Onward Medical (ONWD) Q3 2024 TU earnings summary

Executive summary

• Raised €50 million in new capital, with Ottobock becoming the largest shareholder and strategic partner, acquiring around 10% of share capital.

• Secured exclusive license with CEA for WIMAGINE BCI technology, enabling integrated, non-invasive brain-computer interface solutions as part of ARC-BCI System.

• ARC-EX system named one of Time Magazine's best inventions of 2024.

• Expanded board with experienced medtech leaders, including Rob ten Hoedt as incoming Chairman and Rahma Samow.

Financial highlights

• Closed Q3 with €23.2 million in cash; post-October capital raise, cash balance increased to €65.8 million, providing over two years of operational runway.

• Successfully completed an upsized €50 million capital increase in October 2024.

Outlook and guidance

• Anticipates FDA clearance and first commercial sale of ARC-EX in the U.S. within weeks; European submission expected H1 2025, CE mark in H2 2025.

• Preparing for EmpowerBP pivotal trial for ARC-IM System, with key milestones in H1 2025.

• Ongoing clinical feasibility studies for Parkinson’s disease and upcoming pivotal study for ARC-IM.