Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10,000, down from $24,000 in Q4 2024, reflecting modest revenue fluctuations in the early commercial stage [20] - Total revenue for 2025 was $81,000, slightly up from $77,000 in 2024, indicating a gradual revenue expansion [21] - Operating expenses for Q4 2025 were $9 million, down from $9.4 million in the prior year, showcasing disciplined expense management [20] - Net loss for Q4 2025 was $7.9 million compared to a net loss of $8.6 million in Q4 2024, demonstrating improved financial control [21] Business Line Data and Key Metrics Changes - Research and development expenses for 2025 were $13.2 million, down from $14.7 million in 2024, driven by lower clinical study costs following the completion of the PRIME study [21] - Selling, general, and administrative expenses were $23.3 million in 2025 compared to $21.9 million in 2024, reflecting targeted commercial readiness investments [21] Market Data and Key Metrics Changes - The company engaged with 13 states for partner programs, exceeding its initial goal of six states [9] - The strategy aims to expand to 15-17 states by year-end 2026, representing 58%-60% of U.S. births [9] Company Strategy and Development Direction - The company aims to build evidence, access, and commercial infrastructure to drive preTRM adoption at scale, with a focus on Medicaid and high preterm birth burden states [5][8] - Plans for 2026 include expanding partner programs and generating real-world evidence to support clinical adoption and reimbursement expansion [9][10] - The company is pursuing CE marking approval for the PreTRM Global Test in Europe, with submissions expected in the coming months [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum gained from the PRIME publication and the engagement with payers and state legislators [35] - The company anticipates gradual adoption of its technology, supported by compelling clinical evidence and increasing payer engagement [45] Other Important Information - The company ended 2025 with $95.8 million in cash equivalents, providing a runway through 2028 for significant adoption and commercial milestones [22] - A new Head of Sales and Strategic Accounts was introduced, expected to enhance commercial execution and market access [15] Q&A Session Summary Question: Can you expand on converting payer discussions and partner programs using outcomes and economic data? - The company highlighted the importance of clinical outcomes and economic benefits for payers, particularly regarding NICU admissions and cost drivers [29][30] Question: What feedback was received at the SMFM conference regarding PRIME? - Engagement with providers and leadership at SMFM was positive, focusing on next steps to improve access to the test [33][35] Question: How will the company balance investments in U.S. states versus the EU launch? - The company plans to reallocate spending from clinical and R&D activities towards commercial activities, including EU opportunities [38] Question: Can you elaborate on the profile of new partners? - The company is negotiating with various partners, including large health systems and provider payers, to implement the PreTRM test into clinical workflows [40][42]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10,000, down from $24,000 in Q4 2024, reflecting modest revenue fluctuations typical in early commercial stages [20] - Total revenue for 2025 was $81,000, slightly up from $77,000 in 2024, indicating a gradual revenue expansion [21] - Operating expenses for Q4 2025 were $9 million, down from $9.4 million in the prior year, showcasing disciplined expense management [20] - Net loss for Q4 2025 was $7.9 million compared to a net loss of $8.6 million in Q4 2024, demonstrating improved financial control [21] Business Line Data and Key Metrics Changes - Research and development expenses for 2025 were $13.2 million, down from $14.7 million in 2024, driven by lower clinical study costs following the completion of the PRIME study [21] - Selling, general, and administrative expenses were $23.3 million compared to $21.9 million in the previous year, reflecting targeted commercial readiness investments [21] Market Data and Key Metrics Changes - The company engaged with 13 states for partner programs, exceeding its initial goal of six states, and aims to expand to 15-17 states by year-end 2026 [9] - In Europe, the company is working towards CE marking approval for its preterm global test, with submissions expected in the coming months [10] Company Strategy and Development Direction - The company aims to build evidence, access, and commercial infrastructure to drive preterm birth adoption at scale, with a focus on Medicaid and high preterm birth burden states [5][8] - A disciplined approach to market access and commercial infrastructure investments is being maintained, with a focus on expanding partner programs and generating real-world evidence [11][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum gained from the PRIME publication and the growing engagement with payers and state-level stakeholders [45] - The company anticipates gradual adoption of its technology, supported by compelling clinical evidence and increasing payer engagement [45] Other Important Information - The company ended 2025 with $95.8 million in cash equivalents, which is expected to fund operations through significant adoption and commercial milestones until 2028 [22][25] - A new Head of Sales and Strategic Accounts has been appointed to enhance commercial execution and market access [15] Q&A Session Summary Question: Can you expand on converting payer discussions and partner programs using outcomes and economic data? - The company highlighted the importance of clinical outcomes and economic benefits in discussions with partners, particularly for state Medicaid agencies [29] - The reduction in NICU admissions is a significant cost driver that partners are interested in [30] Question: What feedback was received at the SMFM conference regarding PRIME? - Engagement with providers and leadership at SMFM was strong, focusing on making the test more accessible [33] - The publication has improved credibility and engagement across various stakeholders [35] Question: How will the company balance investments in successful U.S. states versus global EU launch capital requirements? - The company plans to reallocate spending from clinical and R&D activities towards commercial activities, including EU opportunities [38] Question: Can you elaborate on the profile of the new partner? - The company is negotiating with large health systems, provider payers, and group practices, aiming to implement the PreTRM test as standard care [40] - The new partner is an employer collaborative with multi-state opportunities [42]

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $24,000, down from $41,000 in Q4 2023 [20] - Total operating expenses for Q4 2024 were $9,400,000, up 6% from $8,900,000 in the same period last year [20] - Net loss for the quarter was $8,600,000 compared to $7,900,000 for the same period a year ago [21] - Cash, cash equivalents, and available for sale securities as of 12/31/2024 were approximately $68,200,000 [21] - Gross cash expense for 2024 was about $28,600,000, below the expectation of less than $30,000,000 [22] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $3,100,000 from $3,900,000 in Q4 2023, primarily due to reduced expenses related to the PRIME study [21] - Selling, general, and administrative expenses increased to $6,300,000 from $5,000,000 in Q4 2023, driven by spending on commercial activities [21] Market Data and Key Metrics Changes - The company is focusing on states with high preterm birth rates, such as Nevada and Louisiana, which have nearly 50% higher rates than the national average [16] - Medicaid covers approximately 43% of births in the U.S., representing a significant opportunity for the company to reduce costs for Medicaid administrators [33] Company Strategy and Development Direction - The company aims to expand its commercialization efforts and grow adoption of its preterm test, leveraging recent PRIME study results [5][12] - Plans include building a strong sales organization and increasing awareness through targeted education campaigns [50] - The company is also exploring international expansion and developing an immunoassay version of its preterm tests for the European market [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Medicaid to adopt their test more quickly due to the current focus on cost reduction and clinical breakthroughs [34] - The company anticipates a pivotal year in 2025 for engagement with key stakeholders and adoption of their preterm test [23] - Management highlighted the importance of generating real-world evidence to support the adoption of their test and treat strategy [29] Other Important Information - The company successfully raised $57,500,000 through a public follow-on offering to expand commercial operations [21] - The PRIME study showed a 25% reduction in neonatal mortality and morbidity index and an 18% reduction in neonatal length of hospital stay [8] - The company is targeting the launch of its time to birth product in the second half of 2025, priced around $150 [54][55] Q&A Session Summary Question: Can you elaborate on the three tenants of your plan to get into guidelines? - Management discussed plans for publications from the PRIME dataset and the importance of generating real-world evidence to support adoption [27][29][30] Question: What are your plans regarding Medicaid and the opportunity ahead of guidelines? - Management emphasized the significant opportunity with Medicaid, highlighting the potential for quicker adoption due to cost-saving benefits [33][34] Question: How do you view the importance of ACOG and SMFM in the guidelines process? - Management noted that both societies are important and are likely to work together on guidelines, with an emphasis on generating more evidence [37][40] Question: What is the cash runway based on current operating plans? - Management indicated a cash runway into 2028, with operating expenses expected to be between $30,000,000 and $35,000,000 [43] Question: What are the commercial investments planned for 2025? - Management outlined plans to build a sales organization and increase awareness through targeted campaigns [50]