Q4 2024 Sera Prognostics Inc Earnings Call

As a reminder, this call is being recorded for replay purposes, I would now like to turn the call over to Peter Denardo of cap Com partners for a few introductory comments.

Thank you operator, good afternoon, everyone welcome to Sara Prognostics fourth quarter fiscal year 2024 earnings conference call at the close of the market today, there are prognostics worthy its financial results for the quarter and full year ended December 31 2024.

Speaker Change: Lending for the company today will be Daniel Linde Guard, President and CEO and Austin, Eric <unk>, our CFO during 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.

Speaker Change: Dot com this call can be heard Wi Fi webcast at <unk> 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.

Austin Aerts: We previously communicated that our expectation that 2024 gross cash expense would be less than $30 million. We're pleased that our careful cash management during the year resulted in a gross cash expense of about $28.6 million. For 2025, which will be a year of building our business commercially, our targeted range for cash operating expenses is $30 to $35 million. With the expectation of Prime being published, we see this as a pivotal year in which to pursue engagement with and adoption by key stakeholders. As a result, this increase in operating expense is primarily driven by planned new and significant investments in commercialization. While we remain steadfast in prudent oversight of our capital resources, we have begun investing in both broad awareness and targeted education campaigns to begin to build adoption of the PreTRM Test on the heels of exciting Prime study data.

Speaker Change: Good afternoon, and welcome to the Sera Prognostics Conference call to review 4th quarter fiscal year 2024 results. At this time, all participants are in listen only mode.

Speaker Change: Financial results and market trends and opportunity. 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. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's Andy.

Speaker Change: We will be facilitating a question and answer session towards the end of today's call.

Speaker Change: As a reminder, this call is being recorded. Welcome to Sera Prognostics' fourth quarter fiscal year 2024 earnings conference call in December 31, 2024.

Speaker Change: We'll report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on form 8-K. 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.

Speaker Change: 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 Shane yet there are prognostic president and CEO Jenny.

Austin Aerts: Once we have published Prime data, we will expand our investment where we believe the commercial opportunities have the highest likelihood of near-term success and return on investment for our business. The amount we ultimately invest in 2025 will be dictated by the timing of a Prime publication and the commercial opportunities presented for PreTRM and potentially our pipeline. Operator, we can now please open the call for questions.

Speaker Change: Thank you Peter and good afternoon, everyone.

Speaker Change: During 2024 and starting strong in 2025, we effectively executed on our stated plan of putting in place the necessary steps to grow <unk> business and shareholder value.

Speaker Change: That included building, our evidenced portfolio building awareness and seeking publication of clinical trial results to drive adoption and inclusion care guidelines in the future.

Operator: Your first question comes from the line of Dan Brennan from TD Cowen. Please go ahead.

Speaker Change: I am pleased to report that we have made solid progress on each of these.

Speaker Change: We believe we're now poised to take advantage of a new phase following pivotal prime study results to pursue evidenced growth opportunities.

Speaker Change: Towards leveraging the best of these opportunities we're grateful for the support of our investors and pleased to have successfully executed our fundraise last month to help fund these endeavors.

Dan Brennan [Managing Director, Research, Health Care: Great. Thanks for the questions. Maybe just the first one on the three tenets of your plan to get into guidelines. You talked about publishing more information, providing more real-world evidence on healthcare and economic benefits, then driving clinical community adoption and getting institutions on board. Can you just elaborate a little bit on each of those and kind of things investors should be looking for in 2025 on each of those fronts, that will give people confidence that you're making progress?

Speaker Change: Added to our strong debt free balance sheet. This affords us flexibility to cost effectively invest in those with the best potential commercial return on investment to build awareness and adoption of our solution to pre term birth.

Speaker Change: Speaking of awareness, we were excited to recently share the full results of our Prime study at the society for maternal fetal medicine.

Speaker Change: 2025 pregnancy meeting on January 31, and during our virtual R&D event later that day.

Evguenia Lindgardt: Absolutely. Great question. First on the publications front. As you can imagine, with our 5,000-patient trial, Prime, we have unleashed and unearthed an enormous treasure trove of data and have 19 PIs who are currently looking at the data and have discussed plans for further analysis of the dataset and discussing half a dozen to a dozen potential topics that may end up in additional publications from Prime dataset. We think that the more value can be derived from Prime dataset in new publications, the more evidence will there be in the market about the value of the test-and-treat strategy of PreTRM Test. Of course, Prime is not the only dataset we have. We are looking forward to broader analyses from the other studies that we have conducted, namely AVERT, potentially PREVENT, and of course, any future evidence we generate. That's on the publications front.

Speaker Change: Higher to that society for maternal fetal medicine published our abstract as one of just a few late breaking ones chosen for publication. Furthermore, ours was one of just five studies for which society for maternal fetal medicine issued a press release out of about 1200 study's overall reviews in the pregnancy meeting.

Dr. Brian: Let me briefly review compelling data points, Dr. Brian <unk> maternal fetal medicine experts at the high risk pregnancy Center in Las Vegas, and principal investigator for Prime shared during the January presentation.

Speaker Change: First of all Dr. Arie <unk> recap that the Prime study was conducted at 19 locations and included an intent to treat population of 5018 patients in a randomized controlled trial designed to represent the gold standard evidenced in our portfolio.

Speaker Change: Our pre term test and treat strategy yielded statistically significant outcomes on both co primary endpoints in the Prime study with a 25% reduction in the neonatal mortality and morbidity index or <unk> and an 18% reduction in new needle length of hospital stay.

Speaker Change: Furthermore, Dr. Erin highlighted at 20% overall reduction in NICU admissions and a much reduced number needed to screen for NFS of 41 to prevent and NICU admission.

Evguenia Lindgardt: Second tenet is real-world evidence. We truly believe Learning how test performs in real world and partnering with leading institutions to study aspects of it, both in different populations, in context of health disparities, for example, will be accretive to adoption and awareness building across the clinical community. As I mentioned, we are kicking off a first real-world evidence study this year. With a preeminent institution, we will absolutely publish on the results of this study and look forward to sharing the outcomes of that work. We're planning to launch more real-world evidence trials, and generate a continuous flow of evidence on how well the test is performing.

Speaker Change: This number needed to screen compared to a number needed to screen of about 154, the cervical length screening, which is the type of screening currently recommended and guidelines for symptomatic women with a history of preterm birth.

Speaker Change: This significant reduction in NICU admissions is very important.

Speaker Change: As this is a top focus for payers and reducing health care costs for their insured patients.

Speaker Change: The NICU admission reduction showed that we are keeping one out of five babies out of the NICU with our <unk> strategy.

There are various etiologies when it comes to root causes of preterm birth in each case is patient specific as to which lever to use aspirin progesterone care management, but identifying these at risk early is informative and physicians are excited about the potential for our test to predict which mothers are more likely to do.

Speaker Change: Liver prematurely more I can be is in the current tools.

Speaker Change: Since we published this meaningful data society for maternal fetal medicine or just to continue to publish the results of prime and our prior trials to build awareness and illustrate real world utilization.

Evguenia Lindgardt: Additionally, we've launched an investigator-initiated research program at Society for Maternal-Fetal Medicine meeting in January, and are looking forward to all of the submissions review and communicating back to the investigators on the results of which studies we'll support come April of this year. We're hoping that the investigator-initiated research will also provide a lot of interesting evidence around the test that will help whenever the professional society chooses to review the policy and recommendations on preterm birth care to take into account all of the evidence that these three levers generate. The last tenet I talked about was generating clinical adoption, of course. As you can imagine, a lot of the early adopter physicians and institutions will put the test to use in real world.

Speaker Change: Ultimately, we believe there are three linchpins necessary for professional society recommendation inclusion for preterm and these are publishing more information from significant datasets derived from our studies.

Speaker Change: Providing more real world evidence of the health care and economic benefits of using our tests along with an intervention bundle.

Speaker Change: And lastly, driving clinical community adoption and bringing institutions on board that can effectively use preterm testing and based on their experience improving outcomes for months Mbv's ASP with the SMS M&A cost position on preterm test usage in guidelines.

Speaker Change: We plan to continue with our primary goal of achieving publication of the full Prime study in a peer reviewed journal in the meantime, we're continuing to build on our evidenced portfolio to corroborate our test and treat strategy in real World evidence studies. The first of which is already underway. We recently received approval by an institute.

Evguenia Lindgardt: The more adoption we generate, the more, of course, questions will be raised to the professional societies on what is their formal position on utilization of PreTRM Test and our screen and test strategy. We believe that all these three avenues of supporting evidence generation and momentum for PreTRM Test will pull forward getting to professional recommendations on how this test should be used in the community.

Speaker Change: <unk> will review board for a pre implementation study at a Premier Hospital network to observe the impact of our preterm test with intervention in real world.

Speaker Change: We look forward to continuing building awareness with prime results at the upcoming American College of Obstetrics and gynecology meeting in May in Minnesota.

Speaker Change: With the publication of avert an anticipated publication of Prime we have entered a new phase of commercialization focused on driving awareness seeking reimbursement, adding to evidenced for guideline inclusion and accelerating preterm adoption in United States as well as exploring international expansion.

Dan Brennan [Managing Director, Research, Health Care: Great. Maybe as a follow-up, you talked about in the prepared remarks, Medicaid, you talked about paying for 43% of births. You cited the 4 states with a focus on Nevada and Louisiana. How do we think about that opportunity ahead of guidelines? Just maybe elaborate a little bit on the Medicaid opportunity, what your plans are, and if there's any predicates about how Medicaid looks at tests like this. Is this a multi-year process in order to get Medicaid to pay for this test, or could it go faster than that?

Speaker Change: This is a time for us to put our money to work in a focused approach building our presence in waves of geographies will allow us to drive density of adoption awareness and test utilization, where we have achieved reimbursement and built opinion leadership.

Speaker Change: During this phase we expect to leverage cash from our recent capital raise to maximize opportunities.

Speaker Change: Net proceeds from the offering are expected to enable measured expansion in our commercial infrastructure and capabilities in and it states as well as opportunities that we've created.

Evguenia Lindgardt: Great. Another great question. Well, Medicaid, as you can imagine, is our single biggest payer in the United States, and 27% of all inpatient costs that Medicaid covers are related to childbirth and neonatal care. Of course, maternal care and neonatal care slice of Medicaid budget is substantial, with tens of billions of dollars that are spent on both the childbirth and the first year of a baby's life that is covered, in most cases, by Medicaid. Our test and its very low number needed to screen to save a NICU day, and again, very low number to save a NICU admission, is an enormous opportunity for Medicaid leaders to reduce Medicaid budget costs without cutting benefits.

Speaker Change: In addition, this will help accelerate preparations for possible expansion into European Union and fund additional studies designed to increase adoption of preterm, including monitoring milestones set for FDA oversight of LPTA.

Speaker Change: 2024 was the third consecutive year in the United States received a D plus grade from the March of Dimes Annual report card for our persistently high preterm birth rate this needs to change and we can do more to create a paradigm shift to improve outcomes and reduce healthcare cost.

Speaker Change: Following the availability of revert in prime data in our conversations with payers to care result, resonated strongly first is the reduction in NICU admissions.

Speaker Change: And second the number needed to screen of only three or four months to drive savings of one NICU day.

Speaker Change: We are continuing to share with them, our economic model of the value delivered which exceed their target of three to one ROI.

Speaker Change: During this phase we expect to leverage cash from our recent capital raise to maximize opportunities.

Speaker Change: In addition, we are starting a program with acute payer to monitor the cost of care to build on the evidence we have.

Speaker Change: Proceeds from the offering are expected to enable measured expansion in our commercial infrastructure and capabilities Internet states as well as opportunities that we've created.

Evguenia Lindgardt: We think at this moment in time when, unfortunately, United States has struggled to reduce the rates of preterm birth in spite of many innovations in the last couple of decades, we now have both the momentum of the community around clinical breakthrough research, but also focus by Medicaid administrators on cost reduction. We believe that that momentum of both innovations, supportive research, and potential to save money, will be a catalyst for Medicaid moving faster than usual in covering the innovations that can help the community. Of course, it will be different state by state, given a different plan shape across the states.

Speaker Change: In deploying our test and treat strategy.

Speaker Change: In the United States Medicaid pays for approximately 43% of birth.

Speaker Change: In addition, this will help accelerate preparations for a possible expansion into European Union and fund additional studies designed to increase adoption of preterm, including monitoring milestones set for FDA oversight of L. D cheese.

Speaker Change: Given the burden on public health agencies, we expect to pursue partnerships to measure and demonstrate our impact on the patient population spin.

Speaker Change: Specific early states of focus May include Nevada, Louisiana, Texas, and California. According to the March of Dimes. The first two of these states have nearly 50% higher preterm birth rates than the national average our goal is to focus on geographies, where the need is the greatest where prime study site is located or where we <unk>.

Speaker Change: 2024 was the third consecutive year of the United States received a D plus grade from the March of Dimes Annual report card for our persistently high preterm birth rate this needs to change and we can do more to create a paradigm shift to improve outcomes and reduce health care cost.

Speaker Change: Following the availability of avert on prime data in our conversations with payers to care results resonated strongly first is the reduction in NICU admissions.

Speaker Change: Have strong opinion leader support and where we have line of sight to payer coverage. We're analyzing the geographies where these conditions are met and will deploy both digital awareness campaigns at scale and regional account managers to drive adoption.

And second the number needed to screen of only three or four months to drive savings of one NICU day.

Evguenia Lindgardt: The reason we want to start focusing on the states most hard hit by preterm birth is that's where it will become a priority for the administrators to adopt innovations that can make a difference in clinical outcomes as well as save on the budget. We look forward to and are engaging as we speak with Medicaid plans across the country and are looking forward to coming back to which states would jump in with us to start adopting our screen and treat strategy. It is unusual for a screening test to generate savings and especially generate savings within a year, given the test is administered in the second trimester, and within 6 months, the baby is born and therefore the savings are realized. We think it could be not a multi-year affair, but we could make some really nice inroads even this year.

To address condition specific to the European market in February we executed an agreement with a lab to develop an immuno assay version of preterm test. These types of assays enable a decentralized commercialization model better suited to health systems in Europe.

Speaker Change: We are continuing to share with them, our economic model of the value delivered which exceed their target of three to one rois.

Speaker Change: In addition, we're starting a program with acute payer to monitor the cost of care to build on the evidence we have.

Speaker Change: We believe that once this is successfully completed it will allow us the opportunity to strategically partner with other organizations in addressing preterm birth in Europe in commercializing preterm test there.

Speaker Change: In deploying our test and treat strategy.

Speaker Change: In the United States Medicaid pays for approximately 43% of births.

Speaker Change: Given the burden on public health agencies, we expect to pursue partnerships to measure and demonstrate our impact on the patient population.

Speaker Change: With our product pipeline, we continue to work on our time to birth offering here.

Just as with preterm publications will help support the awareness building and provide real world evidence of the value of this technology in early February worked by Cerus key researchers was published by the Journal life.

Specific early states of focus May include Nevada, Louisiana, Texas, and California. According to the March of Dimes. The first two of these states have nearly 50% higher preterm birth rates than the national average our goal is to focus on geographies, where the need is the greatest where prime study site is located or where we have.

Speaker Change: This study showed the ability to accurately predicted the delivery dates of term pregnancies by examining 15 clock proteins found to have direct association with time to birth. These.

Speaker Change: Strong opinion leader support and where we have line of sight to payer coverage. We're analyzing the geographies where these conditions are met and will deploy both digital awareness campaigns at scale and regional account managers to drive adoption.

Speaker Change: These findings suggest that one of these proteins.

Evguenia Lindgardt: We'll, of course, keep the community appraised of our progress.

Speaker Change: 12, as well as potentially other club proteins may serve as predictors of term delivery date and uncomplicated pregnancies.

Dan Brennan [Managing Director, Research, Health Care: Perfect. Maybe just on the guidelines, so between SMFM and ACOG are both important. Is one more important than the other? Any way to think through, given the feedback so far from the PIs and the DACA community and your plans, is this possible in the next year, 2, 3, or is this something that, given predicates, could take 4, 5, 6 years? Just any thoughts on how investors might contemplate the opportunity for you to get in guidelines?

Speaker Change: This study further illustrates our role in supporting and expectant mothers journey with our novel technology.

Speaker Change: To address condition specific to the European market in February we executed an agreement with a lab to develop an immuno assay version of preterm test. These types of assays enable a decentralized commercialization model better suited to health systems in Europe. We believe that once this is successfully completed it will allow us the opportunity to strategically partner.

Speaker Change: Help advance the market opportunity, we see ahead for Sarah we're pleased to announce today the appointment of Jeff Elliott to our board of directors Geoff brings two decades of experience and expertise in guiding companies in the medical diagnostics industry, including as Chief financial and Chief operating officer at exact Sciences.

Speaker Change: With other organizations in addressing preterm birth in Europe in commercializing drug test there.

Speaker Change: With our product pipeline, we continue to work on our time to birth offering here just as with preterm publications will help support the awareness building and provide real world evidence of the value of this technology in early February work by Cirrus key researchers was published by the Journal life.

Speaker Change: During its high growth phase his appointment broadens the depth and breadth of expertise on our board.

Evguenia Lindgardt: Great. Well, it is hard to say which society is more important because ACOG and SMFM work together on the guidelines, and specifically on the ACOG bulletin 234 that governs preterm birth, which is an ACOG bulletin. Society for Maternal-Fetal Medicine is an enormous influencer and partner in developing those guidelines, given their expertise in addressing higher risk pregnancies and preterm birth. In this case, we think that they will work together. There are precedents when Society for Maternal-Fetal Medicine went ahead with practice advisory separately for ACOG. Given how important preterm birth is to the community, we think they will very likely work together on it and will be equally important. Hence, we are engaging with both sets of experts and opinion leaders from both societies.

Also announced today that our longtime board members rial trim Orion Trimble and Marcus Wilson are stepping down in June after many years of service and commitment to serve our mission, we're thankful to them for their role in taking Sarah from startup to commercialization in.

Speaker Change: This study showed the ability to accurately predicted the delivery dates of term pregnancies by examining 15 clock proteins found to have direct association with time to birth.

Speaker Change: In summary, we believe we have momentum behind us and are in a better position than ever to expand from a commercialization grow adoption and revenue and takes era to the next level now I will turn the call over to Austin Austin.

Speaker Change: These findings suggest that one of these proteins a D. A 12 as well as potentially other club proteins may serve as predictors of term delivery date and uncomplicated pregnancies.

Austin: Thank you Tanya and good afternoon, everyone let.

Speaker Change: Let me review our financial results for the fourth quarter I'll, then touch on our view of operating expenses for the year ahead, and our plan to make selective investments that we believe will expand our commercial reach and revenue overtime.

Speaker Change: This study further illustrates our role in supporting and expectant mothers journey with our novel pathology.

Speaker Change: Help advance the market opportunity, we see ahead for Sarah we're pleased to announce today the appointment of Jeff Elliott to our board of directors just brings two decades of experience and expertise in guiding companies in the medical diagnostics industry, including as Chief financial and Chief operating officer at exact Sciences.

Speaker Change: Net revenue for the fourth quarter of 2024 was $24000 compared to $41000 for the fourth quarter of 2023.

Evguenia Lindgardt: Now, as far as the feedback so far from opinion leaders that we're hearing, of course, everybody is eager to dig into the data. Like investors and analysts, we frequently get the question, When is the publication coming? To which our answer is, we don't know quite yet, but we're working very hard on it, and hopefully, it is imminent in the coming months. Happy to dive deeper into the questions around the data, which you can probably anticipate. Questions like what subpopulations, for example, first-time moms or second, third-time moms. Are there performance differences for the screen and treat strategy? Are there differences in the usage of particular intervention levers like aspirin, et cetera. We are working with our principal investigators to feed them the questions that we receive and hope that they pick them up and address them in the publications. What are PIs saying?

Speaker Change: Total operating expenses for the fourth quarter of $9 $4 million were up 6% from $8 9 million for the same period a year ago.

Speaker Change: During its high growth phase his appointment broadens the depth and breadth of expertise on our board.

Speaker Change: Net loss for the quarter was $8 6 million compared to $7 9 million for the same period a year ago.

Speaker Change: Also announced today that our longtime board members real true Ryan Trimble and Marcus Wilson stepping down in June after many years of service and commitment to serve our mission, we're thankful to them for their role in taking share from startup to commercialization in.

Speaker Change: Research and development expenses were $3 1 million down from $3 9 million for the fourth quarter of 2023, due primarily to reduced expenses related to our prime study, which stopped enrollment at the end of 2023.

Speaker Change: Selling general and administrative expenses for the fourth quarter were $6 3 million up from $5 2 million for the fourth quarter of 2023, due primarily to focus spending on commercial activities aimed at broadening awareness of the preterm test to begin growth test volumes and sales over time.

Speaker Change: In summary, we believe we have momentum behind us and are in a better position than ever to expand or commercialization grow adoption and revenue and takes era to the next level now I'll turn the call over to Austin Austin.

Austin: Thank you Daniel and good afternoon, everyone let.

Speaker Change: As of December 31, 2024, the company had cash cash equivalents and available for sale securities of approximately $68 2 million.

Austin: Let me review our financial results for the fourth quarter I'll, then touch on our view of operating expenses for the year ahead, and our plan to make selective investments that we believe will expand our commercial reach and revenue overtime.

Speaker Change: As noted previously in February 2025, we raised $57 5 million through a public follow on offering that allows us to significantly expand our commercial operations in 2025 and beyond while also securing a cash runway through 2028.

Austin: Net revenue for the fourth quarter of 2024 was $24000 compared to $41000 for the fourth quarter of 2023.

Evguenia Lindgardt: All of our principal investigators are incredibly committed to bringing innovative solutions, and bringing great research and rigorous science to the community. We're excited that we have seen several of them step up and start discussing with us what potential topics they might want to take up and look at the data for a possibility of a publication, or a poster session, or digging into the analysis and the data of it. We're excited about their level of engagement. Given the 19 sites and 19 PIs, we're definitely hoping to generate a lot of evidence coming out of that work, which, of course, is critical in terms of the number of references that will exist for ACOG and SMFM committee, which whether it is 1, 2, 3 years from now or more, will be formed to review all of the available literature and evidence.

Austin: Total operating expenses for the fourth quarter of $9 $4 million were up 6% from $8 9 million for the same period a year ago net.

Speaker Change: The capital markets environment, continuing to be extremely challenging, particularly within our space. We believe investors see the promise of what our technology can do to improve the lives of mothers and babies and drive the future growth for Sarah we are thankful for their continued support.

Austin: Net loss for the quarter was $8 $6 million compared to $7 9 million for the same period a year ago.

Austin: Research and development expenses were $3 1 million down from $3 9 million for the fourth quarter of 2023 <unk>.

Speaker Change: We previously communicated our expectation that 2024 gross cash expense would be less than $30 million and we're pleased that our careful cash management during the year resulted in a gross gross cash expense of about $28 6 million.

Austin: Due primarily to reduced expenses related to our Prime study would stop enrollment at the end of 2023.

Austin: Selling general and administrative expenses for the fourth quarter were $6 $3 million up from $5 2 million for the fourth quarter of 2023, due primarily to focus spending on commercial activities aimed at broadening awareness of the preterm test to begin growth test volumes and sales over time.

Speaker Change: For 2025, which will be a year of building our business commercially our targeted range for cash operating expenses is 30% to $35 million.

Speaker Change: With the expectation of Prime being published we see this as a pivotal year in which to pursue engagement with and adoption by key stakeholders as.

Austin: As of December 31, 2024, the company had cash cash equivalents and available for sale securities of approximately $68 2 million.

Speaker Change: As a result of this increase in operating expense is primarily driven by planned new and significant investments in commercialization.

Austin: As noted previously in February 2025, we raised $57 $5 million through a public follow on offering that allows us to significantly expand our commercial operations in 2025 and beyond while also securing a cash runway through 2028.

Evguenia Lindgardt: The more we can create evidence, the better. To your fundamental question, what is our best guess if it could happen in the 1, 2, 3-year timeframe, or it could take longer? It is incredibly difficult to predict. However, I will say that the last time the ACOG bulletin 234 was updated was August 2021, and the societies typically update these bulletins every 24, 36, 48 months. It is prime time, no pun intended, to potentially review these. However, we will be delighted if we have a bit more time to put more evidence out there, more publications out there for the review to take those into account. It is very plausible that the review and update of bulletin 234 will happen in the next 1 to 3 years.

Speaker Change: While we remain steadfast improvement oversight of our capital resources, we have begun investing in both broad awareness and targeted education campaigns to begin to build adoption of the preterm test on the heels of exciting Prime study data.

Speaker Change: Despite the capital markets environment, continuing to be extremely challenging, particularly within our space. We believe investors see the promise of what our technology can do to improve the lives of mothers and babies and drive the future growth for Sarah we are thankful for their continued support.

Speaker Change: Once we have published data, we will expand our investment or we believe the commercial opportunities have the highest likelihood of near term success and return on investment for our business.

Speaker Change: The amount, we ultimately invest in 2025 will be dictated by the timing of our prime publication and the commercial opportunities presented for preterm and potentially our pipeline.

Speaker Change: We previously communicated that our expectation that 2024 gross cash expense would be less than $30 million and we're pleased that our careful cash management. During the year resulted in a gross cat gross cash expense of about $28 6 million for.

Speaker Change: Operator, we can now please open the call for questions.

Speaker Change: Ladies and gentlemen, we will now begin the question and answer session.

Speaker Change: Should you have a question. Please press star followed by the number one on your Touchtone phone, you'll hear a prompt that your hand has been raised.

Speaker Change: For 2025, which will be a year of building our business commercially our targeted range for cash operating expenses is $30 million to $35 million.

Speaker Change: Should you wish to decline from the polling process. Please press star followed by the number too.

Speaker Change: With the expectation of Prime being published we see this as a pivotal year in which to pursue engagement with and adoption by key stakeholders.

Speaker Change: You are using a speaker phone please make sure to lift your handset before pressing any keys.

Speaker Change: As a result of this increase in operating expense is primarily driven by planned new and significant investments in commercialization.

Speaker Change: Your first question comes from the line of Dan Brennan from TD Cowen. Please go ahead.

Dan Brennan [Managing Director, Research, Health Care: Great. Maybe last one. Sorry, I'm asking so many. Maybe one for Austin. Just on the cash on balance sheet today, and basically the burn, which is going up a bit, which makes sense. Just again, walk us through how far in advance or how far out you think the cash on the balance sheet will last. What are some of the key assumptions that go into that? Any color on kind of where the costs are going to this year? Thank you.

Dan Brennan: Great. Thanks for thanks for the questions maybe just the first one on the three tenants.

Speaker Change: While we remain steadfast improvement oversight of our capital resources, we have begun investing in both broad awareness and targeted education campaigns to begin to build adoption of the preterm test on the heels of exciting Prime study data.

Speaker Change: Of your plan to get into guidelines, you talked about publishing more information.

Dan Brennan: Adding more real world evidence.

Dan Brennan: On health care, and economic benefits, and then driving clinical community adoption.

Speaker Change: Once we have published data, we will expand our investment or we believe the commercial opportunities have the highest likelihood of near term success and return on investment for our business.

Dan Brennan: And getting institutions on board keeps us elaborate a little bit.

Dan Brennan: On each of those kind of things investors should be looking for in 2025 on each of those fronts.

Austin Aerts: Yeah. Thanks, Dan. We think we have cash runway into 2028 based on our current operating plans, which, as we stated in the prepared remarks, includes a range of cash operating expenses this year of $30 to $35 million. Where we land in that range will be dictated by the opportunities that are presented for us commercially. The vast majority of that increase spend over last year's roughly $29 million is going to be dedicated to commercial investment. Over the next two or three years, certainly we would expect that to be the majority of where operating expenses increase, is in commercial investment.

Speaker Change: We ultimately invest in 2025 will be dictated by the timing of a prime publication and the commercial opportunities presented for preterm and potentially our pipeline.

Dan Brennan: That will give people confidence that you are making progress.

Dan Brennan: No absolutely great question, So first on the publications front.

Speaker Change: Operator, we can now please open the call for questions.

As you can imagine with our 5000 patient trial Prime we have unleashed and a nurse and enormous a treasure trove of data and have 19, Pis who are currently looking at the data and have.

Speaker Change: Ladies and gentlemen, we will now begin the question and answer session.

Speaker Change: Should you have a question. Please press star followed by the number one on your Touchtone phone, you'll hear a prompt that your hand has been raised.

Speaker Change: Should you wish to decline from the polling process. Please press star followed by the number too.

Speaker Change: If you are using a speaker phone please make sure to lift your handset before pressing any Keith.

Dan Brennan: Just plans for further analysis of the dataset.

Austin Aerts: To get to that 2028 mark, we're looking at some increase in spend over the next 3 or 4 years, and offset by some, in that assumption, are some very modest revenue assumptions as well, which we certainly hope will be much greater than modest over that time period.

Dan Brennan: And discussing them half a dozen to a dozen potential topics that may end up in additional publications from prime dataset, we think that the more value can be derived from prime dataset in new publications.

Speaker Change: Your first question comes from the line of Dan Brennan from T. D. Cohen. Please go ahead.

Dan Brennan: Great. Thanks for thanks for the questions maybe just the first one on the three tenants.

Speaker Change: Do you plan to get into guidelines, you talked about publishing more information <unk>.

Dan Brennan: Adding more real world evidence.

Dan Brennan [Managing Director, Research, Health Care: Are you going to share any details on the revenue assumptions or no?

Dan Brennan: The more evidence will there be in the market about the value of the test and treat strategy preterm test.

Dan Brennan: On health care, and economic benefits, and then driving clinical community adoption.

Austin Aerts: No, not at this time.

Dan Brennan: And getting institutions on board keeps us elaborate a little bit.

Dan Brennan: Of course.

Dan Brennan [Managing Director, Research, Health Care: Great. Thank you.

Dan Brennan: On each of those kind of things investors should be looking for in 2025 on each of those fronts.

Dan Brennan: Prime is not the only data set we have we are looking forward to broader analyses from the other studies that we have conducted namely avert potentially prevent.

Operator: Your next question comes from the line of Andrew Brackmann from William Blair. Your line is now open.

Dan Brennan: That will give people confidence that you are making progress.

Dan Brennan: So absolutely great question. So first on the publications front as you can imagine with our 5000 patient trial Prime we have unleashed our newest an enormous a treasure trove of data and a half now.

Dan Brennan: And of course any future evidence we generate.

Dan Brennan: So that's on the publications front.

Dan Brennan: Tennant is real world evidence, we truly believe that learning how test the forms in real world and partnering with leading institutions to study aspects of it.

Dan Brennan: <unk> Pis, who are currently looking at the data and have discussed plans for further analysis of the dataset and discussing them half a dozen to a dozen potential topics that may end up in additional <unk>.

Maggie Boeye: Hi, everyone. This is Maggie Boeye on for Andrew Brackmann. Thanks for taking our questions. Maybe first, if you could just dive into those commercial investments you were just talking about, what can we expect for 2025 and here on out for what the focus will be, what you're thinking about, how big your commercial organization needs to be as you continue to build Prime Evidence and drive adoption of PreTRM? Thanks.

Dan Brennan: Both in different populations.

Dan Brennan: In context of health disparities for example.

Dan Brennan: Will be accretive to adoption and awareness building across the clinical community.

Dan Brennan: Publications from Prime dataset, we think that the more value can be derived from prime dataset in new publications. The more evidence will there be in the market about the value of the test and treat strategy preterm test.

Speaker Change: As I mentioned, we are kicking off our first real world evidence study.

Evguenia Lindgardt: Hi, Maggie. Good to talk to you. Absolutely. Let me start with the last question, the size of commercial organization and how we are aiming to grow it, to go after the commercial opportunities. We are first building out our sales organization with the regional account managers, to be driving on the ground the adoption in the selected target states that we are addressing with building a strong ecosystem of influence between the opinion leaders, the clinicians, organizing speaker programs, unlocking institutional buy-in, and adoption by individual clinicians and largest practices in those states. As you can imagine, we are teaming with our partners on the payer front, potentially on the public payer side as well, to make sure that the awareness and policy coverage is there to support their efforts. Second, of course, is going to be on the medical liaison front.

Speaker Change: This year and with a permanent institution, we will absolutely published on the results of this study and look forward to sharing the outcomes of that work, we're planning to launch more real world evidence trials.

Dan Brennan: Of course Prime is not the only dataset. We have we are looking forward to a broader analyses from the other studies that we have conducted namely avert potentially prevent and of course any future evidence we generate.

Speaker Change: And and generate a continuous flow of evidence on how well the test is performing.

Speaker Change: Additionally, we have launched and investigator initiated research program at Society for maternal fetal medicine.

Dan Brennan: So that's on the publications front.

Speaker Change: Meeting in January.

Dan Brennan: Second tenant is real world evidence, we truly believe that learning how test the forms in real world and partnering with leading institutions to study aspects of it both in different populations.

Speaker Change: And are looking forward to all of the submissions a review and communicating back to the investigators on the results of which studies will support come April of this year.

Speaker Change: We're hoping that the.

Dan Brennan: In context of health disparities for example.

Speaker Change: The investigator initiated research will also provide.

Dan Brennan: Will be accretive to adoption.

Speaker Change: A lot of interesting evidence around the test that will help.

Dan Brennan: Awareness building across the clinical community.

Speaker Change: Whenever the professional society chooses to review.

Dan Brennan: So as I mentioned, we are kicking off our first real world evidence study them this year and with a preeminent institution, we will absolutely published on the results of this study and look forward to sharing the outcomes of that work, we're planning to launch more real world evidence trials.

Speaker Change: The policy.

Speaker Change: And recommendations on preterm birth care to take into account all of the evidence that these three leavers generate.

Evguenia Lindgardt: We brought in a head of medical liaison group last year and are looking forward to potentially adding to the field presence in selected states as needed, that role. We also grew our revenue cycle organization last year, and we're aiming to optimize that this year, depending on how fast is the uptake. Revenue cycle, as you know, is going to be critical for bringing the revenue in and collecting on the payments. Last but not least, potentially building out our payer group, to ensure that we are expanding reimbursement, and working with both payers, government and commercial payers, as well as employers, benefit design consultants, and others. That's just a start. Of course, as momentum grows and more states become in focus, we will expand our commercial presence in waves as we go into more and more geographies. Hope this helps.

Speaker Change: The last tenant I talked about was generating clinical adoption of course.

Speaker Change: As you can imagine.

Speaker Change: A lot of the early adopter physicians and institutions.

Dan Brennan: And and generate a continuous flow of evidence on how well the test is performing.

Speaker Change: Will.

Speaker Change: Put the test to use in real world and the more adoption, we generate the more of course questions will be raised through the professional societies on what is there a formal position on utilization of preterm test and our screening test strategy. So we believe that all.

Dan Brennan: Additionally, we've launched and investigator initiated research program at the society for maternal fetal medicine.

Dan Brennan: Meeting in January.

Dan Brennan: And are looking forward to all of the submissions a review and are communicating back to the investigators on the results of which studies will support come April of this year.

Speaker Change: All of these three <unk>.

Speaker Change: Revenues of supporting evidence generation and momentum for preterm test.

Dan Brennan: We're hoping that the investigator initiated research will also provide a lot of interesting evidence around the test that will help whenever the professional society chooses to review all of.

Speaker Change: We'll pull forward.

Speaker Change: Getting to professional recommendations on how this test should be used in the community.

Speaker Change: Great maybe as a follow up you talked about in the prepared remarks.

Speaker Change: Medicaid you talked about paying for 43% of births decided.

Dan Brennan: The policy.

Dan Brennan: And recommendations on preterm birth care to take into account all of the evidence that these three leavers generate.

Speaker Change: Four states with a focus on Nevada, Louisiana, how do we think about that.

Speaker Change: That opportunity ahead of guidelines. So are you just maybe elaborate a little bit on the Medicaid opportunity what your plans are.

Dan Brennan: The lost a tenant they talked about was generated clinical adoption of course.

Speaker Change: And if there's any predicates about how Medicaid looks a test like this is.

Dan Brennan: As you can imagine.

Dan Brennan: A lot of the early adopter physicians and institutions.

Maggie Boeye: Got it. Thanks. Thanks so much. Just maybe one on the pipeline. Can you talk about what we should be expecting for pipeline initiatives in the near term? Just level set us on where things stand around the launch of the time to birth assay, relatedly, any updates on how you're thinking about the pricing of that test when launched. Thank you.

Speaker Change: Is this a multi year process in order to get Medicaid to pay for this test.

Dan Brennan: Will.

Dan Brennan: Put the test to use in real world and the more adoption, we generate the more of course questions will be raised through the professional societies on what is there a formal position on utilization of preterm test and our screen into strategy. So we believe that all.

Speaker Change: Could it go faster than that.

Speaker Change: Great another great question.

Speaker Change: Medicaid as you can imagine is our single biggest fare in the United States and 27% of all in patient costs. That's Medicaid covers are related to that childbirth and neonatal care.

Evguenia Lindgardt: Definitely. As we've talked about before, we've prioritized two products from our pipeline to bring to market near term. That's the time to birth product, which we are targeting H2 of this year. The second one is the predictive analytics product, which we are beta testing across the country and are hoping to get to production scale release in H2 of this year as well. In terms of pricing of the time to birth product, it is truly a consumer-directed test, even though it will be helpful for both consumers and physicians. As an immunoassay, it's priced at $150, or around that. It should be accessible and affordable.

Dan Brennan: All of these three avenues.

Avenues of supporting evidence generation and momentum for preterm test.

Speaker Change: So of course maternal care and neonatal care, a slice of Medicaid budget is substantial.

Dan Brennan: Will pull forward I'm getting to professional recommendations on how this test should be used in the community.

Speaker Change: With tens of billions of dollars that are spent on.

Speaker Change: Both the child birth, and the first year of a baby's life that is covered in most cases by Medicaid.

Dan Brennan: Great maybe as a follow up you talked about it in the prepared remarks.

Dan Brennan: Medicaid you talked about paying for 43% of births decided.

Speaker Change: So our test and its very low number needed to screen to say the NICU day, and again very low number to save and NICU admission is an enormous opportunity for Medicaid leaders to reduce Medicaid budget costs without cutting benefits.

Speaker Change: The four states with a focus on Nevada, Louisiana, how do we think about.

Speaker Change: That opportunity ahead of guidelines. So are you kind of just maybe elaborate a little bit on the Medicaid opportunity what their plans are.

Speaker Change: And if theres any predicates about how Medicaid looks a test like this.

Speaker Change: We think at this moment in time when.

Speaker Change: Is this a multi year process in order to get Medicaid to pay for this test.

Maggie Boeye: Great. Thanks so much for taking our questions.

Speaker Change: Unfortunately, the United States has struggled to reduce the rates of preterm birth in spite of many innovations in the last couple of decades.

Speaker Change: Could it go faster than that.

Evguenia Lindgardt: Thank you for the questions.

Speaker Change: Great. Another great question, well Medicaid as you can imagine is our single biggest fare in the United States and 27% of all inpatient costs. That's Medicaid covers are related to that childbirth and neonatal care.

Operator: There are no further questions at this time. I'm going to go ahead and turn the call over to Ms. Evguenia Lindgardt for closing comments. Ma'am, please go ahead.

Speaker Change: We now have both.

Speaker Change: The momentum of the community around our clinical breakthrough research, but also a focus by Medicaid administrators on cost reduction, we believe that that momentum of both innovations supportive research and potential to save.

Speaker Change: Of course maternal care and neonatal care, a slice of Medicaid budget is substantial with tens of billions of dollars that are spent on on both the child birth and the first year of a baby's life that is covered in most cases.

Speaker Change: Money.

Speaker Change: <unk> will be a catalyst for Medicaid moving faster.

Speaker Change: The unusual in covering the innovations that can help the community.

Evguenia Lindgardt: Thank you, operator. Thank you all for attending our call today. We are really pleased with our progress during the year and, of course, more recently, in being able to share the results of PREVENT as we await expected publication of the full study results, which will provide more evidence of the value of utilizing our PreTRM test-and-treat strategy. We're thankful for the support of our investors, including those who participated in our recent fundraise that see the great opportunity that lays ahead for Sera. I'll now turn it back over to the operator to conclude the call. Operator?

Speaker Change: By Medicaid.

So of course, it will be different state by state given <unk>.

So our test and it's very little number needed to screen to say the NICU day, and again very low number to save and NICU admission is an enormous opportunity for Medicaid leaders to reduce Medicaid budget costs without cutting benefits.

Speaker Change: A different plan shape across the states.

Speaker Change: But the reason we want to start focusing on the states most hard hit by preterm birth is that's where it will become a priority.

Speaker Change: For the administrators.

Speaker Change: Two to adopt innovations that can make a difference in clinical outcomes as well as save on the budget. So we look forward to.

Speaker Change: We think at this moment in time, when unfortunately, United States has struggled to reduce the rates of preterm birth. In spite of many innovations in the last couple of decades, we now have both the momentum of the community around our clinical break.

Speaker Change: And are engaging as we speak with Medicaid plans across the country and are looking forward to coming back to which states.

Operator: This concludes this conference call. Thank you everyone for your participation. You may now disconnect.

Speaker Change: I would jump in with us to to start adopting hour.

Speaker Change: Through research, but also a focus by Medicaid administrators on cost reduction, we believe that that momentum of both innovations support of research and potential to save money.

Speaker Change: Our screen and treat strategy. It is unusual for a screening test to generate savings and especially generate savings within the year. Given the test is administered in the second trimester and within six months and the babies born and therefore the savings are realized so we think it could be not a.

Speaker Change: Wil.

Speaker Change: Be a catalyst for Medicaid moving faster.

Speaker Change: Multiyear a fair, but we could make some really nice inroads even this year.

Speaker Change: Than usual in covering the innovations that can help the community.

Speaker Change: So we'll of course keep the community appraised of our progress.

Speaker Change: So of course, it will be different state by state given them a different plan shape across the states, but the reason we want to start focusing on the states. Most hard hit by preterm birth is that's where it will become a priority for the administrators.

Speaker Change: Perfect and then maybe just on the guidelines so between.

Speaker Change: <unk> in a cog.

Speaker Change: Are both important is one more important than the other.

Speaker Change: Any way to think through given the feedback so far from the Pis and the Doctor community in your plans.

Speaker Change: To to adopt innovations that can make a difference in clinical outcomes as well as save on the budget. So we look forward to.

Speaker Change: Is this possible in the next year or two or three or is this something that different predicates could take 456 years any thoughts on how investors might contemplate the opportunity for you to get guidelines.

Speaker Change: And are engaging as we speak with our Medicaid plans across the country and are looking forward to coming back to which states.

Speaker Change: Great well, it's hard to say, which society is more important because E com and S. M. S. M work together on the guidelines and specifically on the E. Com Bulletin 234 that governs preterm birth, which is an equal bulletin.

Speaker Change: I would jump in with us to to start adopting them our screen and treat strategy. It is unusual for a screening test to generate savings and especially generate savings within year. Given the test is administered in the second trimester and within six months the babies born and therefore.

Speaker Change: Society for maternal fetal medicine is an enormous influencer and partner in developing those guidelines given their expertise in addressing high risk pregnancies and preterm birth.

Speaker Change: The savings are realized so we think it could be I'm, not a multiyear affair, but we could make some really nice inroads even this year.

Speaker Change: And in this case, we think that they will work together.

Speaker Change: It will of course keep the community appraised of our progress.

Speaker Change: There are precedents when society for maternal fetal medicine.

Speaker Change: Terrific and then maybe just on the guidelines so between us and S. M F M and a cog.

Speaker Change: It went a went ahead with practice advisory separately for Aegon, but given how important preterm birth is to the community. We think they will very very likely work together on it and will be equally important hence we're engaging with both sets of experts and opinion leaders from both Soc.

Speaker Change: Both important is one more important than the other and.

Speaker Change: Any way to think through given the feedback so far from the Pis and the Doctor community in your plans.

Speaker Change: Is this possible in the next year or two or three or is this something that given predicates could take 456 years any thoughts on how investors might contemplate the opportunity if you can get in guidelines.

Speaker Change: <unk> no.

Speaker Change: As far as the feedback so far from opinion leaders.

Speaker Change: But we are hearing.

Speaker Change: Of course, everybody is eager to dig into the data.

Speaker Change: Great well, it's hard to say, which society is more important because E com and S. M. S. M worked together on the guidelines.

Speaker Change: Like investors and analysts we frequently get the question when does the publication coming.

Speaker Change: To which our answer is we don't know quite yet, but we're working very hard on it and hopefully it is imminent in the coming months.

Speaker Change: And specifically on the a called a bulletin 234 that governs preterm birth, which is an equal bulletin.

Speaker Change:

Speaker Change: Happy to dive deeper into the questions.

Speaker Change: But society for maternal fetal medicine is an enormous influence certain partner in developing those guidelines given their expertise in addressing high risk pregnancies and preterm birth.

Speaker Change: Around the data, which you can probably anticipate questions like.

Speaker Change: What sub populations for example, first time moms or.

Speaker Change: And in this case, we think that they will work together there are precedents when society for maternal fetal medicine. Well went went ahead with practice advisory separately for Aegon, but given how important a preterm birth is to the community. We think they will very very light.

Speaker Change: Second and third time Moms are there performance differences for the screen and treat strategy other differences.

Speaker Change: In the usage of particular intervention leavers like aspirin.

Speaker Change: Et cetera, et cetera, but we are working with our principal investigators to to feed them. The questions that we receive and hope that they pick them up and address them in the publications.

Speaker Change: <unk> worked together on it and will be equally important hence we're engaging with them both sets of experts and opinion leaders from both societies.

Speaker Change: What RPI is saying.

Speaker Change: All of our principal investigators are incredibly committed to bringing innovative solutions.

Speaker Change: As far as the feedback so far from opinion leaders.

Speaker Change: And bringing great research and rigorous science to the community and we're excited that we have seen several of them step up and I start discussing with us what the potential topics they might want to take.

Speaker Change: That we're hearing.

Speaker Change: Of course, everybody is eager to dig into the data like investors and analysts we frequently get the question when does the publication coming to which our answer is we don't know quite yet, but we're working very hard on it and hopefully it is imminent in the coming months.

Speaker Change: To take them take up and look at the data for a possibility of a publication or poster session.

Speaker Change: I'm happy.

Speaker Change: We're happy to dive deeper into the questions around the data, which you can probably anticipate questions like.

Speaker Change: Digging into the analysis and the data of it. So we're excited about their level of engagement and given the 19 sites in 19 T I S.

Speaker Change: What sub populations for example, first time moms or second third time Moms are there performance differences for the screen and treat strategy other differences in the usage of particular intervention leavers like aspirin.

Speaker Change: We're definitely hoping to generate a lot of evidence coming out of that.

Speaker Change: Work, which of course is critical in terms of the number of references that will exist for a kogan S. M. S M.

Speaker Change: Committee, which whether it is 123 years from now or more will be formed to review all of the available literature and evidence.

Speaker Change: Et cetera, et cetera, but we are working with our principal investigators to to feed them. The questions that we receive and hope that they pick them up and address them in the publications.

Speaker Change: The more we can create evidence the better.

Speaker Change: What our P I, saying all of our principal investigators are incredibly committed to bringing innovative solutions.

Speaker Change: And to your fundamental question.

Speaker Change: What is our best guess, if it could happen in the one to three year timeframe or it could take longer.

Speaker Change: And bringing great research and rigorous science to the community and we're excited that we have seen several of them are step up and I start discussing with us what the potential topics they might want to to take them take up.

Speaker Change: It is incredibly difficult to predict however.

Speaker Change: I will say that the last time.

Speaker Change: The eight o'clock Bulletin 234 was updated was August 2021.

Speaker Change: And the societies are typically update these bulletins every 24 36 48 months. So it is primetime no pun intended to potentially review if a review. These however, we will be delighted if.

Speaker Change: And look at the data for a possibility of a publication or poster session.

Speaker Change: Or digging into the analysis and the data of it. So we're excited about their level of engagement and given the 19 sites in 19 T is we're definitely hoping to generate a lot of evidence coming out of that.

Speaker Change: We have a bit more time to put more evidence out there more publications out there.

Speaker Change: Work, which of course is critical in terms of the number of references that will exist for a cog in S. M. S. M. A.

Speaker Change: For the review to take those into the account. So it is very plausible that the review and update.

Speaker Change: <unk> Bulletin 234 will happen in the next one to three years.

Speaker Change: Committee, which whether it is 123 years from now or more will be formed to review all of the available literature and evidence the more we can create evidence the better.

Austin: Great maybe last one sorry, I'm asking just wondering maybe one for Austin just on.

Speaker Change: The cash.

Austin: The cash on balance sheet.

Speaker Change: And to your fundamental question what is our best guess, if it could happen in the one to three year timeframe or it could take longer.

Austin: And basically the burn which is going up a bit which makes sense.

Austin: Walk us through how far in advance or how far out you think the cash on the balance sheet will last.

Speaker Change: It is incredibly difficult to predict however.

Austin: Some of the key assumptions that go into that any color on kind of where the costs are going to this year. Thank you.

Speaker Change: I will say that the last time the eight o'clock Bulletin 234 was updated was August 2021 and the societies typically update. These bulletins every 24 36 48 months. So it is primetime.

Speaker Change: Yeah. Thanks, Dan. So we think we have cash runway into 2028 based on our current operating plans, which as we stated in the prepared remarks that includes a range of cash operating expenses here of $30 million to $35 million.

Austin:

Speaker Change: How much are we where we land in Iran will be dictated by the opportunities that are presented for us commercially.

Speaker Change: No pun intended to potentially review if a review. These however, we will be delighted.

Austin: Majority of.

Austin: Of that increased spend over last year's roughly $29 million is going to be dedicated to commercial investment over the next two or three years, certainly we would expect that to be the majority of where operating expenses increases in commercial investment and so to get to that 2028, Mark we're looking at some increase in <unk>.

Speaker Change: If we have a bit more time to put more evidence out there more publications out there for the review to take those into the account. So it is very plausible that the review and update of our Bulletin 234 will happen in the next one to three years.

Austin: And over the next three or four years.

Speaker Change: Great maybe last one sorry, I'm asking so there maybe one for Austin just on the.

Austin: And offset by some and that assumption or some very modest.

Speaker Change: The cash.

Austin: Revenue assumptions as well.

Speaker Change: The cash on balance sheet.

Austin: Which we certainly hope will be much greater than modest over that time period.

Speaker Change: And basically the burn which is going up a bit which makes sense just to kind of walk us through how far in advance you or how far out you think the cash on the balance sheet will last.

Speaker Change: Are you willing to share any details on the revenue assumptions are now.

Speaker Change: Some of the key assumptions that go into that any color on kind of where the costs are going to this year. Thank you.

No not at this time.

Speaker Change: Great. Thank you.

Speaker Change: Yeah. Thanks, Dan. So we think we have cash runway into 2028 based on our current operating plans, which as I stated in the prepared remarks includes a range of cash operating expenses here of $30 million to $35 million.

Speaker Change: Ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star followed by the number one on your Touchtone phone.

If you wish to decline from the polling process. Please press star two.

Speaker Change: Hum.

Speaker Change: How much are we where we land in Iran will be dictated by the opportunities that are presented for us commercially.

Speaker Change: And if you're using a speaker phone. Please make sure that you lift your handset before pressing any keys.

Speaker Change: Majority.

Speaker Change: Your next question comes from the line of Andrew Brachman from William Blair. Your line is now open.

Speaker Change: Of that increased spend over last year's roughly 29 million is going to be dedicated to commercial investment over the next two or three years, certainly we would expect that to be the majority of where operating expenses increases in commercial investment and so.

Speaker Change: Hi, everyone. This is Maggie on for Andrew Brachman, Thanks for taking our questions.

Speaker Change: Maybe first if you could just dive into those commercial investments you were just talking about what can we expect for 2025 and here on out for what the focus will be you know what youre thinking about how big your commercial organization needs to be as you continue to build prime evidence and drive adoption of return. Thanks.

Speaker Change: So to get to that 2028, Mark where we're looking at some increase in spend over the next three or four years.

Speaker Change: And offset by some you know in that assumption or some very modest.

Speaker Change: Revenue assumptions as well.

Speaker Change: Which we certainly hope will be much greater than modest over that time grid.

Speaker Change: Hi, Maggie and good to talk to you and absolutely. Let me start with the last question the size of commercial organization and how we are aiming to to grow it to go after the commercial opportunities we.

Speaker Change: Are you willing to share any details on the revenue assumptions are now.

No not at this time.

Speaker Change: Great. Thank you.

Speaker Change: We are first building out our sales organization with the regional account managers.

Speaker Change: Ladies and gentlemen, as a reminder, if you would like to ask a question. Please press star followed by the number one on your Touchtone phone.

Speaker Change: To be driving on the ground the adoption in the selected target states that we are addressing with building a strong ecosystem of influence.

Speaker Change: The decline from the polling process. Please press star two.

Speaker Change: And if you are using a speaker phone. Please make sure that you lift your handset before pressing any keys.

Speaker Change: Between the opinion leaders the clinicians.

Speaker Change: Your next question comes from the line of Andrew Blackman from William Blair. Your line is now open.

Speaker Change: Organizing speaker programs, unlocking institutional buying and adoption by individual clinicians.

Speaker Change: Hi, everyone. This is Maggie on for Andrew Brockman, Thanks for taking our questions.

Speaker Change: And largest practices in those states.

Speaker Change: Maybe first if you could just dive into those commercial investments you were just talking about what can we expect for 2025 and here on out for what the focus will be you know what you're thinking about how big your commercial organization needs to be as you continue to build prime evidence and drive adoption of return. Thanks.

Speaker Change:

Speaker Change: As you can imagine we are teaming with our partners on the payer front potentially on the public.

Speaker Change: Public payer side as well to make sure that the awareness and policy coverage is there to support their efforts.

Speaker Change: Hi, Maggie and good to talk to you and absolutely. Let me start with the last question the size of the commercial organization and how we are aiming to to grow it to go after the commercial opportunities. We are first building out our sales organization.

Speaker Change: Second of course is going to be on the medical leaves on front, we brought in a head of medical Hum.

Speaker Change: Liaison group last year and are looking forward to potentially adding.

Speaker Change: To to the field presence in selected states as needed that role.

Speaker Change: With the regional account managers.

Speaker Change: To be driving on the ground the adoption in the selected target states that we are addressing with building a strong ecosystem of influence them between the opinion leaders. The clinicians are organizing speaker programs unlocking.

Speaker Change: We also grew our revenue cycle organization last year, and we're aiming to optimize that this year, depending on how fast is the uptake.

Speaker Change: Secondly, as you know is going to be critical for.

Speaker Change: For bringing the <unk> the revenue in and collecting on the payments.

Speaker Change: <unk> institutional buying and adoption by individual clinicians.

Speaker Change: Last but not least potentially building out our peer group to ensure that we are expanding reimbursement.

Speaker Change: And largest practices in those states.

Speaker Change:

Speaker Change: As you can imagine we are teaming with our partners on the payer front potentially on the public payer side as well to make sure that the awareness and policy coverage is there to support their efforts.

Speaker Change: And working with both payers and government and commercial payers as well as employers benefit design consultants.

Speaker Change: Consultants and others.

Speaker Change: So that's just the start of course as our momentum grows and more states become in focus we will expand our commercial presence in waves as we go into more and more geographies.

Speaker Change: Second of course is going to be on the medical leaves on front, we brought in a head of medical.

Speaker Change: Liaison group of last year and are looking forward to potentially adding a to a to the field presence in selected states as needed that role.

Speaker Change: So this whole got it thanks.

Speaker Change: Thanks, So much and then just maybe one on the pipeline can you talk about what we should be expecting for a pipeline of initiatives in the near term and just kind of level set us on where things stand around the launch at that time to birth assay and then just relatedly any update on how youre thinking about the pricing of that test when months. Thank you.

Speaker Change: We also grew our revenue cycle organization last year, and we're aiming to optimize that this year, depending on how fast is the uptake revenue cycle. As you know is going to be critical for for bringing the <unk> the revenue in and collecting on the payments.

Speaker Change: Definitely so as we've talked about before we've prioritized two products from our pipeline to bring to market near term. That's the time to birth product, which we are targeting the second half of this year and.

Speaker Change: Last but not least potentially building out our peer group to insure that we are expanding reimbursement.

Speaker Change: And working with both payers and our government and commercial payers as well as employers benefit design consultants and others.

Speaker Change: <unk>.

Speaker Change: Second one is the predictive analytics product, which we are beta testing across the country and are hoping to get to production scale release in the second half of this year as well.

Speaker Change: So that's just the start of course as our momentum grows and more states become in focus we will expand our commercial presence in waves as we go into more and more geographies.

Speaker Change: In terms of pricing of the time to birth product. It is truly a consumer directed test even though it will be helpful for both consumers and physicians. So it as an immuno assay, it's priced at $150 or around that.

Speaker Change: So this whole got it thanks.

Speaker Change: So it should be accessible and affordable.

Speaker Change: Yeah. Thanks, so much and then just maybe one on the pipeline can you talk about what we should be expecting for a pipeline of initiatives in the near term and just kind of level set us on where things stand around launch at that time to birth assay and then just relatedly any update there on how you're thinking about the pricing of that test when months. Thank you.

Speaker Change: Great. Thanks, so much for taking our question.

Speaker Change: Thank you for the questions.

Speaker Change: Ladies and gentlemen, again, if you'd like to ask a question. Please press star followed by the number one on your Touchtone phone you will then hear a prompt that <unk> had has been raised.

Speaker Change: Should you wish to decline from the polling process. Please press star two.

Speaker Change: Definitely so as we've talked about before we've prioritized two products from our pipeline to to bring to market near term. That's the time to burst product, which we are targeting the second half of this year and the.

Speaker Change: One moment, while we compile the Q&A roster.

Speaker Change: Second one is the predictive analytics product, which we are beta testing across the country and are hoping to get to production scale release in the second half of this year as well.

Daniel: There are no further questions at this time, so I am going to go ahead and turn the call over to Mr. Daniel <unk> for closing comments Ma'am. Please go ahead.

Daniel: Thank you operator, thank you all for attending our call today, we are really pleased with our progress during the year and of course, more recently and being able to share. The results of Prime is the weeps expected publication of the full study results, which will provide more evidence of the value of utilizing our pre term doesn't treat strategy where.

Speaker Change: In terms of pricing of the time to birth product. It is truly a consumer directed test even though it will be helpful for both consumers and physicians. So it as an immuno assay, it's priced at $150 or around that so it should be accessible and affordable.

Speaker Change: Thankful for the support of our investors, including those who participated in our recent hundreds that see the great opportunity that lies ahead for Sarah I'll now turn it back over to the operator to conclude the call operator.

Speaker Change: Great. Thanks, so much for taking our question.

Speaker Change: Thank you for the questions.

Speaker Change: Ladies and gentlemen, again, if you'd like to ask a question. Please press star followed by the number one on your Touchtone phone you will then hear a prompt that your hand has been raised.

Speaker Change: This concludes today's conference call. Thank you everyone for your participation you may now disconnect.

Speaker Change: Should you wish to decline from the polling process. Please press star two.

Speaker Change: One moment, while we compile the Q&A roster.

Speaker Change: There are no further questions at this time, so I'm going to go ahead and turn the call over to Mr. Daniel Gardner for closing comments Ma'am. Please go ahead.

Daniel Gardner: Thank you operator, thank you all for attending our call today, we are really pleased with our progress during the year and of course, more recently and being able to share the results of prime as the wheat expected publication of the full study results, which will provide more evidence of the value of utilizing our pre term doesn't treat strategy where.

Daniel Gardner: Thankful for the support of our investors, including those who participated in our recent fundraise that see the great opportunity that lies ahead for Sarah I'll now turn it back over to the operator to conclude the call operator.

Daniel Gardner: Okay.

Speaker Change: This concludes today's conference call. Thank you everyone for your participation you may now disconnect.

Speaker Change: [noise] [noise].