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SERA PROGNOSTICS INC

For the period ended Sep 30, 2024. Filed Nov 6, 2024.

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, 2024 · Filed Nov 6, 2024

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 2024-06-30; filed 2024-08-07.

0001534969-24-000152

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

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-06.

0000950170-24-122312

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 94 previous paragraphs and 101 current paragraphs.

66 unchanged; 25 reworded; 8 added; 1 removed; 2 previous and 2 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 (8)

Current report

2024, deliveries of all PRIME study participants were complete, inclusive of the approximately 2,000 remaining participants who were enrolled but had not delivered before enrollment was stopped in December 2023 per DSMB recommendation. In September 2024, the final PRIME database was locked. Top-level trial results were communicated to the DSMB and Sera in October 2024. We are currently seeking publication of these results in a highly respected, peer-reviewed journal, and submitting an abstract for presentation in a key pregnancy and maternal health conference in early 2025.

Current report

The $0.9 million increase was due primarily to increases of $0.4 million in professional services fees, $0.3 million in stock-based compensation expense, and $0.2 million of legal expenses. The increases in professional services fees and legal expenses were partially driven by costs associated with a shelf registration statement on Form S-3 we filed with the SEC in August 2024.

Current report

Comparison of the Nine Months Ended September 30, 2024 and 2023

Current report

On August 7, 2024, we filed a universal shelf registration on Form S-3 with the SEC, which was declared effective on August 13, 2024, pursuant to which we registered for sale up to $100.0 million of any combination of our Class Acommon stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, which we refer to as the 2024 Form S-3. This registration statement will remain in effect for up to three years from the date it became effective.

Current report

The 2024 Form S-3 includes a prospectus covering up to $50.0 million in shares of Class Acommon stock that can be issued and sold under a sales agreement we entered into with TD Securities (USA) LLC, or TD Cowen, on August 7, 2024, which we refer to as the 2024 Sales Agreement, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our Class Acommon stock having an aggregate offering price of up to $50.0 million.

Current report

We make no assurances as to the continued effectiveness of the 2024 Form S-3. As of September 30, 2024, we have not sold any shares of Class Acommon stock to date under the 2024 Sales Agreement.

Current report

We have an effective universal shelf registration on Form S-3 with the SEC pursuant to which we registered for sale up to $100.0 million of any combination of our Class A common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, which we refer to as the 2024 Form S-3. The 2024 Form S-3 includes a prospectus covering up to $50.0 million in shares of Class A common stock that can be issued and sold under a sales agreement we entered into with TD Cowen on August 7, 2024, which we refer to as the 2024 Sales Agreement, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our Class A common stock having an aggregate offering price of up to $50.0 million. As of September 30, 2024, we have not sold any shares of Class A common stock under the 2024 Sales Agreement. We make no assurances as to the continued effectiveness of the 2024 Form S-3.
Removed paragraphs (1)
Reworded paragraphs (25)

Previous wording

Our first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a premature delivery, also known as preterm birth. The PreTRM test is a non-invasive blood test given to a pregnant woman, carrying a single fetus, during weeks 18 through 20 of gestation that provides an accurate prediction of the expectant mother’s risk of delivering spontaneously before 37 weeks’ gestation. Our commercialization strategy includes conducting clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these benefits to healthcare providers and insurance payers, and providing convenient access to the test through streamlined specimen collection options. Beyond demonstration of efficacy, we look forward to studying the effectiveness and implementation of the PreTRM test in a real-world setting. Clinical trials conducted to date include the Prediction and Prevention of Preterm Birth, or the PREVENT-PTB Study, Serum Assessment of Preterm Birth Outcomes Compared to Historical Controls study, or the AVERT PRETERM TRIAL, and the Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outco MEs study, or the PRIME study. Manuscript results of these studies demonstrate consistency in the reported beneficial impact of the PreTRM test-and-treat strategy. Specifically, this includes evidence of a prolongation of gestation, shortened hospital or neonatal intensive care unit, or NICU, length of stay, and improvements in measures of neonatal morbidity/mortality. Our studies demonstrate a model indicating that by identifying and intervening in at-risk pregnancies, not identifiable by other approaches, babies destined for premature delivery remain in utero longer. This prolongation of gestation in the preterm period leads to more mature babies that require shorter hospital/NICU stays due to improved neonatal health. The PRIME study, for which enrollment was stopped due to efficacy at the interim analysis and is being prepared for publication, includes the same Primary and Secondary outcomes as the AVERT PRETERM TRIAL and affords the continued assessment of this model.

Current wording

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

Previous wording

We recently announced the publication of the positive results from the AVERT PRETERM TRIAL in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the journal issue. Notable results indicated an 18% reduction in severe neonatal morbidity and mortality. Additionally, there was a 7-day reduction in the mean neonatal hospital length of stay among neonates with the longest stays. The trial also showed an increase in the average gestational age at birth before 32 weeks by 2.48 weeks. Furthermore, there was a

Current wording

In July 2024, we announced the publication of the positive results from the AVERT PRETERM TRIAL in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the journal issue. Notable results indicated an 18% reduction in severe neonatal morbidity and mortality. Additionally, there was a 7-day reduction in the mean neonatal hospital length of stay among neonates with the longest stays. The trial also showed an increase in the average gestational age at birth before 32 weeks by 2.48 weeks. Furthermore, there was a 28-day reduction in the neonatal length of hospital stay for babies born before 32 weeks’ gestation, significantly reducing the time spent in the hospital for those at risk of the earliest delivery. Significant reductions in neonatal morbidity and mortality were also reported, as well as hospital and 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 December 2023, we announced that the Data Safety Monitoring Board, or DSMB, overseeing our PRIME study recommended stopping enrollment due to efficacy, reporting that either co-primary endpoints, neonatal hospital length of stay and composite neonatal morbidity and mortality, met the stopping criteria for statistical significance at the pre-planned interim analysis. We adopted the DSMB’s recommendation and stopped PRIME study enrollment to focus on analyzing and reporting the available data. In May 2024, deliveries of all PRIME study participants were complete, inclusive of the approximately 2,000 remaining participants who were enrolled but had not delivered before enrollment was stopped in December 2023 per DSMB recommendation. All mothers and babies within the study have left the hospital and data monitoring for the final PRIME dataset is in progress. Manuscripts reporting study results, including top-line and exploratory analyses, are being prepared for submission and peer review after final analysis expected in fall 2024.

Current wording

In December 2023, we announced that the Data Safety Monitoring Board, or DSMB, overseeing our PRIME study recommended stopping enrollment due to efficacy, reporting that either co-primary endpoints, neonatal hospital length of stay and composite neonatal morbidity and mortality, met the stopping criteria for statistical significance at the pre-planned interim analysis. We adopted the DSMB’s recommendation and stopped PRIME study enrollment to focus on analyzing and reporting the available data. In May

Previous wording

Our real-world evidence implementation programs, targeting to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, have been developed for study launches anticipated in the second half of 2024 and in 2025.

Current wording

Beyond demonstration of efficacy, we look forward to studying the effectiveness and implementation of the PreTRM test in a real-world setting. Our real-world evidence implementation programs, targeting to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, have been developed for study launches anticipated in late 2024 or early 2025.

Previous wording

We believe market adoption by both health care providers and payers should be aided by the publications of our PREVENT-PTB study sub-analysis and the peer-reviewed positive data from our AVERT PRETERM TRIAL, as well as upcoming publications, including the results of our PRIME study and other real-world evidence studies. We believe the data that will be published in coming years, together with our current body of evidence, will further demonstrate the clinical and economic utility of our test.

Current wording

We believe market adoption by both health care providers and payers should be aided by the recent publication of our AVERT PRETERM TRIAL, as well as upcoming publications related to our PRIME study and real-world evidence studies. We believe that all data expected to be published in coming years, together with our current body of evidence, will further demonstrate the clinical and economic utility of our test.

Previous wording

We are actively discovering and developing several additional biomarker tests to predict other specific major conditions of pregnancy, such as a pregnancy risk prediction panel test. We believe these tests have the potential to offer significant health benefits to women and their babies. Among other products, we are developing a test designed to provide a more accurate estimate of the delivery date for expectant mothers for the purposes of planning maternity leave, required support, travel arrangements, and related considerations.

Current wording

We are actively discovering and developing additional biomarker tests and predictive analytic products and services related to other specific major conditions of pregnancy. We believe these tests have the potential to offer significant health benefits to women and their babies. Among other products, we are developing a test designed to provide a more accurate estimate of the delivery date for expectant mothers for the purposes of planning maternity leave, required support, travel arrangements, and related considerations.

Previous wording

We have incurred significant operating losses since inception. Our net losses were $8.3 million and $10.5 million for the three months ended June 30, 2024 and 2023, respectively and $16.4 million and $21.1 million for the six months ended June 30, 2024 and 2023, 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 $7.9 million and $7.2 million for the three months ended September 30, 2024 and 2023, respectively and $24.3 million and $28.3 million for the nine months ended September 30, 2024 and 2023, 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 recently completed validation of certain whole-blood collection and whole-blood compatible testing technologies, and have begun marketing and processing whole-blood specimens. This evolution to whole-blood collection will remove laborious specimen processing steps such as centrifugation and enable in-office physician or at-home consumer collection channels. We believe that whole-blood collection technologies, paired with ambient specimen shipment approaches, may enable greater market penetration and an optimal customer experience, while also potentially lowering costs.

Current wording

We have begun marketing and processing whole-blood specimens. This evolution to whole-blood collection will remove laborious specimen processing steps such as centrifugation and enable in-office physician or at-home consumer collection channels. We believe that whole-blood collection technologies, paired with ambient specimen shipment approaches, may enable greater market penetration and an optimal customer experience, while also potentially lowering costs.

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 PREVENT-PTB study sub-analysis, the recent publication of the AVERT PRETERM TRIAL results, the future publication of positive PRIME study data, and other evidence generated within the next three years. We believe market accessibility of the test could be improved by our recent developments in diversifying our specimen collection methods and enhanced awareness and engagement with patients. 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 the recent 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 recent developments in simplified specimen collection methods, and enhanced awareness and engagement with patients, including adding functionality on our PreTRM website allowing patients to now request and pay for the test directly. 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

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, and legal costs related to commercial efforts. We expect selling and marketing expenses will decrease in 2024 compared to 2023 as we recently took steps to further streamline our near-term commercial strategy to refocus on institutional sales as we generate additional clinical data. We expect selling and marketing expenses to accelerate as early as the second half of 2024 and further increase in the medium to long-term as we expand our investment in pursuit of PreTRM commercial opportunities, and as we increase our commercial investments 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, and legal costs related to commercial efforts. We expect selling and marketing expenses to be significantly lower in 2024 compared to 2023 as we streamlined our near-term commercial strategy to refocus on institutional sales as we generated additional clinical data in the PRIME study. We have recently begun carefully adding strategic headcount and consultants, including expertise in payer reimbursement and revenue cycle management, as we prepare for publication of PRIME study data and potential enhanced commercial activities that could drive adoption of the PreTRM test. As such, we expect selling and marketing expenses to accelerate slightly in the fourth quarter of 2024 and increase further in 2025 and beyond as we expand our investment in pursuit of PreTRM commercial opportunities, and as we invest in our product portfolio.

Previous wording

The $0.7 million increase in total research and development expenses was due to a $1.4 million increase in research and bioinformatics costs, partially offset by a $0.4 million decrease in clinical study costs and a $0.3 million decrease in laboratory operations costs. The $1.4 million increase in research and bioinformatics costs was primarily due to a $0.7 million increase in consulting and outside processing expenses related to product development activities, a $0.5 million increase in stock-based compensation expense, and a $0.1 million increase in personnel costs due to increased average headcount. The $0.4 million decrease in clinical study costs was primarily due to a $0.3 million decrease in PRIME study costs resulting from stopping enrollment in December 2023 due to efficacy and a $0.2 million decrease in personnel costs due to decreased average headcount. The $0.3 million decrease in laboratory operations costs was primarily due to a $0.2 million decrease in personnel costs due to decreased average headcount and a $0.1 million decrease in lab supplies.

Current wording

The $37 thousand decrease in total research and development expenses was primarily due to a $0.2 million decrease in clinical study costs and a $0.1 million decrease in laboratory operations costs, partially offset by a $0.2 million increase in research and bioinformatics costs. The $0.2 million decrease in clinical study costs was primarily due to a $0.1 million decrease in PRIME study costs resulting from stopping enrollment in December 2023 due to efficacy and a $0.1 million decrease in personnel costs due to decreased average headcount. The $0.1 million decrease in laboratory operations costs was primarily due to a $0.2 million decrease in personnel costs due to decreased average headcount. The $0.2 million increase in research and bioinformatics costs was primarily due to a $0.1 million increase in consulting and outside processing expenses related to product development activities and a $0.1 million increase in stock-based compensation expense.

Previous wording

The $1.8 million decrease was due primarily to decreases of $1.2 million in personnel-related costs driven by decreased average headcount, $0.2 million in stock-based compensation expense, $0.2 million in marketing programs and materials, and $0.1 million in travel expenses. These decreases are largely a result of steps we took to further streamline our near-term commercial strategy to refocus on institutional sales as we generate additional clinical data.

Current wording

The $0.2 million decrease was due primarily to decreases of $0.1 million in personnel-related costs driven by decreased average headcount and $0.1 million in marketing programs and materials.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

Previous wording

The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023:

Current wording

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023:

Previous wording

The $0.3 million increase in total research and development expenses was due to a $2.1 million increase in research and bioinformatics costs, partially offset by a $1.2 million decrease in clinical study costs and a $0.6 million decrease in laboratory operations costs. The $2.1 million increase in research and bioinformatics costs was primarily due to a $1.2 million increase in consulting and outside processing expenses related to product development activities, a $0.7 million increase in stock-based compensation expense, and a $0.2 million increase in personnel costs due to increased average headcount. The $1.2 million decrease in clinical study costs was primarily due to a $0.9 million decrease in PRIME study costs resulting from stopping enrollment in December 2023 due to efficacy and a $0.5 million decrease in personnel costs due to decreased average headcount, partially offset by a $0.1 million increase in consulting costs. The $0.6 million decrease in laboratory operations costs was primarily due to a $0.5 million decrease in personnel costs due to decreased average headcount and a $0.2 million decrease in lab supplies.

Current wording

The $0.3 million increase in total research and development expenses was primarily due to a $2.3 million increase in research and bioinformatics costs, partially offset by a $1.4 million decrease in clinical study costs and a $0.7 million decrease in laboratory operations costs. The $2.3 million increase in research and bioinformatics costs was primarily due to a $1.3 million increase in consulting and outside processing expenses related to product development activities, a $0.8 million increase in stock-based compensation expense, and a $0.2 million increase in personnel costs due to increased average headcount. The $1.4 million decrease in clinical study costs was primarily due to a $1.0 million decrease in PRIME study costs resulting from stopping enrollment in December 2023 due to efficacy and a $0.6 million decrease in personnel costs due to decreased average headcount, partially offset by a $0.1 million increase in consulting costs. The $0.7 million decrease in laboratory operations costs was primarily due to a $0.7 million decrease in personnel costs due to decreased average headcount and a $0.2 million decrease in lab supplies and equipment, partially offset by a $0.2 million increase in consulting costs.

Previous wording

The $3.4 million decrease was due primarily to decreases of $2.4 million in personnel-related costs driven by decreased average headcount, $0.4 million in travel expenses, $0.3 million in stock-based compensation expense, and $0.3 million in marketing programs and materials. These decreases are largely a result of steps we took to further streamline our near-term commercial strategy to refocus on institutional sales as we generate additional clinical data.

Current wording

The $3.5 million decrease was due primarily to decreases of $2.5 million in personnel-related costs driven by decreased average headcount, $0.4 million in travel expenses, $0.4 million in marketing programs and materials, and $0.3 million in stock-based compensation expense. These decreases are largely a result of steps we took to further streamline our near-term commercial strategy to refocus on institutional sales as we generate additional clinical data.

Previous wording

The $1.5 million decrease was due primarily to decreases of $0.8 million in personnel-related costs driven by decreased average headcount, $0.6 million related to one-time personnel costs, $0.2 million of director and officer insurance costs, $0.2 million in professional services fees, and $0.2 million in other miscellaneous costs (such as facilities and equipment depreciation), partially offset by an increase of $0.6 million in stock-based compensation expense. The decreases in personnel-related and other miscellaneous costs are largely a result of steps we took to streamline our general and administrative expenses to maintain the appropriate level of support for our current level of operations.

Current wording

The $0.6 million decrease was due primarily to decreases of $0.8 million in personnel-related costs driven by decreased average headcount, $0.6 million related to one-time personnel costs, and $0.2 million of director and officer insurance costs, partially offset by increases of $0.9 million in stock-based compensation expense and $0.2 million in professional services fees. The decrease in personnel-related costs is largely a result of steps we took to streamline our general and administrative expenses to maintain the appropriate level of support for our current level of operations.

Previous wording

The $0.3 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 $0.5 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 $1.0 million increase related primarily to interest income on our marketable securities, partially offset by a $0.8 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, and the sale and issuance of Class A common stock in our IPO, which was completed in July 2021. As of June 30, 2024, we had aggregate cash, cash equivalents, and available-for-sale securities of $80.9 million, and an accumulated deficit of $263.3 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, and the sale and issuance of Class A common stock in our IPO, which was completed in July 2021. As of September 30, 2024, we had aggregate cash, cash equivalents, and available-for-sale securities of $74.3 million, and an accumulated deficit of $271.2 million.

Previous wording

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. The net cash used in operating activities during the six months ended June 30, 2023 was primarily due to a net loss of $21.1 million partially offset by non-cash charges of $3.1 million and an increase in operating assets and liabilities of $5.2 million.

Current wording

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. The net cash used in operating activities during the nine months ended September 30, 2023 was primarily due to a net loss of $28.3 million partially offset by non-cash charges of $4.3 million and an increase in operating assets and liabilities of $3.6 million.

Previous wording

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. Net cash provided by investing activities for the six months ended June 30, 2023 was primarily due to $38.1 million in proceeds from maturities and sales of marketable securities, partially offset by $23.1 million in purchases of marketable securities.

Current wording

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. Net cash provided by investing activities for the nine months ended September 30, 2023 was primarily due to $49.1 million in proceeds from maturities and sales of marketable securities and $0.3 million in proceeds from disposals of property and equipment, partially offset by $49.2 million in purchases of marketable securities.

Previous wording

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. Net cash provided by financing activities for the six months ended June 30, 2023 was primarily due to $0.2 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, 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. Net cash provided by financing activities for the nine months ended September 30, 2023 was primarily due to $0.5 million in proceeds from employee equity transactions, partially offset by $0.4 million of finance lease principal payments.

Previous wording

We expect to incur significant additional operating losses and negative cash flows for the foreseeable future. We expect our losses in the future to arise 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, when needed, 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. Any additional equity financing may not be available on favorable terms, most likely will be dilutive to our current stockholders, and debt financing, if available, may involve restrictive covenants and dilutive financing instruments. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned. We currently have no credit facility or committed sources of capital. Our future funding requirements will depend on many factors, including the following:

Current 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 arise 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, when needed, 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.

Previous wording

Our contractual obligations and commitments for the year ended December 31, 2023 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, 2023 filed with the SEC on March 20, 2024. No material changes have occurred during the six months ended June 30, 2024.

Current wording

Our contractual obligations and commitments for the year ended December 31, 2023 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, 2023 filed with the SEC on March 20, 2024. No material changes have occurred during the nine months ended September 30, 2024.

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 on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 20, 2024. 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, 2024.

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 on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 20, 2024. 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, 2024.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Our studies suggest a model indicating that by identifying and intervening in at-risk pregnancies, not identifiable by other approaches, babies destined for premature delivery remain in utero longer. This prolongation of gestation in the preterm period leads to more mature babies that require shorter hospital/NICU stays due to improved neonatal health. The PRIME study includes the same Primary and Secondary outcomes as the AVERT PRETERM TRIAL and affords the continued assessment of this model.

Current report — wording carried from elsewhere

Any additional equity financing may not be available on favorable terms, most likely will be dilutive to our current stockholders, and debt financing, if available, may involve restrictive covenants and dilutive financing instruments. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned. We currently have no credit facility or committed sources of capital. Our future funding requirements will depend on many factors, including the following:
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

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 report — wording carried elsewhere

The $1.2 million decrease was due primarily to decreases of $0.7 million related to one-time personnel costs, $0.3 million in personnel-related costs driven by decreased average headcount, $0.1 million of director and officer insurance costs, and $0.1 million in professional services fees. The decreases in personnel-related costs are largely a result of steps we took to streamline our general and administrative expenses to maintain the appropriate level of support for our current level of operations.