Sera Prognostics(US:SERA)2025-11-13 21:12Clinical Trials and Biomarker Development - The PreTRM test is the only broadly validated, commercially available blood-based biomarker test to predict the risk of preterm birth, providing accurate predictions during weeks 18 through 20 of gestation [88]. - The 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 for at-risk neonates [89]. - The PRIME study indicated a 25% reduction in neonatal morbidity and mortality and an 18% reduction in neonatal hospital length of stay for approximately 10% of babies who stay beyond standard delivery days [91]. - The company is actively developing additional biomarker tests, including one for more accurate delivery date predictions, currently in early market testing [101]. Financial Performance - The company reported net losses of $7.8 million and $7.9 million for the three months ended September 30, 2025 and 2024, respectively, and $24.0 million and $24.3 million for the nine months ended September 30, 2025 and 2024, respectively [104]. - Revenue for the three months ended September 30, 2025, was $16,000, a decrease of $13,000 (44.83%) compared to $29,000 in 2024 [116]. - For the nine months ended September 30, 2025, revenue increased by $18,000 (33.96%) to $71,000 from $53,000 in 2024 [122]. - Total operating expenses for the same period were $8,996,000, an increase of $105,000 (1.18%) from $8,891,000 in 2024 [116]. - Total operating expenses for the nine months ended September 30, 2025, were $27,621,000, an increase of $356,000 (1.31%) from $27,265,000 in 2024 [122]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $19,503,000, compared to $7,929,000 in 2024 [132]. - As of September 30, 2025, the company had cash, cash equivalents, and available-for-sale securities totaling $102.4 million, with an accumulated deficit of $303.8 million [127]. Operational Strategy and Future Outlook - The company completed a public offering in February 2025, resulting in approximately $53.6 million in net proceeds after deducting underwriting discounts and commissions [103]. - The company plans to expand its commercial team, having recently hired a Chief Commercial Officer and field sales representatives in strategic geographies [100]. - The company believes its cash runway is sufficient to operate through 2028 based on existing plans, while continuing to monitor operating expenses [105]. - The company aims to secure contracts with private and governmental payers using positive data from clinical studies to generate material revenues [106]. - The company expects research and development expenses to decrease in 2026 compared to 2025 as it shifts capital allocation toward revenue-generating activities [109]. - Selling and marketing expenses are anticipated to increase in Q4 2025 and further in 2026 due to investments in commercialization activities for the PreTRM test [110]. - The company expects significant additional operating losses and negative cash flows due to commercialization activities for the PreTRM test and other pipeline products [136]. - The company currently has no credit facility or committed sources of capital, and future funding requirements will depend on various factors including sales from the PreTRM test [137]. - Existing cash and cash equivalents are expected to fund operating expenses and capital expenditures for at least the next 12 months [138]. Market and Economic Factors - A hypothetical 100 basis point increase in interest rates would have resulted in a decrease of $0.8 million in the market value of available-for-sale debt securities as of September 30, 2025 [148]. - The company does not regularly incur expenses in foreign currencies, and exchange rate fluctuations have not materially affected results to date [149]. - Inflation has not had a material effect on results, but ongoing inflation could increase costs of labor and supplies, adversely affecting business operations [150].