Onward Medical (ONWD) Q3 2024 TU earnings summary

Executive summary

• Achieved major milestones including exclusive licensing of WIMAGINE BCI technology, €50 million capital raise, and being named a TIME Best Invention of 2024.

• Ottobock became the largest shareholder with around 10% ownership and a strategic partnership to accelerate commercialization.

• Expanded board with experienced medtech leaders, including new Chairman and members from Medtronic and ClearChoice.

• Secured exclusive rights to CEA's WIMAGINE BCI, positioning for first-to-market BCI-enabled movement restoration.

• Listed shares on Euronext Paris, expanding market presence.

Financial highlights

• Closed Q3 with €23.2 million in cash and cash equivalents; cash burn of €8.9 million, in line with historical averages.

• 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, attracting long-only and sector specialist investors.

• Ottobock investment represents approximately 10% of shares.

• Total issued patents increased to 279 after five new patents in Q3 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 Empower BP pivotal trial for ARC-IM, with key milestones in H1 2025 and additional studies in Parkinson's disease.

• Plans to expand labeling and platforms, with new indications under evaluation.

• Focused on commercializing ARC-EX and executing pivotal study for ARC-IM, with future expansion into adjacent indications as resources allow.

• Multiple clinical milestones expected, including IDE approval and pivotal study enrollment for ARC-IM blood pressure indication.