Nyxoah
מודיעה על תוצאות ראשוניות לרבעון השני של 2025
מונט-סנט-גיברט,
בלגיה, 11 באוגוסט 2025, (GLOBE NEWSWIRE) :
Nyxoah SA (נאסד"ק/יורונקסט בריסל:
NYXH) ("Nyxoah" או "החברה"), חברת
טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה
בשינה (OSA) הודיעה היום על תוצאות כספיות
ראשוניות ולא מבוקרות לרבעון השני של 2025 ועדכונים עסקיים אחרים.
Nyxoah
Announces Preliminary Results for the Second Quarter of 2025
Mont-Saint-Guibert, Belgium – August 11, 2025, 7:00am CET / 1:00am
ET -(GLOBE NEWSWIRE):
Nyxoah SA
(Euronext Brussels/Nasdaq: NYXH) (“Nyxoah”
or the “Company”), a medical technology company that develops breakthrough
treatment alternatives for Obstructive Sleep Apnea (OSA), today announced
certain preliminary, unaudited financial results for the second quarter of 2025
and other business updates.
Preliminary, Unaudited Second Quarter 2025 Financial Results and Business
Updates
- Announced on
August 8, 2025, that the U.S. Food and Drug Administration (FDA) has
approved the Genio® system for a subset of adult patients with moderate to
severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to
15 and less than or equal to 65. Press Releases | Nyxoah
Investors
- Revenue for the
second quarter of 2025 is anticipated to be approximately €1.3 million, a
73% increase over the second quarter of 2024.
- Operating expenses
for the second quarter of 2025 are anticipated to be approximately €20.7
million, a 50% increase over the second quarter of 2024.
- Cash, cash
equivalents and financial assets are anticipated to be approximately €43.0
million at June 30, 2025. The Company also has a term debt facility with
€27.5 million of remaining availability which can be drawn down in two
equal tranches subject to revenue and other financial milestones.
- The Company
expects to close patient enrollment in its ACCCESS clinical trial prior to
enrolling all 106 potential patients. The study will continue, with the
patients currently enrolled, with the co-primary endpoints, Apnea-Hypopnea
Index (AHI) and Oxygen Desaturation Index (ODI) responder rates, assessed
at 12 months post implant and followed for five years.
- The Company
reorganized its global R&D function and expects to transition all
ongoing R&D activities from Israel to the U.S. and Belgium.
- The Company
received notice that Inspire Medical Systems, Inc. (“Inspire”) filed a
lawsuit against the Company in the United States alleging infringement of
certain patents owned by Inspire. The Company is well prepared, has the
means and intends to vigorously defend itself in this matter.
“We are pleased with the growth we saw in the
second quarter, which provides further evidence that our commercial proof of
concept in Germany has been successful,” commented Olivier Taelman, Chief
Executive Officer. “With FDA approval in hand, we expect to take the lessons
learned from Germany and apply them to the U.S. as we bring our unique Genio
system to the U.S. In addition, we believe that the patient population
currently enrolled in the ACCCESS study will provide statistically significant
results, which along with the outcomes from prior clinical evidence, will
provide meaningful data with respect to the safety and efficacy of using Genio
therapy in the patient population suffering from Complete Concentric Collapse
(“CCC”). Patients with CCC represent a significant unmet need in the treatment
of OSA as no FDA approved treatment currently exists.”
The preliminary, unaudited financial results
described in this press release, including preliminary revenue and operating
expenses for the second quarter of 2025 and preliminary cash, cash equivalents
and financial assets as of June 30, 2025, are estimates only. These financial
results could change as a result of further review. Accordingly, you should not
place undue reliance on this information. Complete financial results for the
second quarter of 2025 will be announced and issued on Monday, August 18, 2025
after NASDAQ market close. A webcast of the call will be accessible via the
Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2
2025 Earnings Call Webcast.
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 and receipt of approval from
the U.S. Food and Drug Administration (FDA) for a subset of patients with
moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or
equal to 15 and less than or equal to 65.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. FDA approved in August
2025 as prescription-only device.
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