ONWARD Medical N.V. (Euronext: ONWD), the medical technology
company creating innovative spinal cord stimulation therapies to
restore movement, function, and independence in people with spinal
cord injury (SCI), announces today that the Company and its
subsidiaries, ONWARD Medical Inc. and ONWARD Medical S.A., signed a
loan agreement in the amount of up to €52.5 million (the “Loan
Agreement”) with U.S.-based lender Runway Growth Capital LLC (the
“Lender”). The loan will be used to (i) repay all of the Company’s
outstanding debt, (ii) fund the Company’s upcoming commercial and
clinical activities, and (iii) for working capital and general
corporate purposes.
The facility is divided into five individual credit tranches.
The first initial credit tranche of €16.0 million will be available
upon signing of the Loan Agreement and will be drawn down
immediately. Three subsequent credit tranches of €14.0 million, up
to €5.0 million and up to €7.5 million will be available to be
drawn by the Company until March 31, 2025, July 31, 2026 and
January 31, 2027 respectively, in each case subject to the
Company’s achievement of certain milestones under the Loan
Agreement. The fifth credit tranche of up to €10.0 million is
uncommitted and available in the first quarter of 2027 upon the
sole discretion of the Lender.
The loan bears interest at a rate equal to Term Secured
Overnight Financing Rate (SOFR) for a three month interest period
(currently at 6.00% and subject to a 4.25% floor), plus a margin of
6.50%.
The loan documents provide for a number of affirmative and
negative covenants by the Company customary for financings of this
type, including financial covenants relating to revenue, earnings
before interest taxes deprecition and amortization (EBITDA) and
minimum liquidity targets. The loans advanced under the Loan
Agreement will be secured by a security interest in substantially
all of the assets of the ONWARD Medical, N.V. and its
subsidiaries.
In addition, upon signing of the debt financing the Company will
issue to the Lender warrants which will entitle the Lender to
purchase ordinary shares in the capital of the Company at an
exercise price per newly issued share calculated on the basis of
the lowest 30 day volume-weighted average price (VWAP) between
April 9, 2024 and the signing of the debt financing. The number of
shares subject to the warrants are five percent (5.00%) of the
drawn down principal amount initially and upon each subsequent loan
advance, divided by the exercise price of €4.83.
“ONWARD is pleased to enter this long-term relationship with one
of the top U.S. lenders providing growth capital to innovative life
science companies,” said ONWARD Medical CEO Dave Marver. “This
relationship will diversify our capital structure and help to fund
many of our upcoming milestones, including expected launch of our
ARC-EX System later this year and commencement of our pivotal study
for ARC-IM, called Empower BP. We look forward to working closely
with Runway to provide fuel to our effort to bring solutions to the
profound unmet needs of people with spinal cord injury.”
“We are excited to partner with ONWARD Medical to provide
capital for the continued development of their innovative therapies
improving the lives of patients with spinal cord injuries,” said
Greg Greifeld, Managing Director and Deputy Chief Investment
Officer of Runway Growth Capital. “Given our experience in the
healthcare space, we understand the critical impact that
advancements in medical technology can have on patients’ lives and
this investment will help ONWARD Medical achieve its upcoming
milestones and revolutionize the standard of care for the spinal
cord injury community.”
ONWARD Medical was advised by Stifel, a U.S-based full service
investment bank.
*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.
About Runway Growth Capital LLC
Runway Growth Capital LLC is the investment advisor to
investment funds, including Runway Growth Finance Corp.
(Nasdaq: RWAY), a business development
company, and other private funds, which are lenders of growth
capital to companies seeking an alternative to raising equity. Led
by industry veteran David Spreng, these funds provide senior
term loans of $10 million to $75 million to
fast-growing companies based in the United States, Canada, and
Europe. For more information on Runway Growth Capital LLC and its
platform, please visit our website
at www.runwaygrowth.com
For ONWARD Medical Media Inquiries:Aditi Roy, VP
Communications media@onwd.com
For ONWARD Medical Investor Inquiries: Amori Fraser,
Finance Directorinvestors@onwd.com
For Runway Growth Media Inquiries:Jason Holley, Senior
Directorjholley@impactpartners.llc
For Runway Growth Investor Inquiries:Stefan Norbom, Senior Vice
Presidentsnorbom@prosek.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,
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.
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