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SERA PROGNOSTICS, INC.

For the period ended Mar 31, 2026. Filed May 6, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 6, 2026

SERA$2.19+5.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-13.

0001193125-25-280182

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-06.

0001534969-26-000025

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 104 previous paragraphs and 102 current paragraphs.

63 unchanged; 27 reworded; 12 added; 10 removed; 4 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (12)

Current report

In many cases, the complications of preterm birth have profound short- and long-term health consequences for the mother and baby. Beyond the unmet clinical need, the economic consequences of preterm birth are estimated to be approximately $25 billion annually in the United States. The average delivery care cost of a baby born before 32 weeks is more than three times higher than a full-term birth, while the associated health consequences result in average health care costs over the first seven years of life that are also nearly three times higher.

Current report

In January 2026, we announced the publication of the PRIME study in the Pregnancy Journal, a peer-reviewed open access journal, and official journal of the Society for Maternal-Fetal Medicine, or SMFM. Key findings from the PRIME study include a 20% reduction in babies admitted to the Neonatal Intensive Care Unit, or NICU, a 20% reduction in neonatal morbidity and mortality, assessed by a composite index, a 56% reduction in babies born before 32 weeks, and a 32% reduction in babies born before 35 weeks. In addition, the PRIME study showed that the number of patients needed to screen to save a NICU day, or NNS, was 4.2. We are currently processing publication manuscripts of additional PRIME data, including exploratory analyses and economic benefits, to be submitted in the coming months.

Current report

As part of our transition from a clinical-stage company to a commercial organization, we recently completed a comprehensive business review to reallocate investment from research and development toward our reimbursement-focused commercialization of PreTRM and to right size our operating expenses. As a result, on May 6, 2026, we adopted operational changes to concentrate resources on the continued, disciplined commercialization of the PreTRM test by prioritizing resources toward payer engagement, market access, and clinical adoption, while reducing operating expenses in areas that are non-core to these commercialization activities. As part of these changes, we reduced our workforce by 14 full-time employees, or approximately 18% of our workforce. These reductions included Paul Kearney, Chief Data Officer, and Robert Harrison, Chief Information Officer, whose responsibilities will transition to our Director of IT and other functions within the organization. We estimate we will incur approximately $1.3 million in costs related to severance pay and other termination benefits, the majority of which will be incurred in the second and third quarters of 2026. As part of this strategic prioritization, we have initiated additional ongoing cost savings from other personnel-related expenses and pipeline alignment. As a result, we anticipate meaningful cost savings of approximately $9.6 million in 2027, with decreased cash expenses of approximately 35% and 25% in research and development and general and administrative costs, respectively, to enable continued prudent investment in commercial activity. With this new cost structure, we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements through 2029. We will continue to evaluate the allocation of our resources as we focus our efforts on accelerating the market adoption of our PreTRM test.

Current report

On March 18, 2026, we entered into an at-the-market, or ATM, sales agreement, or the 2026 ATM Sales Agreement, with William Blair & Company, L.L.C., or William Blair, and terminated our existing 2024 sales agreement. This 2026 ATM Sales Agreement utilizes the available capacity under our existing Form S-3 shelf registration statement filed in August 2024 and is the subject of a prospectus supplement dated March 18, 2026. We are not obligated to make any sales of Class A common stock under the 2026 ATM Sales Agreement but may make sales under the ATM program at our discretion based on market conditions. No sales occurred under our prior ATM sales program. Under the 2026 ATM Sales Agreement, we may offer and sell, from time to time at our sole discretion, shares of our Class A common stock, having an aggregate offering price of up to $40.0 million through William Blair, as sales agent.
Removed paragraphs (10)

Previous report

In January 2025, key results of the PRIME study were presented at the Society for Maternal Fetal Medicine’s 2025 SMFM Pregnancy Meeting, and an abstract of primary endpoint data was made public in the Pregnancy Journal. Notable results from the PRIME study showed the primary endpoints being met in the prespecified modified intent-to-treat population, or mITT, indicating a 25% reduction in neonatal morbidity and mortality, assessed by a composite index, and an 18% reduction in neonatal hospital length of stay for the approximately 10% of babies who stay beyond the standard number days for routine deliveries. The mITT population excluded any participants identified as high-risk by the test that didn't elect to receive the treatment bundle, focusing on treatment efficacy. In contrast, a more conservative intent-to-treat population, or ITT, was analyzed to assess real-world efficacy. The ITT analysis, inclusive of subjects who declined treatment, indicated a 20% reduction in neonatal morbidity and mortality, and a 20% reduction in NICU admissions. We are currently seeking publication of full PRIME data, which includes these and other study results, in a highly respected, peer-reviewed journal, and we expect to generate additional publications on exploratory analyses and economic benefits in the coming months.

Previous report

We are actively discovering and developing additional biomarker and predictive analytics tests to predict other specific major conditions of pregnancy. We believe these tests have the potential to offer significant health benefits to women and their babies. Among other products, we are developing a test designed to provide a more accurate estimate of the delivery date for expectant mothers for the purposes of planning maternity leave, required support, travel arrangements, and related considerations. The scientific basis underlying this product was recently published in the journal Life in the article titled Clock Proteins Have the Potential to Improve Term Delivery Date Prediction. We are in the early stages of market testing this product in selected geographies in the United States.

Previous report

We significantly reduced our annual operating expenses across all aspects of our business over the past 24 months and will continue to prudently monitor our operating expense levels. We believe our cash runway is sufficient to enable us to operate through 2028 based on our existing operating plans. We will continue to evaluate the allocation of our resources as we focus our efforts on accelerating the market adoption of our PreTRM test and developing and launching additional pipeline products and services.

Previous report

The $0.2 million decrease in total research and development expenses was primarily due to a $0.8 million decrease in clinical study costs, partially offset by a $0.6 million increase in research and bioinformatics costs. The $0.8 million decrease in clinical study costs was primarily due to a $0.9 million decrease in PRIME study costs as we continue winding down study-related costs and advance towards publication. The $0.6 million increase in research and bioinformatics costs was primarily due to a $0.4 million increase in outside processing costs and a $0.2 million increase in personnel costs.

Previous report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Previous report

The $1.4 million increase was due primarily to increases of $0.6 million in personnel costs as we have begun strategically hiring key positions in our commercial organization, $0.4 million in marketing programs and materials as we begin to increase targeted awareness in anticipation of a PRIME study publication, $0.2 million in consulting costs, and $0.1 million in travel costs.

Previous report

The $0.5 million increase was due primarily to increases of $1.2 million in personnel costs due to increased average headcount and $0.4 million in consulting fees, partially offset by decreases of $0.7 million in stock-based compensation expense and $0.4 million in professional and legal fees.

Previous report

The 2024 Form S-3 included a prospectus, or the ATM Prospectus Supplement, covering the issuance and sale of up to $50.0 million of shares of Class A common stock pursuant to the sales agreement, dated August 7, 2024, or the 2024 Sales Agreement, between us and TD Securities (USA) LLC, or TD Cowen, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our Class A common stock having an aggregate offering price of up to $50.0 million, or the ATM Offering.

Previous report

In connection with the February 2025 Offering, on February 10, 2025, we terminated the ATM Prospectus Supplement. As a result, we will not make any sales of our shares of Class A common stock under the ATM Offering unless and until a new prospectus or prospectus supplement relating to the shares eligible to be sold in the ATM Offering is filed. Other than the termination of the ATM Prospectus Supplement, the 2024 Sales Agreement remains in full force and effect. We had not sold any shares of Class A common stock under the ATM Offering.

Previous report

In September 2025, we amended our office lease agreement to extend the lease term through June 30, 2034. Future minimum lease payments are detailed in Note 13—Commitments and Contingencies.
Reworded paragraphs (27)

Previous wording

We are a women’s health company utilizing our proprietary proteomics and bioinformatics platform and significant data resources to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests and predictive analytic products and services. Our vision is to deliver pivotal and actionable information to pregnant women, their physicians, and health care payers to significantly enhance a mother’s pregnancy journey, improve maternal and neonatal health, and reduce health care costs. We believe that our method of combining the disciplines of proteomics and bioinformatics with rigorous clinical testing, data, and economic analysis enables us to provide physicians and expectant mothers with personally insightful, clinically meaningful, and economically impactful information designed to improve the pregnancy experience and outcomes for mothers and babies.

Current wording

We are a women’s health company utilizing our proprietary proteomics and bioinformatics platform and significant data resources to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests and predictive analytic products and services. Our vision is to become the global leader in high-value women’s health diagnostics. We plan to do this by taking a holistic approach to providing pivotal and actionable information to pregnant women, their physicians, and health care payers to significantly enhance a mother’s pregnancy journey, improve maternal and neonatal health, and reduce health care costs. We believe that our method of combining the disciplines of proteomics and bioinformatics with rigorous clinical testing, data, and economic analysis enables us to provide physicians and expectant mothers with personally insightful, clinically meaningful, and economically impactful information designed to improve the pregnancy experience and outcomes for mothers and babies.

Previous wording

There are approximately 140 million births globally each year, and approximately 3.7 million births annually in the United States. Of these, it is estimated that as many as 30% are affected by various complications (i.e., a high-risk pregnancy), including: preterm birth, preeclampsia, fetal growth restriction, stillbirth, hypertension of pregnancy, gestational diabetes, and others. In many cases these complications have profound short- and long-term health consequences for the mother and baby. The health consequences of preterm birth alone are estimated to be approximately $25 billion annually in the United States. This underscores that existing methods to predict adverse pregnancy outcomes are insufficient for timely and effective proactive management for the vast majority of high-risk pregnancies. We believe that positive patient outcomes are the result of appropriate care, and the primary differentiator of patient care should be based on a determination of risk informed by a number of factors including our novel diagnostic tests.

Current wording

There are approximately 140 million births globally each year, and approximately 3.7 million births annually in the United States. Of these, it is estimated that as many as 30% are affected by various complications (i.e., a high-risk pregnancy), including: preterm birth, preeclampsia, fetal growth restriction, stillbirth, hypertension of pregnancy, gestational diabetes, and others. Existing methods to predict adverse pregnancy outcomes are insufficient for timely and effective proactive management for the vast majority of high-risk pregnancies. We believe that positive patient outcomes are the result of appropriate care, and the primary differentiator of patient care should be based on a determination of risk informed by a number of factors including our novel diagnostic tests.

Previous wording

Preterm birth is a major health risk that strains the U.S. health care system both clinically and economically. The 2024 March of Dimes Report Card shows that the preterm birth rate is now 10.4% of U.S. births, or 1 in 10, earning the nation a D+ grade for the third consecutive year. Preterm birth causes numerous medical issues requiring more time spent in the hospital, increases in pediatric care and lifelong health complications, and is estimated to contribute to approximately 34% of newborn deaths. Critically, identifying patients at higher risk of preterm birth is a clinical challenge where at least 50% of pregnant women who deliver prematurely had no known risk factors, limiting the opportunity to receive any personalized treatments or interventions that could potentially improve this outcome. According to the American College of Obstetricians and Gynecologists, or ACOG, “an effective treatment to reduce PTB (preterm birth) should be available, and the screening program should be feasible, cost effective, and accessible to all patients.”

Current wording

Preterm birth is a major health risk that strains the U.S. health care system both clinically and economically. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, making the longest stretch of the lowest grade in Report Card history. Preterm birth causes numerous medical issues requiring more time spent in the hospital, increases in pediatric care and can cause lifelong health complications, and is estimated to contribute to approximately 34% of newborn deaths. Critically, identifying patients at higher risk of preterm birth is a clinical challenge where traditional screening methods fail to identify 81% of spontaneous singleton preterm births, and at least 50% of pregnant women who deliver prematurely had no known risk factors, limiting the opportunity to receive any personalized treatments or interventions that could potentially improve this outcome. According to the American College of Obstetricians and Gynecologists, or ACOG, an “effective treatment to reduce preterm birth should be available, and the screening program should be feasible, cost effective, and accessible to all patients.”

Previous wording

Our first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman carrying a single fetus during weeks 18 through 20 of gestation that provides an accurate prediction of the expectant mother’s risk of delivering spontaneously before 37 weeks’ gestation. Our commercialization strategy includes utilizing results derived from past and future clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these benefits to health care providers, insurance payers, and consumers, while providing convenient access to the test through streamlined specimen collection options. Clinical trials conducted to date include the Prediction and Prevention of Preterm Birth, or the PREVENT-PTB Study, Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls study, or the AVERT PRETERM TRIAL, and the Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outco MEs study, or the PRIME study.

Current wording

Our first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman carrying a single fetus during weeks 18 through 20 of gestation that provides an accurate prediction of the expectant mother’s risk of delivering spontaneously before 37 weeks’ gestation. Our commercialization strategy includes utilizing results derived from past and future clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these benefits to health care providers, insurance payers, and consumers, while providing convenient access to the test through streamlined specimen collection options. Clinical trials conducted to date include the Prediction and Prevention of Preterm Birth, or the PREVENT-PTB Study, the Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls study, or the AVERT PRETERM TRIAL, and the PRIME study.

Previous wording

In July 2024, we announced the publication of the positive results from the AVERT PRETERM TRIAL in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the July issue. Notable results indicated an 18% reduction in severe neonatal morbidity and mortality. Additionally, there was a 7-day reduction in the mean neonatal hospital length of stay among neonates with the longest stays. The trial also showed an increase in the average gestational age at birth before 32 weeks by 2.48 weeks. Furthermore, there was a 28-day reduction in the neonatal length of hospital stay for babies born before 32 weeks’ gestation, significantly reducing the time spent in the hospital for those at risk of the earliest delivery. Significant reductions in neonatal morbidity and mortality were also reported, as well as hospital and Neonatal Intensive Care Unit, or NICU, lengths of stay, in the entire intent-to-treat population. The test-and-treat strategy was linked to decreased odds of preterm birth and spontaneous preterm birth at various gestational ages.

Current wording

The findings of the PRIME study are similar to those from the AVERT PRETERM TRIAL, which was published in July 2024 in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the July issue. Notable results from this study indicated an 18% reduction in severe neonatal morbidity and mortality. Additionally, there was a 7-day reduction in the mean neonatal hospital length of stay among neonates with the longest stays. The trial also showed an increase in the average gestational age at birth before 32 weeks by 2.48 weeks. Furthermore, there was a 28-day reduction in the neonatal length of hospital stay for babies born before 32 weeks’ gestation, significantly reducing the time spent in the hospital for those at risk of the earliest delivery. Significant reductions in neonatal morbidity and mortality were also reported, as well as hospital and NICU lengths of stay, in the entire intent-to-treat population. The test-and-treat strategy was linked to decreased odds of preterm birth and spontaneous preterm birth at various gestational ages.

Previous wording

In May 2025, ACOG released an updated Clinical Consensus on Tailored Prenatal Care Delivery for Pregnant Individuals. The report includes important updates to prenatal care related to incorporation of risk assessments based on medical, social, and structural drivers of health. Recommendations include changes to the frequency of monitoring via visits, the use of telemedicine, and supportive services. In collaboration with providers, patients can elect to tailor prenatal schedules; for example, fewer proposed visits or evaluations for patients that lack risk factors (e.g., prior pregnancy or medical conditions) and more intense schedules for patients at greater risk.

Current wording

ACOG updated its Clinical Consensus on Tailored Prenatal Care Delivery for Pregnant Individuals in May 2025. The report includes important updates to prenatal care related to incorporation of risk assessments based on medical, social, and structural drivers of health. Recommendations include changes to the frequency of monitoring via visits, the use of telemedicine, and supportive services. In collaboration with providers, patients can elect to tailor prenatal schedules, for example, by fewer proposed visits or evaluations for patients that lack risk factors (e.g. prior pregnancy or medical conditions) and more intense schedules for patients at greater risk.

Previous wording

We recognize ACOG’s emphasis on the importance of risk assessments in prenatal care. Our PRIME study supports the use of the PreTRM test as a component of comprehensive risk assessment in prenatal care, as the PreTRM test results can help direct interventions and limited resources toward those most at risk of preterm birth. We believe that PRIME publication in context of ACOG’s updated statement may create an opportunity for clinical opinion leaders to evaluate and issue guidelines around new technologies that can help with the risk assessments called for by ACOG. Any such developments could potentially influence the adoption of our PreTRM test and affect our future market opportunities.

Current wording

We recognize ACOG’s emphasis on the importance of risk assessments in prenatal care. Our PRIME study supports the use of the PreTRM test as a component of comprehensive risk assessment in prenatal care, as the PreTRM test results have been demonstrated in clinical trials to help direct interventions and limited resources toward those most at risk of preterm birth. We believe that PRIME publication in context of ACOG’s updated statement may create an opportunity for clinical opinion leaders to evaluate and issue guidelines around new technologies that can help with the risk assessments called for by ACOG. Any such developments could potentially influence the adoption of our PreTRM test and affect our future market opportunities.

Previous wording

We believe the substantial health benefits of this model translate very favorably to health economic savings, creating a powerful value proposition to insurance payers. Data from these studies suggests that the number of patients needed to screen, or NNS, to save a NICU day is about 3-4, and to save a NICU admission is 41. In contrast, the standard of care for short cervix, an existing clinical risk factor for preterm birth which utilizes transvaginal ultrasound plus progesterone treatments, has an NNS to save a NICU admission of 150. We plan to integrate data from our studies into our health economic model, which we will make available to prospective customers to help estimate potential economic value from adopting the PreTRM test-and-treat strategy in their institutions.

Current wording

We believe the health benefits of this model translate favorably to health economic savings, creating a powerful value proposition to insurance payers. We estimate that the average cost of a NICU day is approximately $6,300 and the average length of a NICU stay is 12-14 days. Data from the PRIME study suggests that the number of patients needed to screen, or NNS, to save a NICU day is 4.2, and to save a NICU admission is 38.5. In contrast, the standard of care for short cervix, an existing clinical risk factor for preterm birth which utilizes transvaginal ultrasound plus progesterone treatments, has an NNS to save a NICU admission of 150. This indicates that the PreTRM test-and-treat strategy is at least three times more effective at saving a NICU admission than a current technology that is already considered standard care. We plan to integrate data from our studies into our health economic model, which we will make available to prospective customers to help estimate potential economic value from adopting the PreTRM test-and-treat strategy in their institutions.

Previous wording

Beyond demonstration of clinical efficacy and health economic savings, we look forward to studying the effectiveness and implementation of the PreTRM test in a real-world setting. Our real-world evidence implementation programs, targeting to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, have been developed and the qualitative pre-implementation phase of the first such study is nearing completion.

Current wording

Beyond demonstration of clinical efficacy and potential health economic savings, we intend to study the effectiveness and implementation of the PreTRM test in a real-world setting. Our real-world evidence implementation programs, targeting to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, have been developed and the first qualitative pre-implementation study has been completed and is being prepared for publication.

Previous wording

2025, the hiring of field sales representatives in strategic geographies. Additionally, in October 2025, we hired a Chief Medical Officer with extensive experience as a practicing OBGYN and clinical leadership expertise at one of the nation’s largest payers. Our commercial philosophy at this stage is to focus our sales and marketing efforts on a few geographies where we anticipate synergistic commercial momentum such as Medicaid pilots, local key opinion leader support, early adopter institutions, PRIME Study site locations, and other opportunities which we believe could combine to drive clinical utilization of the PreTRM test in that region. We expect that it may take a few quarters for each new sales representative to begin seeing significant density of adoption of this novel diagnostic test within their territory and to provide a favorable return on our commercial investment in such territories. Once we have proven this model is effective, we intend to add new geographies, further expand our commercial headcount, and increase sales and marketing investments to achieve meaningful PreTRM test adoption at scale.

Current wording

In order to preserve capital for a time when our commercial opportunity is strongest, we have been operating under a streamlined commercial model for much of the past few years. Recently, with our portfolio of clinical evidence broadening through peer-reviewed publications, we began expanding our commercial team in 2025. This expansion began in the second quarter of 2025 with the hiring of an experienced Chief Commercial Officer with a history of success in the diagnostics space, field sales representatives in strategic geographies, and a Chief Medical Officer with extensive experience as a practicing OBGYN and clinical leadership expertise at one of the nation’s largest payers. Our commercial philosophy remains focused on a few geographies where we anticipate synergistic commercial momentum such as Medicaid pilots, local key opinion leader support, early adopter institutions, PRIME Study site locations, and other opportunities which we believe could combine to drive clinical utilization of the PreTRM test in that region. We expect that it may take time for each new sales representative to begin seeing significant density of adoption of this novel diagnostic test within their territory and to provide a favorable return on our commercial investment in such territories. Once we have proven this model is effective, we intend to add new geographies, further expand our commercial headcount, and increase sales and marketing investments to achieve meaningful PreTRM test adoption at scale.

Previous wording

Our operations are headquartered in Salt Lake City, Utah, including a CLIA-certified laboratory. Since our inception, we have devoted the majority of our efforts and resources to performing research and development, acquiring product rights, raising capital, establishing facilities, conducting clinical trials, and establishing commercial operations to develop and commercialize our testing and analytics products, primarily the PreTRM test.

Current wording

Our operations are headquartered in Salt Lake City, Utah, including a CLIA-certified laboratory. Since our inception, we have devoted the majority of our efforts and resources to performing research and development, acquiring product rights, raising capital, establishing facilities, conducting clinical trials, and establishing commercial operations to develop and commercialize our testing and analytics products, primarily the PreTRM test. We are discovering and developing additional biomarker and predictive analytics tests to predict other specific major conditions of pregnancy. We believe these tests have the potential to offer significant health benefits to women and their babies.

Previous wording

We have incurred significant operating losses since inception. Our net losses were $7.8 million and $7.9 million for the three months ended September 30, 2025 and 2024, respectively, and $24.0 million and $24.3 million for the nine months ended September 30, 2025 and 2024, respectively. We expect to incur significant additional operating losses and negative cash flows for the foreseeable future, principally as a result of our commercialization activities for the PreTRM test and to support additional clinical studies, publications, and anticipated research and development of our other pipeline products and services.

Current wording

We have incurred significant operating losses since inception. Our net losses were $8.4 million and $8.2 million for the three months ended March 31, 2026 and 2025, respectively. We expect to incur significant additional operating losses and negative cash flows for the foreseeable future, principally as a result of our commercialization activities for the PreTRM test and to support additional clinical studies, publications, and anticipated research and development of our other pipeline products and services.

Previous wording

Substantially all of our revenue in the near term is expected to come from sales of the PreTRM test. We expect to derive future revenues from PreTRM and other pipeline tests. As we continue to engage with payers and health systems using our latest evidence, we aim to close additional contracts which are expected to eventually result in additional revenues when health care providers order the PreTRM test. We believe market adoption by both health care providers and payers could be aided by our clinical evidence portfolio, which includes the AVERT PRETERM TRIAL results, the future publication of the PRIME study data, and other evidence generated within the next few years. We believe accessibility of the test for patients could be improved by our simplified specimen collection methods, and enhanced awareness and engagement with patients, which is underway. Revenue from our other pipeline products and services is expected to be dependent on our ability to successfully market them to patients, providers, payers, and, in most cases, a combination of the three.

Current wording

Substantially all of our revenue in the near term is expected to come from sales of the PreTRM test. We expect to derive future revenues from PreTRM and other pipeline tests. As we continue to engage with payers and health systems using our latest evidence, we aim to close additional contracts which are expected to eventually result in additional revenues when health care providers order the PreTRM test. We believe market adoption by both health care providers and payers could be aided by our clinical evidence portfolio, which includes the recent publication of the PRIME study, the AVERT PRETERM TRIAL results, and other evidence generated within the next few years. We believe accessibility of the test for patients could be improved by our simplified specimen collection methods, and enhanced awareness and engagement with patients, which is underway. Revenue from our other pipeline products and services is expected to be dependent on our ability to successfully market them to patients, providers, payers, and, in most cases, a combination of the three.

Previous wording

We expense all research and development costs, both internal and external, in the period in which they are incurred. We expect that our research and development expenses will decrease in 2026 compared to 2025 as we begin shifting capital allocation toward revenue-generating activities. Research and development costs may increase in the long-term as we support additional clinical studies, publications, and other product development activities.

Current wording

We expense all research and development costs, both internal and external, in the period in which they are incurred. We expect that our research and development expenses will decrease in 2026 compared to 2025 as we begin shifting capital allocation toward commercialization activities. Research and development costs may increase in the long-term as we support additional clinical studies, publications, and other product development activities.

Previous wording

Selling and marketing expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for sales, marketing, and payer access personnel. Other significant costs include travel, consulting, public relations, facilities, and legal costs related to commercial efforts. We expect selling and marketing expenses will increase in the fourth quarter of 2025 and increase further in 2026 as we invest in additional commercialization activities for PreTRM following the expected publication of the PRIME study data and continue to invest in our product portfolio.

Current wording

Selling and marketing expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for sales, marketing, and payer access personnel. Other significant costs include travel, consulting, public relations, facilities, and legal costs related to commercial efforts. We expect selling and marketing expenses will increase in 2026 compared to 2025 as we invest in additional commercialization activities for PreTRM following the publication of the PRIME study data and as we continue to invest in our product portfolio.

Previous wording

General and administrative expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for personnel in executive, finance, information technology, human resources, and other administrative functions. Other significant costs include facilities, corporate and intellectual property legal fees, accounting, insurance, consulting, and other professional fees. We expect general and administrative expenses to remain relatively consistent in 2026 compared to 2025 as we support PreTRM commercial opportunities and other strategic initiatives.

Current wording

General and administrative expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for personnel in executive, finance, information technology, human resources, and other administrative functions. Other significant costs include facilities, corporate and intellectual property legal fees, accounting, insurance, consulting, and other professional fees. We expect general and administrative expenses to decrease in 2026 compared to 2025 as we seek cost efficiencies in these areas to preserve capital to support PreTRM commercial opportunities and other strategic initiatives.

Previous wording

The $1.6 million decrease in total research and development expenses was primarily due to a $1.5 million decrease in clinical study costs and a $0.1 million decrease in research and bioinformatics costs. The $1.5 million decrease in clinical study costs was primarily due to a $1.5 million decrease in PRIME study costs as we continue winding down study-related costs and advance towards publication. The $0.1 million decrease in research and bioinformatics costs was primarily due to a $0.4 million decrease in stock-based compensation expense and a $0.3 million decrease in outside processing costs, partially offset by a $0.6 million increase in personnel and consulting costs.

Current wording

The $0.3 million decrease in total research and development expenses was primarily due to a $0.2 million decrease in research and bioinformatics costs and a $0.1 million decrease in laboratory operations costs. The $0.2 million decrease in research and bioinformatics costs was primarily due to a $0.1 million decrease in consulting costs and a $0.1 million decrease in stock-based compensation expense. The $0.1 million decrease in laboratory operations costs was primarily due to a $0.1 million decrease in depreciation expense.

Previous wording

The $0.4 million increase was due primarily to increases of $0.3 million in personnel costs as we continued strategically hiring in our commercial organization and $0.1 million in travel costs.

Current wording

The $0.5 million increase was due primarily to increases of $0.4 million in personnel costs as we continued strategically hiring in our commercial organization and $0.1 million in marketing materials.

Previous wording

The $0.1 million decrease was due primarily to decreases of $0.4 million in professional and legal fees and $0.3 million in stock-based compensation expense, partially offset by increases of $0.5 million in personnel costs due to increased average headcount and $0.1 million in consulting fees.

Current wording

The $0.2 million decrease was due primarily to a decrease of $0.4 million in stock-based compensation expense, partially offset by a $0.2 million increase in professional and legal fees.

Previous wording

The $0.2 million increase in other income, net, was due to a $0.4 million increase related primarily to interest income on our marketable securities, partially offset by a $0.2 million decrease in investment income related primarily to our marketable securities.

Current wording

The $0.1 million decrease in other income, net, was due to a $0.1 million decrease in investment income related primarily to our marketable securities.

Previous wording

Since inception, we have not generated a significant amount of commercial revenue from product sales or any other sources and have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. We have financed our operations primarily through proceeds from the sale and issuance of convertible preferred stock and convertible notes, bank loans, the sale and issuance of Class A common stock in our IPO, which was completed in July 2021, and the sale and issuance of Class A common stock and pre-funded warrants in the February 2025 Offering. As of September 30, 2025, we had aggregate cash, cash equivalents, and available-for-sale securities of $102.4 million, and an accumulated deficit of $303.8 million.

Current wording

Since inception, we have not generated a significant amount of commercial revenue from product sales or any other sources and have incurred significant operating losses and negative cash flows from operations. We anticipate that we will continue to incur net losses for the foreseeable future. We have financed our operations primarily through proceeds from the sale and issuance of convertible preferred stock and convertible notes, bank loans, the sale and issuance of Class A common stock in our IPO, which was completed in July 2021, and the sale and issuance of Class A common stock and pre-funded warrants in the February 2025 Offering. As of March 31, 2026, we had aggregate cash, cash equivalents, and available-for-sale securities of $86.8 million, and an accumulated deficit of $320.1 million.

Previous wording

On August 7, 2024, we filed a universal shelf registration on Form S-3 with the SEC, which was declared effective on August 13, 2024, pursuant to which we registered for sale up to $100.0 million of any combination of our Class Acommon stock, preferred stock, debt securities, warrants, rights, and/or units from time to time and at prices and on terms that we may determine, which we refer to as the 2024 Form S-3. This registration statement will remain in effect for up to three years from the date it became effective. We make no assurances as to the continued effectiveness of the 2024 Form S-3.

Current wording

In August 2024, we filed a universal shelf registration on Form S-3 with the SEC, pursuant to which we registered for sale up to $100.0 million of any combination of our Class Acommon stock, preferred stock, debt securities, warrants, rights, and/or units from time to time and at prices and on terms that we may determine, which we refer to as the 2024 Form S-3. This registration statement will remain in effect for up to three years from the date it became effective. We make no assurances as to the continued effectiveness of the 2024 Form S-3.

Previous wording

The net cash used in operating activities during the nine months ended September 30, 2025 was primarily due to a net loss of $24.0 million and a decrease in operating assets and liabilities of $0.7 million, partially offset by an increase in non-cash charges of $5.3 million. The net cash used in operating activities during the nine months ended September 30, 2024 was primarily due to a net loss of $24.3 million, partially offset by an increase in operating assets and liabilities of $10.7 million and non-cash charges of $5.7 million.

Current wording

The net cash used in operating activities during the three months ended March 31, 2026 was primarily due to a net loss of $8.4 million and a decrease in operating assets and liabilities of $1.5 million, partially offset by an increase in non-cash charges of $1.1 million. The net cash used in operating activities during the three months ended March 31, 2025 was primarily due to a net loss of $8.2 million and a decrease in operating assets and liabilities of $1.2 million, partially offset by an increase in non-cash charges of $1.9 million.

Previous wording

Net cash used in investing activities for the nine months ended September 30, 2025 was primarily due to $79.8 million in purchases of marketable securities and $0.4 million in purchases of property and equipment, partially offset by $45.8 million in proceeds from maturities and sales of marketable securities. Net cash provided by investing activities for the nine months ended September 30, 2024 was primarily due to $35.7 million in proceeds from maturities and sales of marketable securities, partially offset by $30.3 million in purchases of marketable securities and $1.0 million in purchases of intangible assets.

Current wording

Net cash provided by investing activities for the three months ended March 31, 2026 was primarily due to $10.0 million in proceeds from maturities and sales of marketable securities, partially offset by $1.0 million in purchases of marketable securities. Net cash used in investing activities for the three months ended March 31, 2025 was primarily due to $56.6 million in purchases of marketable securities, partially offset by $11.8 million in proceeds from maturities and sales of marketable securities.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was primarily due to $53.6 million in net proceeds from the February 2025 Offering and $0.5 million in proceeds from employee equity transactions, partially offset by $0.2 million of finance lease principal payments. Net cash provided by financing activities for the nine months ended September 30, 2024 was primarily due to $2.7 million in proceeds from employee equity transactions, partially offset by $0.3 million of finance lease principal payments.

Current wording

Net cash provided by financing activities for the three months ended March 31, 2026 was primarily due to $22 thousand in proceeds from employee equity transactions. Net cash provided by financing activities for the three months ended March 31, 2025 was primarily due to $53.6 million in net proceeds from the February 2025 Offering, partially offset by $0.1 million of finance lease principal payments.

Previous wording

Our contractual obligations and commitments for the year ended December 31, 2024, are set forth in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 19, 2025, or the Annual Report.

Current wording

Our contractual obligations and commitments for the year ended December 31, 2025, are set forth in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 18, 2026, or the Annual Report. No material changes have occurred during the three months ended March 31, 2026.

Previous wording

A summary of our critical accounting policies and estimates is included in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report. There have been no significant changes in the application of our critical accounting policies, significant judgments, and use of estimates during the nine months ended September 30, 2025.

Current wording

A summary of our critical accounting policies and estimates is included in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report. There have been no significant changes in the application of our critical accounting policies, significant judgments, and use of estimates during the three months ended March 31, 2026.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

In order to preserve capital for a time when our commercial opportunity is strongest, we have been operating under a streamlined commercial model for much of the previous two years. Now, with our portfolio of clinical evidence broadening through peer-reviewed publications, we have recently begun expanding our commercial team. This expansion began in the second quarter of 2025 with the hiring of an experienced Chief Commercial Officer who brings a history of success in the diagnostics space and, in the third quarter of

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:

Previous report — wording carried elsewhere

The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:

Previous report — wording carried elsewhere

The $0.6 million increase in other income, net was due to a $1.1 million increase related primarily to interest income on our marketable securities, partially offset by a $0.5 million decrease in investment income related primarily to our marketable securities.