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SERA PROGNOSTICS, INC.

For the period ended Sep 30, 2025. Filed Nov 13, 2025.

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.

Sep 30, 2025 · Filed Nov 13, 2025

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 2025-06-30; filed 2025-08-06.

0000950170-25-104007

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

Current 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

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 104 current paragraphs.

71 unchanged; 29 reworded; 3 added; 1 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 5 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 (3)

Current report

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 report

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

Current 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.
Removed paragraphs (1)
Reworded paragraphs (29)

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. These 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. 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.

Previous wording

Preterm birth is a major health risk that strains the U.S. healthcare 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 (Callaghan WM, et al. The Contribution of Preterm Birth to Infant Mortality Rates in the United States.) 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 (Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm Birth: Causes, Consequences, and Prevention. Behrman RE, Butler AS, editors. Washington (DC): National Academies Press (US); 2007. PMID: 20669423), 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 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.”

Previous wording

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 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.

Current wording

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 wording

The PRIME study includes the same Primary and Secondary outcomes as the AVERT PRETERM TRIAL. When performing an aggregate-data meta-analysis from the two studies, we have demonstrated pooled effect sizes showing a 22% decreased risk of prolonged hospital stay and 22% reduction in neonatal morbidity and mortality. This evidence from our studies makes a case for a strategy where using the PreTRM test to identify higher-risk pregnancies not currently identifiable by standard care, and applying widely accepted interventions, can result in prolonged gestation. When babies who were destined for premature delivery remain in utero longer, the result is more mature babies with improved health requiring shorter hospital/NICU stays.

Current wording

The PRIME study includes the same primary and secondary outcomes as the AVERT PRETERM TRIAL. When performing an aggregate-data meta-analysis from the two studies, we have demonstrated pooled effect sizes showing a 22% decreased risk of prolonged hospital stay among those neonates with the longest stays and 22% reduction in neonatal morbidity and mortality assessed by a composite index. This evidence from our studies supports a strategy of using the PreTRM test to identify higher-risk pregnancies not currently identifiable by standard care and applying widely accepted interventions to prolong gestation. When babies who were destined for premature delivery remain in utero longer, the result is more mature babies with improved health requiring shorter hospital/NICU stays.

Previous wording

We believe market adoption by both health care providers and payers should be aided by the publications of our AVERT PRETERM TRIAL, PRIME study, and forthcoming real-world evidence studies. We believe that these and additional data expected to be published in coming months and years, together with our current body of evidence, will continue to demonstrate the clinical and economic utility of using our test.

Current wording

We believe market adoption by both health care providers and payers should be aided by the publications of data from our AVERT PRETERM TRIAL, PRIME study, and forthcoming real-world evidence studies. We believe data expected to be published in coming months and years, together with our current body of evidence, will continue to demonstrate the clinical and economic utility of using our test.

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 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 2025, the hiring of field sales representatives in strategic geographies. Our commercial philosophy at this stage is to focus our sales and marketing efforts in 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

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.

Previous wording

We have incurred significant operating losses since inception. Our net losses were $8.0 million and $8.3 million for the three months ended June 30, 2025 and 2024, respectively, and $16.2 million and $16.4 million for the six months ended June 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 $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.

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 now 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 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.

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 the publication of the AVERT PRETERM TRIAL results, the future publication of positive 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 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.

Previous wording

Cost of revenue reflects the aggregate costs incurred in delivering products to customers (e.g., proteomic testing results to clinicians) and includes expenses related to third-party specimen collection and shipping costs, as well as our lab personnel, materials and supplies, equipment, and infrastructure expenses associated with clinical testing, allocated overhead, including rent and equipment depreciation, and amortization of certain intangible assets. Some of these components can vary significantly in cost and reliability of supply, and we periodically seek ways to strengthen our supplier network. For example, to address the risk posed by potential disruptions in specimen collection services described in the “Risk Factors” section of this Quarterly Report on Form 10-Q, we contracted with alternative specimen collection providers beyond those that have traditionally supplied the majority of our needs and developed additional collection methods. We expect costs of revenue will generally move in line with the sales of our products.

Current wording

Cost of revenue reflects the aggregate costs incurred in delivering products to customers (e.g., proteomic testing results to clinicians) and includes expenses related to third-party specimen collection and shipping costs, as well as our lab personnel, materials and supplies, equipment, and infrastructure expenses associated with clinical testing, allocated overhead, including rent and equipment depreciation, and amortization of certain intangible assets. Some of these components can vary significantly in cost and reliability of supply, and we periodically seek ways to strengthen our supplier network. We expect costs of revenue will generally move in line with the sales of our products.

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 increase in the second half of 2025 compared to the same period in 2024 due to increased product development activities and additional planned studies. Research and development costs may increase in the medium to long-term as we support current and 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 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.

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 second half of 2025 compared to the same period of 2024 as we continue to add strategic headcount and consultants, prepare for publication of PRIME study data, expand our investment in pursuit of PreTRM commercial opportunities, and 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 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.

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 increase slightly in the second half of 2025 compared to the same period 2024 as we begin to scale in the pursuit of 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 remain relatively consistent in 2026 compared to 2025 as we support PreTRM commercial opportunities and other strategic initiatives.

Previous wording

The $1.4 million decrease in total research and development expenses was primarily due to a $0.7 million decrease in research and bioinformatics costs, a $0.7 million decrease in clinical study costs, and a $0.1 million decrease in laboratory operations costs. The $0.7 million decrease in research and bioinformatics costs was primarily due to a $0.6 million decrease in outside processing costs and a $0.4 million decrease in stock-based compensation expense, partially offset by a $0.4 million increase in personnel and consulting costs. The $0.7 million decrease in clinical study costs was primarily due to a $0.6 million decrease in PRIME study costs as we continue winding down study-related costs and advance towards publication. The $0.1 million decrease in laboratory operations costs was primarily due to a $0.1 million decrease in stock-based compensation expense.

Current wording

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 wording

The $0.4 million increase was due primarily to increases of $0.4 million in personnel costs due to increased average headcount and $0.1 million in consulting fees, partially offset by a $0.2 million decrease in stock-based compensation expense.

Current 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.

Previous wording

The $0.3 million increase in other income, net, was due to a $0.5 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 $0.2 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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

The $1.1 million decrease in total research and development expenses was primarily due to a $0.7 million decrease in research and bioinformatics costs and a $0.4 million decrease in clinical study costs. The $0.7 million decrease in research and bioinformatics costs was primarily due to a $0.4 million decrease in stock-based compensation expense and a $0.4 million decrease in outside processing costs, partially offset by a $0.1 million increase in consulting costs. The $0.4 million decrease in clinical study costs was primarily due to a $0.4 million decrease in PRIME study costs as we continue winding down study-related costs and advance towards publication.

Current 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.

Previous wording

The $0.7 million increase was due primarily to an increase of $0.2 million in personnel and consulting costs as we strategically hired key positions in our commercial organization and $0.1 million in marketing programs and materials as we begin to increase targeted awareness in anticipation of a PRIME study publication.

Current wording

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 wording

The $0.7 million increase was due primarily to increases of $0.8 million in personnel costs due to increased average headcount and $0.3 million in consulting fees, partially offset by a $0.3 million decrease in stock-based compensation expense.

Current wording

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 wording

The $0.4 million increase in other income, net was due to a $0.8 million increase related primarily to interest income on our marketable securities, partially offset by a $0.4 million decrease in investment income related primarily to our marketable securities.

Current wording

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.

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 June 30, 2025, we had aggregate cash, cash equivalents, and available-for-sale securities of $108.5 million, and an accumulated deficit of $296.0 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 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.

Previous wording

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. The net cash used in operating activities during the six months ended June 30, 2024 was primarily due to a net loss of $16.4 million, partially offset by an increase in operating assets and liabilities of $11.7 million and non-cash charges of $3.8 million.

Current 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.

Previous wording

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. Net cash used in investing activities for the six months ended June 30, 2024 was primarily due to $26.6 million in purchases of marketable securities and $0.7 million in purchases of intangible assets, partially offset by $26.7 million in proceeds from maturities and sales of marketable securities.

Current 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.

Previous wording

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. Net cash provided by financing activities for the six months ended June 30, 2024 was primarily due to $2.5 million in proceeds from employee equity transactions, partially offset by $0.2 million of finance lease principal payments.

Current 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.

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. No material changes have occurred during the six months ended June 30, 2025.

Current 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.

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 six months ended June 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 nine months ended September 30, 2025.

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, or SOX, 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. 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.
Rearranged current paragraphs (1)

Current report — wording carried from 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
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The $1.0 million increase was due primarily to an increase of $0.4 million in marketing programs and materials as we begin to increase targeted awareness in anticipation of a PRIME study publication and $0.2 million in personnel costs as we strategically hired key positions in our commercial organization.