ONWARD® Medical Reports Half Year 2024 Results and Provides a
Business Update
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 millions
For the six-month period ended June 30 |
2024 |
2023 |
Total Revenues & Other Income |
0.2 |
0.9 |
Total Operating Expenses |
(19.0) |
(19.7) |
Operating Loss for the Period |
(18.7) |
(18.8) |
Net Finance Result |
0.2 |
(0.5) |
Income Taxes |
0.3 |
(0.0) |
Net Loss for the Period |
(18.3) |
(19.3) |
At |
30 June 2024 |
31 December 2023 |
Cash position at the end of the period |
32.1 |
29.8 |
Interest Bearing Loans |
(16.0) |
(15.3) |
Equity |
18.3 |
17.9 |
Business Update: Outlook and Upcoming Milestones
ONWARD Medical expects to continue the steady and consistent
execution of its strategy in the coming quarters, including
preparing for commercialization of its first product.
- The Company expects to obtain FDA clearance to launch its
ARC-EX System in the US in Q4 2024. The Company has commenced the
hiring of a field sales and service organization and plans to
provide more detail about its launch plans during today’s Half Year
2024 Investor Webinar and Business Update.
- The Company expects a peer-reviewed publication in a top-tier
medical journal detailing the results of the first 10+ patients
implanted with investigational ARC-IM Therapy to address blood
pressure instability after SCI.
- The Company is preparing to initiate its Empower BP global
pivotal trial for ARC-IM Therapy to address blood pressure
instability after SCI. Major associated milestones expected to
occur in late 2024 and early 2025 include FDA Investigational
Device Exemption (IDE) submission, FDA IDE approval, and first
participant enrollment.
- The Company plans to advance
clinical and development activities for its ARC-BCI System,
leveraging new grant funding from the Christopher & Dana Reeve
Foundation, ongoing financial support from the European Innovation
Council under the Reverse Paralysis project, the previously
announced FDA Breakthrough Device Designation, and acceptance into
the FDA’s new TAP program. Several additional ARC-BCI System
implants are expected in the second half of 2024 and first half of
2025 as part of the ongoing clinical feasibility study with its
partners at .NeuroRestore and CEA-Clinatec.
Conference Call & Webcast
ONWARD Medical will host a conference call with a live webcast
today, September 10, 2024, at 2:00 pm CET / 8:00 am EDT. The 2024
Half-Year Report and webcast may be accessed on the Financial
Information page of the Company’s website. To join the webcast via
Zoom, please register using this link.
*All ONWARD® Medical devices
and therapies, including but not limited to
ARC-IM®,
ARC-EX®,
ARC-BCI™, and ARC
Therapy™, alone or in combination with
a brain-computer interface (BCI), are investigational and not
available for commercial use.
About ONWARD Medical
ONWARD® Medical is a medical technology company
creating therapies to restore movement, function, and independence
in people with spinal cord injury (SCI) and movement disabilities.
Building on more than a decade of scientific discovery,
preclinical, and clinical research conducted at leading hospitals,
rehabilitation clinics, and neuroscience laboratories, the Company
has developed ARC Therapy™, which has been awarded ten
Breakthrough Device Designations from the US Food and Drug
Administration (FDA).
ONWARD ARC Therapy is targeted, programmed spinal cord
stimulation designed to be delivered by the Company’s
external ARC-EX® or
implantable ARC-IM® platforms. ARC Therapy can also
be delivered by the Company’s ARC-BCI™ platform, which pairs the
ARC-IM System with brain-computer interface (BCI) technology to
restore movement after SCI with thought-driven control.
Use of non-invasive ARC-EX Therapy significantly improved upper
limb function after SCI in the global pivotal Up-LIFT trial, with
results published by Nature Medicine in May
2024. The Company has submitted its regulatory application to the
FDA for clearance of the ARC-EX System in the US and is preparing
for regulatory submission in Europe. In parallel, the Company is
conducting clinical studies with its ARC-IM Therapy, which
demonstrated positive interim clinical outcomes for improved blood
pressure regulation following SCI. Other ongoing clinical studies
focus on using ARC-IM Therapy to address mobility after SCI and
gait challenges in Parkinson’s disease as well as using the ARC-BCI
platform to restore thought-driven movement of both upper and lower
limbs after SCI.
Headquartered in Eindhoven, the Netherlands, ONWARD Medical has
a Science and Engineering Center in Lausanne, Switzerland and a US
office in Boston, Massachusetts. The Company is listed on Euronext
Brussels and Amsterdam (ticker: ONWD).
For more information, visit ONWD.com, and connect with us on
LinkedIn and YouTube.
For Media Inquiries:
Aditi Roy, VP Communications
media@onwd.com
For Investor Inquiries:
Amori Fraser, Finance Director
investors@onwd.com
Disclaimer
Certain statements, beliefs, and opinions in this press release
are forward-looking, which reflect the Company’s or, as
appropriate, the Company directors’ current expectations and
projections about future events. By their nature, forward-looking
statements involve several risks, uncertainties, and assumptions
that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
risks, uncertainties, and assumptions could adversely affect the
outcome and financial effects of the plans and events described
herein. A multitude of factors including, but not limited to,
delays in regulatory approvals, changes in demand, competition, and
technology, can cause actual events, performance, or results to
differ significantly from any anticipated development.
Forward-looking statements contained in this press release
regarding past trends or activities should not be taken as a
representation that such trends or activities will continue in the
future. As a result, the Company expressly disclaims any obligation
or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or any change in events, conditions,
assumptions, or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or
representatives nor any of its subsidiary undertakings or any such
person’s officers or employees guarantees that the assumptions
underlying such forward-looking statements are free from errors nor
does either accept any responsibility for the future accuracy of
the forward-looking statements contained in this press release or
the actual occurrence of the forecasted developments. You should
not place undue reliance on forward-looking statements, which speak
only as of the date of this press release. All ONWARD Medical
devices and therapies referenced here, including but not limited to
ARC-IM®, ARC-EX®, ARC-BCI™ and ARC Therapy™,
are investigational and not available for commercial use.
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 8 2024 まで 9 2024
Onward Medical NV (EU:ONWD)
過去 株価チャート
から 9 2023 まで 9 2024