Financial Data and Key Metrics Changes - Net revenue for Q3 2025 was $16,000, a decrease from $29,000 in the same period last year [17] - Total operating expenses for the quarter were $9.0 million, slightly up from $8.9 million in Q3 2024 [17] - Research and development expenses decreased to $3.3 million from $3.5 million, attributed to lower clinical study costs [17] - Selling, general, and administrative expenses increased to $5.7 million from $5.4 million, reflecting investments in commercial activities [18] - Net loss for the quarter was $7.8 million, down from $7.9 million in Q3 2024 [18] - Cash, cash equivalents, and available-for-sale securities totaled approximately $102.4 million as of September 30, 2025 [18] Business Line Data and Key Metrics Changes - The company is focusing on the PreTRM test adoption, with significant progress in commercialization efforts [4][6] - The first Medicaid pilot program in Nevada is actively enrolling patients, indicating initial traction in the market [7][12] Market Data and Key Metrics Changes - The company is targeting six initial states, representing approximately 33% of U.S. births and 35% of Medicaid births annually [8] - Engagement with 10 payers across 13 states is underway, indicating a diverse mix of national and regional opportunities [12] Company Strategy and Development Direction - The company is executing a geographically focused strategy to enhance coverage, physician education, and patient awareness [4] - A two-prong approach is being utilized for commercialization: targeting state engagement and payer-driven adoption through pilots [9][10] - The company aims to establish the PreTRM test as a standard of care for preterm birth risk [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial momentum and the potential for significant growth opportunities [18] - The timeline for guideline inclusion is estimated to be 24-36 months post-publication of the PRIME study results [31] Other Important Information - The company plans to publish full results of the PRIME study in a peer-reviewed journal by the end of the year [5] - Key leadership appointments have been made to strengthen the team and drive the adoption of the PreTRM test [14][15] Q&A Session Summary Question: Progress on Medicaid pilots and timeline for additional pilots - Management confirmed they are on track with one pilot launched and another in contracting, with discussions ongoing for additional pilots [22] Question: Economics of the Nevada pilot and payment structure - The pilot size is expected to be a few hundred patients, with discussions for value-based healthcare arrangements ongoing [24] Question: Timing of PRIME publication and additional data - Management is confident the publication will be out before year-end and will provide new insights upon release [27][29] Question: Pathway to guideline inclusion and focus areas - The timeline for guideline inclusion remains 24-36 months, with a focus on geographic adoption and broader engagement with payers and providers [31][32] Question: Organizational readiness post-PRIME publication - The company has prepared for the publication with plans for payer engagement and dissemination of information to clinicians [38]

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $24,000, down from $41,000 in Q4 2023 [32] - Total operating expenses for Q4 were $9.4 million, up 6% from $8.9 million in the same period last year [32] - Net loss for the quarter was $8.6 million compared to $7.9 million for the same period a year ago [32] - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were approximately $68.2 million [33] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $3.1 million from $3.9 million in Q4 2023, primarily due to reduced expenses related to the PRIME study [32] - Selling, general, and administrative expenses increased to $6.3 million from $5.0 million in Q4 2023, driven by spending on commercial activities [32] Market Data and Key Metrics Changes - The U.S. received a D+ grade from the March of Dimes for high preterm birth rates, indicating a significant market need for solutions [22] - Medicaid covers approximately 43% of births in the U.S., representing a substantial opportunity for the company to reduce costs for public health agencies [24] Company Strategy and Development Direction - The company aims to leverage the results of the PRIME study to drive awareness and adoption of its PreTRM test, focusing on building its evidence portfolio and seeking reimbursement [19][20] - Plans include expanding commercial operations in the U.S. and exploring international opportunities, particularly in Europe [20][26] - The company is focused on generating real-world evidence to support the adoption of its test and treat strategy [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Medicaid to adopt the PreTRM test more quickly due to the current focus on cost reduction and improving clinical outcomes [51] - The company anticipates a pivotal year in 2025 for engagement with key stakeholders and adoption of its test following the publication of the PRIME study [35] Other Important Information - The company raised $57.5 million through a public follow-on offering to expand its commercial operations and secure a cash runway through 2028 [34] - The company is working on two products from its pipeline, targeting launches in the second half of 2025 [76] Q&A Session Summary Question: Can you elaborate on the three tenants of your plan to get into guidelines? - Management discussed plans for publishing more information, providing real-world evidence, and driving clinical community adoption to support the PreTRM test [40][41][46] Question: What are your plans regarding Medicaid and its coverage of the test? - Management highlighted the significant opportunity with Medicaid, emphasizing the potential for cost savings and the importance of focusing on states with high preterm birth rates [48][50][52] Question: How do you view the timeline for getting into guidelines? - Management indicated that while it is difficult to predict, there is potential for updates to guidelines within the next one to three years, especially with the upcoming publication of the PRIME study [61][62] Question: What is the expected cash runway based on current operating plans? - Management stated that the cash runway extends into 2028, with operating expenses projected between $30 million to $35 million for the year [64] Question: What are the commercial investments planned for 2025? - Management outlined plans to build a sales organization, enhance medical liaison efforts, and optimize the revenue cycle to drive adoption of the PreTRM test [70][73]