SERA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-12

• 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…

• We are currently processing publication manuscripts of additional PRIME data, including exploratory analyses and economic benefits, to be submitted in the coming months. For example, in July 2026, a subgroup analysis of the PRIME randomized controlled trial was published in The Journal of Maternal-F…

• Since March 31, 2026, Key Developments Affecting Our Business Include the Following:

• Advanced Commercial Adoption Strategy with Fourth Partnership Program Launch: In August 2026, we launched fourth partnership program, expanding implementation of PreTRM Test-guided care through a state-based initiative with a national payer. We also exceeded our 2026 payer engagement objective, with…

• Illinois Medicaid Coverage Mandate Expands Access to PreTRM Test: In June 2026, Illinois enacted legislation (Public Act 104-0470, Section 5-54) requiring Medicaid coverage and reimbursement for prescribed proteomic blood tests used to identify spontaneous preterm birth risk and associated intervent…

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

• 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 …

• to us. If we are unable to raise additional funds through equity or debt financings when needed, we may have to significantly delay, reduce, or eliminate some or all of our product development or future commercialization efforts, or grant rights to develop and market product candidates that we would…

• Comparison of the Three Months Ended March 31, 2026 and 2025

• The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:

Text added vs the prior filing · source: 10-Q · 2026-08-12

• 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 June 30, 2026. Based on …

• There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 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 · 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 added vs the prior filing · source: 10-Q · 2026-08-12

• In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which may prohibit certain business combinations with stockholders owning 15% or more

• of our outstanding voting stock. 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 …

• Our inability to maintain effective disclosure controls and procedures could adversely affect our results of operations, liquidity and financial position, as well as our stock price and investor confidence in us.

• As a public company, we are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to m…

• We are required to disclose changes made in our internal controls and procedures on a quarterly basis and our management is required to assess the effectiveness of these controls annually. However, as long as we are an EGC and a smaller reporting company with revenues under $100 million, our indepen…

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

• In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the General Corporation Law of the State of Delaware, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These anti-takeover p…

• the rules and regulations thereunder and that there is uncertainty as to whether a court would enforce an exclusive forum provision for actions arising under the Securities Act.

• 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.

• As a public company, we are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to m…

• We are required to disclose changes made in our internal controls and procedures on a quarterly basis and our management are required to assess the effectiveness of these controls annually. However, as long as we are an EGC and a smaller reporting company

Text added vs the prior filing · source: 10-Q · 2026-08-12

• 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 June 30, 2026 by any director or executive officer who is subject to the filing requirements of Section 16 of the Ex…

• (1) 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.

• (2) The 10b5-1 trading arrangement provides for the sale of up to (i) 334,684 shares of our Class A common stock plus (ii) the net number of shares of our Class A common stock underlying certain restricted stock unit, or RSU, awards. The number of shares to be sold pursuant to the Rule 10b5-1 tradin…

Text removed 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…