn the call over to Zhenya, Theraprognostics' President and CEO. Zhenya? Speaker 200:02:19Thank you so much, Peter, and good afternoon, everyone. We're solidly executing our plan for the year to support increases and test adoption and revenue. This plan, which we've communicated previously, focuses on publication of our clinical trial results, building awareness of preterm birth screening risks and sera solutions, increasing payer coverage, making it easier to access our test, putting scalability in place to harness that growth. Once established, these prerequisites are expected to be the engine of our growth, fueled by the critical need we can and will fulfill in improving maternal health care outcomes for mothers and babies. Following the publication of our positive AVERT preterm trial results on the front cover of the July issue of the international peer reviewed journal Diagnostics, we are eagerly pursuing publication of PRIME results. Speaker 200:03:13As we discussed last quarter, we are now seeking publication of these results in the key pregnancy and maternal health conferences in the spring and a manuscript submission to a high quality peer reviewed journal. The AVERT publication solidly demonstrated that the health risks of babies can be improved in asymptomatic pregnant mothers without typical risk factors. We believe publication of the final PRIME clinical study results could prove even more compelling in supporting the benefits of our preterm test coupled with a 10th and treat program. We locked our database a few weeks ago and are actively working towards publication and abstract submissions. We will update you as more news becomes available on our progress. Speaker 200:03:59While we await this further evidence to become available, we've made progress towards other prerequisites that are required to grow our business commercially. Before I lay out updates to our commercialization progress, I'd like to take a moment to detail how significant the health care problem is that we are addressing and how it represents a huge opportunity for Thera to affect positive change. 1 in 10 babies is born prematurely in the United States and that is increasing. In fact, a recent CDC study found the rate to have risen 12% between 2014 2022. However, most Americans, about 71% are unaware that the rates of infant mortality are higher in the U. Speaker 200:04:41S. Than in other developed countries. Furthermore, 60% don't know that the U. S. Has the highest rate of maternal mortality among such developed countries and about 1 in 4 Americans incorrectly believe it does not. Speaker 200:04:55This shows the extent of the clinical problem and lack of awareness among consumers. And we can do better, certainly for one of the most innovative and advanced countries in the world. Toward that end, we can truly make a difference through education, awareness and Sarah's unique technology to solve this growing problem. We have doubled down on engaging all of our key stakeholders. For example, we've enlisted expert consulting advice on the best strategies and tactics to reach payers through preparing strong evidence in our ongoing dialogue with payers. Speaker 200:05:31As I mentioned on our last call, we've initiated and are continuing education programs with the leading platform for U. S. Medical professionals with more than 80% of United States doctors and 50% of nurse practitioners and physician assistants as members. The first campaign had great engagement across a series of 3 targeted e mails. The first e mail had an open rate of 9% the second, 48% and the 3rd and final, 70%. Speaker 200:06:01If you know anything about e mail marketing, these were stellar results and show that our message is resonating and was effective. Armed with the AVERT publication, we began a second campaign on this platform around mid October. And after just a few days, the data indicated that 9% of our targeted contacts were deeply engaged. We believe these types of campaigns will be a key component of physician demand generation going forward. Beyond reaching out to physicians to create broad awareness, including among consumers, we also have now activated our TV campaign with programs Viewpoint with Dennis Quaid and EMPowered with MedRyan. Speaker 200:06:42These programs are expected to be distributed to public television stations in all 50 states and in over 84,000,000 homes via MSNBC, CNBC, CNN or similar networks broadly supporting Sarah's goal of informing the public about our preterm test and how it can drive improved pregnancy outcomes. Adding to this, we have been executing social media and email campaigns to broaden our product visibility to build adoption across our defined sales channels. Effective October 1, we made the preterm test available for order from our website for home delivery of the collection kit, where expectant mothers can use our new ambient whole blood collection kit and mail it to Sarah's lab. Following the confirmation of the order by a physician, patients will receive the results to be discussed with their health care provider. Time Magazine highlighted this broadened access to the preterm test we made available through the CERA website in October and we're pleased with that exposure in this broadly distributed publication. Speaker 200:07:50Complementing this is, of course, our awareness campaign to encourage consumers to ask their physician about the test or to seek it out on their own via our website patient portal. We've already received a lot of interest following making preterm available for ordering online. In comparison to last year in September, our preterm.com site saw a 2 27% traffic increase. We are excited by the channel opportunity it presents, and we have implemented patient access programs that we believe will enable more mothers to get the test. Beyond these implemented programs in the commercial front, while exercising great care in where we're spending money on staff and technical growth activities, we have selectively strengthened our capabilities and revenue cycle, sales and marketing, market access, regulatory staff members. Speaker 200:08:49This is the result of bringing on a few key hires and consultants focused on enabling future growth. Furthering our strategy to build relationship with women who are pregnant or planning to become pregnant, we've shared with you before our plans to launch an education tool, which leverages predictive analytics to inform expectant mothers about risk factors of preterm birth. I'm pleased to note that this tool is now in beta testing. It is a website where women can explore informative reports based on the data from millions of pregnancy experiences and glean personalized insights into pregnancies like theirs. This will not only educate the likelihood of outcomes based on different pregnancy characteristics, but also establish awareness of Thera product offerings and roles Thera solutions can play in leading positive change in addressing birth health risks. Speaker 200:09:42We believe these predictive analytics tools could have a standalone value as a product, but also maybe a powerful digital front door to our biomarker testing products. We will continue to develop our time to birth products and with multiple offerings for pregnant moms, this portfolio will allow us to generate multiple journeys to Sarah's solutions for pregnant moms. Let me now take a moment to discuss care guidelines, which are an essential part of delivering the benefits of preterm to identify mothers at risk and addressing riskier pregnancies through better informed care. The development of guidelines takes time. For example, in the case of American College of Obstetrics and Gynecologists or ACOG, their development of clinical practice guidelines is a process that typically spans 24 to 36 months from initial topic selection to final publication. Speaker 200:10:34So we've spent considerable time reviewing past guideline changes to prepare for meetings with stakeholders and policymakers next year. This has been well informed by consultants and key experts and we're convening the right groups and focusing on what matters the most, the quality of our evidence and data. When PRIME results are published paired with the awareness campaigns we've already launched and more in the pipeline, we believe we will be fully ready to further engage with the medical community in helping set the guidelines and standards of care necessary to support healthier babies among those at risk. Hand in hand with making progress towards care guidelines is making sure that we continue to have solid quality and rigor in our testing and lab processing from a regulatory standpoint. As many of you know, the FDA published its final rule on laboratory developed tests in late April. Speaker 200:11:28This rule has already seen some legal challenges by various parties. While the outcome of this may not be known until at least the Q1 of next year, we have been taking steps to ensure preterm remains compliant. As a result, we have expanded Sarah's expertise to prepare for engagement with regulatory authorities and are confident in our prior quality controls and reliability of test outcomes. In summary, to date, this has been a very busy year for FASERRA with successful execution of our stated goals thus far to back our growth plans. There is more to be done, but we are pleased with our progress and fortifying our commercial organization to ramp revenue when all necessary prerequisites for growth are aligned and we are ready to expand sales and shareholder value. Speaker 200:12:21Now, I'll turn the call over to Austin for a finance update. Speaker 300:12:25Thanks, Sanya, and good afternoon, everyone. Let me review our financial results for the quarter. Afterward, I'll briefly touch on our view of managing operating expenses, while investing where we need to such that once our prerequisites have been achieved, we can begin accelerating towards revenue growth. Net revenue for the Q3 of 2024 was $29,000 compared to $42,000 for the same period a year ago. Our plan for the year has called for making very careful, cost effective and select investments that we believe will drive commercial sales to a higher magnitude in future quarters and this quarterly revenue level reflects that plan accordingly. Speaker 300:13:03With that in mind, total operating expenses for the Q3 of $8,900,000 were up 8% from $8,200,000 for the same period a year ago. Net loss for the quarter was up 10% to $7,900,000 compared to $7,200,000 for the Q3 of 2023. About 2 thirds of the increased operating costs and net loss year over year was due to an increase in non cash stock compensation expense due to our higher stock price. Adjusting for this, our cost and net loss were relatively flat year over year with only a modest 3% increase. Research and development expenses were $3,500,000 and approximately flat with the Q3 of 2023. Speaker 300:13:46Selling, general and administrative expenses for the Q3 were $5,400,000 and up from $4,600,000 for the same period a year ago due primarily to our selected investment in anticipated growth drivers, costs associated with filing our shelf registration and increased stock compensation expense. As of September 30, 2024, the company had cash, cash equivalents and available for sale securities of approximately $74,300,000 In 2024, our gross cash expense is expected to be less than $30,000,000 with many of our expenses focused on evidence generation, building foundations for scalability and awareness, making select investments in market broadening opportunities, enhancing some of our commercial capabilities and product development. As we begin planning for the year ahead, we are targeting gross cash expenses to remain under that threshold, while we begin allocating more towards commercial activity than in 2024. Therefore, with the projected year end cash balance of approximately $68,000,000 we believe we have cash into 2027 before assuming any future revenues. Operator, we can now open the call for questions. Operator00:14:53Thank you. Ladies and gentlemen, we will now begin the question and answer Andrew Brackman from William Blair. Please go ahead. Speaker 400:15:27Great. Good afternoon. Thanks for taking the questions. Hi, Genia. Hi, Austin. Speaker 400:15:31Maybe on your comments related to sort of the timing precedent here for guidelines. First, could you maybe just clarify your timeline expectations here for preterm? And I guess secondly, I know a lot is not in your control with respect to these guideline bodies actually moving it through their own processes. But can you maybe sort of talk about the levers that are in your control how you're ensuring to make that process go smoothly and hopefully quickly? Speaker 200:16:00Definitely. Thank you so much for your question, Andrew. Good to hear you. ACOG frequently looks at other guideline bodies, for example, in this case, Society For Maternal and Fetal Medicine, SMSM to inform their position. And there is an existing ACOG bulletin with guidelines. Speaker 200:16:27So they will not be developing it from white space, de novo. It would be a consideration for an update, which frequently starts with a commentary letter on a publication. That would be the first meaningful milestone to look out for. Society For Maternal Fetal Medicine typically comments on 20, 30 publications a year. We are excited about PRIME results and we of course will be eagerly waiting to see the reaction of the society to our results as the first green shoot. Speaker 200:17:11The common next milestones would include practice advisory or a practice bulletin. Those usually come later as the questions from the community to the society come up on what is the position of the society on care guidelines of this innovation. We think again, we don't have a crystal ball unfortunately, but we think that that will come in time. But of course, it will start with a key milestone, prime peer reviewed publication. Until that event, we don't expect any significant signals from the societies, SMFM or ACOG. Speaker 200:18:04We should also consider and are developing strategies for other USPS task force for example and we'll keep the community updated on our progress towards these. Overall, the number one lever is the quality of our data, Andrew, to your question what can we control. And that's why we invested so much in our pivotal PRIME study to make sure that the quality of that evidence, the quality of the analytical methods, the input we got and the work of the PIs in that study will speak for itself to the guideline setting body influencers. Speaker 400:18:52Terrific. And then I just want to go back to your comments sort of around your discussion or ongoing discussions with payers. Maybe just sort of talk to us about this at a high level. I guess from your perspective, what gets them across the finish line here? Will it be prime results? Speaker 400:19:10Will it be something else? It seems to me that this is a test that sort of makes common sense for them to bring under coverage. So in your view, what sort of gets them to move there? Thanks. Speaker 200:19:22Absolutely. Program Minimum is a quality peer reviewed publication, which Prime will be and of course coupled with AVERT, it will be really strong evidence base for the potential of preterm test and treat program. 2nd, of course, is the economic modeling. Here, we're very fortunate to have a few tools to make available for payers. Number 1, of course, is Elavance modeling of their own population that delivered results published results of $1600 of savings per member tested on about 40,000 members they've modeled. Speaker 200:20:06Our partners, ELEVANCE, will also be modeling economic impact on the PRIME study subjects that were elavance members and that will be additional evidence that will absolutely be considered by all the other payers reviewing the preterm test for coverage. We also put together a model we'll make available as we begin discussions with all of the payers where they can put in their own cost of care and members' characteristics so that they can see what covering preterm tests can do for their cost of care reductions and cost savings, as well as the potential to improve care in some of their Medicaid plans. So those two key levers will be absolutely essential. And as you can imagine, we're working very hard on a great peer reviewed publication of PRIME. And as I described, we have a really strong economic evidence to put in front of payers. Speaker 200:21:12With that, I think there will be particular payers and we are happy to talk more about that next quarter that will jump on the opportunity for cost of care savings early. Others will follow. It will be a process over many years, but we hope that that process will start robustly post prime publication. Speaker 400:21:37Perfect. Thanks for taking the question. Speaker 200:21:40Thanks for the question, Andrew. Operator00:22:31There are no further questions at this time. I'd now like to turn the call over to Zhenya Lindgaard for final closing comments. Speaker 200:22:40Thank you, operator. Thank you so much everyone for attending our call today. We look forward to the expected publication of our pivotal PRIME clinical study results and continuing to propel our company towards commercial success. Although we have plenty of work to do in the final weeks of 2024, this has been a great year for Cerro Prognostics and we thank our shareholders for their support. I'll now turn it back over to the operator to conclude the call. Speaker 200:23:05Operator?Read morePowered by