THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
Up-LIFT Study results published in Nature Medicine
De Novo application submitted to FDA to obtain clearance to market the investigational ARC-EX® System in the United States
Up to EUR 52.5M in growth financing obtained from US-based Runway Growth Capital
Several additional milestones achieved with the investigational ARC-BCI™ System, leveraging brain-computer interface (BCI) technology to restore thought-driven movement
EINDHOVEN, the Netherlands, Sept. 10, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces its Half Year 2024 Financial Results and provides a Business Update.
"We had an excellent first half of 2024, submitting a De Novo application for our ARC-EX System to the FDA, publishing the results of our Up-LIFT pivotal study in Nature Medicine, and obtaining up to EUR 52.5M in growth financing from Runway Growth Capital," said Dave Marver, CEO of ONWARD Medical. "We also extended our leadership in the brain-computer interface realm, adding an FDA Breakthrough Device Designation (our 10th) and gaining admittance into the FDA's new TAP program to streamline commercialization. We are leading the way in developing a BCI-enabled therapy to restore movement after SCI."
Half Year Operating and Financial Results
Clinical and Development
In January, the Company expanded its HemON clinical feasibility study to explore use of its investigational ARC-IM® System to improve blood pressure regulation after SCI. The addition of Sint Maartenskliniek in the Netherlands prepares the Company for expected initiation in the coming months of its global pivotal trial, Empower BP, to assess the safety and efficacy of ARC-IM Therapy to improve blood pressure regulation after SCI.
In February, the Company announced it was awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI System, which uses BCI technology combined with its ARC-IM Therapy to restore thought-driven lower limb mobility after SCI. This is the Company's 10th BDD.
In March, ONWARD Medical was only the second BCI company admitted into the FDA's new Total Product Lifecycle Advisory Program (TAP), which is intended to streamline the commercialization of innovative new technologies.
In April, the Company announced it submitted a De Novo application to the FDA to obtain regulatory clearance to market its non-invasive ARC-EX System in the US. Clearance is expected Q4 2024.
In May, the Company announced publication of its Up-LIFT pivotal trial results in Nature Medicine. The study achieved all primary and secondary safety and effectiveness endpoints, and ARC-EX Therapy demonstrated significant improvements in upper limb strength, function, and sensation among people with chronic tetraplegia due to cervical SCI.
Science and Intellectual Property
The Company was issued 30 new patents in the first half of 2024, bringing its total number of issued patents to 270+ and strengthening its first-mover advantage.
Corporate
In March, the Company completed a €20M equity financing round that strengthened its cash position to support investments in product development, clinical studies, and operational and commercial capabilities; this financing extended the Company's cash runway into spring 2025.
The Company now has five banks providing equity research coverage. In April, the Company announced that Stifel, a US-based full-service investment bank, had initiated research coverage. In February, the Company announced that KBC Securities also initiated research coverage. The Company continues to be covered by equity research analysts at Bryan Garnier & Co, Degroof Petercam, and Kepler Cheuvreux.
In June, the Company signed a debt financing agreement for up to €52.5 million with US-based lender Runway Growth Capital. The initial tranche of this loan was used to retire the Company's outstanding debt. Future tranches are subject to the Company reaching certain milestones and are expected to be used to fund the Company's upcoming commercial and clinical activities and to support working capital and general corporate purposes.
Financial
The Company reported an operating loss of EUR 18.7 million for the first six months of 2024, in line with the EUR 18.8 million loss recorded in the first half of 2023. Increased spending on clinical, regulatory, and quality activities was balanced by reduced external spending on research and development.
The Company ended the first half of 2024 with a positive cash balance of EUR 32.1 million. The balance at year-end 2023 was EUR 29.8 million. The increase of EUR 2.3 million results from proceeds from the March 2024 equity financing offset by the cash outflows for operating activities.
Half Year 2024 Financial Summary
In EUR millionsFor the six-month period ended June 30
2024
