Sera Prognostics(SERA) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Financial Results and Business Update 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 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] - 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] - 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] CEO Commentary 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] - 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] Financial Performance Analysis (Q2 2025) 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 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] - 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] Net Loss and Capital Resources 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] - Sera expects its current capital resources to fund the company across significant adoption and commercial milestones through 2028[6] Company and Product Information This section provides an overview of Sera Prognostics, details about preterm birth, and information on the PreTRM® Test About Sera Prognostics, Inc. 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] - 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] - Sera has a robust pipeline of innovative diagnostic tests, primarily focused on the early prediction of preterm birth risk and other pregnancy complications[9] Understanding Preterm Birth 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] - 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] - 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] About the PreTRM® Test 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] - The test measures and analyzes proteins in the blood that are highly predictive of preterm birth[11] - 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] Supplemental Information This section provides details on the conference call, a safe harbor statement regarding forward-looking information, and company contact information Conference Call Details 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] - 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] Safe Harbor Statement 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] - 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] - 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] Contact Information 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] Condensed Financial Statements This section presents the company's condensed statements of operations and balance sheets for the specified periods Condensed Statements of Operations 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 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 |