Financial Data and Key Metrics Changes - Total operating expenses for Q2 2025 were $13.5 million, a 24% decrease from $17.7 million in Q2 2024 [14] - GAAP net loss for Q2 2025 was $13.2 million or $2.23 per share, compared to a net loss of $15.2 million or $2.59 per share in Q2 2024 [15] - Non-GAAP adjusted net loss for Q2 2025 was $13.3 million or $2.23 per share, compared to $16.8 million or $2.86 per share in Q2 2024 [15] - Cash burn rate for Q2 2025 was approximately $13.4 million, with an expectation of full-year 2025 cash burn around $50 million [16] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2025 were $9.1 million, down from $10.9 million in Q2 2024 [14] - General and administrative expenses for Q2 2025 were $4.1 million, compared to $5.6 million in Q2 2024 [14] - Sales and marketing expenses for Q2 2025 were $300,000, down from $1.2 million in Q2 2024 [14] Company Strategy and Development Direction - The company is focusing on completing a fully integrated production equivalent system before initiating clinical trials, shifting away from near-term targets for first clinical use (FCU) [11] - The new CEO emphasizes the importance of ensuring the system is ready for commercialization before proceeding with clinical trials [10][11] - The company aims to refine its timelines and evaluate progress across development programs while engaging with the Board and investors regarding capital strategy [12] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges of the current market environment but expresses confidence in the company's technology and mission to transform surgical care [18] - The new CEO is optimistic about the company's potential and the need for a system that addresses real problems in the surgical field [40][44] - Management is committed to providing reliable guidance to investors once a clearer understanding of development timelines is established [36][58] Other Important Information - The company ended Q2 2025 with approximately $24 million in cash, cash equivalents, and short-term investments [15] - The leadership transition is seen as an opportunity to reassess the company's development path and strategy [5][6] Q&A Session Summary Question: Can you discuss the process of prioritizing system readiness and the impact on clinical trial timelines? - The new CEO is focused on understanding the requirements for a full production equivalent system and ensuring that resources are allocated effectively to avoid rushing into clinical trials with an incomplete system [24][25] Question: What was anticipated to be spent on clinical trials, and how does that affect cash burn guidance? - Current budgeted costs for clinical trials are not expected to materially change the overall 2025 budget, as most groundwork does not require significant spending [30] Question: What milestones should investors expect by the end of the year? - The CEO indicates that it is too early to provide specific dates for milestones, as clarity will come after a thorough assessment of the current development status [35][36] Question: How does the company view its ability to fund development with current cash on hand? - The CEO expresses confidence in the company's potential and the need for the system being developed, emphasizing that the groundwork has already been laid for future success [39][41] Question: What led to the conclusion that the system is not ready for first in human trials? - Management identified several issues that need to be addressed before proceeding, including hardware and software adjustments, which require additional time and effort [50][52] Question: Will the timeline for clinical milestones shift significantly? - The CEO cannot provide specific guidance on timeline shifts until the assessment is completed, but he is optimistic about the visibility of the goal line as the assessment progresses [58][59]

Financial Data and Key Metrics Changes - Total operating expenses for Q1 2025 were $15.7 million, a 2% decrease from $16.1 million in Q1 2024 [11] - R&D expenses for Q1 2025 were $9.4 million, down from $10 million in Q1 2024 [11] - GAAP net loss for Q1 2025 was $15.4 million or $2.6 per share, compared to a net loss of $17 million or $2.9 per share in Q1 2024 [12] Business Line Data and Key Metrics Changes - Sales and marketing expenses for Q1 2025 were $1 million, essentially flat compared to the prior year [11] - The company successfully built its first patient card and surgeon console for preclinical testing, marking significant progress in its development timeline [7] Market Data and Key Metrics Changes - The company is preparing for its first human cases, focusing on ventral hernia repair, which aligns with its pivotal trial endpoints [8][9] - The collaboration with UMass Memorial Medical Center aims to optimize the implementation of the robotic system in clinical settings [9][10] Company Strategy and Development Direction - The company aims to revolutionize robotic surgery by overcoming limitations of existing surgical approaches, with a focus on minimally invasive procedures through a single small incision [5] - 2025 is positioned as a transformative year, with expectations to evolve into a clinical stage company and demonstrate the value of its single port surgical system [6][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving major clinical milestones later in 2025, attributing progress to the dedication of the team and support from investors [14] - The company is focused on disciplined spending and strategic financing to ensure continued operations and product development [17][18] Other Important Information - The company ended Q1 2025 with approximately $37 million in cash, cash equivalents, and short-term investments, with a cash burn rate of about $12 million for the quarter [12][13] - Full-year cash burn for 2025 is expected to be around $50 million, with a commitment to disciplined capital allocation [13] Q&A Session Summary Question: What assurances can you give to investors about your continued ability to fund operations? - Management emphasized disciplined spending and strategic evaluation of financing options, with confidence in support from existing and potential new investors [17][18] Question: How are you feeling about your ability to supply remaining components for the V1.0 build? - Management reported effective management of the supply chain, with no significant changes or adjustments to the schedule [20][21] Question: Can you provide details on the review timeline expectations for the technical dossier submission? - The company anticipates filing the technical dossier around mid-2025, with confidence based on assumptions from similar companies' experiences [27][28] Question: To what extent could hospital partners be additive to your development process? - Management indicated that hospital partners are excited about the technology and are actively working on optimizing workflows, which will benefit both development and future commercialization [29]