REGULATED INFORMATION
INSIDE INFORMATION
Nyxoah Has Signed a EUR37.5 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 EUR37.5 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 EUR37.5 million facility is divided into three tranches: EUR10 million for the
first tranche ("Tranche A"), EUR13.75 million for the second tranche ("Tranche B")
and EUR13.75 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 EUR8,11 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 EUR48.5 million, providing us a combined access to over EUR80 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 Nyxoah
Nyxoah 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:
Nyxoah
David DeMartino, Chief Strategy Officer
IR@nyxoah.com (mailto:IR@nyxoah.com)
For Media
Belgium/France
Backstage Communication - Gunther De Backer
gunther@backstagecom.be (mailto:gunther@backstagecom.be)
International/Germany
MC Services - Anne Hennecke
anne.hennecke@mc-services.eu (mailto:anne.hennecke@mc-services.eu)
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