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What changed in SERA PROGNOSTICS, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of SERA PROGNOSTICS, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+298 added−292 removedSource: 10-K (2026-03-18) vs 10-K (2025-03-19)

Top changes in SERA PROGNOSTICS, INC.'s 2025 10-K

298 paragraphs added · 292 removed · 234 edited across 5 sections

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

155 edited+32 added−35 removed496 unchanged
Biggest changeAdditionally, stockholders who hold, in the aggregate, more than 10% of our Class A common stock and Class B common stock, but 10% or less of our Class A common stock, and are not otherwise an insider, may not be required to report changes in their ownership due to transactions in our Class B common stock pursuant to Section 16(a) of the Exchange Act, and may not be subject to the short-swing profit provisions of Section 16(b) of the Exchange Act. 80 Table of Contents We are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors.
Biggest changeWe are an emerging growth company and a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our Class A common stock less attractive to investors. We are an emerging growth company, or EGC, as defined in the JOBS Act.
If any of our partners, suppliers, or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending 45 Table of Contents arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments to us could be adversely affected.
If any of our partners, suppliers, or other parties with whom we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution, such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional 45 Table of Contents payments to us could be adversely affected.
Peer-reviewed publications regarding our products and product candidates may be limited by many factors, including delays in the completion of, poor design of, or lack of compelling data from clinical studies, as well as delays in the review, acceptance, and publication process.
Peer-reviewed publications regarding our products and product candidates may be limited by many factors, including delays in the completion, poor design, or lack of compelling data from clinical studies, as well as delays in the review, acceptance, and publication process.
We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or have had the opportunity to fully and carefully evaluate all data.
We also make assumptions, estimations, calculations, and conclusions as part of our data analyses, and we may not have received or have had the opportunity to fully and carefully evaluate all data.
Accordingly, our business and financial results in the future could be adversely affected due to a variety of factors, including: • multiple, conflicting and changing laws and regulations such as data privacy, information security, and data use regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, anti-corruption laws, regulatory requirements applicable to clinical laboratories and to IVD products, reimbursement or payer regimes and other governmental approvals, permits and licenses; • failure by us or our distributors to obtain any necessary regulatory clearance, authorization or approval for the use of our products and services in various countries; • additional potentially relevant third-party patent rights; • complexities and difficulties in obtaining intellectual property protection and maintaining, defending, and enforcing our intellectual property outside the United States; • difficulties in staffing and managing foreign operations; • employment risks related to hiring employees outside the United States; • complexities associated with managing multiple payer reimbursement regimes, government payers or patient self-pay systems; 52 Table of Contents • difficulties in negotiating favorable reimbursement negotiations with governmental authorities; • logistics and regulations associated with the international shipment of patient specimens, including infrastructure conditions, licensure requirements and transportation delays; • limits in our ability to penetrate international markets if we are not able to sell our products or conduct services locally; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and services and exposure to foreign currency exchange rate fluctuations; • natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions; • regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S.
Accordingly, our business and financial results in the future could be adversely affected due to a variety of factors, including: • multiple, conflicting and changing laws and regulations such as data privacy, information security, and data use regulations, tax laws, export and import restrictions, economic sanctions and embargoes, employment laws, anti-corruption laws, regulatory requirements applicable to clinical laboratories and to IVD products, reimbursement or payer regimes and other governmental approvals, permits and licenses; • failure by us or our distributors to obtain any necessary regulatory clearance, authorization or approval for the use of our products and services in various countries; • additional potentially relevant third-party patent rights; • complexities and difficulties in obtaining intellectual property protection and maintaining, defending, and enforcing our intellectual property outside the United States; • difficulties in staffing and managing foreign operations; • employment risks related to hiring employees outside the United States; • complexities associated with managing multiple payer reimbursement regimes, government payers or patient self-pay systems; • difficulties in negotiating favorable reimbursement negotiations with governmental authorities; 52 Table of Contents • logistics and regulations associated with the international shipment of patient specimens, including infrastructure conditions, licensure requirements and transportation delays; • limits in our ability to penetrate international markets if we are not able to sell our products or conduct services locally; • financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and services and exposure to foreign currency exchange rate fluctuations; • natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions; • regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S.
Foreign Corrupt Practices Act, or FCPA, its books and records provisions, or its anti-bribery provisions, or laws similar to the FCPA in other jurisdictions in which we may operate, such as the United Kingdom Bribery Act of 2010, or the U.K.
Foreign Corrupt Practices Act, or FCPA, or its books and records and anti-bribery provisions, or laws similar to the FCPA in other jurisdictions in which we may operate, such as the United Kingdom Bribery Act of 2010, or the U.K.
If our operations are found to be in violation of any of these (or other) laws and regulations, we may be subject to administrative, civil and/or 53 Table of Contents criminal penalties, damages, fines, individual imprisonment, refunding of payments received by us, exclusion from government health care programs, and/or curtailment or cessation of our operations, among other potential penalties, any of which could harm our reputation and adversely affect our business, operating results, and financial condition.
If our operations are found to be in violation of any of these (or other) laws and regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, refunding of payments received by us, exclusion from 53 Table of Contents government health care programs, and/or curtailment or cessation of our operations, among other potential penalties, any of which could harm our reputation and adversely affect our business, operating results, and financial condition.
The process for submitting a 510(k) premarket notification and receiving FDA clearance usually takes from 3 to 12 months, but it can take significantly longer, and clearance is never guaranteed. The process for submitting and obtaining FDA approval of a PMA generally takes from 1 to 3 years or even longer, and approval is not guaranteed.
The process for submitting a 510(k) premarket notification and receiving FDA clearance usually takes 3 to 12 months, but it can take significantly longer, and clearance is never guaranteed. The process for submitting and obtaining FDA approval of a PMA generally takes from 1 to 3 years or even longer, and approval is not guaranteed.
See related risks described above at “ The results of our clinical trials and studies may not support the use of our tests and other product candidates, or may not be replicated in later studies. ” The Federal Trade Commission and/or state enforcement or regulatory agencies may object to the methods and materials we use to promote our tests, our services and our nonmedical products and initiate enforcement against us, which could adversely affect our business and financial condition.
See related risks described above at “ The results of our clinical trials and studies may not support the use of our tests and other product candidates or may not be replicated in later studies. ” The Federal Trade Commission and/or state enforcement or regulatory agencies may object to the methods and materials we use to promote our tests, our services or our nonmedical products and initiate enforcement against us, which could adversely affect our business and financial condition.
The collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union (EU), including personal health data, is subject to the EU’s General Data Protection Regulation, or GDPR, which became effective on May 25, 2018.
The collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union, or the EU, including personal health data, is subject to the EU’s General Data Protection Regulation, or GDPR, which became effective on May 25, 2018.
Violations of the CMP Law may result in the imposition of civil 72 Table of Contents monetary penalties, as well as damages and possible exclusion from participation in state and federal health care programs. • The federal health care fraud statute, which imposes criminal liability for knowingly and willfully executing or attempting to execute a scheme to defraud any health care benefit program (which includes commercial insurers).
Violations of the CMP Law may result in the imposition of civil monetary penalties, as well as damages and possible exclusion from participation in state and federal health care programs. 72 Table of Contents • The federal health care fraud statute, which imposes criminal liability for knowingly and willfully executing or attempting to execute a scheme to defraud any health care benefit program (which includes commercial insurers).
We recognize that the forum selection clause in our amended and restated certificate of incorporation may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware or the State of Utah, as applicable.
We recognize that the forum selection clause in our amended and restated certificate of incorporation, as amended, may impose additional litigation costs on stockholders in pursuing any such claims, particularly if the stockholders do not reside in or near the State of Delaware or the State of Utah, as applicable.
Some of these provisions include: • a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; • a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; • a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; • advance notice requirements for stockholder proposals and nominations for election to our board of directors; • a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; • a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation; and • the authority of the board of directors to issue convertible preferred stock on terms determined by the board of directors without stockholder approval and which convertible preferred stock may include rights superior to the rights of the holders of common stock.
Some of these provisions include: • a board of directors divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; • a prohibition on stockholder action through written consent, which requires that all stockholder actions be taken at a meeting of our stockholders; • a requirement that special meetings of stockholders be called only by the board of directors acting pursuant to a resolution approved by the affirmative vote of a majority of the directors then in office; • advance notice requirements for stockholder proposals and nominations for election to our board of directors; • a requirement that no member of our board of directors may be removed from office by our stockholders except for cause and, in addition to any other vote required by law, upon the approval of not less than two-thirds of all outstanding shares of our voting stock then entitled to vote in the election of directors; • a requirement of approval of not less than two-thirds of all outstanding shares of our voting stock to amend any bylaws by stockholder action or to amend specific provisions of our certificate of incorporation, as amended; and • the authority of the board of directors to issue convertible preferred stock on terms determined by the board of directors without stockholder approval and which convertible preferred stock may include rights superior to the rights of the holders of common stock.
These anti-takeover provisions and other provisions in our amended and restated certificate of incorporation and amended and restated bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our Company.
These anti-takeover provisions and other provisions in our amended and restated certificate of incorporation, as amended, and amended and restated bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer or proxy contest involving our Company.
Additionally, the forum selection clause in our amended and restated certificate of incorporation may limit our stockholders’ ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers, or employees, which may discourage such lawsuits against us and our directors, officers, and employees even though an action, if successful, might benefit our stockholders.
Additionally, the forum selection clause in our amended and restated certificate of incorporation, as amended, may limit our stockholders’ ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers, or employees, which may discourage such lawsuits against us and our directors, officers, and employees even though an action, if successful, might benefit our stockholders.
The publication of clinical data in peer-reviewed journals can be a crucial step in commercializing and obtaining reimbursement for tests, and our inability to control when, if ever, results are published may delay or limit our ability to derive sufficient revenues from any test that is the subject of a study.
The publication of clinical data in peer-reviewed journals can be a crucial step in commercializing and obtaining reimbursement for clinical diagnostic tests, and our inability to control when, if ever, results are published may delay or limit our ability to derive sufficient revenues from any test that is the subject of a study.
Alternatively, if a court were to find the choice of forum provisions contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
Alternatively, if a court were to find the choice of forum provisions contained in our amended and restated certificate of incorporation, as amended, to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations, and financial condition.
If our CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed. We currently operate a CLIA-certified laboratory facility in Salt Lake City, Utah, which processes the PreTRM test and likely any other future test, if approved, that is or will be the source of substantially all of our revenues.
If our CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests, and our business will be harmed. We currently operate a CLIA-certified laboratory facility in Salt Lake City, Utah, which processes the PreTRM test and likely any other future test that is or will be the source of substantially all of our revenues.
In the future, we expect to incur significant costs in connection with our operations, including, but not limited to, the development, marketing authorization, and commercialization of new tests, new services, and other products. These development activities generally require a substantial investment before we can determine commercial viability.
In the future, we expect to incur significant costs in connection with our operations, including, but not limited to, the development, marketing authorization, and commercialization of new and existing tests, new services, and other products. These development activities generally require a substantial investment before we can determine commercial viability.
Performing additional, new clinical studies and trials in order to obtain product approval from the FDA, if any were to become necessary, would take a significant amount of time and would substantially delay our ability to commercialize the PreTRM test, any or all of which would adversely impact our business.
Performing additional, new clinical studies and trials in order to obtain product approval from the FDA, if any were to become necessary, would take a significant amount of time and would substantially delay our ability to commercialize the test, any or all of which would adversely impact our business.
Our amended and restated certificate of incorporation will further provide that, unless we consent in writing to an alternative forum, the United States District Court for the District of Utah will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.
Our amended and restated certificate of incorporation, as amended, will further provide that, unless we consent in writing to an alternative forum, the United States District Court for the District of Utah will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.
We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.
We cannot predict or estimate the amount or timing of additional costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors or its committees or as executive officers.
As our operations and business grow, including for example in connection with the launch of the LikeMine TM webapp, we may become subject to or affected by new or additional privacy and security laws and regulations and face increased scrutiny or attention from regulatory authorities.
As our operations and business grow, including for example in connection with the launch of the LikeMine webapp, we may become subject to or affected by new or additional privacy and security laws and regulations and face increased scrutiny or attention from regulatory authorities.
Nonetheless, each share of our Class B common stock may be converted at any time into one share of our Class A common stock at the option of its holder by providing written notice to us, subject to the limitations provided for in our amended and restated certificate of incorporation.
Nonetheless, each share of our Class B common stock may be converted at any time into one share of our Class A common stock at the option of its holder by providing written notice to us, subject to the limitations provided for in our amended and restated certificate of incorporation, as amended.
If we are unable to compete successfully with respect to our current or future products or services, we may not be able to increase or sustain our revenues or achieve profitability. • If our CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed. • Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as additional data become available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data. • Our business would be materially harmed if our proprietary biobank were to become contaminated, lost or destroyed. • Some of our products and services rely heavily on access to internal and external databases, and loss of access to such databases could materially harm our business. • We rely on third parties for specimen collection, including phlebotomy services, and commercial courier delivery services, and if these services are disrupted, our business will be harmed. • We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials, as well as for our recently developed whole-blood collection kit, and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all. • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited. 42 Table of Contents • Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at a similar rate. • An inflationary environment could materially adversely impact our business and results of operations. • If third-party payers do not adequately reimburse for the PreTRM test or any new products we may develop, such may not be purchased or used, which may adversely affect our revenue and profits. • New reimbursement methodologies applicable to the PreTRM test, and other future products, including new CPT codes, may decrease reimbursement rates from third-party payers. • Billing disputes with third-party payers, including disagreement regarding the selection and use of CPT codes when submitting claims, may decrease realized revenue and may lead to requests for recoupment of past amounts paid. • When third-party payers deny coverage, we are often unable to collect from the patient or any other source and risk disputes if we attempt to do so. • Our revenues may be adversely impacted if third-party payers withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors. • Status as an out-of-network provider with a large commercial insurer may cause health care providers to avoid recommending our tests. • If the validity of an informed consent from a patient is challenged, we could be precluded from billing for such patient’s testing, be forced to stop performing certain tests, forced to exclude the patient’s data or specimens from clinical trial results or be subject to lawsuits or regulatory enforcement. • Changes in the way the FDA regulates the reagents, other consumables, and testing equipment we use when developing, validating, and performing our tests could result in delay or additional expense in bringing our tests to market or performing such tests for our customers. • If we fail to comply with federal and/or state laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business. • Any failure to obtain, maintain, and enforce our intellectual property rights could impair our ability to protect our proprietary technology and our brand. • Issued patents covering our tests and technology could be found invalid or unenforceable, if challenged. • Our intellectual property may be infringed by a third party. • If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our tests and technology could be significantly diminished. • The price of our Class A common stock may be volatile, and you could lose all or part of your investment. • Sales of a substantial number of shares of our Class A common stock by our existing stockholders in the public market could cause our stock price to fall. • Our inability to maintain effective disclosure controls and procedures could adversely affect our results of operations, liquidity and financial positions, as well as our stock price and investor confidence in us. 43 Table of Contents Risks Related to Our Financial Position and Need for Additional Capital We have incurred net losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future, which could harm our future business prospects.
If we are unable to compete successfully with respect to our current or future products or services, we may not be able to increase or sustain our revenues or achieve profitability. • If our CLIA-certified laboratory facility becomes inoperable, we will be unable to perform our tests, and our business will be harmed. • Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as additional data become available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data. • Our business would be materially harmed if our proprietary biobank were to become contaminated, lost or destroyed. • Some of our products and services rely heavily on access to internal and external databases, and loss of access to data or such databases could materially harm our business. • We rely on third parties for specimen collection, including phlebotomy services, and commercial courier delivery services, and if these services are disrupted, our business will be harmed. • We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials, as well as for our whole-blood collection kit and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all. • Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited. 42 Table of Contents • Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at a similar rate. • An inflationary environment and unstable global economic and geopolitical conditions could materially adversely impact our business and results of operations. • If third-party payers do not adequately reimburse for the PreTRM test or any new products we may develop, such products may not be purchased or used, which may adversely affect our revenue and profits. • New reimbursement methodologies applicable to the PreTRM test, and other future products, including new CPT codes, may decrease reimbursement rates from third-party payers. • Billing disputes with third-party payers, including disagreement regarding the selection and use of CPT codes when submitting claims, may decrease realized revenue and may lead to requests for recoupment of past amounts paid. • When third-party payers deny coverage, we are often unable to collect from the patient or any other source and risk disputes if we attempt to do so. • Our revenues may be adversely impacted if third-party payers withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors. • Status as an out-of-network provider with a large commercial insurer may cause health care providers to avoid recommending our tests. • If the validity of an informed consent from a patient is challenged, we could be precluded from billing for such patient’s testing, be forced to stop performing certain tests, forced to exclude the patient’s data or specimens from clinical trial results or be subject to lawsuits or regulatory enforcement. • Changes in the way the FDA regulates the reagents, other consumables, and testing equipment we use when developing, validating, and performing our tests could result in delay or additional expense in bringing our tests to market or performing such tests for our customers. • If we fail to comply with federal and/or state laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business. • Any failure to obtain, maintain, and enforce our intellectual property rights could impair our ability to protect our proprietary technology and our brand. • Issued patents covering our tests and technology could be found invalid or unenforceable, if challenged. • Our intellectual property may be infringed by a third party. • If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our tests and technology could be significantly diminished. • The price of our Class A common stock may be volatile, and you could lose all or part of your investment. • Sales of a substantial number of shares of our Class A common stock by our existing stockholders in the public market could cause our stock price to decline. • Our inability to maintain effective disclosure controls and procedures could adversely affect our results of operations, liquidity and financial positions, as well as our stock price and investor confidence in us. 43 Table of Contents Risks Related to Our Financial Position and Need for Additional Capital We have incurred net losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future, which could harm our future business prospects.
Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.
Political tensions as a result of such trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets.
In addition, our amended and restated certificate of incorporation will provide that any person or entity purchasing or otherwise acquiring any interest in shares of our Class A common stock is deemed to have notice of and consented to the foregoing provisions.
In addition, our amended and restated certificate of incorporation, as amended, will provide that any person or entity purchasing or otherwise acquiring any interest in shares of our Class A common stock is deemed to have notice of and consented to the foregoing provisions.
Further, even if clinical trials are completed as planned, we cannot be certain that their results would be able to support the PreTRM test’s claims or that the FDA will agree with our conclusions regarding the results of our clinical trials.
Further, even if clinical trials are completed as planned, we cannot be certain that their results would be able to support the PreTRM or future test’s claims or that the FDA will agree with our conclusions regarding the results of our clinical trials.
These stockholders, acting together, would be able to significantly influence our management and affairs and the outcome of matters submitted to our stockholders for approval, including the election of directors and any sale, merger, consolidation, or sale of all or substantially all of our assets.
These stockholders, individually or acting together, would be able to significantly influence our management and affairs and the outcome of matters submitted to our stockholders for approval, including the election of directors and any sale, merger, consolidation, or sale of all or substantially all of our assets.
Our amended and restated certificate of incorporation provides that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claims for (i) any derivative action or proceeding brought on our behalf, (ii) any action or proceeding asserting a claim of breach of fiduciary duty owed by any of our current or former directors, officers and employees, to us or our stockholders, (iii) any action or proceeding asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our bylaws (in each case, as they may be amended from time to time), (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our amended and restated certificate of incorporation or bylaws, (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware, or (vi) any action asserting a claim against us or any of our directors, officers or employees that is governed by the internal affairs doctrine; provided, however, that this exclusive forum provision will not apply to any causes of action arising under the Exchange Act.
Our amended and restated certificate of incorporation, as amended, provides that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any state law claims for (i) any derivative action or proceeding brought on our behalf, (ii) any action or proceeding asserting a claim of breach of fiduciary duty owed by any of our current or former directors, officers and employees, to us or our stockholders, (iii) any action or proceeding asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation, as amended, or our amended and restated bylaws (in each case, as they may be amended from time to time), (iv) any action or proceeding to interpret, apply, enforce or determine the 82 Table of Contents validity of our amended and restated certificate of incorporation, as amended, or our amended and restated bylaws, (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware, or (vi) any action asserting a claim against us or any of our directors, officers or employees that is governed by the internal affairs doctrine; provided, however, that this exclusive forum provision will not apply to any causes of action arising under the Exchange Act.
Our amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent a change in control of our Company or changes in our board of directors that our stockholders might consider favorable.
Our amended and restated certificate of incorporation, as amended, and amended and restated bylaws contain provisions that could delay or prevent a change in control of our Company or changes in our board of directors that our stockholders might consider favorable.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include: • our ability to successfully execute under our commercial agreement with Elevance Health and obtain broader market adoption of our PreTRM test; • actual or anticipated variations in our and our competitors’ results of operations, as well as how those results compare to analyst and investor expectations; • our failure to successfully commercialize our product candidates; • announcements by us or our competitors of new products and services, significant acquisitions, other strategic transactions, including strategic and commercial partnerships and relationships, joint ventures, divestitures, collaborations or capital commitments; • changes in reimbursement practices by current or potential payers; • failure of analysts to initiate or maintain coverage of our Company, issuance of new securities analysts’ reports or changed recommendations for our Class A common stock; • forward-looking statements related to our financial guidance or projections, our failure to meet or exceed our financial guidance or projections or changes in our financial guidance or projections; • actual or anticipated changes in regulatory oversight of our products and services; • development of disputes concerning our intellectual property or other proprietary rights; • commencement of, or our involvement in, litigation; • announcement or expectation of additional debt or equity financing efforts; • any major change in our management; • our inability to establish collaborations, if needed; • additions or departures of key scientific or management personnel; • our ability to effectively manage our growth; • overall performance of the equity markets; • sales of our common stock by us, our directors and officers, or our other stockholders in the future; • trading volume of our Class A common stock; • changes in accounting practices; 79 Table of Contents • ineffectiveness of our internal controls; • general political and economic conditions; and • other events or factors, many of which are beyond our control.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include: • our ability to obtain broader market adoption of our PreTRM test; • actual or anticipated variations in our and our competitors’ results of operations, as well as how those results compare to analyst and investor expectations; • our failure to successfully commercialize our product candidates; • announcements by us or our competitors of new products and services, significant acquisitions, other strategic transactions, including strategic and commercial partnerships and relationships, joint ventures, divestitures, collaborations or capital commitments; • changes in reimbursement practices by current or potential payers; • failure of analysts to initiate or maintain coverage of our Company, issuance of new securities analysts’ reports or changed recommendations for our Class A common stock; • forward-looking statements related to our financial guidance or projections, our failure to meet or exceed our financial guidance or projections or changes in our financial guidance or projections; • actual or anticipated changes in regulatory oversight of our products and services; • development of disputes concerning our intellectual property or other proprietary rights; 79 Table of Contents • commencement of, or our involvement in, litigation; • announcement or expectation of additional debt or equity financing efforts; • any major change in our management; • our inability to establish collaborations, if needed; • additions or departures of key scientific or management personnel; • our ability to effectively manage our growth; • overall performance of the equity markets; • sales of our common stock by us, our directors and officers, or our other stockholders in the future; • trading volume of our Class A common stock; • changes in accounting practices; • ineffectiveness of our internal controls; • general political and economic conditions; and • other events or factors, many of which are beyond our control.
Such coverage and reimbursement may depend upon a number of factors, including the determination that the test and its use or administration for a particular patient are: • a covered benefit; • safe, effective, and medically necessary; • appropriate for the specific patient; • supported by guidelines established by the relevant professional societies; • approved in any states where specific assay approval is necessary; • cost-effective; and • neither experimental nor investigational.
Such coverage and reimbursement may depend upon a number of factors, including the determination that the test and its use or administration for a particular patient are: • a covered benefit; • safe, effective, and medically necessary; • appropriate for the specific patient; • supported by guidelines established by the relevant professional societies; • approved in any state where specific assay approval is necessary; • cost-effective; and • neither experimental nor investigational.
Such third parties may also intentionally circumvent our patents by means of alternate designs or processes or file applications or be granted patents that would block or hurt our efforts; • there may be patents relevant to our tests or technology of which we are not aware; • certain of our intellectual property was partly supported by a U.S. government grant awarded by the National Institutes of Health, and the government accordingly has certain rights in this intellectual property, including a non-exclusive, non-transferable, irrevocable worldwide license to use applicable inventions for any governmental purpose.
Such third parties may also intentionally circumvent our patents by means of alternate designs or processes or file applications or be granted patents that would block or hurt our efforts; • there may be patents relevant to our tests or technology of which we are not aware; 75 Table of Contents • certain of our intellectual property was partly supported by a U.S. government grant awarded by the National Institutes of Health, and the government accordingly has certain rights in this intellectual property, including a non-exclusive, non-transferable, irrevocable worldwide license to use applicable inventions for any governmental purpose.
In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.
In addition, any testing by us conducted in connection with Section 404 of SOX, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement.
Changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the U.S., particularly from China, Canada, and Mexico.
Changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the United States, particularly from China, Canada, and Mexico.
We cannot assure that we will be successful in addressing each of these criteria or other criteria that might affect the market acceptance of any products or services we commercialize, particularly the PreTRM test. If we are unsuccessful in achieving and maintaining market acceptance of the PreTRM test, our business, financial condition, and results of operations would be adversely affected.
We cannot ensure that we will be successful in addressing each of these criteria or other criteria that might affect the market acceptance of any products or services we commercialize, particularly the PreTRM test. If we are unsuccessful in achieving and maintaining market acceptance of the PreTRM test, our business, financial condition, and results of operations would be adversely affected.
We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials, as well as for our recently developed whole-blood collection kit, and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all.
We rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials, as well as for our whole-blood collection kit, and may not be able to find replacements or immediately transition to alternative suppliers on a cost-effective basis, or at all.
Furthermore, the industry is growing, and regulatory agencies such as HHS or the FDA may apply heightened scrutiny to new developments.
Furthermore, the industry is growing, and regulatory agencies such as HHS, CMS, or the FDA may apply heightened scrutiny to new developments.
Furthermore, should it be required in the future, we cannot be sure that the PreTRM test, any new tests that we may develop, or new uses for our products that we may develop, will be reviewed and authorized for marketing by the FDA in a timely or cost-effective manner, if authorized at all.
Furthermore, should it be required in the future, we cannot be sure that premarket submissions for the PreTRM test, any new tests that we may develop, or new uses for our products that we may develop, will be reviewed and authorized for marketing by the FDA in a timely or cost-effective manner, if authorized at all.
Inadequate funding for the FDA, the SEC and other government agencies, or a work slowdown or stoppage at those agencies as part of a broader federal government shutdown, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Inadequate funding for the SEC and other government agencies, or a work slowdown or stoppage at those agencies as part of a broader federal government shutdown or reduction in force, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Unauthorized access, loss, or dissemination of information could disrupt our operations, including our ability to perform tests, provide test results, bill payers or patients, process claims and appeals, provide customer assistance services, conduct 69 Table of Contents research and development activities, develop and commercialize tests, collect, process and prepare company financial information, provide information about our tests, educate patients and health care providers about our service, and manage the administrative aspects of our business, any of which could damage our reputation and adversely affect our business.
Unauthorized access, loss, or dissemination of information could disrupt our operations, including our ability to perform tests, provide test results, bill payers or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, develop and commercialize tests, collect, process and prepare company financial information, provide information about our tests, educate patients and health care providers about our service, and manage the administrative aspects of our business, any of which could damage our reputation and adversely affect our business.
We cannot assure you that manufacturing or quality control problems will not arise as we attempt to increase the production of the recently developed collection kit or that we may be able to increase our manufacturing capabilities and maintain quality control in a timely manner or at commercially reasonable costs.
We cannot assure you that manufacturing or quality control problems will not arise as we attempt to increase the production of the collection kit or that we may be able to increase our manufacturing capabilities and maintain quality control in a timely manner or at commercially reasonable costs.
Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change, by value, in equity ownership over any three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited.
Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change, by value, in equity ownership 56 Table of Contents over any three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited.
The Federal Trade Commission, or FTC, and/or state enforcement or regulatory agencies (including but not limited to the offices of state attorneys general) may object to the materials and methods we use to promote our current tests or other LDTs we may develop in the future, including with respect to the product claims in our promotional materials, as well as our testing services and nonmedical products such as our recently developed LikeMine TM webapp, and may initiate enforcement actions against us.
The Federal Trade Commission, or FTC, and/or state enforcement or regulatory agencies (including but not limited to the offices of state attorneys general) may object to the materials and methods we use to promote our current tests or other LDTs we may develop in the future, including with respect to the product claims in our promotional materials, as well as our testing services and nonmedical products such as our LikeMine webapp, and may initiate enforcement actions against us.
Even if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees. If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our tests and technology could be significantly diminished.
Even if we are successful, litigation could result in substantial costs and be a distraction to our management and other employees. If we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our tests and technology could be significantly diminished.
Our executive officers, directors and their affiliates and our stockholders holding 5% or more of our common stock own a significant percentage of our Class A common stock and will be able to exert significant control over matters subject to stockholder approval.
Risks Related to Our Class A Common Stock Our executive officers, directors and their affiliates and our stockholders holding 5% or more of our common stock own a significant percentage of our Class A common stock and will be able to exert significant control over matters subject to stockholder approval.
We could incur losses resulting from such strategic transactions, including undiscovered liabilities of an acquired business that are not covered by any indemnification we may obtain from the seller. In addition, we may not be able to successfully integrate any acquired personnel, technologies, and operations into our existing business in an effective, timely and non-disruptive manner.
We could incur losses resulting from such strategic transactions, including undiscovered liabilities of an acquired business that are not covered by any indemnification 55 Table of Contents we may obtain from the seller. In addition, we may not be able to successfully integrate any acquired personnel, technologies, and operations into our existing business in an effective, timely and non-disruptive manner.
However, contemplated new initiatives, e.g., marketing the PreTRM test or conducting research in a member country of the EU, may subject us to and require us to comply with the GDPR. 68 Table of Contents In July 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring personal data from the EU to the United States – the EU-U.S.
However, contemplated new initiatives, e.g., marketing the PreTRM test or conducting research in a member country of the EU, may subject us to and require us to comply with the GDPR. In July 2023, the European Commission adopted an adequacy decision for a new mechanism for transferring personal data from the EU to the United States – the EU-U.S.
We have limited experience as a company in sales and marketing and our ability to achieve profitability depends on our being able to attract customers for the PreTRM test and our future products or services, once approved.
We have limited experience as a company in sales and marketing and our ability to achieve profitability depends on our being able to attract customers for the PreTRM test and our future products or services.
Foreign licensure requirements could require review and modification of our tests in order to offer them 64 Table of Contents in certain jurisdictions or could impose other limitations that may limit our ability to make our tests more widely available outside the United States. Complying with licensure requirements, if applicable, in new jurisdictions may be expensive and time-consuming.
Foreign licensure requirements could require review and modification of our tests in order to offer them in certain jurisdictions or could impose other limitations that may limit our ability to make our tests more widely available outside the United States. Complying with licensure requirements, if applicable, in new jurisdictions may be expensive and time-consuming.
If we, our vendors, our suppliers, or our third-party partners experience an actual or perceived breach of privacy or other cybersecurity incident because of the use of generative artificial intelligence, we may lose valuable intellectual property, 71 Table of Contents personal information, and confidential information, and our reputation and the public perception of the effectiveness of our privacy and security measures could be harmed.
If we, our vendors, our suppliers, or our third-party partners experience an actual or perceived breach of privacy or other cybersecurity incident because of the use of generative artificial intelligence, we may lose valuable intellectual property, personal information, and confidential information, and our reputation and the public perception of the effectiveness of our privacy and security measures could be harmed.
There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to do so; 75 Table of Contents • third parties may develop tests or technology that have the same or similar effect as our tests and technology without infringing our patents.
There also may be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless, ultimately be found to do so; • third parties may develop tests or technology that have the same or similar effect as our tests and technology without infringing our patents.
Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of such proceedings and regardless of whether we are successful, we could experience significant costs and our management may be distracted. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of such proceedings and regardless of whether we are successful, we could experience significant 76 Table of Contents costs, and our management may be distracted. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Our ability to use these carryforwards could be limited if we experience an “ownership change.” 56 Table of Contents Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at a similar rate.
Our ability to use these carryforwards could be limited if we experience an “ownership change.” Our estimates of total addressable market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at a similar rate.
Any adverse outcome in one or more of these investigations could include the commencement of civil and/or criminal proceedings, substantial fines, penalties, administrative remedies and/or entry into corporate integrity agreements 74 Table of Contents with governmental agencies, among other penalties. In addition, resolution of any of these matters could involve the imposition of additional costly compliance obligations.
Any adverse outcome in one or more of these investigations could include the commencement of civil and/or criminal proceedings, substantial fines, penalties, administrative remedies and/or entry into corporate integrity agreements with governmental agencies, among other penalties. In addition, resolution of any of these matters could involve the imposition of additional costly compliance obligations.
To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions, that could result 76 Table of Contents in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain.
To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions, that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain.
There is no assurance that we would be successful in a court of law in proving that a third party is infringing one or more of our issued patents or trademarks. Any claims we assert against perceived infringers could also provoke these parties to assert counterclaims against us, alleging that we infringe their intellectual property.
There is no assurance that we would succeed in a court of law proving that a third party is infringing one or more of our issued patents or trademarks. Any claims we assert against perceived infringers could also provoke these parties to assert counterclaims against us, alleging that we infringe their intellectual property.
In addition, the terms of any such agreement may require a physician or qualified practitioner’s signature on test requisitions or require other controls and procedures prior to conducting a test. In particular, third-party payers have been 60 Table of Contents increasingly requiring prior authorization to be obtained prior to conducting a test as a condition to reimbursing for the test.
In addition, the terms of any such agreement may require a physician or qualified practitioner’s signature on test requisitions or require other controls and procedures prior to conducting a test. In particular, third-party payers have been increasingly requiring prior authorization to be obtained prior to conducting a test as a condition to reimbursing for the test.
If we are 66 Table of Contents required to conduct clinical trials to support a premarket submission to the FDA, whether using prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase the development costs for the PreTRM test or any future tests and delay commercialization.
If we are required to conduct clinical trials to support a premarket submission to the FDA, whether using prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase the development costs for the PreTRM test or any future tests and delay commercialization.
Furthermore, we cannot provide assurance that any of our employees, consultants, contract personnel or collaborators, either accidentally or through willful misconduct, will not cause serious damage to our programs and our strategy, for example by disclosing important trade secrets, know-how or proprietary information to our competitors.
Furthermore, we cannot provide assurance that any of our employees, consultants, contract personnel, or collaborators, either accidentally or through willful misconduct, will not cause 78 Table of Contents serious damage to our programs and our strategy, for example by disclosing important trade secrets, know-how, or proprietary information to our competitors.
Many similar laws have been proposed at the federal level and in at least 18 other states; in the event that we are subject to or affected by any such privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. • Federal, state, and local regulations relating to the handling and disposal of regulated medical waste, hazardous waste, and biohazardous waste and workplace safety for health care employees. • Laws and regulations relating to health and safety, labor and employment, public reporting, taxation, and other areas applicable to businesses generally.
Many similar laws have been proposed or adopted at the federal level and in a number of other states; in the event that we are subject to or affected by any such privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. • Federal, state, and local regulations relating to the handling and disposal of regulated medical waste, hazardous waste, and biohazardous waste and workplace safety for health care employees. • Laws and regulations relating to health and safety, labor and employment, public reporting, taxation, and other areas applicable to businesses generally.
We cannot predict the number, timing or size of future strategic transactions or the effect that any such transactions might have on our operating results. 55 Table of Contents We may need to raise additional funds through equity or debt financings, corporate collaborations or licensing arrangements to continue to fund or expand our operations.
We cannot predict the number, timing or size of future strategic transactions or the effect that any such transactions might have on our operating results. We may need to raise additional funds through equity or debt financings, corporate collaborations or licensing arrangements to continue to fund or expand our operations.
These types of decisions could reduce our revenue and harm our financial condition. Changes in government health care policy could increase our costs and negatively impact coverage and reimbursement for our tests by governmental and other third-party payers. The U.S. government is pursuing health care reform and aiming to reduce health care costs.
These types of decisions could reduce our revenue and harm our financial condition. 61 Table of Contents Changes in government health care policy could increase our costs and negatively impact coverage and reimbursement for our tests by governmental and other third-party payers. The U.S. government is pursuing health care reform and aiming to reduce health care costs.
If a breach affects 500 individuals or more in a particular state or jurisdiction, covered entities must report 67 Table of Contents it to the HHS and local media contemporaneously with notice to affected individuals, and HHS will post information regarding the breach, including the name of the entity reporting the breach, on its public website.
If a breach affects 500 individuals or more in a particular state or jurisdiction, covered entities must report it to the HHS and local media contemporaneously with notice to affected individuals, and HHS will post information regarding the breach, including the name of the entity reporting the breach, on its public website.
Furthermore, the number of shares of our Class A common stock reserved for issuance under our 2021 ESPP automatically increases on January 1 of each year, beginning on January 1, 2022, by 1% of the total number of 81 Table of Contents shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our board of directors or compensation committee.
Furthermore, the number of shares of our Class A common stock reserved for issuance under our 2021 ESPP automatically increases on January 1 of each year, beginning on January 1, 2022, by 1% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by our board of directors or compensation committee.
What constitutes a “sufficient” additional feature is uncertain. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply when examining process claims for patent eligibility. 77 Table of Contents In addition, U.S.
What constitutes a “sufficient” additional feature is uncertain. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply when examining process claims for patent eligibility. In addition, U.S.
If our clinical laboratory is out of compliance with these standards, the UT DOH may revoke our approval to perform testing or potentially impose other remedial measures, any of which could materially affect our business. We maintain an approval in good standing with the UT DOH.
If our clinical laboratory is out of compliance with these standards, 64 Table of Contents the UT DOH may revoke our approval to perform testing or potentially impose other remedial measures, any of which could materially affect our business. We maintain an approval in good standing with the UT DOH.
In either case we may become subject to extensive regulatory requirements and may be required to conduct additional clinical trials prior to continuing to sell our existing tests or launching any other tests we may develop, which may increase the cost of conducting, or otherwise harm, our business.
We may become subject to extensive regulatory requirements and may be required to conduct additional clinical trials prior to continuing to sell our existing tests or launching any other tests we may develop, which may increase the cost of conducting, or otherwise harm, our business.
Applicable data privacy and security obligations may require us to notify relevant stakeholders of cybersecurity incidents. Such disclosures may be costly and may result in reputational harm, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.
Applicable data privacy and security obligations 70 Table of Contents may require us to notify relevant stakeholders of cybersecurity incidents. Such disclosures may be costly and may result in reputational harm, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.
The FDA could disagree with a supplier’s or lab's assessment that the supplier’s products are RUOs, or could conclude that products labeled as RUO are actually intended for clinical diagnostic use, and could take enforcement action against the supplier or the lab, including requiring the supplier to cease offering the product to the lab, or requiring the lab to cease distributing the supplier's product, while it seeks appropriate marketing 63 Table of Contents authorization from FDA.
The FDA could disagree with a supplier’s or lab's assessment that the supplier’s products are RUOs, or could conclude that products labeled as RUO are actually intended for clinical diagnostic use, and could take enforcement action against the supplier or the lab, including requiring the supplier to cease offering the product to the lab, or requiring the lab to cease distributing the supplier's product, while it seeks appropriate marketing authorization from FDA.
Claims for recoupment require the time and attention of our management and other key personnel, which can be a distraction from operating our business. If third-party payers deny payment for testing, reimbursement revenue for our testing could decline.
Claims for recoupment require the time and attention of our management and other key personnel, which can be a distraction from operating our business. 59 Table of Contents If third-party payers deny payment for testing, reimbursement revenue for our testing could decline.
CCPA does not apply to health information that is protected by HIPAA or the California Confidentiality of Medical Information Act, but CCPA still applies to other types of personal information held by HIPAA covered entities, such as personnel or marketing information.
CCPA does not 67 Table of Contents apply to health information that is protected by HIPAA or the California Confidentiality of Medical Information Act, but CCPA still applies to other types of personal information held by HIPAA covered entities, such as personnel or marketing information.
There is also no assurance that 78 Table of Contents such agreements will provide for a meaningful protection of our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of information.
There is also no assurance that such agreements will provide for a meaningful protection of our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of information.
Additionally, any product liability or professional liability lawsuit could harm our reputation, result in a cessation of PreTRM testing or cause our partners to terminate our agreements with them, any of which could adversely impact our results of operations.
Additionally, any 50 Table of Contents product liability or professional liability lawsuit could harm our reputation, result in a cessation of PreTRM testing or cause our partners to terminate our agreements with them, any of which could adversely impact our results of operations.
In addition, health-related, privacy, and data protection laws and regulations in the United States and elsewhere are subject to interpretation and enforcement by various governmental authorities and courts, resulting in complex compliance issues and the potential for varying or even conflicting interpretations, particularly as laws and regulations in this area are in flux.
In addition, health-related, privacy, and data protection laws and regulations in the United States and elsewhere are subject to interpretation and enforcement by various governmental authorities and courts, resulting in complex compliance issues and the potential for varying or even conflicting interpretations, particularly as laws and regulations in this area are in 69 Table of Contents flux.
These potential consequences, as well as any adverse outcome from government investigations, could have a material and adverse effect on our business, operating results, and financial condition. Risks Related to Intellectual Property Any failure to obtain, maintain, and enforce our intellectual property rights could impair our ability to protect our proprietary technology and our brand.
These potential consequences, as well as any adverse outcome from government investigations, could have a material and adverse effect on our business, operating results, and financial condition. 74 Table of Contents Risks Related to Intellectual Property Any failure to obtain, maintain, and enforce our intellectual property rights could impair our ability to protect our proprietary technology and our brand.
Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that may have a material adverse effect on our ability to obtain new patents and to defend and enforce our existing patents and patents that we might obtain in the future.
Depending on decisions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations 77 Table of Contents governing patents could change in unpredictable ways that may have a material adverse effect on our ability to obtain new patents and to defend and enforce our existing patents and patents that we might obtain in the future.
Our business activities are, or may in the future be, subject to comprehensive compliance obligations under state and federal laws and regulations, including: • Federal and state laws governing laboratory testing, including but not limited to the Clinical Laboratory Improvement Amendments of 1988 and state laboratory licensure and related laws. • FDA laws and regulations, including but not limited to requirements for offering LDTs following the July 2024 effective date of the agency's LDT final rule. • The federal Anti-Kickback Statute, or AKS, which generally prohibits, among other things knowingly and willfully offering, paying, soliciting, or receiving any remuneration, directly or indirectly, covertly or overtly, in cash or in kind in return for (i) referring an individual to a person for the furnishing or arranging of any item or service, or (ii) purchasing, leasing, ordering, or arranging for or recommending the purchasing, leasing, or ordering of any good, facility, service, or item, for which payment may be made by federal health care programs.
Our business activities are, or may in the future be, subject to comprehensive compliance obligations under state and federal laws and regulations, including: • Federal and state laws governing laboratory testing, including but not limited to the Clinical Laboratory Improvement Amendments of 1988 and state laboratory licensure and related laws. • FDA laws and regulations, including but not limited to requirements for offering LDTs. • The federal Anti-Kickback Statute, or AKS, which generally prohibits, among other things knowingly and willfully offering, paying, soliciting, or receiving any remuneration, directly or indirectly, covertly or overtly, in cash or in kind in return for (i) referring an individual to a person for the furnishing or arranging of any item or service, or (ii) purchasing, leasing, ordering, or arranging for or recommending the purchasing, leasing, or ordering of any good, facility, service, or item, for which payment may be made by federal health care programs.
Further, our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in, or failure or cybersecurity 70 Table of Contents incident impacting, our systems or third-party systems where information important to our business operations or commercial development is stored.
Further, our insurance policies may not be adequate to compensate us for the potential losses arising from any such disruption in, or failure or cybersecurity incident impacting, our systems or third-party systems where information important to our business operations or commercial development is stored.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Prop erties Our corporate headquarters and facilities are located in Salt Lake City, Utah. We currently lease a total of approximately 24,300 square feet of building space in Salt Lake City dedicated to research and development, administration and our CLIA-certified laboratory.
Biggest changeItem 2. Prop erties Our corporate headquarters and facilities are located in Salt Lake City, Utah. We currently lease a total of approximately 20,400 square feet of building space in Salt Lake City dedicated to research and development, administration and our CLIA-certified laboratory. The lease on our existing Salt Lake City facility expires on June 30, 2034.
Removed
The lease on our existing Salt Lake City facility expires on December 31, 2025 and we have had an option to terminate the lease under certain circumstances after July 1, 2024.
Added
The amended lease includes a termination right that permits us to terminate the lease if we move to another space of at least 30,000 square feet that is managed by the landlord of our current office space.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeDividend Policy We have never declared or paid any cash dividend on our common stock. We intend to retain any future earnings to finance the operation and growth of our business, and we do not anticipate declaring or paying any cash dividends in the foreseeable future.
Biggest changeDividend Policy We have never declared or paid any cash dividend on our common stock. We intend to retain any future earnings to finance the operation and growth of our business, and we do not anticipate declaring or paying any cash dividends in the foreseeable future. Unregistered Sales of Securities and Use of Proceeds None.
Stockholders of record are defined as those stockholders whose shares are registered in their names in our stock records and do not include beneficial owners of common stock whose shares are held in the names of brokers, dealers or clearing agencies. As of March 14, 2025, we had two stockholders of record of our Class B common stock.
Stockholders of record are defined as those stockholders whose shares are registered in their names in our stock records and do not include beneficial owners of common stock whose shares are held in the names of brokers, dealers or clearing agencies. As of March 13, 2026, we had two stockholders of record of our Class B common stock.
Our Class B common stock is not listed on any stock exchange nor traded on any public market. Holders of Record As of March 14, 2025, we had 90 stockholders of record of our Class A common stock.
Our Class B common stock is not listed on any stock exchange nor traded on any public market. Holders of Record As of March 13, 2026, we had 80 stockholders of record of our Class A common stock.
Removed
Unregistered Sales of Securities and Use of Proceeds On September 10 2024, we issued 53,827 shares of our Class A common stock to Blue Ox Healthcare Partners, LLC to fulfill our contractual obligations related to the development of strategies for insurance coverage of the PreTRM test. The shares were valued at $7.55 per share.
Added
Issuer Purchases of Equity Securities None. Item 6. [ Reserved ] 87 Table of Contents
Removed
All shares were issued in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act as we did not engage in any general solicitation or advertising.
Removed
The recipient of the shares was an accredited investor (as defined in Rule 501(a) of Regulation D) and represented its intention to acquire the shares for investment purposes only, and not with a view to, or for sale in connection with, any distribution thereof. The recipient received, or had, through its relationship with us, adequate access to information about us.
Removed
Appropriate legends were affixed to the certificates evidencing the shares issued in this transaction. No underwriter participated in the offer and sale of these shares, and no commission or other remuneration was paid or given directly or indirectly in connection therewith. Issuer Purchases of Equity Securities None. Item 6. [ Reserved ] 87 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

73 edited+30 added−18 removed18 unchanged
Biggest changeComparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 $ Change (in thousands) Revenue $ 77 $ 306 $ (229 ) Operating expenses: Cost of revenue 82 210 (128 ) Research and development 14,730 15,225 (495 ) Selling and marketing 5,771 8,349 (2,578 ) General and administrative 16,129 16,343 (214 ) Total operating expenses 36,712 40,127 (3,415 ) Loss from operations (36,635 ) (39,821 ) 3,186 Interest expense (28 ) (55 ) 27 Other income, net 3,765 3,634 131 Net loss $ (32,898 ) $ (36,242 ) $ 3,344 92 Table of Contents Research and Development Expenses The following table summarizes our research and development expenses for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 $ Change (in thousands) Research and development expenses: Clinical studies $ 4,430 $ 6,784 $ (2,354 ) Research and bioinformatics 7,209 4,412 2,797 Laboratory operations 3,091 4,029 (938 ) Total research and development expenses $ 14,730 $ 15,225 $ (495 ) The $0.5 million decrease was due to a $2.4 million decrease in clinical study costs, and a $0.9 million decrease in laboratory operations costs, partially offset by a $2.8 million increase in research and bioinformatics expense.
Biggest changeResults of Operations The results of operations presented below should be reviewed in conjunction with the financial statements and related notes included elsewhere in this Annual Report. 92 Table of Contents Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 $ Change (in thousands) Revenue $ 81 $ 77 $ 4 Operating expenses: Cost of revenue 164 82 82 Research and development 13,171 14,730 (1,559 ) Selling and marketing 6,548 5,771 777 General and administrative 16,702 16,129 573 Total operating expenses 36,585 36,712 (127 ) Loss from operations (36,504 ) (36,635 ) 131 Interest expense (9 ) (28 ) 19 Other income, net 4,585 3,765 820 Net loss $ (31,928 ) $ (32,898 ) $ 970 Research and Development Expenses The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 $ Change (in thousands) Research and development expenses: Clinical studies $ 2,802 $ 4,430 $ (1,628 ) Research and bioinformatics 7,236 7,209 27 Laboratory operations 3,133 3,091 42 Total research and development expenses $ 13,171 $ 14,730 $ (1,559 ) The $1.6 million decrease was primarily due to a $1.6 million decrease in clinical study costs.
Investing Activities Net cash provided by investing activities for the year ended December 31, 2024 was primarily due to $48.7 million in proceeds from maturities and sales of marketable securities, partially offset by $35.8 million in purchases of marketable securities and $1.0 million in purchases of intangible assets.
Net cash provided by investing activities for the year ended December 31, 2024 was primarily due to $48.7 million in proceeds from maturities and sales of marketable securities, partially offset by $35.8 million in purchases of marketable securities and $1.0 million in purchases of intangible assets.
We will continue to pursue contracts with private and governmental payers and health systems with 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.
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.
We evaluated that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. Contractual Obligations and Commitments Our material cash requirements include the following contractual and other obligations. Leases We have lease arrangements for certain equipment and facilities.
We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. Contractual Obligations and Commitments Our material cash requirements include the following contractual and other obligations. Leases We have lease arrangements for certain equipment and facilities.
Under the JOBS Act, emerging growth companies 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.
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.
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 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.
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.
We expect our losses in the future to increase principally as a result of our commercialization activities for the PreTRM test and the development, commercialization, marketing, and distribution of our other pipeline products and services, especially the costs of evidence-generating initiatives.
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 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.
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.
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 90 Table of Contents arrangements.
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, 89 Table of Contents and to support additional clinical studies, publications, and anticipated research and development of our other pipeline products and services.
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.
Operating Expenses Cost of Revenue 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.
Operating Expenses Cost of Revenue 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.
Our commercialization strategy includes utilizing results derived from past and future clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these benefits to health care providers and insurance payers, and providing convenient access to the test through streamlined specimen collection options.
Our commercialization strategy includes utilizing results derived from past and future clinical trials to demonstrate the health and economic benefits of early and accurate detection of preterm birth risk coupled with well-recognized interventions in higher risk patients, illustrating these 88 Table of Contents benefits to health care providers, insurance payers, and consumers, while providing convenient access to the test through streamlined specimen collection options.
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.
If we are unable to achieve significant revenues or raise additional funding on acceptable terms, when needed, or at all, we may not be able to continue the development or commercialization of our products and services and could be required to delay, scale back, or abandon some or all of our development programs and other operations.
We significantly reduced our annual operating expenses across all aspects of our business over the past 18 months and will continue to prudently monitor our operating expense levels. We believe our cash runway is sufficient to enable us to operate through 2028 based on our existing operating plans.
We significantly reduced our annual operating expenses across all aspects of our business over the past few years and will continue to prudently monitor our operating expense levels. We believe our cash runway is sufficient to enable us to operate through 2028 based on our existing operating plans.
We expect costs of revenue will generally move in line with the sales of our products. Research and Development Expenses Research and development expenses consist of costs incurred for our research activities and development of our product candidates.
We expect costs of revenue will generally move in line with the sales of our products. 91 Table of Contents Research and Development Expenses Research and development expenses consist of costs incurred for our research activities and development of our product candidates.
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.
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 IPO, which was completed in July 2021.
Factors Affecting Our Performance We believe there are several important factors that have impacted, and that we expect will continue to impact, our operating performance and results of operations, including: • our ability to furt her increase the use and adoption of the PreTRM test; • our ability to develop and successfully commercialize new products and services in the future; • the continued development of the market for proteomics and bioinformatics; • our ability to secure payer and health system contracts that result in significant revenues or to access additional funds; • raising substantial additional capital to continue operations and execute on our business plan, until such time as we can generate significant revenue from the sales of our products, if ever; • obtaining and maintaining intellectual property protection for our technology and products; and • other factors described in the “Risk Factors” section and elsewhere in this Annual Report. 90 Table of Contents Key Components of Our Results of Operations Revenues Substantially all of our revenue in the near term is expected to come from sales of the PreTRM test.
Factors Affecting Our Performance We believe there are several important factors that have impacted, and that we expect will continue to impact, our operating performance and results of operations, including: • our ability to furt her increase the use and adoption of the PreTRM test; • our ability to develop and successfully commercialize new products and services in the future; • the continued development of the market for proteomics and bioinformatics; • our ability to secure payer and health system contracts that result in significant revenues or to access additional funds; • raising substantial additional capital to continue operations and execute on our business plan, until such time as we can generate significant revenue from the sales of our products, if ever; • obtaining and maintaining intellectual property protection for our technology and products; and • other factors described in the “Risk Factors” section and elsewhere in this Annual Report.
As of December 31, 2024, we had future minimum lease payments of $0.9 million, which is payable within 12 months. Critical Accounting Policies and Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
As of December 31, 2025, we had future minimum lease payments of $5.1 million, with $0.3 million payable within 12 months. Critical Accounting Policies and Estimates Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles.
We have incurred significant operating losses since inception. Our net losses were $32.9 million and $36.2 million for the years ended December 31, 2024 and 2023, respectively.
We have incurred significant operating losses since inception. Our net losses were $31.9 million and $32.9 million for the years ended December 31, 2025 and 2024, respectively.
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.
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.
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.
Some of these components can vary significantly in cost and reliability of supply, and we periodically seek ways to strengthen our supplier network.
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.
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, and the sale and issuance of Class A common stock and pre-funded warrants in the February 2025 Offering.
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.
Our first commercial product, the PreTRM test, is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of a preterm birth.
Recent Accounting Pronouncements A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2—Significant Accounting Policies, appearing in Part II, Item 8 of this Annual Report on Form 10-K. 96 Table of Contents
Recent Accounting Pronouncements A description of recent accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2—Significant Accounting Policies, appearing in Part II, Item 8 of this Annual Report.
The 2024 Form S-3 included a prospectus, or the ATM Prospectus Supplement, covering up to $50.0 million in shares of Class A common stock that could be issued and sold under the sales agreement, dated August 7, 2024, between us and TD Securities (USA) LLC, or TD Cowen, or 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.
The 2024 Form S-3 included a prospectus, or the ATM Prospectus Supplement, covering the issuance and sale of up to $50.0 million of shares of Class A common stock pursuant to the sales agreement, dated August 7, 2024, or the 2024 Sales Agreement, between us and TD Securities (USA) LLC, or TD Cowen, with respect to an at-the-market offering program under which, we may, subject to the filing of a new prospectus or prospectus supplement, offer and sell, from time to time at our sole discretion, shares of our Class A common stock having an aggregate offering price of up to $50.0 million, or the ATM Offering.
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.
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.
Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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 market adoption by both health care providers and payers could be aided by our clinical evidence portfolio, which includes the recent publication of the PRIME study, the AVERT PRETERM TRIAL results, and other evidence generated within the next few years.
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. 91 Table of Contents Selling and Marketing Expenses Selling and marketing expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for sales, marketing, and related commercial support personnel.
Research and development costs may increase in the long-term as we support additional clinical studies, publications, and other product development activities. Selling and Marketing Expenses Selling and marketing expenses consist primarily of salaries, payroll taxes, employee benefits, and stock-based compensation charges for sales, marketing, and payer access personnel.
Our future funding requirements will depend on many factors, including the following: • the timing, receipt, and amount of sales from the PreTRM test and other pipeline products and services, if approved; • the cost and timing of establishing sales, marketing, and other commercialization capabilities in the United States and abroad; • our ability to develop and commercialize other products and services; • the terms and timing of any collaborative, licensing, and other arrangements that we may establish; • the cost, timing, and outcomes of regulatory approvals; • the scope, rate of progress, results, and cost of our clinical, scientific, and real-world studies, and other related activities; • the cost of preparing, filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; • the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions; • partnerships and other strategic options for our PreTRM test and other product candidates; and • other factors described in the “Risk Factors” section and elsewhere in this Annual Report.
Our future funding requirements will depend on many factors, including the following: • the timing, receipt, and amount of sales from the PreTRM test and other pipeline products and services, if approved; • the cost and timing of establishing sales, marketing, and other commercialization capabilities in the United States and abroad; • our ability to develop and commercialize other products and services; • the terms and timing of any collaborative, licensing, and other arrangements that we may establish; • the cost, timing, and outcomes of regulatory approvals; • the scope, rate of progress, results, and cost of our clinical, scientific, and real-world studies, and other related activities; • the cost of preparing, filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; • the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions; • partnerships and other strategic options for our PreTRM test and other product candidates; • the impact of evolving trade policies, including recently imposed tariffs on imported materials and components used in medical diagnostic products, which could increase our costs for critical raw materials, laboratory reagents, specialized equipment, and other supplies necessary for the production, development, and commercialization of our tests and services; and 95 Table of Contents • other factors described in the “Risk Factors” section and elsewhere in this Annual Report.
Overview We are a women’s health company utilizing our proprietary proteomics and bioinformatics platform, and significant data resources, to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests and predictive analytic products and services.
Overview We are a women’s health company utilizing our proprietary proteomics and bioinformatics platform and significant data resources to improve maternal and neonatal health by discovering, developing, and commercializing blood-based biomarker tests and predictive analytic products and services. Our vision is to become the global leader in high-value women’s health diagnostics.
We 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.
We will continue to evaluate the allocation of our resources as we focus our efforts on accelerating the market adoption of our PreTRM test and developing and launching additional pipeline products and services.
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.
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.
As of December 31, 2024, we had aggregate cash, cash equivalents, and available-for-sale securities of $68.2 million, and an accumulated deficit of $279.8 million. 93 Table of Contents 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, or the 2024 Form S-3, 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.
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 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.
Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 was due to $3.0 million in proceeds from employee equity transactions, partially offset by $0.4 million of finance lease principal payments.
Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 was due to $53.6 million in net proceeds from the February 2025 Offering and $0.6 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 year ended December 31, 2023 was due to $1.2 million in proceeds from options exercised, partially offset by $0.5 million of finance lease principal payments. 94 Table of Contents Future Funding Requirements It is likely we will continue to incur significant additional operating losses and negative cash flows for the foreseeable future.
Net cash provided by financing activities for the year ended December 31, 2024 was due to $3.0 million in proceeds from employee equity transactions, partially offset by $0.4 million of finance lease principal payments. Future Funding Requirements It is likely we will continue to incur significant additional operating losses and negative cash flows for the foreseeable future.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2024 2023 (in thousands) Net cash (used in) provided by: Operating activities $ (14,189 ) $ (27,188 ) Investing activities 11,743 438 Financing activities 2,609 752 Net increase (decrease) in cash and cash equivalents $ 163 $ (25,998 ) Operating Activities The net cash used in operating activities during the year ended December 31, 2024 was primarily due to a net loss of $32.9 million, partially offset by non-cash charges of $7.4 million and an increase in operating assets and liabilities of $11.3 million.
Cash Flows The following table summarizes our cash flows for the periods indicated: Year Ended December 31, 2025 2024 (in thousands) Net cash (used in) provided by: Operating activities $ (25,623 ) $ (14,189 ) Investing activities (28,502 ) 11,743 Financing activities 54,026 2,609 Net (decrease) increase in cash and cash equivalents $ (99 ) $ 163 Operating Activities The net cash used in operating activities during the year ended December 31, 2025 was primarily due to a net loss of $31.9 million and a decrease in operating assets and liabilities of $0.8 million, partially offset by non-cash charges of $6.9 million.
We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (2) the last day of the fiscal year in which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) December 31, 2026.
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. 96 Table of Contents We will remain an EGC until the earliest to occur of: (1) the last day of the fiscal year in which we have at least $1.235 billion in annual revenue; (2) the last day of the fiscal year in which we are deemed to be a “large accelerated filer,” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year; (3) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (4) December 31, 2026.
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 2025 compared to 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.
Other significant costs include travel, consulting, public relations, facilities, and legal costs related to commercial efforts. We expect selling and marketing expenses will increase in 2026 compared to 2025 as we invest in additional commercialization activities for PreTRM following the publication of the PRIME study data and as we continue to invest in our product portfolio.
Recent Developments In July 2024, we announced the publication of the positive results from the AVERT PRETERM TRIAL in Diagnostics, an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the July issue. Notable results indicated an 18% reduction in severe neonatal morbidity and mortality.
The findings of the PRIME study are similar to those from the AVERT PRETERM TRIAL, which was published in July 2024 in Diagnostics , an international, peer-reviewed, open access journal on medical diagnosis. Diagnostics highlighted this study on the cover of the July issue. Notable results from this study indicated an 18% reduction in severe neonatal morbidity and mortality.
In February 2025, we completed an underwritten public offering, or the February 2025 Offering, in which we issued and sold shares of Class A common stock and pre-funded warrants to purchase shares of Class A common stock, including shares of Class A common stock issued upon exercise of the underwriters' option to purchase additional shares in full, receiving aggregate gross proceeds of approximately $57.5 million before deducting underwriting discounts and commissions and other offering expenses.
In February 2025, we completed an underwritten public offering, or the February 2025 Offering, in which we issued and sold shares of Class A common stock and pre-funded warrants to purchase shares of Class A common stock resulting in approximately $53.6 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
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.
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.
We expect general and administrative expenses to increase slightly in 2025 compared to 2024 to support the organization as it begins to scale in the pursuit of PreTRM commercial opportunities and other strategic initiatives. Interest Expense Interest expense represents interest incurred on our finance leases.
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. Interest Expense Interest expense represents interest incurred on our finance leases.
Our vision is to deliver pivotal and actionable information to pregnant women, their physicians, and health care payers to significantly enhance a mother’s pregnancy journey, improve maternal and neonatal health, and reduce health care costs.
We plan to do this by taking a holistic approach to providing pivotal and actionable information to pregnant women, their physicians, and health care payers to significantly enhance a mother’s pregnancy journey, improve maternal and neonatal health, and reduce health care costs.
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.
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.
When performing a meta-analysis of data from the two studies, we can demonstrate pooled effect sizes showing a 22% decreased risk of prolonged hospital stay and 22% reduction in neonatal morbidity and mortality.
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.
General and Administrative Expenses The $0.2 million decrease was due primarily to decreases of $0.8 million related to one-time personnel costs, $0.5 million in personnel-related costs driven by decreased average headcount, and $0.2 million of director and officer insurance costs, partially offset by increases of $1.1 million in stock-based compensation expense and $0.3 million in professional service fees.
General and Administrative Expenses The $0.6 million increase was due primarily to increases of $1.4 million in personnel costs driven by increased average headcount and $0.5 million in consulting fees, partially offset by decreases of $1.1 million in stock-based compensation expense and $0.4 million in professional and legal fees.
We believe that all 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. We are actively discovering and developing additional biomarker and predictive analytics tests to predict other specific major conditions of pregnancy.
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.
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.
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.
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 2025 compared to 2024 due to increased product development activities and additional planned studies.
We expense all research and development costs, both internal and external, in the period in which they are incurred. We expect that our research and development expenses will decrease in 2026 compared to 2025 as we begin shifting capital allocation toward commercialization activities.
This registration statement will remain in effect for up to three years from the date it became effective.
This registration statement will remain in effect for up to three years from the date it became effective. We make no assurances as to the continued effectiveness of the 2024 Form S-3.
Data from these studies suggests that the number of patients needed to screen (NNS) to save a NICU admission is 41, and to save a NICU day is only about 3-4. To put this in context, standard of care for short cervix, which utilizes transvaginal ultrasound plus progesterone treatments, has an NNS to save a NICU admission of 150.
Data from the PRIME study suggests that the NNS to save a NICU day is 4.2, and to save a NICU admission is 38.5. In contrast, the standard of care for short cervix, an existing clinical risk factor for preterm birth which utilizes transvaginal ultrasound plus progesterone treatments, has an NNS to save a NICU admission of 150.
Selling and Marketing Expenses The $2.6 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 $0.2 million in marketing programs and materials, partially offset by a $0.8 million increase in consulting and other professional service costs.
The $1.6 million decrease in clinical study costs was primarily due to a $1.8 million decrease in PRIME study costs as we continued winding down study-related costs following the conclusion of the study, a $0.2 million decrease in consulting costs, and a $0.1 million decrease in stock-based compensation expense, partially offset by a $0.4 million increase in personnel costs due to increased average headcount.
Input assumptions used in calculating the fair value of stock-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgment. These input assumptions include the expected term of the awards, the expected common stock price volatility over the term of the awards, risk-free interest rates, and the expected dividend yield.
These input assumptions include the expected term of the awards, the expected common stock price volatility over the term of the awards, risk-free interest rates, and the expected dividend yield. Changes in the assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized.
On February 12, 2025, we closed the February 2025 Offering in which we issued and sold 1,250,000 shares of our Class A Common Stock and pre-funded warrants to purchase up to 11,250,000 shares of our Class A Common Stock.
On February 12, 2025, we completed the February 2025 Offering in which we issued and sold shares of our Class A common stock and pre-funded warrants to purchase shares of our Class A common stock resulting in approximately $53.6 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses.
Emerging Growth Company and Smaller Reporting Company Status We are an emerging growth company, or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
We will continue to use judgment in evaluating the expected volatility and interest rates utilized for our stock-based compensation expense calculations on a prospective basis. Emerging Growth Company and Smaller Reporting Company Status We are an EGC as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
The net cash used in operating activities during the year ended December 31, 2023 was primarily due to a net loss of $36.2 million, partially offset by non-cash charges of $5.5 million and an increase in operating assets and liabilities of $3.5 million.
The net cash used in operating activities during the year ended December 31, 2024 was primarily due to a net loss of $32.9 million, partially offset by non-cash charges of $7.4 million and an increase in operating assets and liabilities of $11.3 million. 94 Table of Contents Investing Activities Net cash used in investing activities for the year ended December 31, 2025 was primarily due to $87.6 million in purchases of marketable securities and $0.7 million in purchases of property and equipment, partially offset by $59.8 million in proceeds from maturities and sales of marketable securities.
This powerful evidence from our studies makes a compelling 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.
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.
Stock-based Compensation We maintain a stock-based compensation plan as a long-term incentive for employees and non-employee consultants. The plan allows for the issuance of incentive stock options and non-qualified stock options, as well as other stock rights.
The plan allows for the issuance of incentive stock options and non-qualified stock options, as well as other stock rights. We recognize stock-based compensation expense for stock options on a straight-line basis over the requisite service period and estimate forfeitures based on historical evidence.
We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company.
We are also a “smaller reporting company” as defined in the Exchange Act.
Liquidity and Capital Resources Sources of Liquidity 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.
Other Income, net The $0.8 million increase in other income was due to a $1.5 million increase related primarily to interest income on our marketable securities, partially offset by a $0.7 million decrease in investment income related primarily to our marketable securities. 93 Table of Contents Liquidity and Capital Resources Sources of Liquidity 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 may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal year following the determination that the market value of our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter.
We may continue to be a smaller reporting company if either (1) the market value of our Class A common stock held by non-affiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our Class A common stock held by non-affiliates is less than $700.0 million.
Actual results 95 Table of Contents may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. Stock-based Compensation We maintain a stock-based compensation plan as a long-term incentive for employees and non-employee consultants.
Beyond demonstration of clinical 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 early 2025.
Our real-world evidence implementation programs, targeting 89 Table of Contents to expand PreTRM clinical utility data and replicate randomized controlled trial evidence in the real world, have been developed and the first qualitative pre-implementation study has been completed and is being prepared for publication.
Other Income, Net Other income, net consists of interest income and other investment income earned on our cash, cash equivalents, and marketable securities, and other gains and losses. Results of Operations The results of operations presented below should be reviewed in conjunction with the financial statements and related notes included elsewhere in this Annual Report.
Other Income, Net Other income, net consists of interest income and other investment income earned on our cash, cash equivalents, and marketable securities, and other gains and losses.
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.
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.
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.
Beyond the unmet clinical need, the economic consequences of preterm birth are estimated to be approximately $25 billion annually in the United States.
As of December 31, 2024, we have not sold any shares of Class A common stock to date under the 2024 Sales Agreement.
Other than the termination of the ATM Prospectus Supplement, the 2024 Sales Agreement remains in full force and effect. We had not sold any shares of Class A common stock under the ATM Offering.
We recognize stock-based compensation expense for stock options on a straight-line basis over the requisite service period and estimate forfeitures based on historical evidence. Our stock-based compensation expenses are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model.
Our stock-based compensation expenses are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. Input assumptions used in calculating the fair value of stock-based awards represent management’s estimates and involve inherent uncertainties and the application of management’s judgment.
The $0.9 million decrease in laboratory operations costs was primarily due to a $0.8 million in personnel costs due to decreased average headcount in this department and a $0.2 million decrease in lab supplies and equipment, partially offset by a $0.1 million increase in consulting costs.
Selling and Marketing Expenses The $0.8 million increase was due primarily to increases of $1.0 million in personnel costs as we have begun strategically hiring key positions in our commercial organization, $0.2 million in travel expenses, and $0.1 million in marketing programs and materials, partially offset by a $0.5 million decrease in consulting costs.
Significant reductions in neonatal morbidity and mortality were also 88 Table of Contents 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.
The test-and-treat strategy was linked to decreased odds of preterm birth and spontaneous preterm birth at various gestational ages. The PRIME study includes the same primary and secondary outcomes as the AVERT PRETERM TRIAL.
When babies who were destined for premature delivery remain in utero longer, the result is that the more mature babies with improved health require shorter hospital/NICU stays. We believe the substantial health benefits of this model translate very favorably to health economic savings, creating a powerful value proposition to insurance payers.
We believe the health benefits of this model translate favorably to health economic savings, creating a powerful value proposition to insurance payers. We estimate that the average cost of a NICU day is approximately $6,300 and the average length of a NICU stay is 12-14 days.
In connection with the February 2025 Offering, we terminated the ATM Prospectus Supplement, but the 2024 Sales Agreement remains in full force and effect. We make no assurances as to the continued effectiveness of the 2024 Form S-3.
In connection with the February 2025 Offering, on February 10, 2025, we terminated the ATM Prospectus Supplement.
Removed
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.
Added
Preterm birth is a major health risk that strains the U.S. health care system both clinically and economically. The 2025 March of Dimes Report Card shows that, for the fourth consecutive year, the United States earned a D+ grade for preterm birth, making the longest stretch of the lowest grade in Report Card history.
Removed
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 P rematurity R isk Assessment Combined With Clinical I nterventions for Improving Neonatal outco ME s study, or the PRIME study.
Added
Preterm birth causes numerous medical issues requiring more time spent in the hospital, increases in pediatric care and can cause lifelong health complications, and is estimated to contribute to approximately 34% of newborn deaths.
Removed
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.
Added
Critically, identifying patients at higher risk of preterm birth is a clinical challenge where traditional screening methods fail to identify 81% of spontaneous singleton preterm births, and at least 50% of pregnant women who deliver prematurely had no known risk factors, limiting the opportunity to receive any personalized treatments or interventions that could potentially improve this outcome.
Removed
Notable results from the PRIME study showed the primary endpoints being met in the prespecified modified intent-to-treat population (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.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeHowever, an inflationary environment could affect us by increasing our costs of labor, laboratory supplies, and clinical trials and could adversely affect our business, results of operations, financial position and cash flows.
Biggest changeHowever, an inflationary environment, including the impact of potential imposition or expansion of trade tariffs in the U.S. and the European Union, could affect us by increasing our costs of labor, laboratory supplies, and clinical trials and could adversely affect our business, results of operations, financial position, and cash flows, if it continues over the long-term.
Changes in U.S. interest rates affect the interest earned on our cash and cash equivalents and marketable securities, and the market value of those securities. A hypothetical 100 basis point increase in interest rates would have resulted in a decrease of $0.4 million in the market value of our available-for-sale debt securities as of December 31, 2024.
Changes in U.S. interest rates affect the interest earned on our cash and cash equivalents and marketable securities, and the market value of those securities. A hypothetical 100 basis point increase in interest rates would have resulted in a decrease of $0.6 million in the market value of our available-for-sale debt securities as of December 31, 2025.

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