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]