NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO
THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN OR ANY OTHER
JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE
UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE THE
IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
THIS PRESS RELEASE
CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF
THE EUROPEAN MARKET ABUSE REGULATION (596/2014)
The Capital Increase is
aimed at institutional investors and certain founders, management
and members of the Board of Directors by way of an accelerated
bookbuild offering through a Private Placement via the Joint
Bookrunners as well as retail investors by way of a Public Offering
in France via the PrimaryBid platform
Existing shareholders
INKEF Capital and EQT Life Sciences as well as certain founders,
management and members of the Board of Directors to participate in
the Accelerated Bookbuild Offering
Issue price of €4.50
per new share, a 16.6% discount to 30-Day Volume Weighted Average
Price (VWAP) from closing price of March 19, 20241
EINDHOVEN, the Netherlands — March 20,
2024, 5:40 pm CET — ONWARD Medical N.V. (Euronext: ONWD) (the
“Company” or “ONWARD Medical”), the medical technology company
creating innovative spinal cord stimulation therapies to restore
movement, function, and independence in people with spinal cord
injury (SCI) and movement disorders, announces today the launch of
a capital increase by way of an accelerated bookbuild offering
through a private placement with institutional investors and
certain founders, management and members of the Board of Directors
(the “Private Placement”) via the Joint Bookrunners (as defined
below) and a separate public offering via the PrimaryBid platform
with retail investors in France (the “Public Offering”) of ordinary
shares with a nominal value of EUR 0.12 each in the Company’s
issued share capital (such shares the “New Shares” and the Private
Placement and the Public Offering together, the “Offerings”). The
final number of New Shares placed and the issue price per New Share
(the “Issue Price”) will be announced after pricing of the
Offerings. The New Shares will be issued from the Company’s
authorized capital under exclusion of the existing shareholders’
pre-emptive rights. “It is the Company’s intention to raise gross
proceeds of indicatively EUR 15 million from the Offerings, with an
up to EUR 5 million upsize option.
1 Source: Euronext
data
ONWARD Medical
currently envisions using the net proceeds of the Offerings
to:
- Fund research & development activities, including continued
product development and regulatory approval of the investigational
ARC-EX® System to restore hand and arm function and the
investigational ARC-IM® System for improved blood pressure
regulation after spinal cord injury (45%);
- Establish a commercial organization in preparation for expected
US launch of the ARC-EX System second half of this year, including
hiring a field sales organization, producing training and education
materials, attending congresses and events, developing customer
support capabilities, and conducting market access and
reimbursement activities (15%);
- Build quality, operations, and other infrastructure
capabilities (35%); and
- Fund working capital requirements (5%).
The net proceeds from the Offerings
are expected to extend the current cash runway of the Company into
mid-2025.
Details of the
Offerings
The New Shares are to
be offered to qualified investors in a Private Placement, which
will be initiated immediately after this announcement. The New
Shares will be offered outside the United States in reliance on
Regulation S under the US Securities Act of 1933, as amended, (the
”Securities Act”) and in the United States to "qualified
institutional buyers" as defined in Rule 144A under the Securities
Act in transactions exempt from, or not otherwise subject to, the
registration requirements of the Securities Act in reliance on
Section 4(a)(2) of the Securities Act. The Public Offering will run
in parallel with the Private Placement and the New Shares in the
Private Placement and the Public Offering will be placed at the
same Issue Price.
A separate
announcement will be made shortly regarding the Public Offer in
France via the PrimaryBid platform and its terms.
The Company expects the existing
shareholders INKEF Capital and EQT Life Sciences (for an aggregated
amount of EUR 3 million) as well as the following management,
founders, and members of the Board of Directors of the Company:
Dave Marver, CEO; Robert Odell, VP Operations; Lorenzo Fanti, VP
Legal; Co-Founders Jocelyne Bloch and Grégoire Courtine, CSO; and
Directors Ian Curtis, Kristina Dziekan, and Fred Colen (for an
aggregated amount of c. EUR 1 million) to support and participate
in the Private Placement.
The results of the
Offerings, including the number of New Shares and the Issue Price
will be announced upon completion of the bookbuilding process,
which is expected prior to market opening on March 21, 2024,
subject to acceleration or extension. The timing of the closing of
the orderbook, pricing, and allocations are at the absolute
discretion of the Company and the Joint Bookrunners.
Subject to
acceleration or extension, the New Shares are expected to be listed
and admitted to trading on Euronext Brussels and Euronext Amsterdam
on March 25, 2024 and payment and delivery of the New Shares are
expected to take place on March 25, 2024. The New Shares will rank
pari passu in all respects with the existing ordinary shares in the
Company.
Bryan, Garnier &
Co is acting as Sole Global Coordinator and, together with Bank
Degroof Petercam SA/NV and KBC Securities NV, as Joint Bookrunners
(the “Joint Bookrunners”) of the Private Placement.
In relation to the
Private Placement, the Company has agreed with the Joint
Bookrunners to a 90-day standstill period on future share issuances
waivable by the Joint Bookrunners and subject to customary
exceptions. Certain members of the Board of Directors and John
Murphy have agreed with the Joint Bookrunners to a market customary
180-day lock-up period waivable by the Joint Bookrunners and
subject to customary exceptions.
*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
science and preclinical research conducted at leading neuroscience
laboratories, the Company has received ten Breakthrough Device
Designations from the US Food and Drug Administration for its ARC
Therapy™ platform.
ONWARD® ARC Therapy,
which can be delivered by external ARC-EX® or implantable ARC-IM®
platforms, is designed to deliver targeted, programmed spinal cord
stimulation. Positive results were presented in 2023 from the
Company’s pivotal study, called Up-LIFT, evaluating the ability for
transcutaneous ARC Therapy to improve upper extremity strength and
function. The Company is now preparing regulatory approval
submissions for ARC-EX for the US and Europe. In parallel, the
Company is conducting studies with its implantable ARC-IM platform,
which demonstrated positive interim clinical outcomes for improved
blood pressure regulation, a component of hemodynamic instability,
following SCI. Other ongoing studies include combination use of
ARC-IM with a brain-computer interface (BCI) to address multiple
symptoms of 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 also has an academic partnership
with .NeuroRestore, a collaboration between the Swiss Federal
Institute of Technology (EPFL) and Lausanne University Hospital
(CHUV).
ONWARD Medical is
listed on Euronext Brussels and Amsterdam (ticker:
ONWD).
For more information,
visit ONWD.com and connect with us on LinkedIn and
YouTube.
For Company
Enquiries:
info@onwd.com
For Media
Enquiries:
Aditi Roy, VP
Communications media@onwd.com
For Investor
Enquiries:
Khaled Bahi, Interim
CFO 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, 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 Therapy™,
and ARC-BCI™ are investigational and not available for commercial
use.
Additional important
information
These materials may
not be published, distributed or transmitted in the United States,
Canada, Australia or Japan. These materials do not contain,
constitute or form part of an offer of securities for sale or a
solicitation of an offer to purchase securities (the “Securities”)
of ONWARD Medical N.V. (the “Company”), in the United States,
Australia, Canada, Japan or any other jurisdiction in which such
offer or solicitation is unlawful. The Securities of the Company
may not be offered or sold in the United States absent registration
or an exemption from registration under the U.S. Securities Act of
1933, as amended (the “Securities Act”). There will be no public
offering of the Securities in the United States. The Securities of
the Company have not been, and will not be, registered under the
Securities Act. The Securities referred to herein may not be
offered or sold in Australia, Canada or Japan or to, or for the
account or benefit of, any national, resident or citizen of
Australia, Canada or Japan subject to certain exceptions. No public
offering of the securities will be made in the United
States.
This document (and the
information contained within) is an advertisement and not a
prospectus within the meaning of the Regulation (EU) 2017/1129 in
each member state (“Member State”) of the European Economic Area
(the “Prospectus Regulation”). The Company has not authorised any
offer to the public of Securities in any Member State of the
European Economic Area other than within the Republic of France.
With respect to each Member State (each a “Relevant State”), no
action has been undertaken or will be undertaken to make an offer
to the public of securities requiring publication of a prospectus
in any Relevant State. As a result, the Private Placement Shares
may and will only be offered in Relevant States (i) to any legal
entity which is a qualified investor as defined in the Prospectus
Regulation; or (ii) in any other circumstances falling within
Article 1(4) of the Prospectus Regulation. The Public Offered
Shares may and will only be offered in the Republic of France
pursuant to Article 3(2) lit. b of the Prospectus Regulation. For
the purpose of this paragraph, the expression "offer of securities
to the public" means the communication in any form and by any means
of sufficient information on the terms of the offer and the
Securities to be offered so as to enable the investor to decide to
exercise, purchase or subscribe for the Securities. Further for the
purpose of this paragraph, “Private Placement Shares” means the
Securities that form part of the Private Placement in the European
Economic Area (other than France) and “Public Offered Shares” means
the Securities that form part of the Public Offer.
This document (and the
information contained within) is an advertisement and not a
prospectus within the meaning of Regulation (EU) 2017/1129, as it
forms part of U.K. domestic law by virtue of the European Union
(Withdrawal) Act 2018 (the “U.K. Prospectus Regulation”). No action
has been undertaken or will be undertaken that constitutes an offer
of the securities referred to herein to the public in the United
Kingdom or requires the publication of a prospectus in the United
Kingdom. The securities referred to herein may not and will not be
offered in the United Kingdom, except to relevant persons in
accordance with the exemptions set forth in the U.K. Prospectus
Regulation.
In the United Kingdom,
this document is only being distributed to and is only directed at
persons who are “qualified investors” within the meaning the U.K.
Prospectus Regulation, and who are also (i) investment
professionals within the meaning of Article 19(5) of the Financial
Services and Markets Act 2000 (Financial Promotion) Order 2005, as
amended (the “Order”), or (ii) high net worth companies,
unincorporated associations and other bodies to whom it may
otherwise lawfully be communicated in accordance with Article
49(2)(a) to (d) of the Order, or (iii) persons to whom an
invitation or inducement to engage in investment activity (within
the meaning of section 21 of the Financial Services and Markets Act
2000) in connection with the issue or sale of any securities may
otherwise lawfully be communicated or caused to be communicated
(all such persons together being referred to as “Relevant
Persons”). This document is directed only at Relevant Persons and
must not be acted on or relied on by persons who are not Relevant
Persons. Any investment or investment activity to which this
document relates is available only to Relevant Persons and will be
engaged in only with Relevant Persons.
This communication is
not a prospectus for the purposes of the Prospectus Regulation.
This communication cannot be used as basis for any investment
agreement or decision. Acquiring investments to which this
announcement relates may expose an investor to a significant risk
of losing the entire amount invested. Persons considering making
such investments should consult an authorised person specialising
in advising on such investments. This announcement does not
constitute a recommendation concerning the securities referred to
herein.
No announcement or
information regarding the offering, listing or securities of the
Company referred to above may be disseminated to the public in
jurisdictions where a prior registration or approval is required
for such purpose. No steps have been taken, or will be taken, for
the offering or listing of securities of the Company in any
jurisdiction where such steps would be required, except for the
admission of the offered shares on the regulated market of Euronext
Brussels and Euronext Amsterdam. The issue, exercise, or sale of,
and the subscription for or purchase of, securities of the Company
are subject to special legal or statutory restrictions in certain
jurisdictions. The Company is not liable if the aforementioned
restrictions are not complied with by any person.
Information to
Distributors
Solely for the
purposes of the product governance requirements contained within:
(a) EU Directive 2014/65/EU on markets in financial instruments, as
amended from time to time (“MiFID II”); (b) Articles 9 and 10 of
Commission Delegated Directive (EU) 2017/593 supplementing MiFID
II; and (c) local implementing measures (together, the “MiFID II
Product Governance Requirements”), and disclaiming all and any
liability, whether arising in tort, contract or otherwise, which
any ‘manufacturer’ (for the purposes of the MiFID II Product
Governance Requirements) may otherwise have with respect thereto,
the offered shares have been subject to a product approval process,
which has determined that the offered shares are: (i) compatible
with an end target market of retail investors and investors who
meet the criteria of professional clients and eligible
counterparties, each as defined in MiFID II; and (ii) eligible for
distribution through all distribution channels as are permitted by
MiFID II (the “Target Market Assessment”). Notwithstanding the
Target Market Assessment, distributors should note that: the price
of the offered shares may decline and investors could lose all or
part of their investment; the offered shares offer no guaranteed
income and no capital protection; and an investment in the offered
shares is compatible only with investors who do not need a
guaranteed income or capital protection, who (either alone or in
conjunction with an appropriate financial or other adviser) are
capable of evaluating the merits and risks of such an investment
and who have sufficient resources to be able to bear any losses
that may result therefrom. The Target Market Assessment is without
prejudice to the requirements of any contractual, legal or
regulatory selling restrictions in relation to the Private
Placement. Furthermore, it is noted that, notwithstanding the
Target Market Assessment, the placement agents in the Private
Placement will only procure investors who meet the criteria of
professional clients and eligible counterparties.
For the avoidance of
doubt, the Target Market Assessment does not constitute: (a) an
assessment of suitability or appropriateness for the purposes of
MiFID II; or (b) a recommendation to any investor or group of
investors to invest in, or purchase, or take any other action
whatsoever with respect to the offered shares.
Each distributor is
responsible for undertaking its own target market assessment in
respect of the offered shares and determining appropriate
distribution channels.
Bryan, Garnier &
Co, Degroof Petercam and KBC are acting exclusively for the Company
and no one else in connection with the Private Placement. In
connection with such matters, they, their affiliates and their
respective directors, officers, employees and agents will not
regard any other person as their client, nor will they be
responsible to any other person for providing the protections
afforded to their clients or for providing advice in relation to
the Private Placement or any other matters referred to in this
announcement.
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