SERA PROGNOSTICS, INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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Sep 30, 2025 · Filed Nov 13, 2025
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Special Note Regarding Forward-Looking Statements
This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
our expectations regarding the rate and degree of market acceptance of our products and services, including our PreTRM test;
the impact of our PreTRM test, including the results of any studies of the test, on the field of bioinformatics and proteomics and the size and growth of the addressable bioinformatics and proteomics market;
our expectations regarding the future use of our PreTRM test based on the PRIME study results and that the PreTRM test has the potential to address a significant unmet need;
our ability to manage and grow our business and commercialize our PreTRM test;
our ability to develop and commercialize new products and services;
the pricing and reimbursement of our products and services, including new Current Procedural Terminology codes and their payment rates;
the implementation of our business model, strategic plans for our business, products, services, and technology;
regulatory developments in the United States and foreign countries, including changes in U.S. Food and Drug Administration regulation of laboratory-developed tests;
the expected impact of global business, political, and macroeconomic conditions, including inflation, fluctuations in interest rates, volatile market conditions, potential for local and/or global economic slowdown or recession, uncertainty with respect to the federal budget and debt ceiling and government shutdowns related thereto, potential changes in trade laws, regulations, and policies in the United States and abroad, including the imposition or expansion of tariffs, trade restrictions, or export controls, and the impact of such changes on the availability and cost of key inputs, including reagents, biological materials, and lab equipment, as well as raw material and shipping costs, global supply chains, and the pace of product and service development, cybersecurity events, instability in the global banking system, and global events, including regional conflicts around the world, on our business, clinical trials, financial condition, liquidity, and results of operations; and
our financial performance.
These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described in the “Risk Factors” section and elsewhere in this Quarterly Report on Form 10-Q. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable as of the date of this Quarterly Report on Form 10-Q, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to new information, actual results or to changes in our expectations, except as required by law.
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