Accessibility StatementSkip Navigation SALT LAKE CITY, Oct. 1, 2025 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker testing to help deliver information to doctors and patients, today announced the appointment of Tiffany Inglis, MD, FACOG, as Chief Medical Officer. With extensive clinical leadership expertise, Dr. Inglis will lead Sera's clinical operations to establish the company as ...

This is my second Sera Prognostics (NASDAQ: SERA ) article, following 01/2024's "Sera Prognostics: The Pregnancy Company On A Hot Streak." In Hot Streak I rated Sera as a "Hold." Its hot streak has cooled noticeably, the company havingWriting under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and fro ...

Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing their offerings in this area [1] - The publication of thousands of quarterly earnings calls per quarter suggests a significant volume of content being generated and shared with readers [1] - The ongoing growth and expansion of coverage highlight the company's strategic direction towards increasing its market presence and service offerings in transcript-related services [1]

Summary of Sera Prognostics Conference Call Company Overview - **Company**: Sera Prognostics - **Industry**: Healthcare, specifically focused on pregnancy and preterm birth risk assessment - **Product**: PreTRM Test, a clinically validated test for screening risks of spontaneous premature birth [2][3][4] Key Points and Arguments Challenges in Preterm Birth - **Prevalence**: 1 in 10 babies are born prematurely, defined as birth before 37 weeks of gestation [2][3] - **Trends**: Preterm birth rates in the U.S. have increased from 9.4% in 2013 to 10.4% in 2023, indicating a double-digit compound growth rate [5] - **Healthcare Costs**: Prematurity costs the U.S. healthcare system approximately $25 billion annually [4] - **NICU Costs**: Average NICU stay costs around $4,500 per day, with extremely premature babies costing up to $20,000 per day [6] PreTRM Test Overview - **Unique Selling Proposition**: The PreTRM Test is the only clinically validated test for early prediction of premature birth, utilizing proteomics to measure biomarkers [10][15] - **Biomarkers**: The test measures the ratio of IGFBP4 and SHBG proteins to assess risk for spontaneous preterm birth [10][11] - **Timing**: The test is conducted during weeks 18 to 20 of pregnancy, integrating into standard care [11] Clinical Validation and Efficacy - **Clinical Studies**: The PreTRM Test has been validated through studies like AVERT and PRIME, showing significant reductions in NICU admissions and improved neonatal health outcomes [16][19] - **Efficiency**: The number needed to screen to avoid one NICU admission is 40, compared to 150 for traditional methods [17] - **Cost Savings**: Only four women need to be screened to avoid one NICU day stay [20] Commercialization Strategy - **Funding**: Sera Prognostics is well-funded with approximately $110 million in cash and a $30 million annual operating budget [4] - **Targeted States**: The company is focusing on six key states for commercialization, with a sales force and access team to ensure reimbursement and awareness [21][22] - **Partnerships**: Collaborations with payers and digital education channels to increase awareness among clinicians and expectant mothers [23][25] Future Outlook - **Guideline Inclusion**: Aiming for inclusion in clinical guidelines and payer coverage based on clinical evidence [21] - **Health Economic Model**: The breakeven for deploying the test could be achieved within a year, presenting data at the ISPOR Europe Conference [24] - **Community Impact**: The goal is to empower mothers and educate providers to improve health outcomes for babies [25] Additional Important Information - **Healthcare System Impact**: The implications of preterm birth extend beyond immediate healthcare costs, affecting long-term health and economic outcomes for families [6][7] - **Awareness Gap**: Only 20% of expectant mothers are informed about the risks of preterm birth during their first appointment [9] - **Technological Investment**: Sera Prognostics is investing in AI and machine learning to enhance predictive algorithms for the PreTRM Test [13][14] This summary encapsulates the critical insights from the conference call, highlighting the challenges, solutions, and strategic direction of Sera Prognostics in addressing preterm birth risks.

Core Insights - Sera Prognostics Inc. will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, highlighting the company's latest achievements [1] - The company focuses on improving maternal and neonatal health through innovative pregnancy biomarker information [1][3] Company Overview - Sera Prognostics is dedicated to enhancing the lives of women and babies via precision pregnancy care, aiming to provide early pregnancy information to improve health outcomes and reduce healthcare costs [3] - The company has a robust pipeline of diagnostic tests, particularly the PreTRM® Test, which predicts the risk of spontaneous premature delivery [3][5] Preterm Birth Context - Preterm birth, defined as any birth before 37 weeks' gestation, is a leading cause of illness and death in newborns, with over 10% of infants born prematurely in the U.S. for the last six years [4] - The annual healthcare costs associated with managing complications from prematurity in the U.S. were estimated at approximately $25 billion in 2016 [4] PreTRM® Test Details - The PreTRM® Test is the only broadly validated blood-based biomarker test that provides early and accurate risk predictions for spontaneous preterm birth in asymptomatic singleton pregnancies [5] - This test allows physicians to identify women at increased risk for preterm birth between weeks 18 and 20 of pregnancy, facilitating personalized clinical decisions [5]

Financial Data and Key Metrics Changes - Net revenue for the second quarter of fiscal year 2025 was $17 million, down from $24 million in the same quarter of 2024 [18] - Total operating expenses remained flat at $9.3 million compared to the previous year [18] - Research and development expenses decreased by approximately 24% to $3.3 million from $4.4 million due to lower clinical study costs [18] - Selling, general and administrative expenses increased to $6 million from $4.9 million as the company invests in targeted commercial activities [18] - Net loss for the quarter was $8 million, slightly improved from $8.3 million in the prior year [18] - As of June 30, 2025, the company had cash and cash equivalents of approximately $108.5 million, expected to fund operations through significant adoption and commercial milestones until 2028 [18] Business Line Data and Key Metrics Changes - The company is focusing on commercial strategies and tactics to enhance market awareness through data generation, particularly with the PRIME study results [5][6] - The company plans to publish additional data on health economic benefits and subpopulation analysis to support its reimbursement strategy [6][7] Market Data and Key Metrics Changes - The company is targeting Medicaid plan pilots in states with above-average premature birth rates, with hopes to sign two to four pilot programs in the coming months [9][10] - The company is also expanding its commercial reach in Europe, particularly in the UK, France, and Germany, where there is a recognized unmet need for preterm birth risk assessment [15][16] Company Strategy and Development Direction - The company aims to build market awareness and revenue through strategic partnerships and by enhancing its commercial team [12][13] - The transition of the preterm test from mass spectrometry to an immunoassay is part of the strategy to facilitate market entry in Europe [16][17] - The company is focused on generating evidence that meets regulatory standards for approval and reimbursement in Europe [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming publication of the PRIME study results and the potential impact on reimbursement strategies [6][25] - The company is actively engaging with healthcare provider organizations and opinion leaders to drive clinical utilization of its tests [9][10] - Management highlighted the importance of the upcoming medical conferences for sharing data and increasing awareness among clinicians [13][14] Other Important Information - The company has made key strategic leadership hires to enhance its commercial capabilities, including a new Chief Commercial Officer and head of market access [11][12] - The company plans to report on key commercialization performance indicators in the coming quarters [15] Q&A Session Summary Question: Can you discuss the milestones in your commercial efforts since adding Lee? - Management noted that Lee has emphasized the test's role in augmenting care protocols and has focused on expanding the commercial team with experienced sales leaders [22][23] Question: What is the rationale for expanding into the EU market? - Management explained that European opinion leaders encouraged the company to expand, and they plan to partner with local entities to minimize costs [29][30] Question: How many sales representatives have been hired, and how will Medicaid coverage affect hiring? - Management indicated that they currently have a 10% sales force and are prepared to hire more as reimbursement traction is achieved in targeted states [31][32] Question: Any updates on feedback regarding the ACOG bulletin? - Management highlighted the positive shift in ACOG's approach towards tailored care pathways, which aligns with the company's objectives [34][36]

[Special Note Regarding Forward-Looking Statements](index=3&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section highlights forward-looking statements, emphasizing their inherent risks and uncertainties, and disclaims any obligation to update them, except as required by law - Forward-looking statements are subject to risks, uncertainties, and assumptions, including those described in the 'Risk Factors' section[10](index=10&type=chunk) - The company operates in a competitive and rapidly changing environment, with new risks emerging frequently[10](index=10&type=chunk) - The company undertakes no obligation to publicly update forward-looking statements after the report date, except as required by law[11](index=11&type=chunk) [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)) This section presents unaudited condensed financial statements, including balance sheets, statements of operations, equity, and cash flows, with detailed notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------------------------- | :-------------- | :---------------- | :----- | | Total assets | $111,828 | $72,575 | +$39,253 | | Total liabilities | $23,602 | $24,772 | -$1,170 | | Total stockholders' equity | $88,226 | $47,803 | +$40,423 | | Cash and cash equivalents | $5,016 | $4,043 | +$973 | | Marketable securities (current) | $35,144 | $42,193 | -$7,049 | | Long-term marketable securities | $68,351 | $21,973 | +$46,378 | [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Statements of Operations and Comprehensive Loss Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Revenue | $17 | $24 | $55 | $24 | | Total operating expenses | $9,337 | $9,277 | $18,625 | $18,374 | | Loss from operations | $(9,320) | $(9,253) | $(18,570) | $(18,350) | | Net loss | $(8,046) | $(8,303) | $(16,233) | $(16,400) | | Net loss per share, basic and diluted | $(0.16) | $(0.25) | $(0.36) | $(0.50) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Changes in Stockholders' Equity (in thousands) | Metric | Balance as of Dec 31, 2024 | Issuance of common stock and pre-funded warrants, net | Stock-based compensation expense | Net loss | Balance as of June 30, 2025 | | :--------------------------------- | :------------------------- | :------------------------------------------ | :------------------------------- | :--------- | :-------------------------- | | Total Stockholders' Equity | $47,803 | $53,611 | $2,837 | $(16,233) | $88,226 | - Net proceeds from the February 2025 Offering contributed **$53.6 million** to additional paid-in capital[21](index=21&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(13,026) | $(934) | | Net cash used in investing activities | $(39,561) | $(540) | | Net cash provided by financing activities | $53,560 | $2,258 | | Net increase in cash and cash equivalents | $973 | $784 | | Cash and cash equivalents at end of period | $5,016 | $4,664 | - Net cash provided by financing activities in 2025 was primarily due to **$53.6 million** from the February 2025 Offering[135](index=135&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) [1. Description of the Business](index=9&type=section&id=1.%20Description%20of%20the%20Business) - Sera Prognostics, Inc is a women's health company utilizing its proprietary proteomics and bioinformatics platform to improve maternal and neonatal health[26](index=26&type=chunk) - The company's primary product is the PreTRM test, a blood-based biomarker test[27](index=27&type=chunk) [2. Significant Accounting Policies](index=9&type=section&id=2.%20Significant%20Accounting%20Policies) - Unaudited condensed financial statements are prepared in accordance with U.S GAAP and SEC interim reporting rules, with estimates made based on historical and anticipated results[28](index=28&type=chunk)[30](index=30&type=chunk) - Pre-funded warrants issued in February 2025 are equity classified as they are freestanding, immediately exercisable, and indexed to Class A common stock[32](index=32&type=chunk) - The company is evaluating the impact of recently issued accounting pronouncements ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation Disclosures)[33](index=33&type=chunk)[34](index=34&type=chunk) [3. Cash, Cash Equivalents and Marketable Securities](index=11&type=section&id=3.%20Cash,%20Cash%20Equivalents%20and%20Marketable%20Securities) Cash, Cash Equivalents and Marketable Securities (in thousands) | Category | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :--------------------------------- | :------------------------- | :------------------------- | | Cash and cash equivalents | $5,016 | $4,043 | | Current marketable securities | $35,144 | $42,193 | | Long-term marketable securities | $68,351 | $21,973 | | Total | $108,511 | $68,209 | - All marketable securities are classified as available-for-sale, with unrealized losses attributed to normal market and interest rate fluctuations, not credit quality[36](index=36&type=chunk) Marketable Securities by Contractual Maturities (in thousands) as of June 30, 2025 | Maturity | Amortized Cost | Fair Value | | :-------------------------- | :------------- | :--------- | | Due within one year | $35,106 | $35,144 | | Due after one year through five years | $68,244 | $68,351 | | Total | $103,350 | $103,495 | [4. Property and Equipment](index=13&type=section&id=4.%20Property%20and%20Equipment) Property and Equipment, Net (in thousands) | Component | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Total property and equipment | $9,303 | $8,995 | | Less accumulated depreciation and amortization | $(8,099) | $(7,756) | | Property and equipment, net | $1,204 | $1,239 | - Depreciation and amortization expense was **$0.2 million** for each of the three months ended June 30, 2025 and 2024, and **$0.4 million** for each of the six months ended June 30, 2025 and 2024[39](index=39&type=chunk) [5. Intangible Assets, Net](index=13&type=section&id=5.%20Intangible%20Assets,%20Net) Intangible Assets, Net (in thousands) | Category | June 30, 2025 Net Carrying Amount | December 31, 2024 Net Carrying Amount | | :--------------------------------- | :-------------------------------- | :------------------------------------ | | Indefinite-lived intangible assets: Domain names | $697 | $697 | | Definite-lived intangible assets: Software developed for sale | $271 | $329 | | Total intangible assets, net | $968 | $1,026 | - Amortization expense for software developed for sale was **$29 thousand** for the three months and **$58 thousand** for the six months ended June 30, 2025, recorded in cost of revenue[40](index=40&type=chunk) [6. Accrued and Other Current Liabilities](index=13&type=section&id=6.%20Accrued%20and%20Other%20Current%20Liabilities) Accrued and Other Current Liabilities (in thousands) | Component | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Accrued compensation | $865 | $1,041 | | Accrued vacation | $574 | $403 | | Operating lease liability, current portion | $328 | $644 | | Other current liabilities | $529 | $296 | | Total accrued and other current liabilities | $2,296 | $2,384 | [7. Other Income, Net](index=15&type=section&id=7.%20Other%20Income,%20Net) Other Income, Net (in thousands) | Component | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Interest income | $1,194 | $671 | $2,115 | $1,341 | | Investment income, net | $82 | $287 | $228 | $626 | | Total other income, net | $1,276 | $958 | $2,343 | $1,967 | [8. Fair Value Measurements](index=15&type=section&id=8.%20Fair%20Value%20Measurements) - Fair value hierarchy prioritizes inputs: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), Level 3 (unobservable inputs)[46](index=46&type=chunk)[47](index=47&type=chunk) Assets Measured at Fair Value (in thousands) as of June 30, 2025 | Asset Category | Level 1 | Level 2 | Level 3 | | :--------------------------------- | :------ | :-------- | :------ | | Money market funds | $3,885 | $— | $— | | Commercial paper | $— | $2,954 | $— | | Corporate debt securities | $— | $78,424 | $— | | Municipal debt securities | $— | $8,715 | $— | | U.S. federal agency securities | $— | $13,402 | $— | | Total assets | $3,885 | $103,495 | $— | [9. Related Party Transactions](index=16&type=section&id=9.%20Related%20Party%20Transactions) - Commercial Collaboration Agreement with Elevance Health provides defined payment for PreTRM test use within their network, with minimum test purchases for the first three years[51](index=51&type=chunk) - Enrollment in the PRIME study, involving Carelon Research (Elevance Health subsidiary), ceased in December 2023 due to efficacy, leading to no revenue from this agreement in the current periods[50](index=50&type=chunk)[52](index=52&type=chunk) - Affiliates of principal stockholders purchased **11,250,000** pre-funded warrants and **625,000** Class A common stock shares in the February 2025 public offering[53](index=53&type=chunk)[54](index=54&type=chunk) [10. Capital Structure](index=18&type=section&id=10.%20Capital%20Structure) - The company has Class A (voting) and Class B (non-voting, convertible) common stock[55](index=55&type=chunk) February 2025 Public Offering Details | Item | Quantity | Price | Net Proceeds | | :--------------------------------- | :--------- | :---------- | :----------- | | Class A Common Stock | 3,125,000 shares | $4.00/share | $53.6 million | | Pre-Funded Warrants | 11,250,000 shares | $3.9999/warrant | | Shares Reserved for Future Issuance (Class A Common Stock) | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Warrants to purchase Class A common stock | 13,896,247 | 2,646,247 | | Options to purchase Class A common stock | 6,778,649 | 6,113,155 | | Restricted stock units outstanding | 1,895,616 | 1,631,162 | | Available for future grants (2021 Equity Incentive Plan) | 1,799,984 | 2,071,498 | | Available for future grants (2021 Employee Stock Purchase Plan) | 1,335,718 | 1,060,293 | | Total | 25,706,214 | 13,522,355 | [11. Stock-Based Compensation](index=19&type=section&id=11.%20Stock-Based%20Compensation) - The company has three equity incentive plans: 2011 Plan (terminated for new grants), 2021 Plan, and 2021 ESPP[61](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) Stock Options and RSUs Outstanding | Metric | Stock Options (June 30, 2025) | RSUs (June 30, 2025) | | :--------------------------------- | :---------------------------- | :------------------- | | Number Outstanding | 6,778,649 | 1,895,616 | | Weighted-Average Exercise Price/Grant Date Fair Value | $3.85 | $3.01 | Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development expense | $453 | $918 | $909 | $1,444 | | Sales and marketing expense | $67 | $92 | $166 | $177 | | General and administrative expense | $824 | $1,013 | $1,762 | $2,095 | | Total employee stock-based compensation | $1,344 | $2,023 | $2,837 | $3,716 | - Total unrecognized stock-based compensation expense for outstanding unvested stock options and RSUs was **$6.276 million** as of June 30, 2025, with weighted-average recognition periods of 2.3 and 2.7 years, respectively[66](index=66&type=chunk) [12. Warrants](index=20&type=section&id=12.%20Warrants) Common Stock Warrants Outstanding | Exercise Price | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | $0.0001 | 11,250,000 | — | | $9.03 | 969,275 | 969,275 | | $10.84 | 946,666 | 946,666 | | $12.38 | 8,083 | 8,083 | | $20.77 | 722,223 | 722,223 | | Total | 13,896,247 | 2,646,247 | - The increase in warrants is primarily due to the issuance of **11,250,000** Pre-Funded Warrants in the February 2025 Offering[67](index=67&type=chunk) [13. Commitments and Contingencies](index=20&type=section&id=13.%20Commitments%20and%20Contingencies) Lease-Related Assets and Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Total right-of-use assets | $855 | $1,312 | | Total lease liabilities | $351 | $840 | Future Minimum Lease Payments (in thousands) as of June 30, 2025 | Year | Operating Leases | Finance Leases | Total | | :-------------------------- | :--------------- | :------------- | :---- | | 2025 | $333 | $22 | $355 | | 2026 | $— | $2 | $2 | | Total minimum lease payments | $333 | $24 | $357 | - The company indemnifies its officers and directors for certain events, with unlimited potential future indemnification, but maintains director and officer insurance[72](index=72&type=chunk) - The company is not currently a party to any material litigation or other material legal proceedings[73](index=73&type=chunk) [14. Net Loss Per Share](index=23&type=section&id=14.%20Net%20Loss%20Per%20Share) Net Loss Per Share (Basic and Diluted) | Period | Net Loss Per Share | | :--------------------------------- | :----------------- | | Three Months Ended June 30, 2025 | $(0.16) | | Three Months Ended June 30, 2024 | $(0.25) | | Six Months Ended June 30, 2025 | $(0.36) | | Six Months Ended June 30, 2024 | $(0.50) | - All potentially dilutive securities were excluded from diluted net loss per share calculation because their impact would have been anti-dilutive due to net losses[75](index=75&type=chunk)[77](index=77&type=chunk) [15. Segment Information](index=23&type=section&id=15.%20Segment%20Information) - The company operates as one operating segment: developing and commercializing medical diagnostic products and services[81](index=81&type=chunk) - All revenue and assets are located in the United States[82](index=82&type=chunk) Segment Information (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Revenue | $17 | $24 | $55 | $24 | | Cost of revenue | $41 | $20 | $81 | $37 | | Payroll related expenses | $3,992 | $3,257 | $7,892 | $6,635 | | Consulting and professional fees | $2,042 | $1,479 | $3,875 | $3,332 | | Stock-based compensation expense | $1,344 | $2,023 | $2,837 | $3,716 | | Clinical studies and outside processing | $430 | $1,239 | $717 | $1,867 | | Net loss | $(8,046) | $(8,303) | $(16,233) | $(16,400) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition and operations, covering business overview, revenue/expense analysis, performance, liquidity, and future funding [Overview](index=26&type=section&id=Overview) - Sera Prognostics is a women's health company using proteomics and bioinformatics to develop blood-based biomarker tests, primarily the PreTRM test, for maternal and neonatal health[87](index=87&type=chunk) - The PreTRM test is the only broadly validated, commercially available blood-based biomarker test to accurately predict the risk of preterm birth[89](index=89&type=chunk) - AVERT PRETERM TRIAL showed an **18% reduction** in severe neonatal morbidity and mortality and a **7-day reduction** in mean neonatal hospital length of stay[91](index=91&type=chunk) - PRIME study met primary endpoints, indicating a **25% reduction** in neonatal morbidity and mortality and an **18% reduction** in neonatal hospital length of stay in the mITT population[92](index=92&type=chunk) - The company is expanding its commercial team and developing additional biomarker tests, including one for estimating delivery dates, while aiming to operate through 2028 with existing cash[99](index=99&type=chunk)[102](index=102&type=chunk)[106](index=106&type=chunk) [Key Components of Our Results of Operations](index=32&type=section&id=Key%20Components%20of%20Our%20Results%20of%20Operations) [Revenues](index=32&type=section&id=Revenues) - Substantially all near-term revenue is expected from PreTRM test sales, with future revenues from PreTRM and other pipeline tests[108](index=108&type=chunk) - Market adoption and additional payer contracts are crucial for revenue growth, supported by clinical evidence and simplified specimen collection methods[108](index=108&type=chunk) [Operating Expenses](index=32&type=section&id=Operating%20Expenses) [Cost of Revenue](index=32&type=section&id=Cost%20of%20Revenue) - Cost of revenue includes third-party specimen collection/shipping, lab personnel, materials, equipment, infrastructure, and intangible asset amortization[109](index=109&type=chunk) - Costs are expected to move in line with sales, and the company is strengthening its supplier network and diversifying collection methods[109](index=109&type=chunk) [Research and Development Expenses](index=32&type=section&id=Research%20and%20Development%20Expenses) - R&D expenses include costs for clinical and real-world studies, laboratory processes, research, bioinformatic activities, and personnel[110](index=110&type=chunk) - R&D expenses are expected to increase in the second half of 2025 and potentially in the medium to long-term due to increased product development and planned studies[110](index=110&type=chunk) [Selling and Marketing Expenses](index=34&type=section&id=Selling%20and%20Marketing%20Expenses) - Selling and marketing expenses primarily include salaries, payroll taxes, employee benefits, stock-based compensation, travel, consulting, public relations, facilities, and legal costs[111](index=111&type=chunk) - These expenses are expected to increase in the second half of 2025 due to strategic hiring, PRIME study publication preparation, and expanded commercial investments[112](index=112&type=chunk) [General and Administrative Expenses](index=34&type=section&id=General%20and%20Administrative%20Expenses) - G&A expenses consist primarily of personnel costs for executive, finance, IT, HR, and administrative functions, plus facilities, legal, accounting, insurance, and professional fees[113](index=113&type=chunk) - G&A expenses are expected to slightly increase in the second half of 2025 to support scaling commercial opportunities and strategic initiatives[113](index=113&type=chunk) [Interest Expense](index=34&type=section&id=Interest%20Expense) - Interest expense represents interest incurred on finance leases[114](index=114&type=chunk) [Other Income, Net](index=34&type=section&id=Other%20Income,%20Net) - Other income, net, consists of interest income and other investment income from cash, cash equivalents, and marketable securities[115](index=115&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=34&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Three Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | $ Change | | :--------------------------------- | :--- | :--- | :------- | | Revenue | $17 | $24 | $(7) | | Research and development | $3,337 | $4,406 | $(1,069) | | Selling and marketing | $1,821 | $1,099 | $722 | | General and administrative | $4,138 | $3,752 | $386 | | Net loss | $(8,046) | $(8,303) | $257 | | Other income, net | $1,276 | $958 | $318 | - Decrease in R&D was primarily due to a **$0.7 million** decrease in research and bioinformatics costs and a **$0.4 million** decrease in clinical study costs (PRIME study winding down)[118](index=118&type=chunk) - Increase in S&M was due to **$0.2 million** in personnel/consulting and **$0.1 million** in marketing programs[119](index=119&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=35&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Six Months Ended June 30, 2025 vs. 2024 (in thousands) | Metric | 2025 | 2024 | $ Change | | :--------------------------------- | :--- | :--- | :------- | | Revenue | $55 | $24 | $31 | | Research and development | $6,671 | $8,089 | $(1,418) | | Selling and marketing | $3,291 | $2,326 | $965 | | General and administrative | $8,582 | $7,922 | $660 | | Net loss | $(16,233) | $(16,400) | $167 | | Other income, net | $2,343 | $1,967 | $376 | - Decrease in R&D was primarily due to **$0.7 million** in research and bioinformatics costs and **$0.7 million** in clinical study costs (PRIME study winding down)[123](index=123&type=chunk) - Increase in S&M was due to **$0.4 million** in marketing programs and **$0.2 million** in personnel costs[124](index=124&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) [Sources of Liquidity](index=36&type=section&id=Sources%20of%20Liquidity) - The company has financed operations primarily through equity and debt financings, including a **$53.6 million** net proceeds public offering in February 2025[127](index=127&type=chunk)[130](index=130&type=chunk) Liquidity Position (in millions) | Metric | As of June 30, 2025 | | :--------------------------------- | :------------------ | | Cash, cash equivalents, and available-for-sale securities | **$108.5** | | Accumulated deficit | **$(296.0)** | - A universal shelf registration on Form S-3 for up to **$100.0 million** is effective, but the ATM Prospectus Supplement was terminated in February 2025[128](index=128&type=chunk)[131](index=131&type=chunk) [Cash Flows](index=37&type=section&id=Cash%20Flows) Summary of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(13,026) | $(934) | | Net cash used in investing activities | $(39,561) | $(540) | | Net cash provided by financing activities | $53,560 | $2,258 | | Net increase in cash and cash equivalents | $973 | $784 | - Net cash provided by financing activities in 2025 was primarily due to **$53.6 million** from the February 2025 Offering[135](index=135&type=chunk) [Future Funding Requirements](index=38&type=section&id=Future%20Funding%20Requirements) - The company expects to incur significant additional operating losses and negative cash flows, primarily due to commercialization of the PreTRM test and development of other pipeline products[136](index=136&type=chunk) - Existing cash and cash equivalents are believed to fund operating expenses and capital expenditure requirements for **at least the next 12 months**[138](index=138&type=chunk) - Future funding requirements depend on factors like sales, development costs, regulatory approvals, and market acceptance, with no assurance of obtaining capital on acceptable terms[137](index=137&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) - No material changes have occurred in contractual obligations and commitments during the six months ended June 30, 2025[139](index=139&type=chunk) [Critical Accounting Policies and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - No significant changes in the application of critical accounting policies, significant judgments, and use of estimates during the six months ended June 30, 2025[140](index=140&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=38&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) - The company is an Emerging Growth Company (EGC) and a Smaller Reporting Company (SRC), benefiting from reduced reporting requirements[141](index=141&type=chunk)[145](index=145&type=chunk) - EGC status allows delayed adoption of new accounting standards and reduced executive compensation disclosures[143](index=143&type=chunk)[158](index=158&type=chunk) - EGC status will end based on annual revenue (**$1.235 billion**), market value (**$700.0 million**), non-convertible debt (**$1.0 billion**), or December 31, 2026[144](index=144&type=chunk) [Recent Accounting Pronouncements](index=40&type=section&id=Recent%20Accounting%20Pronouncements) - Refer to Note 2—Significant Accounting Policies for details on recent accounting pronouncements[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) This section discusses the company's market risk exposure, focusing on interest rate risk for cash and marketable securities, with minimal foreign currency and inflation impact [Interest Rate Risk](index=40&type=section&id=Interest%20Rate%20Risk) - A hypothetical 100 basis point increase in interest rates would decrease the market value of available-for-sale debt securities by **$0.9 million** as of June 30, 2025[148](index=148&type=chunk) - The company's investment policy focuses on capital preservation and liquidity, and it does not intend to sell investments in an unrealized loss position[148](index=148&type=chunk) [Foreign Currency](index=40&type=section&id=Foreign%20Currency) - The company does not regularly incur foreign currency expenses, and exchange rate fluctuations have not had a material effect on results of operations to date[149](index=149&type=chunk) [Effects of Inflation](index=40&type=section&id=Effects%20of%20Inflation) - Inflation has not had a material effect on results of operations during the periods presented[150](index=150&type=chunk) - A sustained inflationary environment could increase costs (labor, supplies, clinical trials) and adversely affect borrowing rates and funding ability[150](index=150&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated disclosure controls and procedures as effective, with no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=42&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Disclosure controls and procedures were evaluated by management, including the CEO and CFO, and deemed effective at the reasonable assurance level as of June 30, 2025[152](index=152&type=chunk) [Changes in Internal Control Over Financial Reporting](index=42&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - No material changes in internal control over financial reporting occurred during the period covered by this Quarterly Report on Form 10-Q[153](index=153&type=chunk) [PART II – OTHER INFORMATION](index=43&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in material litigation, but future legal proceedings could adversely impact financial results - The company is not currently a party to any material litigation or other material legal proceedings[156](index=156&type=chunk) - Unfavorable resolution of future legal proceedings could materially affect the company's future results of operations, cash flows, or financial position[156](index=156&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) Investing in Class A common stock carries high risk due to financial, operational, regulatory, and market uncertainties, potentially harming business and stock price [Summary of Risk Factors](index=43&type=section&id=Summary%20of%20Risk%20Factors) - The company has incurred net losses since inception and anticipates continued losses, requiring significant cash for operations[159](index=159&type=chunk) - Substantially all revenues are from the PreTRM test, and failure to increase its adoption or develop new products would harm the business[159](index=159&type=chunk) - Key risks include intense competition, potential inoperability of the CLIA laboratory, reliance on third parties for supplies and services, and challenges in intellectual property protection[159](index=159&type=chunk)[160](index=160&type=chunk) - Reimbursement adequacy, new methodologies, billing disputes, and changes in government healthcare policy pose significant risks to revenue and profits[160](index=160&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=46&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company has incurred net losses since inception, with a **$296.0 million** accumulated deficit as of June 30, 2025, and expects continued losses[161](index=161&type=chunk) - Significant cash is required for operations, and the ability to raise additional funds through equity or debt financing is uncertain, potentially leading to dilution or restrictive covenants[164](index=164&type=chunk)[169](index=169&type=chunk) - Adverse developments in the financial services industry could significantly impair access to funding sources and negatively impact financial condition[172](index=172&type=chunk)[175](index=175&type=chunk) - Quarterly and annual results may fluctuate due to various factors, including competitive pricing, reimbursement pressures, and evolving trade policies[171](index=171&type=chunk) [Risks Related to Our Business and Industry](index=51&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) - Substantially all revenues are from the PreTRM test; failure to increase adoption or develop new products would harm the business[179](index=179&type=chunk) - Market acceptance of PreTRM depends on demonstrating value, convenience, accuracy, and competing against alternatives, with success influenced by scientific and medical community acceptance and peer-reviewed publications[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - Intense competition in the life science industry, rapid technological changes, and the need for continuous product improvement pose significant challenges[191](index=191&type=chunk)[193](index=193&type=chunk) - Risks include potential inoperability of the CLIA-certified laboratory, substantial product liability claims, and clinical trial results not supporting or replicating test use[196](index=196&type=chunk)[197](index=197&type=chunk)[199](index=199&type=chunk) - Reliance on third parties for specimen collection and supplies, challenges in scaling operations, attracting and retaining skilled employees, and risks associated with international expansion could adversely affect the business[209](index=209&type=chunk)[215](index=215&type=chunk)[217](index=217&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk) [Risks Related to Reimbursement](index=70&type=section&id=Risks%20Related%20to%20Reimbursement) - Adequate coverage and reimbursement from third-party payers (federal, state, commercial) are critical for PreTRM test acceptance and revenue generation[237](index=237&type=chunk) - New reimbursement methodologies, including CPT codes, may decrease rates, and the company cannot guarantee favorable rates or coverage for its unique PLA code[245](index=245&type=chunk)[247](index=247&type=chunk) - Billing disputes, recoupment requests, and challenges to medical necessity or coding practices could decrease realized revenue and impact financial condition[249](index=249&type=chunk)[250](index=250&type=chunk) - Changes in government healthcare policy (ACA, PAMA, OBBBA) and cost-containment measures could increase costs, reduce reimbursement rates, and negatively impact test volumes[263](index=263&type=chunk)[265](index=265&type=chunk)[267](index=267&type=chunk) [Risks Related to Government Regulation](index=78&type=section&id=Risks%20Related%20to%20Government%20Regulation) - The healthcare industry is highly regulated, with complex and often unclear laws, increasing the risk of non-compliance and potential sanctions[273](index=273&type=chunk)[274](index=274&type=chunk) - Changes in FDA regulation of LDTs, despite a recent court decision vacating a final rule, remain a risk, potentially requiring premarket authorization and additional clinical trials[285](index=285&type=chunk)[287](index=287&type=chunk)[291](index=291&type=chunk) - Failure to comply with CLIA and state laboratory licensing requirements could lead to loss of ability to perform tests or business disruptions[278](index=278&type=chunk)[284](index=284&type=chunk) - The company is subject to various healthcare fraud and abuse laws (AKS, Stark Law, FCA, EKRA) and data privacy/security laws (HIPAA, CCPA, CPRA, GDPR), with potential for substantial penalties and reputational harm for violations[275](index=275&type=chunk)[295](index=295&type=chunk)[303](index=303&type=chunk)[323](index=323&type=chunk) - Cybersecurity incidents, data breaches, and the use of artificial intelligence present significant risks to sensitive information, operations, and compliance, potentially leading to liability and reputational damage[307](index=307&type=chunk)[312](index=312&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) [Risks Related to Intellectual Property](index=96&type=section&id=Risks%20Related%20to%20Intellectual%20Property) - Ability to compete depends on obtaining, maintaining, and enforcing patents, trade secrets, trademarks, and other intellectual property rights[331](index=331&type=chunk) - Patent positions in the diagnostics industry are highly uncertain, with complex legal and factual questions, and changes in patent laws or interpretations could negatively impact patent rights[331](index=331&type=chunk)[332](index=332&type=chunk)[338](index=338&type=chunk)[341](index=341&type=chunk) - Issued patents could be found invalid or unenforceable if challenged in litigation or administrative proceedings, leading to increased competition[334](index=334&type=chunk) - Third-party infringement of patents, trademarks, or other IP rights could lead to costly lawsuits, loss of market share, and financial harm[337](index=337&type=chunk) - Reliance on trade secret protection for proprietary know-how and algorithms, with risks of unauthorized disclosure or independent discovery by third parties[345](index=345&type=chunk)[346](index=346&type=chunk) [Risks Related to Our Class A Common Stock](index=104&type=section&id=Risks%20Related%20to%20Our%20Class%20A%20Common%20Stock) - The trading price of Class A common stock is likely to be highly volatile due to various factors, including operating results, competition, regulatory changes, and overall market conditions[347](index=347&type=chunk)[348](index=348&type=chunk) - The company does not intend to pay dividends, so returns are limited to stock appreciation[349](index=349&type=chunk) - Executive officers, directors, and **5%+** stockholders own a significant percentage of Class A common stock, allowing them to exert significant control over corporate matters[350](index=350&type=chunk) - The dual-class common stock structure (Class A voting, Class B non-voting but convertible) may limit stockholders' ability to influence corporate matters[351](index=351&type=chunk)[354](index=354&type=chunk) - EGC and SRC status provides reduced reporting requirements but may make Class A common stock less attractive to some investors, potentially increasing price volatility[355](index=355&type=chunk)[357](index=357&type=chunk) - Anti-takeover provisions in charter documents and Delaware law could delay or prevent a change in control, limiting the market price of Class A common stock[363](index=363&type=chunk)[364](index=364&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=113&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the quarter ended June 30, 2025 - No unregistered sales of equity securities or use of proceeds to report for the quarter ended June 30, 2025[376](index=376&type=chunk) [Item 5. Other Information](index=113&type=section&id=Item%205.%20Other%20Information) This section details Rule 10b5-1 trading arrangements adopted by executive officers and a director, with RSU-related sales indeterminable due to market price variability [Insider Trading Arrangements and Policies](index=113&type=section&id=Insider%20Trading%20Arrangements%20and%20Policies) - Several executive officers and a director adopted Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025[377](index=377&type=chunk)[380](index=380&type=chunk) Rule 10b5-1 Trading Arrangements Adopted (Q2 2025) | Name and Position | Adoption Date | Duration/Expiration Date | Aggregate Number of Shares to be Sold | | :--------------------------------- | :------------ | :----------------------- | :------------------------------------ | | Zhenya Lindgardt, President and CEO | 6/13/2025 | 9/1/2026 | Up to 104,979 | | John J. Boniface, Chief Scientific Officer | 5/21/2025 | 6/1/2026 | Indeterminable (RSU-related) | | Robert G. Harrison, Chief Information Officer | 5/21/2025 | 6/1/2026 | Indeterminable (RSU-related) | | Benjamin G. Jackson, General Counsel | 5/28/2025 | 5/13/2026 | Indeterminable (RSU-related) | | Paul Kearney, Ph.D., Chief Data Officer | 5/21/2025 | 6/1/2026 | Indeterminable (RSU-related) | | Sandra A.J. Lawrence, Director | 6/10/2025 | 6/30/2026 | Up to 132,310 | [Item 6. Exhibits](index=116&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, warrant forms, agreements, and certifications - The section lists all exhibits filed with the Form 10-Q, including organizational documents, warrant forms, agreements, and certifications[382](index=382&type=chunk) [Signatures](index=117&type=section&id=Signatures) This section contains the official signatures of Sera Prognostics, Inc.'s CEO and CFO, certifying the accuracy and completeness of the Form 10-Q as of August 6, 2025 - The report is signed by Zhenya Lindgardt, President and Chief Executive Officer, and Austin Aerts, Chief Financial Officer, on August 6, 2025[388](index=388&type=chunk)

[Second Quarter 2025 Financial Results and Business Update](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results%20and%20Business%20Update) This section provides an overview of Sera Prognostics' operational progress and strategic initiatives during the second quarter of 2025, alongside key commentary from the CEO [Operational and Strategic Highlights](index=1&type=section&id=Operational%20and%20Strategic%20Highlights) Sera Prognostics reported ongoing progress in engaging Medicaid plans in targeted states, particularly those with high premature birth rates, and is on track to publish full PRIME study results this year, followed by additional data on health economic benefits, while strengthening its leadership team with key appointments - Ongoing progress in engaging Medicaid plans in targeted states, with notable traction in two states with above-average premature birth rates and growing momentum in two additional states with leading healthcare systems[2](index=2&type=chunk) - On track to publish full study results of the PRIME study this year, with additional data on health economic benefits, sub-population analysis, and Medicaid expected cost-saving benefits of the PreTRM Test to follow[2](index=2&type=chunk) - Strengthened leadership team with the appointment of Lee Anderson as Chief Commercial Officer (May), Chuck Hyde as Head of Market Access (July), and Jennifer Zibuda as Head of Investor Relations (July)[2](index=2&type=chunk) [CEO Commentary](index=2&type=section&id=CEO%20Commentary) President and CEO Zhenya Lindgardt emphasized building a foundation for accelerated commercial momentum, driven by the full PRIME pivotal study results, and plans to share additional data demonstrating the PreTRM test's ability to improve pregnancy outcomes and reduce healthcare costs - The company is building the foundation for expected acceleration in commercial momentum, leveraging full PRIME pivotal study results for increased traction with managed Medicaid and other organizations[3](index=3&type=chunk) - Plans to share additional compelling data and evidence showing the PreTRM test can address premature births, empower doctors with actionable information, and reduce healthcare costs[3](index=3&type=chunk) [Financial Performance Analysis (Q2 2025)](index=2&type=section&id=Financial%20Performance%20Analysis%20%28Q2%202025%29) This section analyzes Sera Prognostics' financial results for the second quarter of 2025, covering revenue, operating expenses, net loss, and capital resources [Revenue and Operating Expenses](index=2&type=section&id=Revenue%20and%20Operating%20Expenses) Sera Prognostics reported a decrease in second-quarter 2025 revenue compared to the prior year, with total operating expenses remaining flat due to a significant reduction in R&D expenses from PRIME study completion, offset by increased SG&A for commercialization efforts Revenue and Operating Expenses (in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (%) | | :----------------------- | :--------------------- | :--------------------- | :--------- | | Revenue | $17 | $24 | -29.17% | | Total Operating Expenses | $9,337 | $9,277 | +0.65% | | Research and Development | $3,337 | $4,406 | -24.26% | | Selling, General & Admin | $6,000 | $4,851 | +23.68% | - Research and development expenses decreased by approximately **24%** primarily due to lower clinical study costs following the completion of the pivotal PRIME study and a shift towards commercialization[4](index=4&type=chunk) - Selling, general and administrative expenses increased from **$4.9 million** to **$6.0 million**, reflecting targeted investments in commercial activities, strategic headcount additions, and market awareness in preparation for PRIME study data publication[5](index=5&type=chunk) [Net Loss and Capital Resources](index=2&type=section&id=Net%20Loss%20and%20Capital%20Resources) The company's net loss for Q2 2025 improved slightly year-over-year, and Sera Prognostics maintained a strong cash position, which is expected to fund operations through significant adoption and commercial milestones until 2028 Net Loss (in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(8,046) | $(8,303) | -3.10% | - As of June 30, 2025, the Company had cash, cash equivalents, and available-for-sale securities of approximately **$108.5 million**[6](index=6&type=chunk) - Sera expects its current capital resources to fund the company across significant adoption and commercial milestones through **2028**[6](index=6&type=chunk) [Company and Product Information](index=3&type=section&id=Company%20and%20Product%20Information) This section provides an overview of Sera Prognostics, details about preterm birth, and information on the PreTRM® Test [About Sera Prognostics, Inc.](index=3&type=section&id=About%20Sera%20Prognostics%2C%20Inc.) Sera Prognostics is a health diagnostics company focused on improving maternal and neonatal health through precision pregnancy care, with a mission to provide early, pivotal pregnancy information to reduce healthcare costs and improve outcomes, supported by a pipeline of diagnostic tests for preterm birth risk and other complications - Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care[9](index=9&type=chunk) - The company's mission is to provide early, pivotal pregnancy information to improve the health of mothers and newborns, aiming to reduce healthcare delivery costs[9](index=9&type=chunk) - Sera has a robust pipeline of innovative diagnostic tests, primarily focused on the early prediction of preterm birth risk and other pregnancy complications[9](index=9&type=chunk) [Understanding Preterm Birth](index=3&type=section&id=Understanding%20Preterm%20Birth) Preterm birth, defined as birth before 37 weeks' gestation, is the leading cause of illness and death in newborns, associated with significant long-term medical complications and substantial annual healthcare costs in the United States - Preterm birth is defined as any birth before **37 weeks' gestation** and is the leading cause of illness and death in newborns[10](index=10&type=chunk) - More than **one in ten infants** is born prematurely in the United States for the last six consecutive years (2024 March of Dimes Report Card)[10](index=10&type=chunk) - Annual healthcare costs to manage short- and long-term complications of prematurity in the U.S. were estimated at approximately **$25 billion** for 2016[10](index=10&type=chunk) [About the PreTRM® Test](index=3&type=section&id=About%20the%20PreTRM%C2%AE%20Test) The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test for early, accurate, and individualized risk prediction of spontaneous preterm birth in asymptomatic singleton pregnancies, measuring and analyzing blood proteins to identify high-risk women between 18 and 20 weeks of pregnancy, enabling personalized clinical decisions - The PreTRM® Test is the only broadly validated, commercially available blood-based biomarker test providing early, accurate, and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies[11](index=11&type=chunk) - The test measures and analyzes proteins in the blood that are highly predictive of preterm birth[11](index=11&type=chunk) - It allows physicians to identify women at increased risk for preterm birth between **18 and 20 weeks of pregnancy**, facilitating more informed and personalized clinical decisions[11](index=11&type=chunk) [Supplemental Information](index=2&type=section&id=Supplemental%20Information) This section provides details on the conference call, a safe harbor statement regarding forward-looking information, and company contact information [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) Sera Prognostics hosted a conference call and live webcast on August 6, 2025, to discuss its second-quarter 2025 operational highlights and financial results, with the webcast archived on the company's investor relations page - Sera Prognostics hosted a conference call and live webcast on **August 6, 2025**, at **5:00 p.m. Eastern Time** to discuss Q2 2025 results[7](index=7&type=chunk) - The live audio of the webcast is available online from the Investors page of the Company's website and will be archived for one year[8](index=8&type=chunk) [Safe Harbor Statement](index=4&type=section&id=Safe%20Harbor%20Statement) This press release contains forward-looking statements regarding future events, including Medicaid engagement, PRIME study results, commercial expansion, and financial projections, which are subject to various risks and uncertainties that could cause actual results to differ materially, as detailed in the company's SEC filings - The press release contains forward-looking statements regarding ongoing progress with Medicaid plans, publication of PRIME study results, anticipated revenue growth, and funding through **2028**[13](index=13&type=chunk) - These statements are based on management's current expectations and are subject to risks and uncertainties, including net losses, need for capital, market acceptance of PreTRM Test, competition, payer coverage, and regulatory changes[13](index=13&type=chunk) - The company undertakes no duty to update this information unless required by law, and readers are directed to risk factors discussed in SEC filings[13](index=13&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) Investor inquiries can be directed to Jennifer Zibuda, Head of Investor Relations, via email or phone - Investor Contact: **Jennifer Zibuda**, Head of Investor Relations, jzibuda@sera.com, **+1 (801) 396-8043**[14](index=14&type=chunk) [Condensed Financial Statements](index=5&type=section&id=Condensed%20Financial%20Statements) This section presents the company's condensed statements of operations and balance sheets for the specified periods [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations provide a detailed breakdown of revenue, operating expenses, and net loss for the three and six months ended June 30, 2025, compared to the same periods in 2024 Condensed Statements of Operations (in thousands, except per share) | Metric (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $17 | $24 | $55 | $24 | | Cost of revenue | $41 | $20 | $81 | $37 | | Research and development | $3,337 | $4,406 | $6,671 | $8,089 | | Selling and marketing | $1,821 | $1,099 | $3,291 | $2,326 | | General and administrative | $4,138 | $3,752 | $8,582 | $7,922 | | Total operating expenses | $9,337 | $9,277 | $18,625 | $18,374 | | Loss from operations | $(9,320) | $(9,253) | $(18,570) | $(18,350) | | Other income, net | $1,276 | $958 | $2,343 | $1,967 | | Net loss | $(8,046) | $(8,303) | $(16,233) | $(16,400) | | Net loss per share, basic and diluted | $(0.16) | $(0.25) | $(0.36) | $(0.50) | | Weighted-average shares outstanding | 49,066,398 | 32,932,903 | 45,536,846 | 32,576,470 | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The condensed balance sheets present the company's financial position as of June 30, 2025, compared to December 31, 2024, detailing assets, liabilities, and stockholders' equity Condensed Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $5,016 | $4,043 | | Marketable securities | $35,144 | $42,193 | | Long-term marketable securities | $68,351 | $21,973 | | Total assets | $111,828 | $72,575 | | **Liabilities** | | | | Accounts payable | $1,063 | $1,969 | | Deferred revenue | $20,220 | $20,223 | | Total liabilities | $23,602 | $24,772 | | **Stockholders' Equity** | | | | Additional paid-in capital | $384,104 | $327,534 | | Accumulated deficit | $(296,027) | $(279,794) | | Total stockholders' equity | $88,226 | $47,803 | | Total liabilities and equity | $111,828 | $72,575 |

Core Insights - Sera Prognostics Inc. reported a revenue of $17,000 for Q2 2025, a decrease from $24,000 in Q2 2024, while total operating expenses remained flat at $9.3 million [4][6] - The company is focusing on commercial momentum following the completion of its pivotal PRIME study, which is expected to enhance engagement with managed Medicaid and other organizations [3][9] - The net loss for the quarter was $8.0 million, slightly improved from $8.3 million in the same period last year, with cash reserves of approximately $108.5 million expected to support operations through 2028 [6][15] Financial Performance - Revenue for Q2 2025 was $17,000, down from $24,000 in Q2 2024 [4] - Total operating expenses were $9.3 million, consistent with the previous year [4] - Research and development expenses decreased by approximately 24% to $3.3 million, attributed to lower clinical study costs [4] - Selling, general, and administrative expenses increased to $6.0 million from $4.9 million, reflecting investments in commercial activities [5] - The net loss for the quarter was $8.0 million, compared to $8.3 million a year ago [6] Strategic Initiatives - The company is engaging Medicaid plans in targeted states, particularly those with high premature birth rates, to capitalize on commercial opportunities [9] - Sera Prognostics plans to publish full results of the PRIME study this year, along with additional data on health economic benefits and expected cost savings [9] - Recent leadership appointments aim to strengthen the company's commercial capabilities and investor relations [9] Product Overview - The PreTRM® Test is a blood-based biomarker test that predicts the risk of spontaneous preterm birth, allowing for earlier interventions [12] - The test is designed to provide individualized risk assessments during weeks 18 to 20 of pregnancy, enabling personalized clinical decisions [12]

Preterm Birth Challenge - Preterm birth affects 1 in 10 babies[9], contributing to 342% of newborn deaths[9, 14] - The US preterm birth rate increased from 94% to 104% between 2013 and 2023[11] - In 2016, the average cost to manage complications of prematurity in the US was $64,815 per preterm birth[17] - Preterm births account for 61% of neonatal costs for in-hospital deliveries[17] - 50% of women who deliver prematurely have no known risk factors[22] PreTRM Test & AVERT Trial - The PreTRM test is designed to screen women without obvious risk factors for preterm birth, using a blood draw between 18 and 20 6/7 weeks of gestation[32, 34] - The AVERT PRETERM Trial demonstrated that the PreTRM test-and-treat strategy reduced neonatal hospital length of stay by 7 days[57] - The AVERT study showed an 18% reduction in severe neonatal morbidity and mortality with the PreTRM test-and-treat strategy[59, 60] PRIME Trial Results - The PRIME trial (2025) showed that the odds of adverse outcomes on the Neonatal Morbidity Index (NMI) scale were 25% lower in the intervention group compared to the control group (Odds Ratio 075)[90, 93] - The PRIME trial also indicated that infants in the intervention group had an 18% lower risk of prolonged hospital stays (Hazard Ratio 082) when focusing on the 10% with the longest stays[98] - In the full analysis set and intent-to-treat population of the PRIME trial, there was a 20% reduction in odds of NMI and a 22% reduction in odds of NICU admissions[103] Meta-Analysis of PRIME and AVERT - A meta-analysis of the AVERT and PRIME trials demonstrated a 22% decreased risk of prolonged hospital stay[113] - The meta-analysis also showed a 22% decreased odds of Neonatal Morbidity and Mortality (NMI)[120] Economic Value - With 5 million covered lives, the annual cost savings from PreTRM is $148 million, or $296 per covered life, with 39,773 pregnancies eligible and screened[128] - The PreTRM test shows powerful results, with the Number Needed to Screen (NNS) to prevent one NICU day demonstrated in the PRIME and AVERT study to be 3-4[125]