Onward Medical (ONWD) H1 2024 earnings summary

Executive summary

• Achieved key milestones in 1H 2024, including De Novo FDA submission for ARC-EX, pivotal Up-LIFT study publication in Nature Medicine, and strong clinical results for upper limb function in SCI patients.

• Secured €20M equity raise and up to €52.5M debt facility, extending cash runway into spring 2025.

• Expanded clinical pipeline with new grants, 10th FDA Breakthrough Device Designation, and admission to FDA's TAP program for ARC-BCI System.

• Strengthened organizational capabilities and leadership in preparation for commercialization in 2H 2024.

• Commercial revenues expected in 2H 2024 following anticipated FDA clearance and US launch of ARC-EX.

Financial highlights

• H1 2024 revenues and other income totaled €0.2M, down from €0.9M in H1 2023, mainly from royalties and grants.

• Operating loss for H1 2024 was €18.7M–€19.0M, nearly unchanged from H1 2023.

• Net loss for H1 2024 was €18.3M, compared to €19.3M in H1 2023.

• Cash balance at June 30, 2024 was €32.1M, up from €29.8M at end-2023, with €16M drawn from new debt facility.

• Cash expected to fund operations through spring 2025.

Outlook and guidance

• FDA clearance and US commercial launch of ARC-EX anticipated in Q4 2024.

• Initial commercial focus on ~75 key US and ~30 European rehabilitation centers, with sales force ramping as needed.

• Empower BP pivotal trial for ARC-IM Therapy to begin late 2024/early 2025, with IDE submission planned.

• Additional ARC-BCI System implants and ongoing clinical development supported by new grants.

• Expansion into additional indications and geographies to follow initial US and Western Europe launch.