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SERA PROGNOSTICS, INC.

For the period ended Jun 30, 2026. Filed Aug 12, 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.

Jun 30, 2026 · Filed Aug 12, 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 2026-03-31; filed 2026-05-06.

0001534969-26-000025

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

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-12.

0001193125-26-346862

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 102 previous paragraphs and 111 current paragraphs.

72 unchanged; 23 reworded; 12 added; 6 removed; 1 previous and 4 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 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

We are currently processing publication manuscripts of additional PRIME data, including exploratory analyses and economic benefits, to be submitted in the coming months. For example, in July 2026, a subgroup analysis of the PRIME randomized controlled trial was published in The Journal of Maternal-Fetal & Neonatal Medicine. The analysis demonstrated the benefit afforded by PreTRM test risk assessment in the nulliparous (i.e., first-time mothers) subgroup of PRIME. This group of pregnant women are at increased risk of premature delivery and also lack prior obstetric history, further limiting traditional preterm birth risk stratification (i.e., a history of premature delivery), and this analysis demonstrates that the PreTRM test is particularly valuable for nulliparous mothers. Neonatal benefits to this subgroup were even more favorable than the already strong impact observed in the overall study population. Screen-guided care reduced NICU admissions by 22% compared with routine care, reduced severe composite neonatal morbidity by 30%, and achieved an NNS of 28 to prevent one NICU admission. These findings support the clinical utility of PreTRM test-guided care for identifying and improving outcomes among first-time mothers, who could particularly benefit from improved risk screening tools.

Current report

Since March 31, 2026, Key Developments Affecting Our Business Include the Following:

Current report

Advanced Commercial Adoption Strategy with Fourth Partnership Program Launch: In August 2026, we launched fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer. We also exceeded our 2026 payer engagement objective, with active discussions now spanning more than 20 payer opportunities across over 20 states, and are increasingly focused on advancing implementation, reimbursement readiness, and adoption within priority markets.

Current report

Illinois Medicaid Coverage Mandate Expands Access to PreTRM Test: In June 2026, Illinois enacted legislation (Public Act 104-0470, Section 5-54) requiring Medicaid coverage and reimbursement for prescribed proteomic blood tests used to identify spontaneous preterm birth risk and associated interventions. In July, the Illinois Department of Healthcare and Family Services published a Provider Notice confirming the coverage of biomarker testing to include assessing risk of preterm birth in pregnant individuals. The Department also confirmed for providers that coverage applies to all Medicaid pregnancies in Illinois, representing approximately 50,000 annual Medicaid births.

Current report

Scientific Recognition Highlights New Clinical and Economic PRIME Data: Two abstracts from the PRIME randomized controlled trial were accepted for presentation at the SMFM Global Congress 2026, reflecting continued external validation of our growing clinical evidence base.

Current report

Oral Presentation: Subgroup analysis evaluating outcomes among first-time mothers (nulliparous pregnancies), selected as one of 63 oral presentations from more than 400 submissions.

Current report

Top-Ranked Poster Presentation: New health economic analysis assessing the clinical and economic impact of PreTRM test-guided care, recognized among the top five posters in its session.

Current report

Advanced European Regulatory and Commercial Readiness: European expert commentary published supporting the role of biomarker-based risk prediction and biology-driven prevention strategies in addressing preterm birth, the convening of a European Expert Advisory Board representing nine countries, and completion of additional ELISA-based assay performance testing strengthened our CE marking submission package, with pre-application activities expected to commence in the third quarter and submission to conclude in the fourth quarter of 2026.

Current report

Publication Demonstrates Clinical and Health Economic Value in First-Time Pregnancies: In July 2026, a PRIME study subgroup analysis was published in The Journal of Maternal-Fetal & Neonatal Medicine demonstrating that PreTRM test-guided care reduced NICU admissions by 22% among first-time mothers, including a two-fold reduction among newborns following spontaneous preterm birth, while reducing severe composite neonatal morbidity by 30%. The analysis also demonstrated strong screening efficiency, with only 28 first-time pregnancies needing to be screened and treated to prevent one NICU admission.

Current report

Strengthened Leadership Team and Board to Support Commercial Growth: Expanded commercial leadership capabilities in marketing and payer and government strategy and appointed healthcare diagnostics veteran Mark Capone to the Board of Directors, adding deep expertise in diagnostics commercialization, reimbursement, and scaling innovative healthcare businesses.

Current report

The $1.0 million increase was due primarily to increases of $0.7 million in personnel costs as we continued strategically hiring in our commercial organization, $0.5 million in marketing materials and programs, and $0.2 million in travel expenses. These increases were partially offset by a decrease of $0.5 million in consulting and professional services.
Removed paragraphs (6)
Reworded paragraphs (23)

Previous 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.”

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, marking 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

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.

Current wording

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, and to save a NICU admission was 38.5. The findings of the PRIME study are consistent with 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 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.

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. With our portfolio of clinical evidence broadening through peer-reviewed publications, we began expanding our commercial team in the second quarter of 2025, beginning 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

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 wording

As part of our transition from a clinical-stage company to a commercial organization, we recently completed a comprehensive business review to reallocate a portion of our capital investment from research and development and general and administrative expenses 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 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.

Previous 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.

Current wording

We have incurred significant operating losses since inception. Our net losses were $9.1 million and $8.0 million for the three months ended June 30, 2026 and 2025, respectively, and $17.5 million and $16.2 million for the six months ended June 30, 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

We will continue to pursue contracts with private and governmental payers and health systems using positive data from the PREVENT-PTB study, the AVERT PRETERM TRIAL, and the PRIME study, along with real-world evidence studies and other data we plan to generate, and we believe these efforts may eventually result in material revenues. However, if we are unable to secure payer contracts and generate significant market adoption by providers resulting in significant revenues, or if we fail to develop and successfully market our additional tests that generate additional revenues, we may be required to delay, scale back, or abandon some, or all, of our development programs and other operations. Until such time as we can generate significant revenue from the sales of our products, if ever, we may need to continue to finance our cash needs through equity offerings, debt financings, or other capital sources, potentially including collaborations or other similar arrangements. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends and may require the issuance of warrants. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may need to relinquish valuable rights to our technologies, future revenue streams, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may have to significantly delay, reduce, or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our ability to access capital on acceptable terms when needed, or at all, is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition, and results of operations.

Current wording

We continue to pursue contracts with private and governmental payers and health systems using positive data from the PREVENT-PTB study, the AVERT PRETERM TRIAL, and the PRIME study, along with real-world evidence studies and other data we plan to generate, and we believe these efforts may eventually result in material revenues. However, if we are unable to secure payer contracts and generate significant market adoption by providers resulting in significant revenues, or if we fail to develop and successfully market our additional tests that generate additional revenues, we may be required to delay, scale back, or abandon some, or all, of our development programs and other operations. Until such time as we can generate significant revenue from the sales of our products, if ever, we may need to continue to finance our cash needs through equity offerings, debt financings, or other capital sources, potentially including collaborations or other similar arrangements. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends and may require the issuance of warrants. If we raise additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, we may need to relinquish valuable rights to our technologies, future revenue streams, or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may have to significantly delay, reduce, or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our ability to access capital on acceptable terms when needed, or at all, is not assured and, if not achieved on a timely basis, will materially harm our business, financial condition, and results of operations.

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 commercialization 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 the second half of 2026 compared to the first half of 2026 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 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.

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 the second half of 2026 compared to the first half of 2026 as we invest in additional commercialization activities for PreTRM following the publication of the PRIME study data and in response to potential coverage successes.

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 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.

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 the second half of 2026 compared to the first half of 2026 as we seek cost efficiencies in these areas to preserve capital to support PreTRM commercial opportunities and other strategic initiatives.

Previous 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.

Current wording

The $0.4 million increase was due primarily to increases of $0.4 million in marketing materials and programs, $0.3 million in personnel costs as we continued strategically hiring in our commercial organization and $0.1 million in travel expenses. These increases were partially offset by a decrease of $0.4 million in consulting and professional services.

Previous 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.

Current wording

The $0.1 million increase was due primarily to an increase of $0.4 million in severance costs, partially offset by a decrease of $0.3 million in stock-based compensation expense.

Previous 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.

Current wording

The $0.4 million decrease in other income, net, was due to a $0.4 million decrease in interest income related primarily to our marketable securities.

Previous 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.

Current wording

The $0.1 million decrease in total research and development expenses was primarily due to a $0.3 million decrease in laboratory operations costs, partially offset by a $0.1 million increase in research and bioinformatics costs and a $0.1 million increase in clinical study costs. The $0.3 million decrease in laboratory operations costs was primarily due to a $0.2 million decrease in depreciation expense and a $0.1 million decrease in stock-based compensation expense. The $0.1 million increase in research and bioinformatics costs was primarily due to a $0.3 million increase in severance costs and a $0.1 million increase in personnel expense, partially offset by a $0.2 million decrease in stock-based compensation expense and a $0.1 million decrease in consulting costs. The $0.1 million increase in clinical study costs was primarily due to a $0.1 million increase in severance costs.

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 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.

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 June 30, 2026, we had aggregate cash, cash equivalents, and available-for-sale securities of $80.3 million, and an accumulated deficit of $329.3 million.

Previous wording

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.

Current wording

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. We may make sales under the 2026 ATM Sales Agreement pursuant to our existing Form S-3 shelf registration statement filed in August 2024 and the 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. We did not sell any shares of our Class A common stock pursuant to the 2026 ATM Sales Agreement during the six months ended June 30, 2026.

Previous 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.

Current wording

The net cash used in operating activities during the six months ended June 30, 2026 was primarily due to a net loss of $17.5 million, partially offset by an increase in operating assets and liabilities of $0.1 million and an increase in non-cash charges of $2.4 million. The net cash used in operating activities during the six months ended June 30, 2025 was primarily due to a net loss of $16.2 million and a decrease in operating assets and liabilities of $0.7 million, partially offset by an increase in non-cash charges of $3.6 million.

Previous 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.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2026 was primarily due to $27.1 million in proceeds from maturities and sales of marketable securities, partially offset by $11.7 million in purchases of marketable securities. Net cash used in investing activities for the six months ended June 30, 2025 was primarily due to $71.9 million in purchases of marketable securities and $0.3 million in purchases of property and equipment, partially offset by $32.6 million in proceeds from maturities and sales of marketable securities.

Previous 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.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2026 was primarily due to $0.2 million in proceeds from employee equity transactions. Net cash provided by financing activities for the six months ended June 30, 2025 was primarily due to $53.6 million in net proceeds from the February 2025 Offering and $0.1 million in proceeds from employee equity transactions, partially offset by $0.2 million of finance lease principal payments.

Previous wording

It is likely we will continue to incur significant additional operating losses and negative cash flows for the foreseeable future. We expect our losses in the future to increase principally as a result of our commercialization activities for the PreTRM test and the development, commercialization, marketing, and distribution of our other pipeline products and services, especially the costs of evidence-generating initiatives. There can be no assurance that we will eventually achieve significant revenues or profitability, or if achieved, can sustain either on a continuing basis. If we are unable to achieve significant revenues or raise additional funding on acceptable terms, when needed, or at all, we may not be able to continue the development or commercialization of our products and services and could be required to delay, scale back, or abandon some or all of our development programs and other operations. No assurance can be given that we will be successful in raising the required capital at reasonable cost and at the required times, or at all, particularly in light of the current economic uncertainty, fluctuating interest rates and inflation, tariffs, and the potential for local and/or global economic slowdown or recession.

Current wording

We expect to continue incurring significant additional operating losses and negative cash flows for the foreseeable future. We expect our losses in the future to increase principally as a result of our commercialization activities for the PreTRM test and the development, commercialization, marketing, and distribution of our other pipeline products and services, especially the costs of evidence-generating initiatives. There can be no assurance that we will eventually achieve significant revenues or profitability, or if achieved, can sustain either on a continuing basis. If we are unable to achieve significant revenues or raise additional funding on acceptable terms, when needed, or at all, we may not be able to continue the development or commercialization of our products and services and could be required to delay, scale back, or abandon some or all of our development programs and other operations. No assurance can be given that we will be successful in raising the required capital at reasonable cost and at the required times, or at all, particularly in light of the current economic uncertainty, fluctuating interest rates and inflation, tariffs, and the potential for local and/or global economic slowdown or recession.

Previous 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.

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 six months ended June 30, 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 three months ended March 31, 2026.

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 six months ended June 30, 2026.

Previous wording

We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (1) are no longer an EGC or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. Under the JOBS Act, EGCs can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies, reduce disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and are exempt from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. As an EGC, we are also not required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, as amended. As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates and we are not required to provide auditor attestation regarding requirements of Section 404(b) of SOX.

Current wording

We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We elected to use the extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that we (1) are no longer an EGC or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. Under the JOBS Act, EGCs can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies, reduce disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and are exempt from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. As an EGC, we are also not required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404 of the Sarbanes-Oxley Act, as amended (“SOX”). As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates and we are not required to provide auditor attestation regarding requirements of Section 404(b) of SOX.

Previous wording

We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (2) the last day of the fiscal year in which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) December 31, 2026.

Current wording

We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (2) the last day of the fiscal year in which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) December 31, 2026.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

The $0.2 million increase in total research and development expenses was primarily due to a $0.2 million increase in research and bioinformatics costs and a $0.1 million increase in clinical study costs, partially offset by a $0.2 million decrease in laboratory operations costs. The $0.2 million increase in research and bioinformatics costs was primarily due to a $0.3 million increase in severance costs and a $0.1 million increase in personnel expense, partially offset by a $0.1 million decrease in consulting costs and a $0.1 million decrease in stock-based compensation expense. The $0.1 million increase in clinical study costs was primarily due to a $0.1 million increase in severance costs. The $0.2 million decrease in laboratory operations costs was primarily due to a $0.1 million decrease in depreciation expense and a $0.1 million decrease in personnel expense due to lower average headcount.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:

Current report — wording carried from elsewhere

The $0.5 million decrease in other income, net, was due to a $0.4 million decrease in interest income and a $0.1 million decrease in investment income related primarily to our marketable securities.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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.