
Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $31.8 million, an increase of $5.1 million or 19% compared to Q1 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to Q1 2024 [29] - Non-GAAP adjusted gross profit for Q1 2025 was $14.3 million, an increase of $2.3 million or 19% year-over-year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - More than 37,000 Gallery tests were sold in Q1 2025, with repeat test volumes increasing over time, now accounting for over 20% of total volume [26][27] - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021 [7] Market Data and Key Metrics Changes - The company has launched Gallery commercially in Israel in partnership with OncoTest, with initial test orders being received [9] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [8] Company Strategy and Development Direction - The company aims to advance Gallery through key clinical and regulatory milestones to unlock broad access while managing costs [5] - A new educational campaign called "Generation Possible" has been initiated to raise public awareness of multi-cancer early detection [9] - The company is focused on achieving FDA approval for Gallery and pursuing broad reimbursement [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for Gallery and the progress towards major milestones, including TRICARE coverage and integration with Quest Diagnostics [31] - The company expects to share interim data from the PATHFINDER II study in late 2025 and complete its PMA submission to the FDA in the first half of 2026 [31] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [12][14] - The company has made significant investments to optimize technology and laboratory infrastructure, including the rollout of an enhanced version of the Gallery test [7] Q&A Session Summary Question: Can you quantify the expected short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as they transition to the new version [35][36] Question: How is the cash burn tracking towards the $320 million target? - The company burned just under $90 million in Q1, with expectations that cash burn will align with the target as margins improve [42][44] Question: What is the rationale behind not raising money to derisk the outlook? - Management believes that achieving major milestones will create value and that they have sufficient cash runway to reach these goals [62][66] Question: How are recent conversations with NHS progressing regarding Gallery commercialization? - Management stated they are in constant dialogue with NHS and that decisions on commercialization will wait for final results from the study [70][72]