SERA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-06

• In many cases, the complications of preterm birth have profound short- and long-term health consequences for the mother and baby. Beyond the unmet clinical need, the economic consequences of preterm birth are estimated to be approximately $25 billion annually in the United States. The average delive…

• 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. The PreTRM test is a non-invasive blood test given to a pregnant woman carrying a single fetus during weeks 18 through 20…

• In January 2026, we announced the publication of the PRIME study in the Pregnancy Journal, a peer-reviewed open access journal, and official journal of the Society for Maternal-Fetal Medicine, or SMFM. Key findings from the PRIME study include a 20% reduction in babies admitted to the Neonatal Inten…

• 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 …

• In order to preserve capital for a time when our commercial opportunity is strongest, we have been operating under a streamlined commercial model for much of the past few years. Recently, with our portfolio of clinical evidence broadening through peer-reviewed publications, we began expanding our co…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• 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. The PreTRM test is a non-invasive blood test given to a pregnant woman carrying a single fetus during weeks 18 through 20…

• 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 …

• 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 Neonatal Intensive Care Unit, or NICU, le…

• In January 2025, key results of the PRIME study were presented at the Society for Maternal Fetal Medicine’s 2025 SMFM Pregnancy Meeting, and an abstract of primary endpoint data was made public in the Pregnancy Journal. Notable results from the PRIME study showed the primary endpoints being met in t…

• In order to preserve capital for a time when our commercial opportunity is strongest, we have been operating under a streamlined commercial model for much of the previous two years. Now, with our portfolio of clinical evidence broadening through peer-reviewed publications, we have recently begun exp…

Text added vs the prior filing · source: 10-Q · 2026-05-06

• provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

• Our management, with the participation of our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based on…

• There were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Our management, with the participation of our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. Base…

• There were no changes in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• If our strategic prioritization fails to achieve some or all of the expected benefits therefrom, our cash resources may not last as long as estimated and our business, results of operations, and financial condition could be materially and adversely affected.

• If our strategic prioritization fails to achieve some or all of the expected benefits therefrom, our cash resources may not last as long as estimated and our business, results of operations, and financial condition could be materially and adversely affected.

• There can be no assurance that our strategic prioritization will achieve the cost savings, operating efficiencies, or other benefits that we may initially expect. These activities may also result in a loss of continuity, loss of accumulated knowledge, and inefficiency during transitional periods and…

• 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 Un…

• pursuant to a separate executive order and trade authority. 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 econom…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• 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.…

• Obtaining coverage and reimbursement approval for a test from each third-party payer is a time-consuming and costly process that could require us to provide to each payer supporting scientific and clinical information, as well as information about patient insurance eligibility and benefits, and bill…

• test incorporating new technology. Even when a payer determines that a test is eligible for reimbursement, the payer may impose coverage limitations that preclude payment under certain circumstances or for certain patient populations. Moreover, eligibility for coverage does not mean that any test wi…

• The CCPA, the CPRA, and similar laws may increase our compliance costs and potential liability. Any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. All U.S. states have implemented data breach notification laws that overlap and oft…

• personal information. We must comply with all of these laws simultaneously in the event of a data breach which is a complicated and expensive proposition.

Text added vs the prior filing · source: 10-Q · 2026-05-06

• As part of our transition from a clinical-stage company to a commercial organization, we recently completed a comprehensive business review to reallocate investment from research and development toward our reimbursement-focused commercialization of PreTRM and to right size our operating expenses. As…

• Effective as of July 1, 2026 (the “Effective Date”), Paul Kearney will separate from Sera as our Chief Data Officer pursuant to the strategic prioritization. As a condition to Sera providing Dr. Kearney the severance benefits specified in his amended and restated executive employment agreement, date…

• During the quarter ended March 31, 2026, none of our executive officers (as defined in Section 16 of the Exchange Act) and directors adopted or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense of Rul…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• The following table provides information concerning Rule 10b5-1 trading arrangements (as defined in Item 408 of Regulation S-K under the Exchange Act) adopted during the quarter ended September 30, 2025 by any director or executive officer who is subject to the filing requirements of Section 16 of t…

• Sales under the trading arrangement will not commence until the selling start date. Subject to compliance with Rule 10b5-1, duration could cease earlier than the final date shown above pursuant to the terms of the trading arrangement.

• The 10b5-1 trading arrangement provides for the sale of up to (i) 132,021 shares of our Class A common stock plus (ii) the net number of shares of our Class A common stock underlying certain RSU awards. The number of shares to be sold pursuant to the Rule 10b5-1 trading arrangement is indeterminable…