REGULATED
INFORMATIONINSIDE INFORMATION
Nyxoah Has Signed a €37.5 Million Loan
Facility Agreement with the European Investment
Bank
Mont-Saint-Guibert, Belgium – July 3,
2024, 12:30pm CET / 6:30am ET – Nyxoah SA (Euronext
Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a
medical technology company focused on the development and
commercialization of innovative solutions to treat Obstructive
Sleep Apnea (“OSA”), today announced that it has signed a €37.5
million loan facility agreement with the European Investment Bank
(“EIB”). The agreement is backed by the European Commission’s
InvestEU program. Nyxoah plans to use the funding for research and
development, and for scaling-up its manufacturing capacity to meet
demand in Europe and the U.S.
The €37.5 million facility is divided into three
tranches: €10 million for the first tranche (“Tranche A”), €13.75
million for the second tranche (“Tranche B”) and €13.75 million for
the third tranche (“Tranche C”). Disbursement under the
various tranches is subject to certain conditions. Tranche A
carries an annual 5% cash and 5% capitalized interest rate, and
features a five-year bullet repayment schedule. The various
tranches do not contain revenue or liquidity covenants.
In connection with the loan facility agreement,
and as a condition to drawdown thereunder, the Company also intends
to enter into a “synthetic warrant agreement” with the EIB. Under
the intended synthetic warrant agreement, in consideration for the
facility, in connection with each tranche of the facility, the EIB
will be granted “synthetic warrants” with a duration of 20 years.
The number and strike price of the synthetic warrants will be
calculated based on tranche specific formulas provided for in the
synthetic warrant agreement. The synthetic warrants can be
exercised as of the maturity date of the relevant tranche of the
facility or, in exceptional situations, earlier. Such synthetic
warrants will entitle the EIB to receive from the Company a cash
consideration equal to the 20-day volume weighted average price of
a share in the Company on the stock exchange, reduced by the
applicable strike price per synthetic warrant, and multiplied by
the number of synthetic warrants that the EIB exercises. In
connection with Tranche A, it is expected that the EIB will be
granted 468,384 synthetic warrants with a strike price of €8,11
that the EIB can exercise after the maturity of Tranche A (5 years)
or, in exceptional situations, earlier.
Since certain provisions of the loan facility
agreement and the synthetic warrant agreement are dependent on a
change of control, those provisions will be submitted for approval
to a shareholders' meeting of the Company in accordance with
article 7:151 of the Belgian Companies and Associations Code.
EIB Vice-President Robert de
Groot said: “Belgium stands at the forefront of innovation
in the area of life sciences and med tech. As the EIB, we take
pride in supporting this thriving industry and fostering growth.
Nyxoah, with its groundbreaking approach, is making a valuable
contribution. We are eager to see the company progressing,
benefitting patients worldwide.”
Olivier Taelman, CEO of Nyxoah,
commented: “We are excited and grateful for the support and
confidence in our cutting-edge technology shown by the European
Investment Bank. This loan follows our recent successful equity
offering where we raised €48.5 million, providing us a combined
access to over €80 million in growth capital. This will aid in the
commercialization of Genio in Europe and in the U.S., if approved,
while helping increase production capacity and sustain
innovation.”
About NyxoahNyxoah is a medical
technology company focused on the development and commercialization
of innovative solutions to treat Obstructive Sleep Apnea (OSA).
Nyxoah’s lead solution is the Genio® system, a patient-centered,
leadless and battery-free hypoglossal neurostimulation therapy for
OSA, the world’s most common sleep disordered breathing condition
that is associated with increased mortality risk and cardiovascular
comorbidities. Nyxoah is driven by the vision that OSA patients
should enjoy restful nights and feel enabled to live their life to
its fullest.
Following the successful completion of the BLAST
OSA study, the Genio® system received its European CE Mark in 2019.
Nyxoah completed two successful IPOs: on Euronext Brussels in
September 2020 and NASDAQ in July 2021. Following the positive
outcomes of the BETTER SLEEP study, Nyxoah received CE mark
approval for the expansion of its therapeutic indications to
Complete Concentric Collapse (CCC) patients, currently
contraindicated in competitors’ therapy. Additionally, the Company
announced positive outcomes from the DREAM IDE pivotal study for
FDA and U.S. commercialization approval.
For more information, please see the Company’s
annual report for the financial year 2023 and visit
http://www.nyxoah.com/.
Caution – CE marked since 2019.
Investigational device in the United States. Limited by U.S.
federal law to investigational use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions in this
press release are forward-looking, which reflect the Company’s or,
as appropriate, the Company directors’ or managements’ current
expectations regarding the entry into of the loan facility
agreement and the synthetic warrant agreement with the EIB; the use
of proceeds from the loan facility agreement; the Genio® system and
ongoing clinical studies of the Genio® system; the potential
advantages of the Genio® system; Nyxoah’s goals with respect to the
development, regulatory pathway and potential use of the Genio®
system; the utility of clinical data in potentially obtaining FDA
approval of the Genio® system; reporting data from Nyxoah’s DREAM
U.S. pivotal trial; filing for FDA approval; and entrance to the
U.S. market. By their nature, forward-looking statements involve a
number of risks, uncertainties, assumptions and other factors that
could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These
risks, uncertainties, assumptions and factors could adversely
affect the outcome and financial effects of the plans and events
described herein. Additionally, these risks and uncertainties
include, but are not limited to, the risks and uncertainties set
forth in the “Risk Factors” section of the Company’s Annual Report
on Form 20-F for the year ended December 31, 2023, filed with the
Securities and Exchange Commission (“SEC”) on March 20, 2024, and
subsequent reports that the Company files with the SEC. 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 are not guarantees of future
performance and should not be taken as a representation that such
trends or activities will continue in the future. In addition, even
if actual results or developments are consistent with the
forward-looking statements contained in this press release, those
results or developments may not be indicative of results or
developments in future periods. No representations and warranties
are made as to the accuracy or fairness of such forward-looking
statements. As a result, the Company expressly disclaims any
obligation or undertaking to release any updates 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, except if specifically required to do so by
law or regulation. 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.
Contacts:
NyxoahDavid DeMartino, Chief
Strategy OfficerIR@nyxoah.com
For
MediaBelgium/FranceBackstage Communication – Gunther De
Backergunther@backstagecom.be
International/GermanyMC Services – Anne
Henneckeanne.hennecke@mc-services.eu
- ENGLISH_Nyxoah Has Signed a Senior Loan Facility Agreement with
the EIB
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