Shares of RBOT rose 3.6% to $9.98 apiece after the market closed today. BTIG analysts Ryan Zimmerman and Iseult McMahon maintained a “neutral” rating for the company on the back of the update.
Waltham, Massachusetts–based Vicarious develops the Version 1.0 (V1.0) robot aimed at increasing the efficiency of surgical procedures. The company hopes to improve patient outcomes and reduce healthcare costs. With a novel approach, V1.0 uses proprietary, human-like surgical robots to transport surgeons inside the patient to perform minimally invasive surgery.
(Vicarious Surgical was one of 57 companies included in our Surgical Robotics Special Report. Download it for free here.)
The company previously eyed first-in-human trials midway through this year, but it pushed V1.0’s timeline back in November 2023. In March 2024, the company maintained its timeline to have V1.0 ready for an FDA submission by early- to mid-fiscal 2026.
Last fall, the company said it planned for a year-end cadaver lab for V1.0, followed by efforts toward verification, validation, and optimization of the system ahead of formal clinical testing. It completed integration, validating it through that cadaveric testing in late fiscal 2024. Now, the company has begun manufacturing the instrument’s arm, camera and capital equipment required to support testing.
According to Zimmerman, Vicarious today cited material procurement issues with some suppliers that delayed the build-out of the system. As a result, management expects the first patients treated by the end of 2025, rather than the previously suggested “mid-to-late 2025.” That also pushes its submission expectations back a bit to by late fiscal 2026. The analysts say the delays could range from about three to six months compared to previous expectations.
Notably, Vicarious said it has resolved those supply issues by this point. It continues working through Institutional Ethics Committee approvals for clinical trials, having identified several clinical sites. It plans to submit a Technical Dossier to the Ministry of Health around mid-fiscal 2025.
“Between cash on hand, expected cash burn and the timelines [Vicarious] is now laying out, the company will need to either reduce cash burn or find some sources of non-dilutive financing,” the analysts wrote. “None of this is easy in this environment.”
A look at the fourth-quarter results for Vicarious Surgical
Vicarious Surgical reported $15 million in operating expenses for the quarter, with $8.5 million spent on R&D. It delivered an adjusted net loss of $14.4 million, equaling $2.43 per share, which landed ahead of Wall Street’s estimates of $2.69 per share in losses.
The company had $49.1 million in cash and investments as of Dec. 31, 2024. Its cash burn rate for the full year was $49.1 million. That fell in line with the company’s 2024 guidance for a cash burn of about $50 million.
Vicarious Surgical expects its full-year 2025 cash burn to come in around $50 million.
“2024 was a pivotal year of progress for Vicarious Surgical, as we expanded our strategic hospital partnerships with LSU Health New Orleans, Temple Health, and University of Illinois Health, narrowed our clinical site selection for first clinical use, and successfully completed the integration of our Version 1.0 System,” said Adam Sachs, co-founder and CEO. “Entering 2025, our focus is directed on preparing for our first clinical patients later this year. Our team is diligently building inventory to support all required essential performance and safety testing, and securing Institutional Ethics Committee site approvals. We eagerly anticipate the opportunity to demonstrate the value of the Vicarious Surgical System in a live clinical setting.”
