SERA PROGNOSTICS INC

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 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 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 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.

Previous wording

We believe market adoption by both health care providers and payers should be aided by the publication of our PREVENT-PTB study sub-analysis, the publication of the positive data from our AVERT PRETERM TRIAL, upcoming publication of our PRIME study, and other real-world evidence studies. We believe the data that will be published the upcoming 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 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.

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. A manuscript reporting study results, including top-line and exploratory analyses, is being prepared for submission and peer review.

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 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.

Previous wording

Our operations are headquartered in Salt Lake City, Utah, including a CLIA-certified laboratory. Since our inception, we have devoted the majority of our efforts and resources to performing research and development, acquiring product rights, raising capital, establishing facilities, conducting clinical trials, and establishing commercial operations to develop and commercialize the PreTRM test. During this period, we have incurred annual net losses. We have largely funded our operations with proceeds from the sale and issuance of convertible preferred stock, debt financings, bank loans, and the sale and issuance of Class A common stock in our initial public offering, or IPO, which was completed in July 2021.

Current wording

Our operations are headquartered in Salt Lake City, Utah, including a CLIA-certified laboratory. Since our inception, we have devoted the majority of our efforts and resources to performing research and development, acquiring product rights, raising capital, establishing facilities, conducting clinical trials, and establishing commercial operations to develop and commercialize our testing and analytics products, primarily the PreTRM test. During this period, we have incurred annual net losses. We have largely funded our operations with proceeds from the sale and issuance of convertible preferred stock, debt financings, bank loans, and the sale and issuance of Class A common stock in our initial public offering, or IPO, which was completed in July 2021.

Previous wording

We have incurred significant operating losses since inception. Our net losses were $8.1 million and $10.6 million for the three months ended March 31, 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 $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.

Previous wording

We have taken steps to significantly reduce our annual operating expenses across all aspects of our business and we believe our cash runway is sufficient to enable us to operate into 2027 based on our existing operating plans. We will continue to evaluate the allocation of our resources as we focus our efforts to accelerate the market adoption of our PreTRM test and the development and launch of additional pipeline products and services. Our evidence portfolio continues to grow with the publication of the PREVENT-PTB study sub-analysis of the potential benefit of care coordination and low-dose aspirin paired with PreTRM test results. We have finalized the AVERT PRETERM TRIAL primary analysis for peer review, the details of which can be found on the medRxiv pre-print server. 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 2024 and 2025.

Current wording

We have taken steps to significantly reduce our annual operating expenses across all aspects of our business and we believe our cash runway is sufficient to enable us to operate into 2027 based on our existing operating plans. We will continue to evaluate the allocation of our resources as we focus our efforts to accelerate the market adoption of our PreTRM test and the development and launch of additional pipeline products and services. Our evidence portfolio continues to grow with the publication of the PREVENT-PTB study sub-analysis of the potential benefit of care coordination and low-dose aspirin paired with PreTRM test results.

Previous wording

We continue to make progress validating whole-blood collection technologies. Whole-blood collection can remove laborious specimen processing steps such as centrifugation and enable physician office or at-home consumer 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 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.

Previous wording

We will continue to opportunistically negotiate contracts with private and governmental payers and health systems with new 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 have 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 when needed 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 opportunistically pursue contracts with private and governmental payers and health systems with new 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 have 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 when needed 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 would 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 publication of the AVERT PRETERM TRIAL results, the publication of positive PRIME study interim data, and other evidence generated within the next three years. We believe market accessibility of the test could be improved by our progress toward 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 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.

Previous wording

Cost of revenue reflects the aggregate costs incurred in delivering the proteomic testing results to clinicians and includes expenses for third-party specimen collection and shipping costs, as well as our lab personnel, materials and supplies, equipment, and infrastructure expenses associated with clinical testing, and allocated overhead including rent and equipment depreciation. Some of these components can vary significantly in cost and reliability of supply, and we periodically seek ways to make our supplier network more robust. For example, to address the risk posed by potential disruptions in specimen collection services described in the “Risk Factors” section of this report, we have contracted with alternative specimen collection providers beyond those that have traditionally supplied the majority of our needs, and are developing additional collection methods. We expect costs of revenue will generally move in line with the sales of the PreTRM test.

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, and allocated overhead including rent and equipment depreciation. Some of these components can vary significantly in cost and reliability of supply, and we periodically seek ways to make our supplier network more robust. For example, to address the risk posed by potential disruptions in specimen collection services described in the “Risk Factors” section of this report, we have contracted with alternative specimen collection providers beyond those that have traditionally supplied the majority of our needs, and have developed additional collection methods. 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 decrease slightly in 2024 compared to 2023 following the cessation of enrollment in the PRIME study due to efficacy at the interim analysis at the end of 2023. 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 increase slightly in 2024 compared to 2023 due to increased product development activities, offset by decreased clinical study costs following our ending enrollment in the PRIME study due to efficacy at the interim analysis at the end of 2023. Research and development costs may continue to increase in the medium to long-term as we support current and 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, 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 begin to increase as early as the second half of 2024 and in the medium to long-term as we expand our commercial efforts as opportunity for PreTRM dictates and as we increase 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 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.

Previous wording

The $0.4 million decrease in total research and development expenses was due to a $0.8 million decrease in clinical study costs and a $0.3 million decrease in laboratory operations costs partially offset by a $0.7 million increase in research and bioinformatics costs. The $0.8 million decrease in clinical study costs was primarily due to a $0.6 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. The $0.7 million increase in research and bioinformatics costs was primarily due to a $0.4 million increase in consulting and outside processing expenses related to product development activities, a $0.1 million increase in personnel costs due to increased average headcount, and a $0.1 million increase in stock-based compensation expense.

Current 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.

Previous wording

The $1.6 million decrease was due primarily to decreases of $1.2 million in personnel-related costs driven by decreased average headcount, $0.2 million in travel expenses, and $0.2 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 $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.

Previous wording

The $0.3 million decrease was due primarily to decreases of $0.5 million in personnel-related costs driven by decreased average headcount and $0.1 million of director and officer insurance costs, partially offset by a $0.3 million increase in stock-based compensation expense. 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.

Current wording

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.

Previous wording

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

Current 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.

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 March 31, 2024, we had aggregate cash, cash equivalents, and available-for-sale securities of $85.4 million, and an accumulated deficit of $255.0 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, 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.

Previous wording

The net cash provided by operating activities during the three months ended March 31, 2024 was primarily due to an increase in operating assets and liabilities of $11.3 million and non-cash charges of $1.8 million, partially offset by a net loss of $8.1 million. The net cash used in operating activities during the three months ended March 31, 2023 was primarily due to a net loss of $10.6 million partially offset by non-cash charges of $1.5 million and an increase in operating assets and liabilities of $4.2 million.

Current 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.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2024 was primarily due to $16.2 million in purchases of marketable securities and $0.7 million in purchases of intangible assets, partially offset by $11.3 million in proceeds from maturities and sales of marketable securities. Net cash provided by investing activities for the three months ended March 31, 2023 was primarily due to $17.1 million in proceeds from maturities and sales of marketable securities, partially offset by $14.7 million in purchases of marketable securities.

Current 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.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2024 was primarily due to $1.2 million in proceeds from employee equity transactions, partially offset by $0.1 million of finance lease principal payments. Net cash used in financing activities for the three months ended March 31, 2023 was primarily due to $0.1 million of finance lease principal payments.

Current 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.

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 our PRIME study and additional 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

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:

Previous wording

•the timing, receipt, and amount of sales from the PreTRM test and other pipeline products and services, if approved;

Current wording

•the timing, receipt, and amount of sales from the PreTRM test and other pipeline products and services;

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 three months ended March 31, 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 six months ended June 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 three months ended March 31, 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 six months ended June 30, 2024.