(Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ SERA PROGNOSTICS, INC. ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40606 ___________________________ (Exact Name of Registrant as Specified in its Char ...

Exhibit 99.1 SERA PROGNOSTICS REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS Salt Lake City – May 8, 2024 – Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the first quarter of 2024 ended March 31, 2024. Recent Highlights: "While revenue for the quarter was impacted by revenue adjustments related to old accounts, we continue to b ...

Financial Data and Key Metrics Changes - Revenue for Q4 2023 was $41,000, down from $65,000 in Q4 2022, with total revenue for 2023 at $306,000, below the expected $400,000 [54] - Total operating expenses for Q4 2023 were $8.9 million, down from $10.5 million in the same period last year, due to streamlined operations [55] - Net loss for Q4 2023 was $7.9 million, improved from $9.7 million in Q4 2022, with cash and equivalents at approximately $79.9 million as of December 31, 2023 [57][58] Business Line Data and Key Metrics Changes - Research and development expenses increased to $3.9 million in Q4 2023 from $3.5 million in Q4 2022, primarily due to higher clinical study costs [55] - Selling, general and administrative expenses decreased to $5 million in Q4 2023 from $6.9 million in Q4 2022, reflecting cost reduction efforts [56] Market Data and Key Metrics Changes - The company anticipates a significant revenue inflection in 2025, contingent on achieving key milestones in 2024, including publications and payer coverage [19][61] Company Strategy and Development Direction - The company is focused on generating publications to validate its PreTRM Test, increasing contracts with insurance payers, and enhancing awareness among consumers and physicians [18][48] - A digital storefront is planned to provide expectant mothers with key information and facilitate easier ordering of products, aiming to expand revenue opportunities [50][51] - The company is working on a self-collection device for blood tests to improve accessibility and convenience for consumers [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2024, highlighting expected catalysts for commercial expansion and shareholder value [9] - The company is preparing for a potential major revenue increase in 2025, with a focus on executing key objectives in 2024 [62] - Management emphasized the importance of publications and payer coverage for driving physician adoption and revenue growth [90] Other Important Information - The Data Safety Monitoring Board recommended stopping enrollment in the PRIME study due to efficacy, which is expected to yield breakthrough results [10][11] - The company is engaging with guideline-setting bodies to ensure the adoption of its test and is preparing for multiple publications to support its strategy [70][88] Q&A Session Summary Question: Discussion on PRIME publication and engagement with guideline groups - Management confirmed ongoing updates to guideline-setting bodies and expressed confidence in the interest surrounding the results [68][70] Question: What is needed for successful engagement with payers? - Management highlighted the importance of leveraging data from studies and collaborating with payers to drive adoption [72][73] Question: Magnitude of benefits expected from the PRIME study - Management indicated that even modest improvements in outcomes could significantly impact health outcomes for mothers and infants [80][82] Question: Cash runway and assumptions for 2027 - Management stated that current cash levels are sufficient to extend into 2027, with careful investment in opportunities [83] Question: Timeline for guideline incorporation and necessity for payer coverage - Management noted that while guidelines are important for physician adoption, they are not a prerequisite for payer coverage [90][91]

Part I [Business](index=4&type=section&id=Item%201.%20Business) Sera Prognostics develops blood-based biomarker tests for maternal and neonatal health, with PreTRM® for preterm birth as its key product [Overview and Strategy](index=4&type=section&id=Overview%20and%20Strategy) Sera Prognostics develops blood-based tests for maternal health, expanding PreTRM payment and developing new pregnancy tests - The company's core business is developing and commercializing blood-based biomarker tests to improve pregnancy outcomes, with the PreTRM test for preterm birth risk as its first commercial product[16](index=16&type=chunk) - A key strategy is to expand payment for the PreTRM test across various market segments, including integrated systems, self-insured employers, and major health insurance payers, leveraging its commercial collaboration with Elevance Health[31](index=31&type=chunk) - Sera is actively developing a pipeline of new products to address other major pregnancy conditions, such as time-to-birth, preeclampsia, and gestational diabetes, by leveraging its proprietary technology platform[31](index=31&type=chunk) - Technological evolution is central to the company's strategy, including migrating from mass-spectrometry to immunoassays and implementing whole-blood collection and ambient specimen shipping to lower costs and improve user experience[31](index=31&type=chunk) [Proprietary Technology Platform and Development Approach](index=10&type=section&id=Proprietary%20Technology%20Platform%20and%20Development%20Approach) The company's platform uses biobanks, mass spectrometry, and bioinformatics to discover pregnancy biomarkers, adhering to NAM guidelines - The platform integrates proprietary biobanks, advanced mass spectrometry, and bioinformatics to characterize pregnancy biology and predict outcomes[39](index=39&type=chunk) - The company is enhancing its analytical techniques by developing an automated affinity-capture mass-spectrometry (AC-MS) PreTRM assay, expected to launch in H1 2024, which will increase throughput and lower costs[46](index=46&type=chunk) - Sera's development process strictly adheres to National Academy of Medicine (NAM) guidelines, requiring disciplined validation of predictions in independent specimen cohorts before clinical or commercial use[48](index=48&type=chunk) - A key part of the commercialization strategy is conducting controlled intervention trials (PREVENT-PTB, AVERT, PRIME) to demonstrate that its 'test and treat' strategy improves health outcomes and saves healthcare costs[50](index=50&type=chunk) [The PreTRM Test and Clinical Evidence](index=13&type=section&id=The%20PreTRM%20Test%20and%20Clinical%20Evidence) The PreTRM test predicts spontaneous preterm birth risk, validated in studies, with clinical utility shown in intervention trials - The PreTRM test is the only broadly validated, commercially available blood test to predict the risk of spontaneous preterm birth in singleton pregnancies[62](index=62&type=chunk) - The PREVENT-PTB study showed that for preterm infants, the test-and-treat strategy reduced hospital/NICU length-of-stay by over 70% and severe neonatal morbidity or death by 66%[78](index=78&type=chunk) - The AVERT PRETERM TRIAL met both co-primary endpoints, demonstrating a statistically significant reduction in severe neonatal morbidity/death and decreased length of neonatal hospital stay[80](index=80&type=chunk) - In December 2023, the Data Safety Monitoring Board for the PRIME study recommended stopping enrollment due to efficacy, as co-primary endpoints (neonatal hospital length of stay and composite neonatal morbidity/mortality) met statistical significance at the interim analysis[81](index=81&type=chunk) [Product Pipeline](index=20&type=section&id=Product%20Pipeline) Sera Prognostics develops a pipeline of biomarker tests for pregnancy conditions, following NAM guidelines Product Pipeline Development Status | Product Candidate | Condition Addressed | Development Stage | | :--- | :--- | :--- | | **Molecular Time-to-Birth** | Inaccurate due date prediction | Discovery and verification complete; assessing commercialization. | | **Predictive Analytics** | Various pregnancy features/conditions | Discovery complete; market assessment of prototype underway. | | **Pregnancy Risk Prediction Panel** | Overall risk of significant complications | Discovery and verification complete; market assessment underway. | | **Preeclampsia Test** | Preterm preeclampsia risk | Discovery, verification, and validation complete; selecting final predictor. | | **Growth Restriction Test** | Fetal Growth Restriction (FGR) | Discovery of placental dysfunction biomarkers complete. | | **Gestational Diabetes (GDM) Test** | Gestational Diabetes Mellitus | Discovery and verification complete. | | **Stillbirth Predictor** | Stillbirth risk | Discovery phase. | | **Postpartum Depression Predictor** | Postpartum depression risk | Discovery phase. | - The company estimates that the timing for its next commercially available product is a matter of months or years, contingent on performance data meeting NAM guidelines and the need for additional capital to accelerate progress[121](index=121&type=chunk) [Commercialization, Operations, and Agreements](index=24&type=section&id=Commercialization,%20Operations,%20and%20Agreements) Sera's commercialization focuses on payer reimbursement, operating a CLIA-certified lab, and developing cost-efficient processes - The company has a multi-year commercial collaboration agreement with Elevance Health, which agreed to purchase a specified minimum number of PreTRM tests for the first three years and facilitate commercialization among its members[122](index=122&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - The company operates a CLIA-certified and CAP-accredited laboratory in Salt Lake City, Utah[125](index=125&type=chunk) - Sera is developing an affinity-capture mass spectrometry (AC-MS) process to increase capacity, decrease turn-around time, and lower the cost of goods sold for its tests[126](index=126&type=chunk) [Competition and Intellectual Property](index=25&type=section&id=Competition%20and%20Intellectual%20Property) Sera believes PreTRM has a first-to-market advantage but anticipates competition, protecting its technology with patents and trade secrets - The company believes it has a first-to-market advantage, as it is not aware of any other broadly validated, commercially available blood-based biomarker test to predict a woman's risk of spontaneous preterm birth[133](index=133&type=chunk) - As of December 31, 2023, the company's intellectual property portfolio includes 3 issued U.S. patents, 5 pending U.S. non-provisional applications, 23 granted foreign patents, and 26 pending foreign patent applications[139](index=139&type=chunk) - Patents and applications related to the PreTRM test are expected to expire between 2034 and 2043[140](index=140&type=chunk) [Government Regulation](index=28&type=section&id=Government%20Regulation) Sera Prognostics is subject to extensive government regulation, including CLIA/CAP, state licensing, and potential FDA LDT oversight - The company's clinical laboratory in Salt Lake City holds a CLIA Certificate of Accreditation and is also accredited by the College of American Pathologists (CAP)[148](index=148&type=chunk)[149](index=149&type=chunk) - The PreTRM test is a Laboratory Developed Test (LDT) The FDA has historically exercised enforcement discretion over LDTs but issued a proposed rule in October 2023 to regulate them under the medical device framework, which could increase regulatory burdens[162](index=162&type=chunk)[165](index=165&type=chunk) - The company is subject to federal and state data privacy and security laws, including the Health Insurance Portability and Accountability Act (HIPAA) and the California Consumer Privacy Act (CCPA)[172](index=172&type=chunk)[180](index=180&type=chunk) - Operations are subject to federal and state anti-fraud laws, including the Anti-Kickback Statute (AKS), the Stark Law, and the Eliminating Kickbacks in Recovery Act (EKRA), which govern relationships with healthcare providers and referral sources[183](index=183&type=chunk)[187](index=187&type=chunk)[189](index=189&type=chunk) [Reimbursement and Billing](index=35&type=section&id=Reimbursement%20and%20Billing) Commercial success depends on securing payer reimbursement, influenced by PAMA, with PreTRM's PLA code priced at $750 - The company's ability to commercialize its products depends on obtaining adequate coverage and reimbursement from third-party payers, who assess whether a product is a covered benefit, medically necessary, and cost-effective[200](index=200&type=chunk)[201](index=201&type=chunk) - The Protecting Access to Medicare Act of 2014 (PAMA) has changed how clinical laboratory services are paid under Medicare, basing reimbursement on weighted-median private insurer payment rates[207](index=207&type=chunk) - In November 2021, CMS priced the unique PLA code for the PreTRM test at **$750** under the PAMA framework, which influences reimbursement rates from commercial insurers[213](index=213&type=chunk) [Human Capital](index=38&type=section&id=Human%20Capital) As of December 31, 2023, Sera Prognostics had 57 employees, focusing on talent acquisition and retention - As of **December 31, 2023**, the company had **57 employees**, **55** of whom were full-time[223](index=223&type=chunk) - The company's human capital strategy focuses on talent acquisition and retention, competitive total rewards, employee health and wellness, diversity, and training[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including net losses, PreTRM test reimbursement, competition, regulatory changes, and operational challenges - The company has a history of net losses (**$36.2 million** in 2023) and expects to incur future losses, with an accumulated deficit of **$246.9 million** as of December 31, 2023[237](index=237&type=chunk) - Substantially all revenue is derived from the PreTRM test, and the business is harmed if adoption and reimbursement do not increase[235](index=235&type=chunk)[255](index=255&type=chunk) - The company faces regulatory risk from potential FDA changes to the oversight of Laboratory Developed Tests (LDTs), which could increase costs and require additional clinical trials[353](index=353&type=chunk) - Operations are dependent on a single CLIA-certified laboratory in Salt Lake City, which, if it became inoperable, would halt testing and harm the business[235](index=235&type=chunk)[270](index=270&type=chunk) - The company relies on a limited number of customers, including Elevance Health, for a significant portion of its revenue, creating customer concentration risk[259](index=259&type=chunk) [Unresolved Staff Comments](index=80&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[431](index=431&type=chunk) [Cybersecurity](index=80&type=section&id=Item%201C.%20Cybersecurity) The company has established a comprehensive cybersecurity program based on NIST frameworks to manage and mitigate threats - The company's cybersecurity policies and practices are based on recognized frameworks from the National Institute of Standards and Technology (NIST)[432](index=432&type=chunk) - The Audit Committee of the Board of Directors is responsible for overseeing risks from cybersecurity threats and receives updates from management at least annually[438](index=438&type=chunk)[439](index=439&type=chunk) - The cybersecurity risk management and strategy are led by the Chief Information Officer and the information technology team[440](index=440&type=chunk) [Properties](index=82&type=section&id=Item%202.%20Properties) The company's headquarters, R&D, and CLIA-certified laboratory are in Salt Lake City, leasing 24,300 square feet until 2025 - The company leases approximately **24,300 square feet** in Salt Lake City, Utah for its headquarters, R&D, and laboratory[441](index=441&type=chunk) - The current facility lease expires on **December 31, 2025**, with an option to terminate after **July 1, 2024**[441](index=441&type=chunk) [Legal Proceedings](index=82&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, the company is not a party to any material litigation or other material legal proceedings - The company is not currently a party to any material legal proceedings[442](index=442&type=chunk) [Mine Safety Disclosures](index=82&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[443](index=443&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=83&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Sera Prognostics' Class A common stock trades on Nasdaq under "SERA"; the company has never paid cash dividends and does not plan to - The company's Class A common stock trades on the Nasdaq Global Market under the symbol "SERA"[445](index=445&type=chunk) - As of **March 15, 2024**, there were **120 stockholders** of record for Class A common stock and **2** for Class B common stock[446](index=446&type=chunk) - The company has never declared or paid a cash dividend and does not plan to in the foreseeable future[447](index=447&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=83&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2023, Sera Prognostics reported a reduced net loss of $36.2 million, driven by lower selling and marketing expenses [Results of Operations](index=87&type=section&id=Results%20of%20Operations) For 2023, Sera Prognostics reported a net loss of $36.2 million, improved from 2022, due to lower selling and marketing expenses Results of Operations (2023 vs. 2022) | | Year Ended December 31, | | | | :--- | :--- | :--- | :--- | | (in thousands) | **2023** | **2022** | **$ Change** | | **Revenue** | $306 | $268 | $38 | | **Operating Expenses** | | | | | Cost of revenue | $210 | $193 | $17 | | Research and development | $15,225 | $14,244 | $981 | | Selling and marketing | $8,349 | $14,699 | ($6,350) | | General and administrative | $16,343 | $16,784 | ($441) | | **Total operating expenses** | **$40,127** | **$45,920** | **($5,793)** | | **Loss from operations** | **($39,821)** | **($45,652)** | **$5,831** | | **Net loss** | **($36,242)** | **($44,186)** | **$7,944** | - Research and development expenses increased by **$1.0 million**, primarily due to a **$1.0 million** rise in clinical study costs related to increased activity in the PRIME study[475](index=475&type=chunk) - Selling and marketing expenses decreased by **$6.4 million**, mainly from a **$4.3 million** reduction in personnel-related costs and a **$0.7 million** cut in marketing programs, reflecting a strategic shift to focus on institutional sales[476](index=476&type=chunk) [Liquidity and Capital Resources](index=88&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had $79.9 million in cash, with net cash used in operations decreasing - As of **December 31, 2023**, the company had **$79.9 million** in cash, cash equivalents, and available-for-sale securities, with an accumulated deficit of **$246.9 million**[479](index=479&type=chunk) Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($27,188) | ($34,610) | | **Net cash provided by investing activities** | $438 | $5,551 | | **Net cash provided by financing activities** | $752 | $5 | | **Net decrease in cash and cash equivalents** | ($25,998) | ($29,054) | - The company believes its current cash runway is sufficient to fund operations into **2027** based on its existing operating plans[462](index=462&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=91&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate risk on its cash and marketable securities, with no significant foreign currency risk - The company's main market risk is interest rate risk on its cash and marketable securities A hypothetical **100 basis point** interest rate increase would decrease the market value of its securities by **$0.6 million** as of year-end 2023[499](index=499&type=chunk) - The company does not have material exposure to foreign currency risk but acknowledges that inflation could increase operating costs[501](index=501&type=chunk)[502](index=502&type=chunk) [Financial Statements and Supplementary Data](index=93&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for 2023 and 2022 are presented, detailing assets, liabilities, equity, and net loss [Financial Position](index=95&type=section&id=Financial%20Position) As of December 31, 2023, total assets were $95.4 million, liabilities $25.3 million, and stockholders' equity $70.2 million Balance Sheet Summary (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | $61,344 | $90,125 | | **Total Assets** | **$95,441** | **$116,329** | | **Total Current Liabilities** | $24,443 | $15,538 | | **Total Liabilities** | **$25,283** | **$17,386** | | **Total Stockholders' Equity** | **$70,158** | **$98,943** | [Operating Results](index=96&type=section&id=Operating%20Results) For 2023, the company reported revenue of $306,000 and a net loss of $36.2 million, improved from 2022 due to lower expenses Statement of Operations Summary (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Revenue** | $306 | $268 | | **Total Operating Expenses** | $40,127 | $45,920 | | **Loss from Operations** | ($39,821) | ($45,652) | | **Net Loss** | **($36,242)** | **($44,186)** | | **Net Loss Per Share** | **($1.16)** | **($1.43)** | [Cash Flows](index=98&type=section&id=Cash%20Flows) For 2023, net cash used in operating activities was $27.2 million, an improvement, with cash and equivalents ending at $3.9 million Statement of Cash Flows Summary (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($27,188) | ($34,610) | | **Net cash provided by investing activities** | $438 | $5,551 | | **Net cash provided by financing activities** | $752 | $5 | | **Net decrease in cash and cash equivalents** | ($25,998) | ($29,054) | | **Cash and cash equivalents at end of period** | $3,880 | $29,878 | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=117&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[616](index=616&type=chunk) [Controls and Procedures](index=117&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2023 - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **December 31, 2023**[619](index=619&type=chunk) - Management assessed internal control over financial reporting based on the COSO framework and concluded it was effective as of **December 31, 2023**[622](index=622&type=chunk) [Other Information](index=118&type=section&id=Item%209B.%20Other%20Information) CSO adopted a Rule 10b5-1 trading plan, and the Board approved accelerated RSU vesting for CEO and CFO - On **December 15, 2023**, the Chief Scientific Officer adopted a Rule 10b5-1 trading arrangement for the sale of **120,737 shares**[623](index=623&type=chunk) - On **March 15, 2024**, the Board approved accelerating the vesting of **100,000 RSUs** for CEO Zhenya Lindgardt and **26,250 RSUs** for CFO Austin Aerts[626](index=626&type=chunk)[628](index=628&type=chunk) [Disclosure Regarding Foreign Jurisdiction that Prevent Inspections](index=119&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdiction%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[630](index=630&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=120&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding the company's directors, executive officers, and corporate governance is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[633](index=633&type=chunk) [Executive Compensation](index=120&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[634](index=634&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=120&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners and management is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[635](index=635&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=120&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[636](index=636&type=chunk) [Principal Accounting Fees and Services](index=120&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from its upcoming proxy statement - This information is incorporated by reference from the company's upcoming Proxy Statement[637](index=637&type=chunk) Part IV [Exhibit and Financial Statement Schedules](index=121&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Annual Report on Form 10-K, including financial statements and exhibits - This section contains the index to financial statements and a list of all exhibits filed with the Form 10-K[639](index=639&type=chunk)[641](index=641&type=chunk) [Form 10-K Summary](index=124&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for this item - None[648](index=648&type=chunk)

Exhibit 99.1 SERA PROGNOSTICS REPORTS FOURTH QUARTER 2023 FINANCIAL RESULTS Salt Lake City – March 20, 2024 – Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the fourth quarter and full year ended December 31, 2023. Recent Highlights: "We are looking forward to an exciting year of developments for Sera, including publication of ...

Sera Prognostics, Inc (NASDAQ:SERA) Q3 2023 Earnings Conference Call November 8, 2023 5:00 PM ET Company Participants Peter DeNardo - Investor Relations Zhenya Lindgardt - President and Chief Executive Officer Austin Aerts - Chief Financial Officer Conference Call Participants Maggie Boeye - William Blair Tom Stevens - TD Cowen Operator Good afternoon, and welcome to the Sera Prognostics Conference Call to review Third Quarter Fiscal Year 2023 results. [Operator Instructions] As a reminder, this call is bei ...

[PART I — FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company's financial statements show reduced net losses and negative operating cash flow, with declining assets and equity [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) The company's balance sheet reflects a decrease in total assets and stockholders' equity, mainly due to reduced cash Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,655 | $29,878 | | Total current assets | $47,546 | $90,125 | | Total assets | $90,057 | $116,329 | | **Liabilities & Equity** | | | | Total current liabilities | $13,545 | $15,538 | | Total liabilities | $14,646 | $17,386 | | Total stockholders' equity | $75,411 | $98,943 | - The company had an accumulated deficit of **$239.0 million** as of September 30, 2023[25](index=25&type=chunk)[14](index=14&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a reduced net loss for Q3 and the nine months ended September 30, 2023, driven by lower operating expenses Statement of Operations Summary (in thousands) | Metric | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $42 | $87 | $265 | $203 | | Total operating expenses | $8,226 | $11,275 | $31,238 | $35,437 | | Loss from operations | $(8,184) | $(11,188) | $(30,973) | $(35,234) | | Net loss | $(7,210) | $(10,712) | $(28,317) | $(34,440) | | Net loss per share | $(0.23) | $(0.35) | $(0.91) | $(1.11) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased for the nine months ended September 30, 2023, ending the period with **$9.7 million** in cash Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,423) | $(27,372) | | Net cash provided by investing activities | $64 | $7,129 | | Net cash provided by financing activities | $136 | $121 | | **Net decrease in cash and cash equivalents** | **$(20,223)** | **$(20,122)** | | Cash and cash equivalents at end of period | $9,655 | $38,810 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes to financial statements detail the company's accumulated deficit, liquidity outlook, and significant commercial and compensation agreements - The company has incurred net losses since inception and had an accumulated deficit of **$239.0 million** as of September 30, 2023[25](index=25&type=chunk) - Management believes that existing financial resources, including **$85.0 million** in cash, cash equivalents, and marketable securities, are sufficient to continue operating activities for at least 12 months from the filing date[26](index=26&type=chunk)[27](index=27&type=chunk) - The company has a commercial collaboration agreement with Elevance Health, which includes minimum test purchase and payment commitments; **$6.0 million** was received during the first nine months of 2023 related to minimum payments for 2022[49](index=49&type=chunk) - As of September 30, 2023, there was **$6.9 million** of total unrecognized stock-based compensation expense related to unvested stock options and RSUs[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses PreTRM test commercialization, expense reduction, and the sufficiency of current cash to fund operations for at least 12 months [Overview](index=20&type=section&id=Overview) Sera Prognostics focuses on the PreTRM test and PRIME study, managing operating losses to extend its cash runway - The company's 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[77](index=77&type=chunk) - The ongoing PRIME study will have an interim analysis in 2023, with final enrollment expected in 2024 and final results reported in 2025; the company is adding up to **1,000** more patients to the study based on insights from the AVERT trial[78](index=78&type=chunk)[79](index=79&type=chunk) - The company has incurred significant operating losses, with net losses of **$28.3 million** for the nine months ended September 30, 2023; it has taken steps to reduce annual operating expenses and believes its cash runway is sufficient for several years[84](index=84&type=chunk)[85](index=85&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Net loss improved for Q3 and the nine months ended September 30, 2023, primarily due to reduced operating expenses Comparison of Operating Results (in thousands) | Metric | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $42 | $87 | $265 | $203 | | Research and development | $3,539 | $4,176 | $11,330 | $10,759 | | Selling and marketing | $1,355 | $2,967 | $7,045 | $11,644 | | General and administrative | $3,288 | $4,074 | $12,677 | $12,900 | | **Net loss** | **$(7,210)** | **$(10,712)** | **$(28,317)** | **$(34,440)** | - The **$1.6 million** decrease in Q3 2023 selling and marketing expenses was primarily due to a **$1.2 million** reduction in personnel-related costs from decreased headcount, reflecting a streamlined commercial strategy focused on institutional sales[100](index=100&type=chunk) - The **$0.6 million** increase in R&D expenses for the nine-month period was mainly due to a **$0.7 million** increase in costs from increased enrollment and site setup activity in the PRIME study[104](index=104&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position, including **$85.0 million** in cash and equivalents, is deemed sufficient for at least 12 months despite an accumulated deficit - As of September 30, 2023, the company had aggregate cash, cash equivalents, and available-for-sale securities of **$85.0 million** and an accumulated deficit of **$239.0 million**[109](index=109&type=chunk) - The company believes its existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements for at least the next 12 months[115](index=115&type=chunk) Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,423) | $(27,372) | | Net cash provided by investing activities | $64 | $7,129 | | Net cash provided by financing activities | $136 | $121 | [Quantitative and Qualitative Disclosure About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on marketable securities, with potential cost increases from inflation - The company's primary market risk is interest rate risk on its cash, cash equivalents, and marketable securities; a hypothetical **100 basis point** interest rate increase would have resulted in a **$0.7 million** decrease in the market value of its available-for-sale debt securities as of September 30, 2023[123](index=123&type=chunk) - The company does not believe inflation has had a material effect on results to date, but acknowledges the current inflationary environment could increase costs of labor, supplies, and clinical trials[125](index=125&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2023, with no material changes to internal financial reporting controls - The company's management, including the CEO and CFO, concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[127](index=127&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[128](index=128&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings, but may be in the future - The company is not currently a party to any material litigation or other material legal proceedings[130](index=130&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to financial position, product commercialization, regulatory environment, intellectual property, and stock price volatility [Risks Related to Financial Position and Capital](index=33&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company faces risks from ongoing net losses, dependence on PreTRM test adoption, and challenges in raising capital efficiently - The company has incurred net losses since inception and anticipates continued losses, which could harm future business prospects[134](index=134&type=chunk)[136](index=136&type=chunk) - The business relies substantially on revenues from the PreTRM test, and failure to increase its adoption and secure reimbursement will harm the business[134](index=134&type=chunk)[155](index=155&type=chunk) - Due to a failure to timely file a Form 8-K, the company is currently ineligible to file new short-form registration statements on Form S-3, which may impair its ability to raise capital favorably or in a timely manner[153](index=153&type=chunk)[154](index=154&type=chunk) [Risks Related to Business and Industry](index=37&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company faces business risks from intense competition, reliance on a single lab, and dependence on limited suppliers for key materials - The company faces intense competition from companies with greater financial resources and expertise in R&D, manufacturing, and commercialization[134](index=134&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk) - The company's CLIA-certified laboratory in Salt Lake City is its sole facility for processing tests; if it becomes inoperable, the business will be harmed[134](index=134&type=chunk)[170](index=170&type=chunk) - The company relies on a limited number of, or single-source, suppliers for laboratory instruments and materials, as well as third parties for specimen collection, creating supply chain and operational vulnerabilities[134](index=134&type=chunk)[189](index=189&type=chunk)[191](index=191&type=chunk) [Risks Related to Reimbursement](index=47&type=section&id=Risks%20Related%20to%20Reimbursement) The company faces critical risks from the uncertainty of obtaining and maintaining adequate reimbursement for the PreTRM test from third-party payers - The company's ability to generate revenue is highly dependent on obtaining adequate coverage and reimbursement from third-party payers, which is uncertain and may not be achieved[135](index=135&type=chunk)[206](index=206&type=chunk) - The AMA has issued a unique CPT PLA code for the PreTRM test, but there is no guarantee of favorable reimbursement rates; billing disputes and potential recoupment of past payments from payers are significant risks[213](index=213&type=chunk)[216](index=216&type=chunk) - Being an out-of-network provider for major insurers may cause healthcare providers to avoid recommending the company's tests, negatively impacting test volume[135](index=135&type=chunk)[229](index=229&type=chunk) [Risks Related to Government Regulation](index=52&type=section&id=Risks%20Related%20to%20Government%20Regulation) The company faces significant regulatory risks from potential FDA regulation of LDTs, CLIA compliance, and adherence to data privacy and anti-kickback laws - The FDA has issued a proposed rule to regulate LDTs, which could subject the PreTRM test to extensive regulatory requirements, including premarket approval, and significantly increase costs[135](index=135&type=chunk)[252](index=252&type=chunk) - Failure to comply with federal (CLIA) and state laboratory licensing requirements could lead to sanctions, including the loss of the ability to perform tests, which would severely disrupt business[135](index=135&type=chunk)[245](index=245&type=chunk) - The company is subject to complex data privacy and security laws like HIPAA and CCPA, and a security breach could lead to significant liability, fines, and reputational damage[261](index=261&type=chunk)[271](index=271&type=chunk) - Business activities are subject to federal and state anti-kickback and fraud and abuse laws (e.g., AKS, Stark Law), and violations could result in substantial penalties, exclusion from healthcare programs, and criminal proceedings[277](index=277&type=chunk)[278](index=278&type=chunk) [Risks Related to Intellectual Property](index=61&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company faces intellectual property risks related to obtaining, maintaining, and enforcing rights, including patent challenges and trade secret protection - Failure to obtain, maintain, and enforce intellectual property rights for its tests and technology could impair the company's ability to compete[135](index=135&type=chunk)[287](index=287&type=chunk) - Issued patents could be found invalid or unenforceable if challenged, and recent court decisions have created uncertainty regarding the patent-eligibility of diagnostic methods[135](index=135&type=chunk)[291](index=291&type=chunk)[296](index=296&type=chunk) - The company relies on trade secrets, including its proprietary algorithm, and if it cannot prevent their disclosure, the value of its technology could be significantly diminished[135](index=135&type=chunk)[302](index=302&type=chunk) [Risks Related to Class A Common Stock](index=65&type=section&id=Risks%20Related%20to%20Our%20Class%20A%20Common%20Stock) The company's Class A common stock faces risks from price volatility, concentrated ownership, dual-class structure, and anti-takeover provisions - The trading price of the Class A common stock is likely to be highly volatile due to various factors, including operating results, competitor announcements, and market fluctuations[135](index=135&type=chunk)[304](index=304&type=chunk) - Executive officers, directors, and stockholders with **5%** or more ownership hold a significant percentage of stock, enabling them to exert significant control over matters subject to stockholder approval[309](index=309&type=chunk) - The company is an emerging growth company and a smaller reporting company, which allows for reduced disclosure requirements that may make its stock less attractive to investors[313](index=313&type=chunk) - Anti-takeover provisions in the company's charter and Delaware law could delay or prevent a change in control, potentially limiting the market price of the stock[320](index=320&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered equity sales or repurchases in Q3 2023, and confirmed no material change in IPO proceeds use - The company received net proceeds of approximately **$66.6 million** from its IPO in July 2021, and there has been no material change in the planned use of these proceeds[336](index=336&type=chunk) - There were no unregistered sales of equity securities or issuer repurchases of equity securities during the quarter ended September 30, 2023[333](index=333&type=chunk)[337](index=337&type=chunk) [Other Information](index=72&type=section&id=Item%205.%20Other%20Information) The company appointed new permanent CEO and CFO, reduced executive compensation for cost savings, and granted new RSU awards for employee retention - On November 6, 2023, the Board appointed Evguenia (Zhenya) Lindgardt as President and Chief Executive Officer and Austin Aerts as Treasurer and Chief Financial Officer[338](index=338&type=chunk)[346](index=346&type=chunk) - Effective November 6, 2023, all executive officers' annual base salaries were reduced by **15%** and annual target bonuses were reduced by **50%**, expected to result in savings of at least **$900,000** in 2024[354](index=354&type=chunk) - On November 6, 2023, the company granted new RSU awards to all employees, including its executive officers, to help retain key talent[355](index=355&type=chunk) [Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents and new executive and RSU agreements - Filed exhibits include new employment agreements for CEO Evguenia Lindgardt and CFO Austin Aerts, and the form of a new Restricted Stock Unit (RSU) agreement[358](index=358&type=chunk)

Sera Prognostics, Inc. (NASDAQ:SERA) Q2 2023 Earnings Conference Call August 9, 2023 5:00 PM ET Company Participants Peter DeNardo – Investor Relations-CapComm Partners Zhenya Lindgardt – Interim President and Chief Executive Officer Austin Aerts – Interim Chief Financial Officer Conference Call Participants Dustin Scaringe – Blair Operator Good afternoon. And welcome to the Sera Prognostics’ conference call to review Second Quarter Fiscal Year 2023 Results. [Operators Instructions] As a reminder, this call ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40606 ___________________________ SERA PROGNOSTICS, INC. (Exact Name of Registrant as Specified in its Chart ...

Sera Prognostics, Inc. (NASDAQ:SERA) Q1 2023 Earnings Conference Call May 10, 2023 5:00 PM ET Company Participants Peter DeNardo - CapComm Partners, IR Greg Critchfield - Chairman, President & Chief Executive Officer Jay Moyes - Chief Financial Officer Conference Call Participants Tom Stevens - Cowen Dan Brennan - Cowen Andrew Brackmann - William Blair Operator Good afternoon, and welcome to the Sera Prognostics Conference Call to review the First Quarter Fiscal Year 2023 results. At this time, all particip ...