Q1 2024 Sera Prognostics Inc Earnings Call
Operator: Good afternoon, and welcome to the Sera Prognostics conference call to review first quarter fiscal year 2024 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, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DeNardo of Capcom Partners for a few introductory comments
Good afternoon, and welcome to the separate does de <unk> Conference call to review first quarter fiscal year 'twenty 'twenty four is out.
Peter Denardo: At this time, all participants in a listen only mode. We.
Peter Denardo: We will be facilitating a question and answer session towards the end of today's call.
Peter Denardo: As a reminder, this call is being liquidated for replay purposes.
Peter Denardo: I would now like to turn the call over to Peter Denardo, I've kept completely with you introductory comment.
Peter Denardo: Thank you, operator. Good afternoon, everyone.
Peter Denardo: Thank you operator, good afternoon, everyone welcome to throw Prognostics first quarter fiscal year 2024 earnings conference call at the close of the market today. They are a prognostic released its financial results for the quarter ended March 31, 2024, because then you put a company today will be Lynn.
Peter Denardo: Welcome to Sera Prognostics' first quarter fiscal year 2024 earnings conference call. At the close of the market today, Sera Prognostics released its financial results for the quarter ended March 31, 2024. Presenting for the company today will be Evguenia Lindgardt, President and CEO, and Austin Aerts, our CFO.
Peter Denardo: 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 on our website at serapognostics.com, This call can be heard live via webcast at serapognostics.com, and a recording will be archived in the investor section of our website. Please note that some of the information presented today may contain projections or other forelooking 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.
Peter Denardo: <unk>, President and CEO and Austin Ayers, our CFO during the call. We were review of 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 zero prognostic stopped caught this.
Peter Denardo: Call it could be heard wildfire webcast that serve prognostic dot com and a recording will be archived in the investors section of our website.
Peter Denardo: Note that some of the information presented today may contain projections or other forward looking statements.
Peter Denardo: And circumstances that have not yet occurred including plans and projections for our business.
Peter Denardo: Our financial results and market trends and opportunities. These statements are based on management's current expectation and the.
Peter Denardo: 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 annual 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 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 Xenia, Sera Prognostics president and CEO. Xenia?
Xenia: 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 annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on form 8-K.
Xenia: 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.
Xenia: 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 us yet and yet there are prognostics, president and CEO Shanghai.
Evguenia Lindgardt: Thank you, Peter, and good afternoon, everyone. We continue to make progress in putting key prerequisites in place for an inflection in test volumes and revenue growth, coupled with improved margins. As Austin will detail, we believe 2024 is a foundational year of development for Sera with strategic goals we are pursuing to position the company for increased asset options in the quarters ahead, while diligently preserving our strong balance sheet and cash position as we manage the business for future growth. These strategic goals include
Xenia: Thank you Peter and good afternoon, everyone. We continue to make progress in putting keep erect with is in place for inflection in test volumes and revenue growth coupled with improved margins as.
Evguenia Lindgardt: It's often will detail. We believe 2024 is a foundational here of development for Sarah with strategic goals, we are pursuing to position the company for increased test adoption in the quarters ahead, well diligently preserving our strong balance sheet and cash position.
Evguenia Lindgardt: The business for future growth.
Evguenia Lindgardt: These strategic goals include.
Evguenia Lindgardt: Publication of our important AVERT and PRIME clinical study results to showcase the health and economic benefits of the preterm test, building awareness of our capabilities to help improve patient care and outcomes. Continuing our strong focus on R&D to bring new products in our pipeline and new collection methods to market, all the while improving access to our products to afford better health equity, scalability for our lab once demand inflection occurs, as well as increased product margins and profitability.
Evguenia Lindgardt: Publication of our important effort and private clinical study results to showcase the health economic benefits of the preterm test Bill.
Evguenia Lindgardt: Building awareness of our capabilities to help improve patient care and outcomes.
Evguenia Lindgardt: Our strong focus on R&D to bring new products and our pipeline of new collection method to market.
Evguenia Lindgardt: All the while improving access to our products to afford a better health equity scalability for our lab once demand inflection occurs as well as increased product margins and profitability.
Evguenia Lindgardt: Since the beginning of the year, we've made progress across these strategic priorities, including: Submission of prime study interim findings for publication, shipped first whole blood collection kits to our customers, shifted to a more cost-effective laboratory test analysis process, resulting in an estimated 60% COGS savings at scale, and prepared two television programs, which will air on public and network stations later this year to increase awareness surrounding preterm birth. Deliveries of prime study participants, the remaining 2200 who were enrolled before the enrollment stopped per DSMB recommendation in December 2023, are also now complete.
Evguenia Lindgardt: Since the beginning of the year, we've made progress across these strategic priorities, including.
Evguenia Lindgardt: Submission of Prime study interim findings for publication.
Evguenia Lindgardt: First whole blood collection kits to our customers.
Evguenia Lindgardt: Shifting to a more cost effective laboratory test analysis process, resulting in an estimated 60%.
Evguenia Lindgardt: Savings at scale.
Evguenia Lindgardt: Prepare to television programs, which will air on public and network stations later this year to increase awareness surrounding preterm birth.
Evguenia Lindgardt: Deliveries of Prime study participants the remaining 2200, who were enrolled before the enrollment stopped for D. S. M. B recommendation in December 2023 are also now complete and we're now planning analysis and data for the final Prime study publication.
Evguenia Lindgardt: And we're now planning analyses and data for the final prime study publication. We're pleased to report that we've validated ambient whole blood collection and have begun shipping our new kits to customers. We expect to see whole blood collection kits start running through our laboratory in the coming weeks. This, together with our laboratory enhancements, is expected to yield several distinct advantages, primarily ease of collection, increased lab capacity, and decreased turnaround time, and reduced cost of goods.
Evguenia Lindgardt: We're pleased to report that the validated ambient whole blood collection and have begun shipping our new kits to customers, we expect to see whole blood collection kits start running through our laboratory in the coming weeks.
Evguenia Lindgardt: This together with our laboratory enhancements.
Evguenia Lindgardt: Are expected to yield several distinct advantages primarily.
Evguenia Lindgardt: He is a collection increased lab capacity and decreased turnaround time.
Evguenia Lindgardt: And reduced cost of goods.
Evguenia Lindgardt: By improving and simplifying the collection method, we expect to enable greater patient access to our tests, which should allow us to reach more mothers across the country. Simplified collection also means an improved user experience for the patient and provider. We believe less friction for the physician ordering process will lead to more repeat orders by providers. The processing of whole blood samples is coupled with the rollout of our newly validated laboratory process that leverages Sera proprietary antibodies used in mass spectrometry.
Evguenia Lindgardt: By improving and simplifying the collection method, we expect to enable greater patient access to our test, which should really allow us to reach more mothers across the country.
Evguenia Lindgardt: Simplified collection also means an improved user experience for the patient and provider, we believe less friction for the physician ordering process will lead to more repeat orders by providers.
Evguenia Lindgardt: The processing of whole blood samples is coupled with the rollout of our newly validated laboratory process, that's leverages Sara.
Evguenia Lindgardt: Primary antibodies used in mass spectrometry.
Evguenia Lindgardt: In addition to enabling the processing of whole blood specimens, this new technology affords an approximate five-fold improvement in sample processing capacity per laboratory technician, an approximate tenfold increase in throughput, and cuts our turnaround time by about 50 percent. In addition to capacity and scalability enhancements, a faster and simpler laboratory process reduces material and labor costs, while whole blood ambient samples can be drawn and shipped at a much reduced cost when compared to frozen serum. Overall, we expect an estimated cost of goods reduction of up to 60 percent, possibly higher, beyond certain scale milestones.
Evguenia Lindgardt: In addition to enabling the processing of whole blood specimens. This new technology affords an approximate five fold improvement in sample processing capacity for laboratory technician.
Evguenia Lindgardt: And then approximate 10 fold increase in throughput.
Evguenia Lindgardt: And cuts our turnaround time by about 50%.
Evguenia Lindgardt: In addition to capacity and scalability enhancements, a faster and simpler laboratory process reduces material and labor costs.
Evguenia Lindgardt: While whole blood ambient samples can be drawn and shipped at a much reduced cost when compared to frozen and CRM.
Evguenia Lindgardt: Overall, we expect an estimated cost of goods reduction of up to 60%, possibly higher beyond certain scale milestones.
Evguenia Lindgardt: These improvements to our margins should serve to increase access to our technology, a key prerequisite to our growth strategy. While we work to communicate data from our VRT and PRIME studies, we believe this will provide strong validation of the benefit of utilizing the preterm test for guideline development and adoption. A recent ACOG note on guidelines on biomarker testing for preeclampsia points to the attention from guideline-setting bodies to preterm birth complications. For now, we're continuing engagement with various stakeholders to increase adoption of our test in order to improve pregnancy and maternal outcomes.
Evguenia Lindgardt: These improvements to our margins should serve to increase access to our technology, a key prerequisite to our growth strategy.
Evguenia Lindgardt: While we work to communicate data from our effort in prior studies. We believe this will provide strong validation of the benefit of utilizing the preterm tests for guideline development and adoption.
Evguenia Lindgardt: A recent eight notes on guidelines on biomarker testing for preeclampsia points to the attention from guideline setting bodies to preterm birth complications.
Evguenia Lindgardt: For now we're continuing engagement with various stakeholders to increase adoption of our test in order to improve pregnancy and material outcomes.
Evguenia Lindgardt: These stakeholders include providers we're teaming up with to target the states hit hardest by spontaneous premature birth rates. Our plans include working with payers and providers in collaboration with other stakeholders on targeted state implementation programs to promote health equity to address spontaneous premature births and improve pregnancy care, particularly among undisturbed populations and communities. This could provide a way to resolve a big problem and broaden awareness and increase adoption of preterm by patients, physicians, and the medical community overall. There has been a lot of interest in the potential impact of the FDA's review of laboratory-developed tests, often called LDTs. The FDA published its final LDT rule last week on April 29th.
Evguenia Lindgardt: These stakeholders include providers, we're teaming up with to target the states hit hardest by this but peneus premature birth rates.
Evguenia Lindgardt: Our plans include working with payers and providers in collaboration with other stakeholders on targeted state implementation programs to promote health equity to address spontaneous premature births and improve pregnancy care, particularly among undisturbed populations and communities.
Evguenia Lindgardt: This could provide a way to resolve a big problem and broaden awareness and increase adoption of preterm by patients physicians and the medical community overall.
Evguenia Lindgardt: There has been a lot of interest in the potential impact of the Fda's review of laboratory developed tests, often called L. D. Keith.
Evguenia Lindgardt: The FDA published its final Elisia rule last week on April 29th and while there may be subsequent changes given pushback from certain industry stakeholders, we share the goal of keeping patients safe with a reasonable oversight of ldcs.
Evguenia Lindgardt: And while there may be subsequent changes given pushback from certain industry stakeholders, we share the goal of keeping patients safe with reasonable oversight of LDT. A higher level of review and approval for new tests, whether under FDA's final LVT rule or the VALID Act that has been pending in Congress for a while, could set a new and higher bar for new entrants into the space we serve. There's always uncertainty whether a new regulation may be challenged, but we believe we're well-placed to work within the FDA's proposed LDT framework to continue bringing our tests to patients. For example, the FDA's new LDT rule includes continued enforcement discretion.
Evguenia Lindgardt: A higher level of review and approval for new tests, whether under Fda's final Lvg rule for the valid act that has been pending in Congress for a wild card.
Evguenia Lindgardt: Set the new and higher bar for new entrants into the space we serve.
Evguenia Lindgardt: There's always uncertainty whether a new regulation may be challenged but we believe we are well placed to work within the Fda's proposed OTT framework to continue bringing our tests to patients for example, the Fda's New LDC rule includes continued enforcement discretion.
Evguenia Lindgardt: The pre-existing status quo for LDTs approved by the New York State Clinical Laboratory Evaluation Program, which includes our preterm test. Given our strong long-term R&D-driven history and extensive clinical study data, we believe the higher bar set by stronger regulations could serve as a source of advantage for Sera by requiring competitors to dedicate years of work and significant investment. FDA states that increased oversight may help promote adequate representation in validation studies, which would help advance health equity and which lines up nicely with our mission.
Evguenia Lindgardt: The existing status quo for L. D. Ts approved by the New York State Clinical Laboratory evaluation program, which includes our pre term test.
Evguenia Lindgardt: Given our strong long term R&D driven history and extensive clinical study data, we believe the higher bar set by stronger regulations could serve as a source of advantage for Sarah by requiring competitors, a dedicated years of work and significant investments.
Evguenia Lindgardt: As these states that increased oversight they help promote adequate representation in validation studies, which would help advance health equity and which lines up nicely with our mission.
Evguenia Lindgardt: As a reminder, about 1 in 10 babies is born prematurely in the United States at a rate of 10.4% according to CDC for 2022, while racial and ethnic differences in preterm birth rates remain. For example, for 2022, the rate of preterm birth among African American women of 14.6% was about 50% higher than the rate of preterm birth among white or Hispanic women at 9.4% and 10.1%, respectively.
Evguenia Lindgardt: As a reminder, about one in 10 babies is born prematurely in the United States at a rate of 10, 4%. According to CDC for 2022, while the racial and ethnic differences in preterm birth rates remain well.
Evguenia Lindgardt: For 2022, the rate of preterm birth, among African American women, a 14, 6% was about 50% higher than the rate of preterm birth, among white or Hispanic women at nine 4% and 10, 1% respectively.
Evguenia Lindgardt: We need to do more, and we can with Preterm. Sera was recently invited to support broadening awareness of innovative solutions available to expectant mothers and their physicians to understand the risk of preterm birth. Later this year, Sera will be featured on two television programs: Viewpoint with Dennis Quaid and Empowered with Meg Ryan.
Evguenia Lindgardt: We need to do more and we can with preterm.
Evguenia Lindgardt: Sarah was recently invited to support broadening awareness of innovative solutions available to expectant mothers and their physicians to understand the risk of preterm birth.
Evguenia Lindgardt: Later this year Sarah will be featured on two TV programs viewpoint, with Dennis Quaid and empowered wasn't that Brian.
Evguenia Lindgardt: Distribution of these programs is expected to reach over 100 million people in the United States. This will be a strong awareness building tool for Sera in 2024 to follow the physician education campaigns we're launching this summer. Outside of our current core market in the United States, we're exploring attractive international markets. This process is expected to involve engaging with regulators in countries with a significant number of premature births, where the addressable market for the Sera preterm test is compelling.
Evguenia Lindgardt: Distribution of these programs is expected to reach over 100 million people in the United States. This.
Evguenia Lindgardt: This will be a strong awareness building tool for Sarah in 2024 to follow the physician education campaigns, we're launching this summer.
Evguenia Lindgardt: Outside of our current core market in the United States, we're exploring attractive international markets. This process is expected to involve engaging with regulators in countries with a significant number of premature birth, where the addressable market for the therapy term test is compelling.
Evguenia Lindgardt: Upon publication of our Pivotal, AVERT, and PRIME studies, we plan to share the data with regulators. We also plan to engage with multiple potential partners to assess what may be needed to enter key international markets. If we ultimately enter such markets, our ambient whole blood kit collection methods are expected to ease market access, promote accessibility to address health care equity, and have optionality on test cost to promote adoption while still leveraging healthy product margins.
Evguenia Lindgardt: Upon publication of our pivotal effort in Prime studies, we plan to share the data with regulators. We also plan to engage with multiple potential partners to assess what may be needed to enter key international markets.
Evguenia Lindgardt: If we ultimately into such markets, our ambient whole blood collection methods are expected to ease market access promote accessibility to address health care equity and have optionality on test cost to promote adoption, while still leveraging healthy product margins.
Evguenia Lindgardt: Developing test processing via ELISA would also make it easier for Sera to go to market internationally. In conclusion, we're pursuing multiple shots at goal to build awareness and adoption, and believe our pathway will not only become easier upon publication of the studies I mentioned, but such validated and compelling data in regard to preterm will also bolster and embolden the pursuit of our mission. Now over to you, Austin. Thanks, Evguenia, and good afternoon.
Evguenia Lindgardt: Developing test processing via Elisa would also make it easier for Sarah to go to market internationally.
Austin: In conclusion, we're pursuing multiple shots on goal to build awareness and adoption and believe our pathway will not only become easier upon publication of the study as I mentioned, but such validated and compelling data in regard to preterm will also bolster and embolden the pursuit of our mission.
Evguenia Lindgardt: Now over to you Austin.
Austin Aerts: Thanks, Evguenia, and good afternoon, everyone. Let me review our financial results for the quarter and then briefly review our thinking on commercial investment. Net revenue for the first quarter of 2024 was nil due to revenue adjustments made as part of our normal revenue recognition process, updating our expected collection amounts through periodic refinement of revenue estimates as described in detail in our 10-K. Gross revenues before adjustments were approximately $39,000 compared to $100,000 for the first quarter of 2023.
Austin: Thanks, Dan and good afternoon, everyone.
Austin Aerts: Let me review our financial results for the quarter and then briefly review our thinking on commercial investment.
Austin Aerts: Net revenue for the first quarter of 2024 was nil due to revenue adjustments made as part of our normal revenue recognition process updating our expected collection amounts through periodic refinement of revenue estimates as described in detail in our 10-K.
Austin Aerts: Gross revenues before adjustments were approximately $39000 compared to $100000 for the first quarter of 2023.
Austin Aerts: This reduction in our revenue is an expected outcome of optimizing our investment in commercial activities and preserving capital to deploy for future commercial investments once we have built our evidence portfolio and executed on other prerequisites for success. Our decision to right-size our cost structure last year has materially improved our cash runway. As we've previously noted, it was highly uncertain that we would achieve all of the key requirements that could foster immediate revenue, such as publications validating our preterm test, insurance coverage, and consumer and physician awareness and adoption during the first half of 2024. As Jenny mentioned in this call, we are working diligently to execute each of these prerequisites in the first half of this year and hope to share exciting news with you in the coming quarter.
Austin Aerts: This reduction in our revenue is an expected outcome of optimizing our investment in commercial activities and preserving capital to deploy for future commercial investments. Once we have built our portfolio and executed on other prerequisite for success.
Austin Aerts: Our decision to rightsize, our cost structure last year has materially improved our cash runway.
Austin Aerts: As we've previously noted it was highly uncertain that we would achieve all of the key requirements that could foster an immediate revenue ramp such as publications validating our pre term test insurance coverage and consumer and physician awareness and adoption during the first half of 2024.
Austin Aerts: Dan You mentioned in this call we are working diligently to execute each of these prerequisites in the first half of this year and hope to share exciting news with you in the coming quarters.
Austin Aerts: Total operating expenses for the first quarter of $9.1 million were down 20% from $11.4 million for the same period a year ago due to steps we took to streamline commercial operations, better focus our commercial strategy, and reduce overall operating costs. Net loss for the first quarter of 2024 was $8.1 million, down 24% from $10.6 million for the first quarter of 2023. Research and development expenses were $3.7 million, down 10% from $4.1 million for the first quarter of 2023 due primarily to lower clinical study costs.
Austin Aerts: Total operating expenses for the first quarter of $9 $1 million were down 20% from $11 4 million for the same period, a year ago due to steps, we took to streamline commercial operations better focus our commercial strategy and reduce overall operating expenses.
Austin Aerts: Net loss for the first quarter of 2024 was $8 1 million down 24% from $10 6 million for the first quarter of 2023.
Austin Aerts: Research and development expenses were $3 $7 million and down 10% from $4 1 million for the first quarter of 2023, due primarily to lower clinical study costs.
Austin Aerts: Selling General and Administrative Expenses for the first quarter were $5.4 million, down 26% from $7.3 million for the same period a year ago due to the steps we've taken to reduce expenses while focusing on the most efficient means to build revenue in the quarters ahead. We have begun planning for a prudent expansion of our commercial operations, and, while we are not expecting an immediate return to previous expense levels, we are prepared to invest quickly in any commercial opportunities generated by study publications and increase market awareness when appropriate.
Austin Aerts: Selling general and administrative expenses for the first quarter were $5 4 million down 26% from $7 3 million.
Austin Aerts: For the same period, a year ago due to the steps we've taken to reduce expenses, while focusing on the most efficient means to build revenue in the quarters ahead.
Austin Aerts: We have begun planning for a prudent expansion of our commercial operations and while we are not expecting an immediate return to previous expense levels. We are prepared to invest quickly into any commercial opportunities generated by study publications and increased market awareness when appropriate.
Austin Aerts: As of March 31st, 2024, the company had cash, cash equivalents, and available for sale securities of approximately $85.4 million. This was an improvement of about $5.5 million over $79.9 million at December 31, 2023 and resulted primarily from a payment received from our strategic partner in January, offset by regular cash operating expenses. We continue to be mindful of our cash burn rate and understand the uncertainties of the current and future capital markets environment.
Austin Aerts: As of March 31, 2024, the company had cash cash equivalents and available for sale securities of approximately $85 4 million.
Austin Aerts: This was an improvement of about $5 $5 million over $79 $9 million at December 31, 2023, and resulted primarily from the payment received from our strategic partner in January offset by regular cash operating expenses.
Austin Aerts: We continue to be mindful of our cash burn rate and understand the uncertainties of the current and future capital markets environment.
Austin Aerts: We will remain diligent in our strong fiduciary management of cash, balancing this with strategic investment and execution that we believe will position the company for commercial progress in the quarters and years ahead. Operator, we can now please open the call to questions.
Austin Aerts: We will remain diligent in our strong fiduciary management of cash balancing this with strategic investments and execution that we believe will position the company for our commercial progress in the quarters and years ahead.
Speaker Change: Operator, we can now please open the call for questions.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star, followed by the number. If you are using a speakerphone, please lift the handset before pressing any button. One moment, please, for your first question. Our first question comes from the line of Andrew Brackmann from William Blair. Go ahead.
Speaker Change: Ladies and gentlemen, you will now begin the question and answer session should you have a question. Please press star followed by the number one on your Touchstone Sun.
Operator: Tom did you hand has been raised should you wish to decline from the polling process. Please press star followed by the number to it.
Operator: If you are using a speaker phone please lift the handset before pressing any key.
Operator: One moment. Please for your first question.
Andrew Frederick Brackmann: Our first question comes from the line of Andrew Backman from William Blair Go ahead. Please.
Dustin G. Scaringe: Hi, this is Dustin on the line for Andrew. Thanks for taking our questions. First question I have is just on the latest updates you've had in conversations with KOL since the publication or positive update on PRIME with DSMB. And then, similarly, what kind of conversations are you having with guideline bodies as well? And do you think they'll give... sort of any statement that very shortly after PRIME gets published in the interim analysis? Thank you.
Operator: Hi, This is Dustin on Milan for Andrew Thanks for taking our questions first question I have just on the latest updates you are having with conversations with kols since the publication here positive update on prime with the SMB and then similarly, what kind of conversations are you having with.
Dustin G. Scaringe: Guideline bodies as well and do you think they'll give.
Dustin G. Scaringe: Any statement that very shortly after.
Dustin G. Scaringe: Time gets published and the interim analysis. Thank you.
Evguenia Lindgardt: Dustin, hi, this is Evguenia. Thank you so much for your question. You're absolutely right.
Dustin G. Scaringe: Dustin Hi, this is Daniel Thank you so much for your question, you're absolutely right, we're engaging our foreign wide with our Kols and regulators.
Evguenia Lindgardt: We're engaging far and wide with KOLs and regulators. In our last touch point with the guideline setting bodies, professional society members, we said that as soon as we are closer to publication, we will reconvene with them to share all of the details of the results. It's certainly something that guideline setting bodies do, issue commentary on breakthrough results. I can't foresee or guarantee that they will do that, but their level of interest and engagement so far certainly points to some signals from their side. And we will absolutely update all of the investors on any developments on that front.
Evguenia Lindgardt: And our last touch point with the guideline setting our bodies professional society members was as soon as we are closer to the publication, we will reconvene with them to share all of the details of the results.
Evguenia Lindgardt: It's certainly.
Evguenia Lindgardt: Something that deadline setting bodies do issue commentary on breakthrough results I can't foresee a or guarantee that they will do that but their level of interest and engagement. So far certainly points to a to some signal from their side.
Evguenia Lindgardt: And we will absolutely.
Evguenia Lindgardt: Update all of the investors to any developments on that front.
Speaker Change: Understood. Thank you.
Evguenia Lindgardt: Understood. Thank you. Question on the pipeline. Just wondering where the time to birth assay is in development now. What can we expect in terms of data generation? I think you previously said some data may be this year or next year for time to birth. Thank you.
Evguenia Lindgardt: A question on the pipeline just wondering what are the timing of birth I'd say, it's a development, Alabama what.
Evguenia Lindgardt: What can we expect in terms of data generation I think you previously said.
Evguenia Lindgardt: Some data maybe this year or next year for time to Barry. Thank you.
Evguenia Lindgardt: That's right Dustin. The time to birth product is... Getting enhanced as we speak. As I mentioned, we decided to put it on the ELISA platform to really ensure that there are strong economics for this product. Certainly, data making data available on the product will be on our mind as the first step in the sequence of launch, so I absolutely count on that happening in the coming months. I don't have a precise timeline on that, but as you suggested in your question, certainly before the end of the year or early next year is what I would expect as the timing for that, shortly before launch.
Speaker Change: That's right Justin.
Evguenia Lindgardt: The time to birth product is getting enhanced as we speak as I mentioned, we decided to put it on a like the platform to really ensure that there are strong economics for this product certainly.
Evguenia Lindgardt: Data, making data available on that product will be on our mind as the first step in the sequence of lunch.
Evguenia Lindgardt: So absolutely are counting on that happening in the coming months I don't have a precise timeline on that but as you as you suggested in your question certainly.
Evguenia Lindgardt: Before the end of the year or early next year is what I would expect as the timing for that.
Evguenia Lindgardt: Shortly before lunch.
Dustin G. Scaringe: Okay, that's helpful, thank you. And then just one more from us. I know previously you talked about an additional $5 million investment option in the context of expenses that you baked in the guidance. Are those two campaigns part of that $5 million, or would that $5 million be on top of that?
Speaker Change: Okay. That's helpful. Thank you.
Dustin G. Scaringe: And then just one more from US I know previously you talked about and additional $5 million investment option.
Dustin G. Scaringe: The context of expenses.
Dustin G. Scaringe: Baked in the guidance is the marketing that you announced today.
Dustin G. Scaringe: Those two campaigns is that part of that 5 million are what about 5 billion would be on top of that thank you.
Dustin G. Scaringe: Yeah.
Austin Aerts: Austin, do you want to take this one?
Dustin G. Scaringe: Austin do you want to take that one.
Austin Aerts: Sure. Yeah, the marketing campaigns, as Jenny mentioned, are actually incredibly cost-effective and don't really have a material impact on our current budget or current operating expenses. As Jenny mentioned, these opportunities came to us and are very beneficial for us in terms of the low cost and the reach. As far as the $5 million that we've talked about previously, we sort of, you know, we talked about how we budgeted this $5 million of additional investment beyond our current run rate to invest behind the achievement of our milestones and into commercial opportunities.
Austin Aerts: Store Yeah. These are the marketing campaigns that you mentioned are actually incredibly cost effective and don't really have a material impact on our.
Austin Aerts: Current budget, our current operating expenses as Eddie mentioned these opportunities came to us and were very beneficial for us in terms of the low cost and the reach.
Austin Aerts: As far as the $5 million that we've talked about previously.
Austin Aerts: We've talked about how we budgeted $5 million of additional investment beyond our current run rate.
Austin Aerts: To invest behind the achievement of our milestones and into commercial opportunities.
Austin Aerts: The majority of that will be in sort of commercial deployments, but we're going to remain vigilant. You know, we're not going out and spending that quite yet. We're going to evaluate each opportunity in terms of ROI and creating near and long-term value for the company before we start to really dig into that sort of $5 million pot that we talked about last time.
Austin Aerts: The majority of that will be in sort of commercial deployment.
Austin Aerts: But we're going to remain vigilant you know, we're not going out and spending that quite yet.
Austin Aerts: We're going to evaluate each opportunity in terms of ROI, and creating near and long term value for the company.
Austin Aerts: Before we start to really dig into that sort of $5 million. The part that we talked about last time.
Dustin G. Scaringe: Yep, spot on. And Dustin, so basically, the two campaigns are already paid for and baked into our. It makes sense, okay?
Speaker Change: Yep spot on and Dustin So basically the the two campaigns already paid for and baked into our cost.
Dustin G. Scaringe: It makes sense. Okay. That's it from us. Thank you. Thank you for the questions.
Dustin G. Scaringe: That makes sense okay.
Speaker Change: That's it from us thank you.
Dustin G. Scaringe: Thank you for the question.
Operator: Thank you. Ladies and gentlemen, just a reminder, should you have a question, please press star followed by the number one on your touchstone sign. Again, ladies and gentlemen, just a reminder, should you have a question, please press star one on your touchtone phone. As there seems to be no further questions at this time, I'd now like to turn the call back over to Ms. Evguenia Lindgardt for her final
Speaker Change: Thank you.
Dustin G. Scaringe: Ladies and gentlemen, just a reminder, should you have a question. Please press star followed by the number one on you touched on that.
Operator: Again, ladies and gentlemen, just a reminder, should you have a question. Please press star one on your Touchtone phone.
Evguenia Lindgardt: As days seems to be no further questions at this time I'd now like to turn the call back over to Mr. Mrs. Daniella. Thank God for final closing comments.
Evguenia Lindgardt: Thank you so much, Operator, and thank you all for attending our call today. We have a lot of work to do through the remainder of the year, launching self-pay and employer-paid channels in parallel to pursuing pay reimbursement as well as education and awareness campaigns for pre-term. We are invigorated by growing interest in our technology portfolio and our expectation of publications of overt and prime studies. We believe these studies, when published, will fuel even greater interest in preterm birth and pave the way for adoption that can help solve the crisis of premature birth while helping accelerate our growth. I'll now turn it back over to the operator to conclude the call. Operator?
Evguenia Lindgardt: Thank you so much operator, and thank you all for attending our call today.
Evguenia Lindgardt: We have a lot of work to do through the remainder of the year launching self being employer paid channels and parallel to pursuing fair reimbursement as well as education and awareness campaigns for preterm, we are invigorated by growing interest in our technology portfolio and our expectation of publications of overt and Prime studies. We believe these studies one.
Evguenia Lindgardt: Published will fuel, even greater interest in preterm and pave the way for adoption that can help solve the crisis of premature birth help solve the crisis, a premature birth, while helping accelerate our growth.
Operator: Thank you, ma'am. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a lovely day.
Evguenia Lindgardt: I'll now turn it back over to the operator to conclude the call operator.
Speaker Change: Thank you ma'am, ladies and gentlemen. This concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines have a lovely day.
Operator: [music].
Operator: Okay.
Operator: Yeah.
Operator: [music].