Q1 2026 Sera Prognostics Inc Earnings Call
Operator: Ladies and gentlemen, welcome to Sera Prognostics Q1 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star 0 for the operator. Please be advised that this call is being recorded today, Wednesday, 6 May 2026. I will now turn the call over to our first speaker today, Jennifer Zibuda, Investor Relations. Please go ahead.
Operator: Ladies and gentlemen, welcome to Sera Prognostics Q1 2026 Financial Results Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star 0 for the operator. Please be advised that this call is being recorded today, Wednesday, 6 May 2026. I will now turn the call over to our first speaker today, Jennifer Zibuda, Investor Relations. Please go ahead.
Speaker #2: If at any time during this call you require immediate assistance, please press *0 for the operator. Please be advised that this call is being recorded.
Speaker #2: Recorded today. Once they may 6, 2026, I will now turn the call over to our first speaker today, Jennifer Zibuda, investor relations. Please go ahead.
Speaker #2: Thank you, operator. Welcome to SERA PROGNOSTICS, first quarter fiscal year 2026 earnings conference call. At the close of market today, SERA PROGNOSTICS released its financial results for the quarter ended March 31, 2026.
Jennifer Zibuda: Thank you, operator. Welcome to Sera Prognostics Q1 fiscal year 2026 Earnings Conference Call. At the close of market today, Sera Prognostics released its financial results for the quarter ended 31 March 2026. Presenting for the company today will be Zhenya Lindgardt, President and CEO, and Austin Aerts, 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 at sera.com. This call can be heard live via webcast at sera.com, and a recording will be archived in the investors section of our website.
Jennifer Zibuda: Thank you, operator. Welcome to Sera Prognostics Q1 fiscal year 2026 Earnings Conference Call. At the close of market today, Sera Prognostics released its financial results for the quarter ended 31 March 2026. Presenting for the company today will be Zhenya Lindgardt, President and CEO, and Austin Aerts, our CFO. During the call, we will review the financial results we released today, after which we will host a question-and-answer session.
Speaker #2: Presenting for the company today, will be Jenya Lingard, president and CEO, and Austin Aerts, RCFO. During the call, we will review the financial results we released today after which we will host a question-and-answer session.
Speaker #2: If you've not had a chance to review our quarterly earnings release, it can be found on our website at SERA.com. This call can be heard live via webcast at SERA.com and a recording will be archived in the investors section of our website.
Jennifer Zibuda: If you've not had a chance to review our quarterly earnings release, it can be found on our website at sera.com. This call can be heard live via webcast at sera.com, and a recording will be archived in the investors section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities.
Speaker #2: Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities.
Jennifer Zibuda: Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from those 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 the actual results to differ materially from those contained in our projections and other forward-looking statements. I will now turn the call over to Zhenya.
Speaker #2: These statements are based on management's current expectations and the actual events or results may differ materially and adversely from those expectations for a variety of reasons.
Jennifer Zibuda: These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from those 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 the actual results to differ materially from those contained in our projections and other forward-looking statements. I will now turn the call over to Zhenya.
Speaker #2: 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.
Speaker #2: 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 #2: I will now turn the call over to Jenya.
Speaker #3: Thank you, Jennifer. And thank you, everyone, for joining us today. Given that we reported full-year results just over six weeks ago, I'll focus my remarks on several key developments that continue to advance our commercial strategy and expand access to pre-term.
Zhenya Lindgardt: Thank you, Jennifer, and thank you everyone for joining us today. Given that we reported full-year results just over six weeks ago, I'll focus my remarks on several key developments that continue to advance our commercial strategy and expand access to PreTRM. Following the publication of the full PRIME study results in January, our primary focus in the first quarter was building awareness with both clinicians and broader stakeholders. Our education and outreach efforts were designed to broaden understanding of preterm birth risk and prevention, including among audiences that are difficult to reach through traditional healthcare channels. From a provider engagement standpoint, we maintained a strong presence across key clinical forums, including the SMFM annual meeting in February and more recently, the ACOG annual clinical and scientific meeting.
Zhenya Lindgardt: Thank you, Jennifer, and thank you everyone for joining us today. Given that we reported full-year results just over six weeks ago, I'll focus my remarks on several key developments that continue to advance our commercial strategy and expand access to PreTRM. Following the publication of the full PRIME study results in January, our primary focus in the Q1 was building awareness with both clinicians and broader stakeholders.
Speaker #3: Following the publication of the full prime study results in January, our primary focus in the first quarter was building awareness with both clinicians and broader stakeholders.
Speaker #3: Our education and outreach efforts were designed to broaden understanding of pre-term birth risk and prevention, including among audiences that are difficult to reach through traditional healthcare channels.
Zhenya Lindgardt: Our education and outreach efforts were designed to broaden understanding of preterm birth risk and prevention, including among audiences that are difficult to reach through traditional healthcare channels. From a provider engagement standpoint, we maintained a strong presence across key clinical forums, including the SMFM annual meeting in February and more recently, the ACOG annual clinical and scientific meeting.
Speaker #3: From a provider engagement standpoint, we maintained a strong presence across key clinical forums. Including the SMFM annual meeting in February, and more recently, the ACOG annual clinical and scientific meeting.
Speaker #3: At SMFM, we highlighted key clinical evidence and engaged directly with maternal fetal medicine specialists on pre-term's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss prime study outcomes.
Zhenya Lindgardt: At SMFM, we highlighted key clinical evidence and engaged directly with maternal fetal medicine specialists on PreTRM's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss PRIME study outcomes. At ACOG, we built on that momentum with a targeted product theater that showcased both the PRIME data and practical implementation strategies, underscoring how PreTRM can be seamlessly integrated into routine clinical care. We have been featured in several targeted podcasts this year, which complements our presence at medical meetings and extends our reach. In March, the SHE MD Podcast featured an interview with Hailey Bieber discussing her pregnancy and the PreTRM test, which she received under the care of Dr. Aliabadi, SHE MD co-host and Sera customer. This generated a high level of awareness of PreTRM, given Hailey's global visibility and social following, along with a subsequent People magazine exclusive interview.
Zhenya Lindgardt: At SMFM, we highlighted key clinical evidence and engaged directly with maternal fetal medicine specialists on PreTRM's role in risk stratification and early intervention. We also engaged with SMFM leadership to discuss PRIME study outcomes. At ACOG, we built on that momentum with a targeted product theater that showcased both the PRIME data and practical implementation strategies, underscoring how PreTRM can be seamlessly integrated into routine clinical care.
Speaker #3: At ACOG, we built on that momentum with a targeted product theater that showcased both the prime data and practical implementation strategies, underscoring how pre-term can be seamlessly integrated into routine clinical care.
Speaker #3: We have been featured in several targeted podcasts this year. Which complements our presence at medical meetings and extends our reach. In March, the CMD podcast featured an interview with Hailey Bieber, discussing her pregnancy.
Zhenya Lindgardt: We have been featured in several targeted podcasts this year, which complements our presence at medical meetings and extends our reach. In March, the SHE MD Podcast featured an interview with Hailey Bieber discussing her pregnancy and the PreTRM test, which she received under the care of Dr. Aliabadi, SHE MD co-host and Sera customer. This generated a high level of awareness of PreTRM, given Hailey's global visibility and social following, along with a subsequent People magazine exclusive interview.
Speaker #3: And the pre-term test, which she received under the care of Dr. Ali Abadi. CMD co-host and SERA customer. This generated high-level awareness of pre-term, given Hailey's global visibility and social following along with a subsequent People Magazine exclusive interview.
Speaker #3: The episode surpassed half a million views and continues to drive awareness. Following that, we engaged with CMD to record a new podcast episode releasing May 14 to coincide with National Women's Health Week.
Zhenya Lindgardt: The episode surpassed half a million views and continued to drive awareness. Following that, we engaged with SHE MD to record a new podcast episode releasing 14 May to coincide with National Women's Health Week. This interview will feature a conversation on the science behind Sera, the clinical evidence from PRIME, and how the PreTRM test needs broad awareness and should be considered a future standard of care. The episode discusses Dr. Aliabadi's experience with PreTRM tests over the last few years and the value of prevention and evidence-based risk identification. We hope you will all tune in next week. As we look ahead, we will also be featured on Medscape's Hear from Her: The Women in Healthcare Leadership podcast, engaging in conversation with the podcast host, Jelena Sgouropoulou, and Dr. Mollie McDonnold, Maternal Fetal Medicine Specialist at St. David's Women's Center in Austin, Texas.
Zhenya Lindgardt: The episode surpassed half a million views and continued to drive awareness. Following that, we engaged with SHE MD to record a new podcast episode releasing 14 May to coincide with National Women's Health Week. This interview will feature a conversation on the science behind Sera, the clinical evidence from PRIME, and how the PreTRM test needs broad awareness and should be considered a future standard of care.
Speaker #3: This interview will feature a conversation on the science behind SERA, the clinical evidence from prime, and how the pre-term test needs broad awareness and should be considered as future standard of care.
Speaker #3: The episode discusses Dr. Ali Abadi's experience with pre-term tests over the last few years and the value of prevention and evidence-based risk identification. We hope you will all tune in next week.
Zhenya Lindgardt: The episode discusses Dr. Aliabadi's experience with PreTRM tests over the last few years and the value of prevention and evidence-based risk identification. We hope you will all tune in next week. As we look ahead, we will also be featured on Medscape's Hear from Her: The Women in Healthcare Leadership podcast, engaging in conversation with the podcast host, Jelena Sgouropoulou, and Dr. Mollie McDonnold, Maternal Fetal Medicine Specialist at St. David's Women's Center in Austin, Texas.
Speaker #3: As we look ahead, we will also be featured on Medscape's Hear From Her, the Women in Healthcare Leadership podcast, engaging in conversation with a podcast host, Zelena Spyropoulos, and Dr. Molly McDonald, maternal fetal medicine specialist and St.
Speaker #3: David's Women's Center in Austin, Texas. The episode dives into the realities of pre-term birth, the need for proper intervention, and what can be done to help patients.
Zhenya Lindgardt: The episode dives into the realities of preterm birth, the need for proper intervention, and what can be done to help patients. Together, these media efforts continue to drive awareness across patients and providers, policymakers, and payers who play an important role in improving pregnancy outcomes. Turning to our commercial progress, our efforts during the quarter remained focused on building sustainable access points and referral pathways that we expect to support our long-term volume and revenue. Adding to our two live programs, we launched our third partnership program during the quarter, further expanding education and access to PreTRM.
Zhenya Lindgardt: The episode dives into the realities of preterm birth, the need for proper intervention, and what can be done to help patients. Together, these media efforts continue to drive awareness across patients and providers, policymakers, and payers who play an important role in improving pregnancy outcomes.
Speaker #3: Together, these media efforts continue to drive awareness across patients and providers, policymakers, and payers who play an important role in improving pregnancy outcomes. Turning to our commercial progress, our efforts during the quarter remained focused on building sustainable access points and referral pathways that we expect to support our long-term volume and revenue.
Zhenya Lindgardt: Turning to our commercial progress, our efforts during the quarter remained focused on building sustainable access points and referral pathways that we expect to support our long-term volume and revenue. Adding to our two live programs, we launched our third partnership program during the quarter, further expanding education and access to PreTRM.
Speaker #3: Adding to our two live programs we launched our third partnership program during the quarter, further expanding education and access to pre-term. This program is expected to reach over 350 providers across three states, expanding our clinical footprint and advancing earlier identification and intervention for at-risk pregnancies.
Zhenya Lindgardt: This program is expected to reach over 350 providers across three states, expanding our clinical footprint and advancing earlier identification and intervention for at-risk pregnancies. Beyond these established programs, we are contracting with additional partners and expect to provide more detail as these initiatives transition from contracting into live implementation. In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships with a focused set of target markets. We believe this concentrated approach is more effective in driving meaningful implementation and adoption than pursuing broader but less integrated engagement. Across all of these efforts, our priorities remain execution, reimbursement, physician awareness, clinical integration, and provider adoption. We view these steps as foundational to broader coverage and scale over time.
Zhenya Lindgardt: This program is expected to reach over 350 providers across three states, expanding our clinical footprint and advancing earlier identification and intervention for at-risk pregnancies. Beyond these established programs, we are contracting with additional partners and expect to provide more detail as these initiatives transition from contracting into live implementation.
Speaker #3: Beyond these established programs, we are contracting with additional partners and expect to provide more detail as these initiatives transition from contracting into live implementation.
Speaker #3: In parallel, we are now engaged in active discussions with 13 payers across 15 states reflecting our strategy to deepen relationships with a focused set of target markets.
Zhenya Lindgardt: In parallel, we are now engaged in active discussions with 13 payers across 15 states, reflecting our strategy to deepen relationships with a focused set of target markets. We believe this concentrated approach is more effective in driving meaningful implementation and adoption than pursuing broader but less integrated engagement. Across all of these efforts, our priorities remain execution, reimbursement, physician awareness, clinical integration, and provider adoption. We view these steps as foundational to broader coverage and scale over time.
Speaker #3: We believe this concentrated approach is more effective in driving meaningful implementation and adoption than pursuing broader but less integrated engagement. Across all of these efforts, our priorities remain execution, reimbursement, physician awareness, clinical integration, and provider adoption.
Speaker #3: We view these steps as foundational to broader coverage and scale over time. In addition to reimbursement, we are making steady progress in our efforts to drive guideline inclusion.
Zhenya Lindgardt: In addition to reimbursement, we are making steady progress in our efforts to drive guideline inclusion while continuing to expand the evidence base supporting PreTRM. As discussed in our year-end call, European expert commentary on the PRIME trial was published in The Journal of Maternal-Fetal & Neonatal Medicine in March. The authors emphasized that current preterm birth prevention strategies failed to identify the majority of women who ultimately deliver preterm, and highlighted the alignment of the PreTRM approach with existing European healthcare systems. Also in March, results from the PREPARE survey were accepted for publication in the Journal of Women's Health. This survey examined preterm birth awareness and risk perception among women across 5 European countries and identified a meaningful gap between perceived awareness and actionable understanding, reinforcing the need for earlier and more standardized risk communication. We look forward to the formal publication expected in May.
Zhenya Lindgardt: In addition to reimbursement, we are making steady progress in our efforts to drive guideline inclusion while continuing to expand the evidence base supporting PreTRM. As discussed in our year-end call, European expert commentary on the PRIME trial was published in The Journal of Maternal-Fetal & Neonatal Medicine in March. The authors emphasized that current preterm birth prevention strategies failed to identify the majority of women who ultimately deliver preterm, and highlighted the alignment of the PreTRM approach with existing European healthcare systems.
Speaker #3: While continuing to expand the evidence-based supporting pre-term. As discussed in our year-end call, European expert commentary on the prime trial was published in the Journal of Maternal Fetal and Neonatal Medicine in March.
Speaker #3: The authors emphasized that current pre-term birth prevention strategies fail to identify the majority of women who ultimately deliver pre-term and highlighted the alignment of the pre-term approach with existing European healthcare systems.
Speaker #3: Also in March, results from the PREPARE survey were accepted for publication in the Journal of Women's Health. The survey examined pre-term birth awareness and risk perception among women across five European countries, and identified a meaningful gap between perceived awareness and actionable understanding.
Zhenya Lindgardt: Also in March, results from the PREPARE survey were accepted for publication in the Journal of Women's Health. This survey examined preterm birth awareness and risk perception among women across 5 European countries and identified a meaningful gap between perceived awareness and actionable understanding, reinforcing the need for earlier and more standardized risk communication. We look forward to the formal publication expected in May.
Speaker #3: Reinforcing the need for earlier and more standardized risk communication, we look forward to the formal publication, expected in May. Together, these publications support our stakeholder engagement efforts in Europe and underscore the global relevance of risk-based preterm birth prevention, as healthcare systems increasingly emphasize prevention, education, and cost-effective maternal care.
Zhenya Lindgardt: Together, these publications support our stakeholder engagement efforts in Europe and underscore the global relevance of risk-based preterm birth prevention as healthcare systems increasingly emphasize prevention, education, and cost-effective maternal care. Looking ahead, we remain on track to publish several additional PRIME sub-analyses in 2026, including a highly anticipated health economic study, Medicaid population outcomes of the PRIME study, and a focus analysis on first-time moms, further strengthening the clinical and economic foundation for adoption. During the quarter, we also continued to advance our advocacy strategy. Preterm birth is not only a clinical challenge, but a public health and policy issue. We're engaging with stakeholders across multiple states to monitor and, where appropriate, support legislative initiatives and policy discussions focused on earlier identification and prevention, particularly in Medicaid and value-based care settings.
Zhenya Lindgardt: Together, these publications support our stakeholder engagement efforts in Europe and underscore the global relevance of risk-based preterm birth prevention as healthcare systems increasingly emphasize prevention, education, and cost-effective maternal care. Looking ahead, we remain on track to publish several additional PRIME sub-analyses in 2026, including a highly anticipated health economic study, Medicaid population outcomes of the PRIME study, and a focus analysis on first-time moms, further strengthening the clinical and economic foundation for adoption.
Speaker #3: Looking ahead, we remain on track to publish several additional prime sub-analyses in 2026, including a highly anticipated health economics study Medicaid population outcomes of the prime study and a focused analysis of first-time moms further strengthening the clinical and economic foundation for adoption.
Speaker #3: During the quarter, we also continue to advance our advocacy strategy. Pre-term birth is not only a clinical challenge, but a public health and policy issue.
Zhenya Lindgardt: During the quarter, we also continued to advance our advocacy strategy. Preterm birth is not only a clinical challenge, but a public health and policy issue. We're engaging with stakeholders across multiple states to monitor and, where appropriate, support legislative initiatives and policy discussions focused on earlier identification and prevention, particularly in Medicaid and value-based care settings.
Speaker #3: We're engaging with stakeholders across multiple states to monitor and, where appropriate, support legislative initiatives and policy discussions focused on earlier identification and prevention, particularly in Medicaid and value-based care settings.
Speaker #3: We also recently launched a targeted letter writing campaign designed to encourage physicians and patients to engage with state Medicaid programs on reimbursement for the pre-term test.
Zhenya Lindgardt: We also recently launched a targeted letter-writing campaign designed to encourage physicians and patients to engage with state Medicaid programs on reimbursement for the PreTRM test. The initiative is intended to amplify at the local level the existing clinical voice calling for access for at-risk populations. To date, we've seen encouraging participation with multiple letters submitted across several states, reflecting growing physician advocacy and awareness. We believe these grassroots efforts will play an important role in advancing broader coverage discussions over time. Through these efforts, we continue to build awareness and alignment well in advance of formal coverage decisions and to help policymakers understand both the clinical and the economic burden of preterm birth. We view advocacy as an important complement to our commercial and scientific strategies. In Europe, we continue to make progress towards commercialization readiness.
Zhenya Lindgardt: We also recently launched a targeted letter-writing campaign designed to encourage physicians and patients to engage with state Medicaid programs on reimbursement for the PreTRM test. The initiative is intended to amplify at the local level the existing clinical voice calling for access for at-risk populations. To date, we've seen encouraging participation with multiple letters submitted across several states, reflecting growing physician advocacy and awareness.
Speaker #3: The initiative is intended to amplify at the local level the existing clinical voice calling for access for at-risk populations. To date, we've seen encouraging participation with multiple letters submitted across several states reflecting growing physician advocacy and awareness.
Speaker #3: We believe these grassroots efforts will play an important role in advancing broader coverage discussions over time. Through these efforts, we continue to build awareness and alignment well in advance of formal coverage decisions, and to help policymakers understand both the clinical and the economic burden of pre-term birth.
Zhenya Lindgardt: We believe these grassroots efforts will play an important role in advancing broader coverage discussions over time. Through these efforts, we continue to build awareness and alignment well in advance of formal coverage decisions and to help policymakers understand both the clinical and the economic burden of preterm birth. We view advocacy as an important complement to our commercial and scientific strategies. In Europe, we continue to make progress towards commercialization readiness.
Speaker #3: We view advocacy as an important complement to our commercial and scientific strategies. In Europe, we continue to make progress towards commercialization readiness. We remain on track for a mid-year submission of our CE marking dossier and have had constructive discussions with regulators and clinical stakeholders.
Zhenya Lindgardt: We remain on track for a mid-year submission of our CE marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisor group continues to reinforce alignment around clinical utility, evidence requirements, and implementation considerations. On capital deployment, we have completed the next phase of our evolution from a clinical stage company to a commercial organization driven to secure reimbursement and revenue. Following comprehensive business review, we realigned resources, identified significant operational efficiencies, and streamlined R&D and G&A functions. We are prioritizing investments in payer engagement, market access, and clinical adoption of PreTRM. As part of this realignment, we are intentionally shifting capital away from R&D and clinical operations towards commercial and medical activities that directly support access and adoption.
Zhenya Lindgardt: We remain on track for a mid-year submission of our CE marking dossier and have had constructive discussions with regulators and clinical stakeholders. Engagement with our European advisor group continues to reinforce alignment around clinical utility, evidence requirements, and implementation considerations.
Speaker #3: Engagement with our European advisor group continues to reinforce alignment around clinical utility, evidence requirements, and implementation considerations. On capital deployment, we have completed the next phase of our evolution from a clinical stage company to a commercial organization driven to secure reimbursement and revenue.
Zhenya Lindgardt: On capital deployment, we have completed the next phase of our evolution from a clinical stage company to a commercial organization driven to secure reimbursement and revenue. Following comprehensive business review, we realigned resources, identified significant operational efficiencies, and streamlined R&D and G&A functions. We are prioritizing investments in payer engagement, market access, and clinical adoption of PreTRM.
Speaker #3: Following comprehensive business review, we're realigned resources, identified significant operational efficiencies, and streamlined R&D and G&A functions. We are prioritizing investments in payer engagement, market access, and clinical adoption of pre-term.
Speaker #3: As part of this realignment, we are intentionally shifting capital away from R&D and clinical operations towards commercial and medical activities that directly support access and adoption.
Zhenya Lindgardt: As part of this realignment, we are intentionally shifting capital away from R&D and clinical operations towards commercial and medical activities that directly support access and adoption. Over time, this results in a meaningfully higher proportion of our operating spend focused on commercialization and medical engagement, with R&D becoming a smaller share of our overall expense base as we move into 2027 and beyond.
Speaker #3: Over time, this results in a meaningfully higher proportion of our operating spend focused on commercialization and medical engagement with R&D becoming a smaller share of our overall expense base as we move into 2027 and beyond.
Zhenya Lindgardt: Over time, this results in a meaningfully higher proportion of our operating spend focused on commercialization and medical engagement, with R&D becoming a smaller share of our overall expense base as we move into 2027 and beyond. These actions are expected to reduce our base operating expenses by nearly $10 million annually while enhancing our ability to focus capital on commercialization efforts. At this new operating level, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029. By extending our runway by an additional year, we have positioned the company to capitalize on meaningful growth expected over the next 12 months and to achieve key access and commercialization milestones in the years to come.
Speaker #3: These actions are expected to reduce our base operating expenses by nearly $10 million annually, while enhancing our ability to focus capital on commercialization efforts.
Zhenya Lindgardt: These actions are expected to reduce our base operating expenses by nearly $10 million annually while enhancing our ability to focus capital on commercialization efforts. At this new operating level, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029. By extending our runway by an additional year, we have positioned the company to capitalize on meaningful growth expected over the next 12 months and to achieve key access and commercialization milestones in the years to come.
Speaker #3: At this new operating level, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029.
Speaker #3: By extending our runway by an additional year, we have positioned the company to capitalize on meaningful growth expected over the next 12 months and to achieve key access and commercialization milestones in the years to come.
Speaker #3: To wrap up, the first quarter was characterized by awareness building and intentional positioning. Expanding access points, strengthening referral pathways, advancing advocacy efforts, and continuing to build the scientific foundation necessary for long-term adoption.
Zhenya Lindgardt: To wrap up, Q1 was characterized by awareness building and intentional positioning, expanding access points, strengthening referral pathways, advancing advocacy efforts, and continuing to build the scientific foundation necessary for long-term adoption. Everything we've discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption. While these adoption cycles take time, we remain encouraged by the level of engagement we are seeing and confident that the foundation we are laying will support meaningful long-term pull-through. With that, I'll turn the call over to Austin.
Zhenya Lindgardt: To wrap up, Q1 was characterized by awareness building and intentional positioning, expanding access points, strengthening referral pathways, advancing advocacy efforts, and continuing to build the scientific foundation necessary for long-term adoption. Everything we've discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption. While these adoption cycles take time, we remain encouraged by the level of engagement we are seeing and confident that the foundation we are laying will support meaningful long-term pull-through. With that, I'll turn the call over to Austin.
Speaker #3: Everything we've discussed today reflects a consistent strategy focused on establishing the prerequisites for durable, scalable adoption, and while these adoption cycles take time, we remain encouraged by the level of engagement we are seeing and confident that the foundation we are laying will support meaningful long-term pull-through.
Speaker #3: With that, I'll turn the call over to Austin. Thanks, Jennifer. And good afternoon, everyone. Revenue for the quarter was $14,000 compared to $38,000 in the first quarter of 2025.
Austin Aerts: Thanks, Zhenya, and good afternoon, everyone. Revenue for the Q1 was $14,000 compared to $38,000 in Q1 2025. As expected, revenue in the Q1 remained modest, reflecting the timing and nature of our geographically targeted commercialization strategy and our ongoing effort to build advocacy and awareness following the PRIME publication. Operating expenses for the Q1 were $9.4 million, up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in evidence generation, regulatory preparation, and advocacy activities. As discussed following our business review, we expect to reduce our operating expense base by nearly $10 million on an annualized basis.
Austin Aerts: Thanks, Zhenya, and good afternoon, everyone. Revenue for the Q1 was $14,000 compared to $38,000 in Q1 2025. As expected, revenue in the Q1 remained modest, reflecting the timing and nature of our geographically targeted commercialization strategy and our ongoing effort to build advocacy and awareness following the PRIME publication.
Speaker #3: As expected, revenue in the quarter remained modest, reflecting the timing and nature of our geographically targeted commercialization strategy and our ongoing effort to build advocacy and awareness following the PRIME publication.
Speaker #3: Operating expenses for the quarter were $9.4 million up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in avenue evidence generation, regulatory preparation, and advocacy activities.
Austin Aerts: Operating expenses for the Q1 were $9.4 million, up slightly from $9.3 million in the prior year period, consistent with our expectations and reflecting disciplined cost management alongside continued investment in evidence generation, regulatory preparation, and advocacy activities. As discussed following our business review, we expect to reduce our operating expense base by nearly $10 million on an annualized basis.
Speaker #3: As discussed, following our business review, we expect to reduce our operating expense base by nearly $10 million on an annualized basis. The benefit in 2026 will be limited due to the phasing of activities and related charges, with the majority of the savings expected to be realized in 2027 and beyond.
Austin Aerts: The benefit in 2026 will be limited due to the phasing of activities and related charges, with the majority of the savings expected to be realized in 2027 and beyond. Research and development expenses were $3.0 million compared to $3.3 million in 2025. With the PRIME study now published, R&D expenses will continue to decrease as we focus resources on activities that more directly drive commercialization and awareness building. Selling general and administrative expenses were $6.3 million versus $5.9 million in the prior year, reflecting our transition from clinical stage investments toward targeted commercial initiatives and strategic headcount. Net loss for the quarter was $8.4 million compared to a net loss of $8.2 million in Q1 2025.
Austin Aerts: The benefit in 2026 will be limited due to the phasing of activities and related charges, with the majority of the savings expected to be realized in 2027 and beyond. Research and development expenses were $3.0 million compared to $3.3 million in 2025. With the PRIME study now published, R&D expenses will continue to decrease as we focus resources on activities that more directly drive commercialization and awareness building.
Speaker #3: Research and development expenses were $3.0 million compared to $3.3 million in 2025, with the prime study now published, R&D expenses will continue to decrease as we focus resources on activities that more directly drive commercialization and awareness building.
Speaker #3: Selling, general, and administrative expenses were $6.3 million versus $5.9 million in the prior year, reflecting our transition from clinical-stage investments toward targeted commercial initiatives and strategic headcount.
Austin Aerts: Selling general and administrative expenses were $6.3 million versus $5.9 million in the prior year, reflecting our transition from clinical stage investments toward targeted commercial initiatives and strategic headcount. Net loss for the quarter was $8.4 million compared to a net loss of $8.2 million in Q1 2025.
Speaker #3: Net loss for the quarter was $8.4 million compared to a net loss of $8.2 million in the first quarter of 2025. We ended March 31st, 2026, with $86.8 million in cash, cash equivalents, and available for sale securities.
Austin Aerts: We ended 31 March 2026 with $86.8 million in cash equivalents, and available for sale securities. Based on our measured commercialization strategy and a more sustainable cost base resulting from the activities discussed earlier, we believe our capital resources will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As Zhenya outlined, our strategy prioritizes building durable prerequisites for adoption. From a financial perspective, that means revenue in 2026 could remain modest and uneven as we continue pushing reimbursement, awareness, and advocacy campaigns, and as programs move from setup to implementation, with increasing pull-through anticipated later in the year and into 2027. In summary, the Q1 reflects continued financial discipline alongside steady progress in laying the groundwork for broader adoption. We remain focused on execution as these initiatives mature.
Austin Aerts: We ended 31 March 2026 with $86.8 million in cash equivalents, and available for sale securities. Based on our measured commercialization strategy and a more sustainable cost base resulting from the activities discussed earlier, we believe our capital resources will be sufficient to fund the company across significant adoption and commercial milestones through 2029. As Zhenya outlined, our strategy prioritizes building durable prerequisites for adoption.
Speaker #3: Based on our measured commercialization strategy and a more sustainable cost-based resulting from the activities discussed earlier, we believe our capital resources will be sufficient to fund the company across significant adoption and commercial milestones through 2029.
Speaker #3: As Jennifer outlined, our strategy prioritizes building durable prerequisites for adoption. From a financial perspective, that means revenue in 2026 could remain modest and uneven as we continue pushing reimbursement, awareness, and advocacy campaigns and as programs move from setup to implementation.
Austin Aerts: From a financial perspective, that means revenue in 2026 could remain modest and uneven as we continue pushing reimbursement, awareness, and advocacy campaigns, and as programs move from setup to implementation, with increasing pull-through anticipated later in the year and into 2027. In summary, the Q1 reflects continued financial discipline alongside steady progress in laying the groundwork for broader adoption. We remain focused on execution as these initiatives mature. With that, let's open the line for questions. Operator?
Speaker #3: With increasing pull-through anticipated later in the year and into 2027. In summary, the first quarter reflects continued financial discipline alongside steady progress in laying the groundwork for broader adoption.
Speaker #3: We remain focused on execution as these initiatives mature. With that, let's open the line for questions. Operator?
Austin Aerts: With that, let's open the line for questions. Operator?
Speaker #4: Thank you, ladies and gentlemen. We will now begin the question-and-answer session. Should you have a question, please press the star followed by the number 1 on your touch-tone phone.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys. Please be advised to ask 1 question and 1 follow-up. Your question comes from Tycho Peterson from Jefferies. Please go ahead.
Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your touch-tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys. Please be advised to ask 1 question and 1 follow-up. Your question comes from Tycho Peterson from Jefferies. Please go ahead.
Speaker #4: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2.
Speaker #4: If you are using a speakerphone, please lift the handset before pressing any keys. Please be advised to ask one question in one follow-up. Your question comes from Taiko, Peterson from Jefferies.
Speaker #4: Please go ahead.
Speaker #5: Hey, team. This is Lauren on for Taiko. A few from me. First, on the partner program, so could we get maybe a little bit of color on the kind of profile of the third partner?
Lauren: Hey, team. This is Lauren on for Tycho Peterson. A few from me. First on the partner program. Could we get maybe a little bit color on the kind of profile of the third partner, kind of how it compares to the first two? In terms of kind of the required cadence throughout the rest of the year to hit the goal of 5 to 7 partner programs, what that's going to look like for the next couple of quarters. Second, for the new reps, I think you've talked about before how it could take a couple of quarters to kind of see density of adoption and increased productivity. Are you measuring anything in terms of tests per rep per month or other KPIs that you're targeting for the H2 of the year for these reps? Thanks.
Lauren Carrieri: Hey, team. This is Lauren on for Tycho Peterson. A few from me. First on the partner program. Could we get maybe a little bit color on the kind of profile of the third partner, kind of how it compares to the first two? In terms of kind of the required cadence throughout the rest of the year to hit the goal of 5 to 7 partner programs, what that's going to look like for the next couple of quarters. Second, for the new reps, I think you've talked about before how it could take a couple of quarters to kind of see density of adoption and increased productivity. Are you measuring anything in terms of tests per rep per month or other KPIs that you're targeting for the H2 of the year for these reps? Thanks.
Speaker #5: And kind of how it compares to the first two. And then in terms of kind of the required cadence throughout the rest of the year to hit the goal of five to seven partner programs, what that's going to look like for the next couple of quarters.
Speaker #5: And then second, for the new reps, I think you've talked about before how it could take a couple of quarters to kind of see density of adoption and increased productivity.
Speaker #5: Are you measuring anything in terms of tests per rep per month or other KPIs that you're targeting for the second half of the year for these reps?
Speaker #5: Thanks.
Speaker #6: Lauren, thank you so much for the questions. On the programs—indeed, very exciting. The way we planned our pipeline of potential programs is to launch roughly one a quarter to make sure that we swarm the organization and stand them up well.
Zhenya Lindgardt: Lauren, thank you so much for the questions. On the programs, indeed, very exciting. The way we planned our pipeline of the potential programs is to launch roughly 1 a quarter to make sure that we swarm the organization and stand them up well. Each program typically is a combination of a payer and provider groups to ensure that the pull-through can happen on the ground in the offices quickly. We've learned over the last couple of years that it takes a few months to iron out how the patients who test for higher risk of PreTRM birth get cared for by the physician offices with the intervention bundle. We make it as seamlessly integrated into the workflow of those offices as possible.
Zhenya Lindgardt: Lauren, thank you so much for the questions. On the programs, indeed, very exciting. The way we planned our pipeline of the potential programs is to launch roughly 1 a quarter to make sure that we swarm the organization and stand them up well. Each program typically is a combination of a payer and provider groups to ensure that the pull-through can happen on the ground in the offices quickly. We've learned over the last couple of years that it takes a few months to iron out how the patients who test for higher risk of PreTRM birth get cared for by the physician offices with the intervention bundle.
Speaker #6: Each program typically is a combination of a payer and provider groups to ensure that the pull-through can happen on the ground in the offices quickly.
Speaker #6: We've learned over the last couple of years that it takes a few months to iron out how the patients who test for higher risk of preterm birth get cared for by the physician offices.
Speaker #6: With the intervention bundle, so we make it as seamlessly integrated into the workflow of those offices as possible. So for us, each of these programs, that's why one a quarter, roughly, and we're right on track with that with another launch.
Zhenya Lindgardt: We make it as seamlessly integrated into the workflow of those offices as possible. For us, each of these programs, that's why 1 a quarter, roughly, and we're right on track with that with another launch this quarter. We first select how will the test get paid for, engage on reimbursement, then, with the payers, figure out what is the set of providers that are going to partner with us to adopt the test and get them ready for seamless integration to their workflow and delivery of the intervention bundle. That is critical for fast recruitment, and delivery of the test to the participant, which of course, in turn, gives the results to both payers and providers faster.
Zhenya Lindgardt: For us, each of these programs, that's why 1 a quarter, roughly, and we're right on track with that with another launch this quarter. We first select how will the test get paid for, engage on reimbursement, then, with the payers, figure out what is the set of providers that are going to partner with us to adopt the test and get them ready for seamless integration to their workflow and delivery of the intervention bundle. That is critical for fast recruitment, and delivery of the test to the participant, which of course, in turn, gives the results to both payers and providers faster.
Speaker #6: This quarter, we first select how will the tests get paid for, engage on reimbursement, then with the payers figure out what is the set of providers that are going to partner with us to adopt the test and get them ready for seamless integration to their workflow and delivery of the intervention bundle.
Speaker #6: So that is critical for fast recruitment and delivery of the test to the participant, which, of course, in turn, gives the result to both payers and providers faster.
Speaker #6: So it's in all of the partners' interests in these programs to prepare well to get to, for us, to revenue for them to impact faster.
Zhenya Lindgardt: It's in all of the partners' interests in these programs to prepare well to get to, you know, for us to revenue, for them to impact faster. For many programs, we are engaged deeply with the state as well. On a quarterly basis, we report out the progress of the programs to the state Medicaid agencies, and these are usually public forums where other payers are present. Another reason why one a quarter is because there's a fair bit of follow-up with other payers in the state that have the Medicaid plans, who are starting to also reach out and want to participate. We're excited to report that our pipeline of payers that we're engaged with is growing steadily from 10 payers in 13 states, which we reported last quarter, to 13 payers in 15 states.
Zhenya Lindgardt: It's in all of the partners' interests in these programs to prepare well to get to, you know, for us to revenue, for them to impact faster. For many programs, we are engaged deeply with the state as well. On a quarterly basis, we report out the progress of the programs to the state Medicaid agencies, and these are usually public forums where other payers are present. Another reason why one a quarter is because there's a fair bit of follow-up with other payers in the state that have the Medicaid plans, who are starting to also reach out and want to participate.
Speaker #6: For many programs, we are engaged deeply with the state as well. So on a quarterly basis, we report out the progress of the programs to the state Medicaid agencies.
Speaker #6: And these are usually public forums where other payers are present. And another reason why one a quarter is because there is a fair bit of follow-up with other payers in the state that have the Medicaid plans who are starting to also reach out and want to participate.
Speaker #6: So, we're excited to report that our pipeline of payers that we're engaged with is growing steadily, from 10 payers in 13 states, which we reported last quarter, to 13 payers in 15 states.
Zhenya Lindgardt: We're excited to report that our pipeline of payers that we're engaged with is growing steadily from 10 payers in 13 states, which we reported last quarter, to 13 payers in 15 states. We're still sticking to our target states. What we're seeing happen is the payers that we're running the program with now for 6 to 9 months are introducing us to other parts of their organization that cover plans in other states, which is exactly what we were hoping for, and expanding with these payers into other regions.
Speaker #6: We're still sticking to our target states. But what we're seeing happen is the payers that we're running the program with now for six to nine us to other parts of their organization that cover plans in other states, which is exactly what we were hoping for.
Zhenya Lindgardt: We're still sticking to our target states. What we're seeing happen is the payers that we're running the program with now for 6 to 9 months are introducing us to other parts of their organization that cover plans in other states, which is exactly what we were hoping for, and expanding with these payers into other regions. That's why we're pacing it 1 a quarter roughly, and you can certainly anticipate us announcing 1 per quarter. Of course, we'll go faster if we can go faster. I described the activities so that you get a feel for what an undertaking it is to stand up these pretty substantial provider institutions who partner with us.
Speaker #6: And expanding with these payers into other regions. So that's why we're pacing it one a quarter roughly. And you can certainly anticipate us announcing one per quarter.
Zhenya Lindgardt: That's why we're pacing it 1 a quarter roughly, and you can certainly anticipate us announcing 1 per quarter. Of course, we'll go faster if we can go faster. I described the activities so that you get a feel for what an undertaking it is to stand up these pretty substantial provider institutions who partner with us.
Speaker #6: Of course, we'll go faster if we can go faster. But I described the activities so that you get a feel for what an undertaking it is.
Speaker #6: To stand up these pretty substantial provider institutions who partner with us, obviously, of course, because we with the payers select large volume institutions so that we could get the density of test ordering after we get reimbursement to go faster.
Zhenya Lindgardt: Obviously, of course, because we, with the payers, select large volume institutions so that we could get the density of test ordering, after we get reimbursement, to go faster and the pull-through to be clear, for about once a quarter to give us 3 months to execute on the launch of the program. Does that answer the first part of your question?
Zhenya Lindgardt: Obviously, of course, because we, with the payers, select large volume institutions so that we could get the density of test ordering, after we get reimbursement, to go faster and the pull-through to be clear, for about once a quarter to give us 3 months to execute on the launch of the program. Does that answer the first part of your question?
Speaker #6: And the pull-through to be clear. For about once a quarter to give us three months to execute on the launch of the program. Does that answer the first part of your question?
Speaker #5: Yeah, that's helpful color. Thank you.
Lauren: Yeah, that's helpful, Carla. Thank you.
Lauren Carrieri: Yeah, that's helpful, Carla. Thank you.
Speaker #6: Perfect. And then the second question, of course, rep productivity is critical. Actually, our chief commercial officer and our head of sales that's exactly how they engage with Austin and me on our forecasting on the number of reps and the number of tests per month per rep that is anticipated.
Zhenya Lindgardt: Perfect. The second question, of course, rep productivity is critical. Actually, our chief commercial officer and our head of sales, that's exactly how they engage with Austin and me on our forecasting on the number of reps and the number of tests per month per rep that is anticipated, so that we can goal the reps and drive towards steady progress. Of course, we're cautiously optimistic, but we wanna watch it for another few quarters. We are seeing these metrics move. The question behind the question probably is when are you guys going to report on some of these metrics? Let us see the steady progress on them internally first, and as soon as we see the steady up and up, we will start reporting on those.
Zhenya Lindgardt: Perfect. The second question, of course, rep productivity is critical. Actually, our chief commercial officer and our head of sales, that's exactly how they engage with Austin and me on our forecasting on the number of reps and the number of tests per month per rep that is anticipated, so that we can goal the reps and drive towards steady progress.
Speaker #6: So that we can goal the reps and drive towards steady progress. And of course, we're cautiously optimistic, but we want to watch it for another few quarters.
Zhenya Lindgardt: Of course, we're cautiously optimistic, but we wanna watch it for another few quarters. We are seeing these metrics move. The question behind the question probably is when are you guys going to report on some of these metrics? Let us see the steady progress on them internally first, and as soon as we see the steady up and up, we will start reporting on those.
Speaker #6: We are seeing these metrics move. Your the question behind the question probably is, when are you guys going to report on some of these metrics?
Speaker #6: Let us see the steady progress on them internally first. And as soon as we see the steady up and up, we will start reporting on those.
Speaker #5: That's great. Thank you.
Lauren: That's great. Thank you.
Lauren Carrieri: That's great. Thank you.
Zhenya Lindgardt: Appreciate it. Thanks, Laura.
Zhenya Lindgardt: Appreciate it. Thanks, Laura.
Speaker #1: Your next question. Thank you. Your next question comes from Dan Brennan from TD Cohen. Please go ahead.
Operator: Your next question. Thank you. Your next question comes from Dan Brennan from TD Cowen. Please go ahead.
Operator: Your next question. Thank you. Your next question comes from Dan Brennan from TD Cowen. Please go ahead.
Speaker #7: Great. Thank you. Thanks for the questions. Maybe first one, just on you both talked about the shift to a more direct commercial effort, maybe pulling back some resources on the R&D side, extend the cash runway.
Dan Brennan: Great. Thank you. Thanks for the questions. Maybe first one just on the, you both talked about the shift to a more direct commercial effort, maybe pulling back some resources on the R&D side, extend the cash runway. Just, I guess, what prompted the shift? It kind of makes sense logically, but I'm just wondering kind of is there any feedback in the market about timing, how long it's gonna take, or was this in discussion with the board? Just maybe a little color behind that.
Dan Brennan: Great. Thank you. Thanks for the questions. Maybe first one just on the, you both talked about the shift to a more direct commercial effort, maybe pulling back some resources on the R&D side, extend the cash runway. Just, I guess, what prompted the shift? It kind of makes sense logically, but I'm just wondering kind of is there any feedback in the market about timing, how long it's gonna take, or was this in discussion with the board? Just maybe a little color behind that.
Speaker #7: Just, I guess, what prompted the shift? It kind of makes sense logically. But I'm just wondering, kind of, is there any feedback in the market about timing?
Speaker #7: How long is it going to take? Or was this in discussion with the Board? Just maybe a little color behind that.
Speaker #6: Dan, thank you for the question. It's a very logical one. There's actually two root causes that drove that happening now. First, of course, as you know, the R&D and clinical operations efforts, both of these groups, were incredibly focused on prime.
Zhenya Lindgardt: Dan, thank you for the question. It's a very logical one. There's actually 2 root causes that drove that happening now. First, of course, as you know, the R&D and clinical operations efforts, both of these groups, were incredibly focused on PRIME, and that was a 7-year effort, if you can believe it, with very, very heavy resourcing devoted to that. As we're shifting towards now publishing as much as possible with a couple of dozen publications in the pipeline from our data, we realized that we need less capacity specifically for our preterm birth product, R&D and clinical operations capacity. Of course, we have a pipeline of other products that we're working on, but we had inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests.
Zhenya Lindgardt: Dan, thank you for the question. It's a very logical one. There's actually 2 root causes that drove that happening now. First, of course, as you know, the R&D and clinical operations efforts, both of these groups, were incredibly focused on PRIME, and that was a 7-year effort, if you can believe it, with very, very heavy resourcing devoted to that. As we're shifting towards now publishing as much as possible with a couple of dozen publications in the pipeline from our data, we realized that we need less capacity specifically for our preterm birth product, R&D and clinical operations capacity.
Speaker #6: And that was a seven-year effort, if you can believe it, with very, very heavy resourcing devoted to that. As we're shifting towards now publishing as much as possible with a couple of dozen publications in a pipeline, from our data we realized that we need less capacity specifically for our pre-term birth product, R&D and colonoscopy capacity.
Speaker #6: Of course, we have a pipeline of other products that we're working on. But we had inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests.
Zhenya Lindgardt: Of course, we have a pipeline of other products that we're working on, but we had inbound interest from partners to collaborate on R&D and clinical operations efforts in developing new tests. What you're really seeing as the first impetus, is the less demand on R&D and clinical operations capacity internally, and the second one is the demand externally to continue developing the tests. As soon as we lock in these partnerships, of course, we'll communicate all of those to you.
Speaker #6: So what you're really seeing as the first impetus is the less demand on R&D and colonoscopy capacity internally. And the second one is the demand externally.
Zhenya Lindgardt: What you're really seeing as the first impetus, is the less demand on R&D and clinical operations capacity internally, and the second one is the demand externally to continue developing the tests. As soon as we lock in these partnerships, of course, we'll communicate all of those to you. You can imagine, our R&D proteomics platform is a great asset with a biobank of thousands and perhaps tens of thousands of samples, which will allow us to support other diagnostic and screening tests in pregnancy, perhaps also support therapeutics of screening in for eligibility for drug interventions in pregnancy.
Speaker #6: To continue developing the tests. And as soon as we lock in these partnerships, of course, we'll communicate all of those to you and you can imagine our R&D proteomics platform is a great asset with a biobank of thousands and perhaps a couple of tens of thousands of samples which will allow us to support other diagnostic and screening tests in pregnancy perhaps also supports therapeutics of screening in for eligibility for drug interventions in pregnancy.
Zhenya Lindgardt: You can imagine, our R&D proteomics platform is a great asset with a biobank of thousands and perhaps tens of thousands of samples, which will allow us to support other diagnostic and screening tests in pregnancy, perhaps also support therapeutics of screening in for eligibility for drug interventions in pregnancy. You can imagine that's a strategic move, as well as just simply less demand, internally for now until we pick up in this collaborative model on other assets. That's the answer on the R&D side. Does that help?
Speaker #6: You can imagine it's a strategic move. As well as just simply less demand internally for now until we pick up in this collaborative model on other assets.
Zhenya Lindgardt: You can imagine that's a strategic move, as well as just simply less demand, internally for now until we pick up in this collaborative model on other assets. That's the answer on the R&D side. Does that help?
Speaker #6: So that's the answer on the R&D side. Does that help?
Speaker #7: Yep. Yeah, that helps. Yep. Very logical. Maybe just a couple other quick ones. Just on the I think previously you talked about low single-digit thousand volumes this year.
Dan Brennan: Yep. Yeah, that helps. Yep. No, very logical. Maybe just a couple other quick ones. Just on the, I think previously you talked about low single-digit thousand volumes this year. Is that still on track or just maybe kinda how should we think about that?
Dan Brennan: Yep. Yeah, that helps. Yep. No, very logical. Maybe just a couple other quick ones. Just on the, I think previously you talked about low single-digit thousand volumes this year. Is that still on track or just maybe kinda how should we think about that?
Speaker #7: Is that still on track or just maybe kind of how should we think about that?
Speaker #6: Dan, I didn't hear you quite well. Low single-digit thousand.
Zhenya Lindgardt: Dan, I didn't hear you quite well. A low single-digit 1,000 volumes was-
Zhenya Lindgardt: Dan, I didn't hear you quite well. A low single-digit 1,000 volumes was-
Dan Brennan: For you, I was talking about volumes for 2026. I think in the past.
Dan Brennan: For you, I was talking about volumes for 2026. I think in the past.
Speaker #7: Well, you know, I was talking about volumes for '26. I think in the past, maybe.
Speaker #6: I got you.
Zhenya Lindgardt: I got you. I got you.
Zhenya Lindgardt: I got you. I got you.
Speaker #7: Yeah. How do we think about that?
Dan Brennan: Yeah. How do we think about it?
Dan Brennan: Yeah. How do we think about it?
Zhenya Lindgardt: Yeah, that's not unreasonable. That's not unreasonable. As you know, we don't report the volume of orders, but it's certainly not an unreasonable number to be thinking about. Given your question, Dan, in our conversations, of course, we'll as soon as we see steadiness, we'll start reporting on it. Yes, that assumption is not unreasonable.
Zhenya Lindgardt: Yeah, that's not unreasonable. That's not unreasonable. As you know, we don't report the volume of orders, but it's certainly not an unreasonable number to be thinking about. Given your question, Dan, in our conversations, of course, we'll as soon as we see steadiness, we'll start reporting on it. Yes, that assumption is not unreasonable.
Speaker #6: That's not unreasonable. That's not unreasonable. As you know, we don't report the volume of orders. But it's certainly not an unreasonable number. To be thinking about and given your question, Dan and our conversations, of course, we'll as soon as we see steadiness, we'll start reporting on it.
Speaker #6: But yes, that assumption is not unreasonable.
Speaker #7: Got it. And then maybe just on the first Medicaid program that began, I think a little over a year ago, when can you see that program potentially turn into a positive coverage decision, do you think?
Dan Brennan: Got it. Then maybe just on, you know, the first Medicaid program that began, I think you know, a little over a year ago, when can you see that program potentially turn into a positive coverage decision, do you think?
Dan Brennan: Got it. Then maybe just on, you know, the first Medicaid program that began, I think you know, a little over a year ago, when can you see that program potentially turn into a positive coverage decision, do you think?
Speaker #6: Great question. And I think when we announced it, we, I believe I even talked through the timeline for that particular program. We believe it will take us—it took us about six months to stand it up with EMR integration and all of the provider setup to provide care management for the patients.
Zhenya Lindgardt: Great question. I think, when we announced it, I believe I even talked through the timeline for that particular program. We believe it will take us, it took us about 6 months to stand it up with EMR integration and all of the provider setup, to provide care management for the patients. Actually that set of collaborators are now piloting a digital tool with us that allows the providers to deliver care management a lot more efficiently with weekly symptom check tooling. We're looking forward to reporting on how that goes because that is something that will remove a significant barrier in terms of taking the OBGYN nursing capacity from the office for that care management.
Zhenya Lindgardt: Great question. I think, when we announced it, I believe I even talked through the timeline for that particular program. We believe it will take us, it took us about 6 months to stand it up with EMR integration and all of the provider setup, to provide care management for the patients. Actually that set of collaborators are now piloting a digital tool with us that allows the providers to deliver care management a lot more efficiently with weekly symptom check tooling.
Speaker #6: And actually, that set of collaborators are now piloting a digital tool with us that allows the providers to deliver care management a lot more efficiently with weekly symptom check tooling.
Speaker #6: And we're looking forward to reporting on how that goes, because that is something that will remove a significant barrier in terms of taking the OB-GYN nursing capacity from the office for that care management.
Zhenya Lindgardt: We're looking forward to reporting on how that goes because that is something that will remove a significant barrier in terms of taking the OBGYN nursing capacity from the office for that care management. It took us 6 months to do that. It will take us about 9 to 12 months to fully recruit the program. About 4 to 5 months for the patients to deliver, obviously on a rolling basis.
Speaker #6: So it took us six months to do that. It will take us about nine to 12 months to fully recruit the program, about four to five months for the patients to deliver.
Zhenya Lindgardt: It took us 6 months to do that. It will take us about 9 to 12 months to fully recruit the program. About 4 to 5 months for the patients to deliver, obviously on a rolling basis. A couple of months to collect data on the outcomes, NICU admissions, health of the baby, weight of the baby, all of the other outcomes we typically would monitor in these implementation studies. Of course, take it to the state. I will tell you, the state is not waiting for it. The state already engaged with us for that particular program on what would coverage mean? Why is it needed? We are mobilizing our clinical advocates in that state, and that's what I meant when I said our letter-writing campaign.
Speaker #6: Obviously, on a rolling basis. Then a couple of months to collect data on the outcomes, NICU admissions, health of the baby, weight of the baby, all of the other outcomes we typically would monitor in these implementation studies.
Zhenya Lindgardt: A couple of months to collect data on the outcomes, NICU admissions, health of the baby, weight of the baby, all of the other outcomes we typically would monitor in these implementation studies. Of course, take it to the state. I will tell you, the state is not waiting for it. The state already engaged with us for that particular program on what would coverage mean? Why is it needed? We are mobilizing our clinical advocates in that state, and that's what I meant when I said our letter-writing campaign.
Speaker #6: And then, of course, take it to the state. I will tell you the state is not waiting for it. The state already engaged with us on for that particular program on what would coverage mean, why is it needed, we are mobilizing our clinical advocates in that state and that's what I meant when I said our letter writing campaign.
Speaker #6: We're asking every provider to write to the state Medicaid and advocate why this test needs to be paid for in the state for all of the pregnant moms there.
Zhenya Lindgardt: We're asking every provider to write to the state Medicaid and advocate why this test needs to be paid for in the state for all of the pregnant moms there. You know, the tactical timeline I laid out nets out to be about 2 years to decision timeline for the state. I think that's, you know, that probably has plus or minus a quarter or 2 on each side of that 2-year estimate. Could go faster, it could go a little bit slower if data is messy, for example, because in some states, they assign the baby into a different Medicaid plan at birth. Don't ask me why that gets done, but that's the case. It requires us to do some data chasing to combine the mom and baby outcomes.
Zhenya Lindgardt: We're asking every provider to write to the state Medicaid and advocate why this test needs to be paid for in the state for all of the pregnant moms there. You know, the tactical timeline I laid out nets out to be about 2 years to decision timeline for the state. I think that's, you know, that probably has plus or minus a quarter or 2 on each side of that 2-year estimate.
Speaker #6: So the tactical timeline, I laid out nets out to be about two years to decision timeline for the state. I think that's that probably has plus or minus a quarter or two on each side.
Speaker #6: Of that two-year estimate could go faster; it could go a little bit slower if data is messy, for example, because in some states they assign the baby into a different Medicaid plan at birth.
Zhenya Lindgardt: Could go faster, it could go a little bit slower if data is messy, for example, because in some states, they assign the baby into a different Medicaid plan at birth. Don't ask me why that gets done, but that's the case. It requires us to do some data chasing to combine the mom and baby outcomes. For that program, we expect, probably beginning of 2027, to bring the decision, and the results of the program, to us. Of course, we'll report on that. Does that help?
Speaker #6: Don't ask me why that gets done, but that's the case. And it requires us to do some data chasing to combine the mom and baby outcomes.
Zhenya Lindgardt: For that program, we expect, probably beginning of 2027, to bring the decision, and the results of the program, to us. Of course, we'll report on that. Does that help?
Speaker #6: So for that program, we expect probably beginning of 2027 to bring the decision and the results of the program. To us. And of course, we'll report on that.
Speaker #6: Does that help?
Speaker #7: Terrific. Yep. Yeah, that helps a lot. Terrific. All right. Well, thanks a lot.
Dan Brennan: Yeah. Yeah, that helps a lot. Terrific. Well, thanks a lot.
Dan Brennan: Yeah. Yeah, that helps a lot. Terrific. Well, thanks a lot.
Speaker #1: There are no further questions. Oh, sorry. There are no further questions at this time. I will now turn the call over to Zenya Lingard, president and CEO.
Operator: There are no further questions.
Operator: There are no further questions.
Zhenya Lindgardt: Thank you for the question.
Zhenya Lindgardt: Thank you for the question.
Operator: Oh, sorry. There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt, President and CEO. Please continue.
Operator: Oh, sorry. There are no further questions at this time. I will now turn the call over to Zhenya Lindgardt, President and CEO. Please continue.
Speaker #1: Please continue.
Speaker #6: Thank you so much, operator. In summary, we're building the medical reimbursement and advocacy foundations necessary for commercialization and guideline inclusion efforts. And the engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead.
Zhenya Lindgardt: Thank you so much, operator. In summary, we're building the medical reimbursement and advocacy foundations necessary for commercialization and guideline inclusion efforts, and the engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead. Thank you so much, everyone, for your time today, and we look forward to continuing to share our progress steadily each quarter.
Zhenya Lindgardt: Thank you so much, operator. In summary, we're building the medical reimbursement and advocacy foundations necessary for commercialization and guideline inclusion efforts, and the engagement we're seeing across stakeholders reinforces our confidence in the opportunity ahead. Thank you so much, everyone, for your time today, and we look forward to continuing to share our progress steadily each quarter.
Speaker #6: Thank you so much, everyone, for your time today. We look forward to continuing to share our progress steadily each quarter.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participation. You may now disconnect.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participation. You may now disconnect.
