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]

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $38,000 compared to nil in Q1 2024 [20] - Total operating expenses for Q1 2025 were $9.3 million, slightly up from $9.1 million in the same period last year [20] - Research and development expenses decreased by approximately 9% to $3.3 million due to lower clinical study costs [20] - Selling, general and administrative expenses increased to $5.9 million from $5.4 million year-over-year [21] - Net loss for the quarter was $8.2 million, relatively flat compared to $8.1 million for the same period last year [21] - As of March 31, 2025, the company had cash and equivalents of approximately $114.2 million [21] Business Line Data and Key Metrics Changes - The company is focusing on expanding its commercial presence by adding 5 to 10 full-time employees (FTEs) to enhance its sales force in targeted states [24][25] - The company is ramping up Medicaid plan pilots in states with high rates of premature births [6][10] Market Data and Key Metrics Changes - The company is targeting states with higher premature birth rates than the national average, particularly focusing on Medicaid as a key payer [6][10] - Approximately 43% of all births in the U.S. are paid for by Medicaid, highlighting the importance of this payer in the company's strategy [6] Company Strategy and Development Direction - The company aims to transition from clinical evidence development to commercial growth, with a focus on reimbursement strategies involving commercial insurers, employers, and Medicaid [6][10] - The commercial roadmap includes a geographically focused ecosystem playbook, starting with targeted states and expanding based on success [6][10] - The company plans to build awareness through localized campaigns and partnerships with organizations that reach expectant mothers [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the PRIME study results to generate commercial momentum and influence physician adoption of the preterm test [15][19] - The company recognizes the urgency of addressing rising maternal mortality rates and believes its preterm test can contribute to better health outcomes [16][17] - Management anticipates 2025 will be a pivotal year for commercialization and building a movement for improved maternal care [19][49] Other Important Information - The company is preparing for the publication of the PRIME study results in a peer-reviewed journal, which is expected to enhance its market position [5][19] - The ACOG bulletin update emphasizes risk stratification in prenatal care, aligning with the company's preterm test strategy [30][31] Q&A Session Summary Question: Can you discuss the strategic headcount investments? - The company plans to expand its commercial presence by 5 to 10 FTEs and will monitor progress in targeted states before further expansion [24][25] Question: Any updates on the PRIME study publication? - The company has passed the next milestone in engagement with the target journal but does not have a precise publication date yet [26][27] Question: What was the ACOG bulletin update? - The ACOG bulletin shifted towards tailoring care based on risk stratification, which aligns with the company's preterm test strategy [30][31] Question: How often does ACOG update guidelines? - ACOG updates bulletins every 24 to 48 months, with the relevant bulletin last updated in August 2021 [35] Question: What are the potential outcomes with Medicaid engagement? - The company is excited about Medicaid engagement and is focusing on states that prioritize solutions for preterm birth [41][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]