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Nyxoah Announces Preliminary Results for the Second Quarter of 2025

Nyxoah Announces Preliminary Results for the Second Quarter of 2025

Mont–Saint–Guibert, Belgium – August 11, 2025, 7:00am CET / 1:00am ET – 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.

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 Company’s financial results for the second quarter ended June 30, 2025; the Company’s estimates of revenue and operating expenses for the second quarter of 2025 and cash, cash equivalents and financial assets as of June 30, 2025; the Genio system; planned and ongoing clinical studies of the Genio system, including the ACCCESS study; 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 Company's commercialization strategy and entrance to the U.S. market; the Company’s plans to transition its ongoing R&D activities to the U.S. and Belgium; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. 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. 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 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
John Landry, CFO
[email protected]

For Media
In United States
FINN Partners – Alyssa Paldo [email protected]

In International/Germany
MC Services – Anne Hennecke nyxoah@mc–services.eu

In Belgium/France
Backstage Communication – Gunther De Backer [email protected]

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GLOBENEWSWIRE (Distribution ID 1001122216)

Nyxoah Annonce ses Résultats Préliminaires pour le Deuxième Trimestre 2025

Nyxoah Annonce ses Résultats Préliminaires pour le Deuxième Trimestre 2025 

Mont–Saint–Guibert, Belgique – 11 août 2025, 7h00 CET / 01h00 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques révolutionnaires pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a annoncé aujourd'hui certains résultats financiers préliminaires non audités pour le deuxième trimestre 2025 et d'autres informations sur l'activité.

Résultats Financiers Préliminaires Non Audités du Deuxième Trimestre 2025 et Mises à Jour sur les Activités

  • A annoncé le 8 août 2025, que la Food and Drug Administration (FDA) américaine a approuvé le système Genio® pour un sous–groupe de patients adultes atteints d'AOS modérée à sévère avec un indice d'apnée–hypopnée (IAH) supérieur ou égal à 15 et inférieur ou égal à 65. Press Releases | Nyxoah Investors
  • Le chiffre d'affaires pour le deuxième trimestre 2025 devrait s'élever à environ 1,3 million d'euros, soit une augmentation de 73 % par rapport au deuxième trimestre 2024.
  • Les dépenses d'exploitation pour le deuxième trimestre 2025 devraient s'élever à environ 20,7 millions d'euros, soit une augmentation de 50 % par rapport au deuxième trimestre 2024.
  • La trésorerie, les équivalents de trésorerie et les actifs financiers devraient s'élever à environ 43,0 millions d'euros au 30 juin 2025. La société dispose également d'une facilité de crédit à terme avec une disponibilité restante de 27,5 millions d'euros, qui peut être utilisée en deux tranches égales sous réserve de la réalisation d'objectifs en matière de chiffre d'affaires et d'autres objectifs financiers.
  • La Société prévoit de clôturer le recrutement des patients pour son essai clinique ACCCESS avant d'avoir recruté les 106 patients potentiels. L'étude se poursuivra avec les patients actuellement recrutés, les critères d'évaluation co–principaux, à savoir les taux de réponse à l'indice d'apnée–hypopnée (IAH) et à l'indice de désaturation en oxygène (IDO), étant évalués 12 mois après l'implantation et suivis pendant cinq ans.
  • La Société a réorganisé sa fonction R&D mondiale et prévoit de transférer toutes ses activités de R&D en cours depuis Israel aux États–Unis et en Belgique. 
  • La Société a été informée qu'Inspire Medical Systems, Inc. (“Inspire”) a intenté une action en justice contre elle aux États–Unis pour violation de certains brevets détenus par Inspire. La Société est bien préparée, dispose des moyens nécessaires et a l'intention de se défendre vigoureusement dans cette affaire. 

“Nous sommes heureux de la croissance enregistrée au deuxième trimestre, qui confirme une nouvelle fois le succès de notre preuve de concept commerciale en Allemagne”, a commenté Olivier Taelman, CEO. “Avec l'autorisation de la FDA en notre possession, nous comptons mettre à profit les enseignements tirés de l'expérience allemande et les appliquer aux États–Unis, où nous allons commercialiser notre système Genio unique en son genre. De plus, nous pensons que la population de patients actuellement inscrite à l'étude ACCCESS fournira des résultats statistiquement significatifs qui, associés aux résultats des preuves cliniques antérieures, fourniront des données significatives sur la sécurité et l'efficacité de la thérapie Genio chez les patients souffrant d'un collapsus concentrique complet (CCC). Les patients atteints de CCC représentent un besoin important non satisfait dans le traitement de l'AOS, car il n'existe actuellement aucun traitement approuvé par la FDA.”

Les résultats financiers préliminaires et non audités décrits dans le présent communiqué de presse, y compris les revenus et les charges d'exploitation préliminaires pour le deuxième trimestre 2025 et les liquidités, équivalents de trésorerie et actifs financiers préliminaires au 30 juin 2025, ne sont que des estimations. Ces résultats financiers pourraient être modifiés à la suite d'un examen plus approfondi. Par conséquent, vous ne devez pas vous fier indûment à ces informations. Les résultats financiers complets pour le deuxième trimestre 2025 seront annoncés et publiés le lundi 18 août 2025 après la clôture du marché NASDAQ. Une webdiffusion de la conférence téléphonique sera accessible via la page Relations avec les investisseurs du site web de Nyxoah ou via ce lien : Nyxoah's Q2 2025 Earnings Call Webcast.  

A propos de Nyxoah

Nyxoah opère dans le secteur des technologies médicales. Elle se concentre sur le développement et la commercialisation de solutions innovantes destinées à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS). La principale solution de Nyxoah est le système Genio®, une thérapie de neurostimulation du nerf hypoglosse sans sonde et sans batterie qui a reçu le marquage CE, centrée sur le patient et destinée à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS), le trouble respiratoire du sommeil le plus courant au monde. Ce dernier est associé à un risque accru de mortalité et des comorbidités, dont les maladies cardiovasculaires. La vision de Nyxoah est que les patients souffrant de SAOS doivent pouvoir profiter de nuits réparatrices et vivre pleinement leur vie.

À la suite de la finalisation probante de l’étude BLAST OSA, le système Genio® a reçu le marquage européen CE en 2019. Nyxoah a réalisé avec succès deux IPO : l’une sur Euronext Bruxelles en septembre 2020 et l’autre sur le NASDAQ en juillet 2021. Grâce aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu le marquage CE pour l’extension de ses indications thérapeutiques aux patients souffrant de collapsus concentrique complet (CCC), pour lesquels les thérapies concurrentes sont actuellement contre–indiquées. En outre, la Société a annoncé les résultats positifs de l'étude pivot DREAM IDE et l'obtention de l'autorisation de la Food and Drug Administration (FDA) américaine pour un sous–groupe de patients atteints d'AOS modérée à sévère avec un indice d'apnée–hypopnée (IAH) supérieur ou égal à 15 et inférieur ou égal à 65.

Pour plus d’informations, visitez www.nyxoah.com

Attention – Marquage CE depuis 2019. Approuvé par la FDA en août 2025 en tant que dispositif disponible uniquement sur ordonnance.

Déclarations Prospectives

Certaines déclarations, convictions et opinions contenues dans ce communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la Société ou, le cas échéant, de ses administrateurs ou de sa direction concernant le système Genio ; les études cliniques prévues et en cours sur le système Genio ; les avantages potentiels du système Genio ; les objectifs de Nyxoah en matière de développement, de parcours réglementaire et d'utilisation potentielle du système Genio ; la stratégie de commercialisation de la société et son entrée sur le marché américain ; et les résultats d'exploitation, la situation financière, la liquidité, les performances, les perspectives, la croissance et les stratégies de la société. De par leur nature, les déclarations prospectives comportent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou événements réels diffèrent sensiblement de ceux exprimés ou sous–entendus dans les déclarations prospectives. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence défavorable sur les résultats et les effets financiers des plans et événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2024, déposé auprès de la Securities and Exchange Commission (« SEC ») le 20 mars 2025, et dans les rapports ultérieurs que la Société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent considérablement de toute évolution prévue. Les déclarations prospectives contenues dans le présent communiqué de presse concernant les tendances ou activités passées ne constituent pas des garanties de performances futures et ne doivent pas être interprétées comme une indication que ces tendances ou activités se poursuivront à l'avenir. En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements ne sont pas nécessairement indicatifs des résultats ou développements futurs. Aucune déclaration ni garantie n'est faite quant à l'exactitude ou à l'équité de ces déclarations prospectives. Par conséquent, la Société décline expressément toute obligation ou engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement dans les attentes ou d'un changement dans les événements, les conditions, les hypothèses ou les circonstances sur lesquels ces déclarations prospectives sont fondées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni aucun des dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs, et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans le présent communiqué de presse ou à la réalisation effective des développements prévus. Vous ne devez pas vous fier indûment aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contacts :

Nyxoah
John Landry, CFO
[email protected]

Medias
Aux États–Unis
FINN Partners – Alyssa Paldo
[email protected]

International / Allemagne
MC Services – Anne Hennecke
nyxoah@mc–services.eu

Belgique / France
Backstage Communication – Gunther De Backer
[email protected]

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GLOBENEWSWIRE (Distribution ID 1001122216)

From Conflict to Climate Crusade, Refugees Lead the Charge in Kenya

Lionel Ngukusenge (18), a Burundian refugee in Kenya staying at Kakuma refugee camp, has planted 70 trees at his homestead in the refugee camp in Kenya. Credit: Jeffrey Moyo/IPS.

Lionel Ngukusenge (18), a Burundian refugee in Kenya staying at Kakuma refugee camp, has planted 70 trees at his homestead. Credit: Jeffrey Moyo/IPS

By Jeffrey Moyo
KAKUMA, Kenya, Aug 11 2025 – For 18-year-old Lionel Ngukusenge, a refugee from Burundi, where he was forced into hiding because of a repressive regime, he has found another foe to contend with at the Kakuma refugee camp in Kenya: climate change.

Against all odds, Lionel, a Grade 9 student at Future Primary School, has planted 70 trees at his homestead in the refugee camp, which accommodates 300,000 refugees and has over 7,200 learners.

There are only 23 teachers at Lionel’s school, where each class has 209 learners, after 48 teachers were retrenched this year following the US government aid cuts to the organizations assisting refugees in this East African nation.

In the arid Kakuma refugee camp, 800 kilometers northwest of Nairobi, Lionel’s school also has students from South Sudan, Sudan, the Democratic Republic of Congo, Ethiopia, Somalia and Afghanistan.

“I’ve planted 70 trees at home because I learned the importance of trees. While doing my homework, I sit under the trees I planted. The oxygen is fantastic. I feel proud,” Lionel told IPS.

He (Lionel) is one of the refugees ‘weaponizing’ tree-planting to contend with climate change.

A difficult task, according to Kenya’s Department of Refugee Services in the Office of the President, because the trees have to be watered using the scarce precious water.

This, said the camp manager, Edwin Chabari, is rationed at 18 liters per head daily.

Nema John Zechariah (22), who eight years ago arrived in Kenya fleeing from conflict in Sudan, said tree planting is not new to her, as she started it in Sudan, planting fruit trees and fending off hunger amidst a raging war, as there was hardly enough to eat. Credit: Jeffrey Moyo/IPS.

Nema John Zechariah (22), who eight years ago arrived in Kenya fleeing from conflict in Sudan, said tree planting is not new to her, as she started it in Sudan, planting fruit trees and fending off hunger amidst a raging war, as there was hardly enough to eat. Credit: Jeffrey Moyo/IPS.

Kakuma is a Kenyan town in northwestern Turkana County, an arid region experiencing extreme temperatures as high as 40 degrees.

Despite these challenges, refugees like Lionel are managing to survive.

They are planting the Neem tree, an exotic tree known to thrive in arid regions.

Kakuma, a Turkana name, means “out of nowhere,” owing to the remote conditions of the place. Now, despite the hostile climate and environment, it has been home to fleeing refugees since 1992.

Non-governmental organizations like the Girl Child Network and the Education Above All Foundation, based in Qatar, support the learners’ tree-planting efforts.

Kenya’s Girl Child Network deputy director, Dennis Mutiso, said, “They (the youths) are a resource that can be used to reverse the current trends of environmental degradation. We are making deliberate efforts to make sure that they start passing the knowledge from the school to communities so that the project can be sustained.”

In schools and in homes, tree planting has balanced deforestation and desertification fueled by hundreds of refugees dependent on firewood at the Kenyan refugee camp, the biggest in Africa.

However, the latest aid cuts in Kenya have not spared tree planting, according to government officials.

Chabari said that some NGOs and partners who were helping with climate action have not been funded, and that the effects of climate change will be felt by all.

“The support from Girl Child Network came in at the right time. We have been trying to train our learners to plant as many trees as possible. The trees are not only being planted in schools but also at home,” Joseph Ochura, Kenya’s Turkana West Teachers’ Services Commission director, told IPS.

According to Ochura, the heat is abnormally high in Kakuma, forcing learners to start school at 6am because by midday, it would be extremely hot.

That has not deterred learners.

In this war against the heat, 17-year-old Baballa Samir, a Sudanese national who came to Kenya in 2020 fleeing from conflict and is now doing Grade 8 at Arid Zone Primary school in Kakuma, said in the five years he has lived in Kenya, he has planted 35 trees.

Tareeq Al Bakri, Program Specialist at the Education Above All Foundation, said, “Although Kakuma remains a very arid and challenging environment, learners’ involvement in tree planting has led to increased awareness and ownership of environmental stewardship among youths.”

Founded to cater for pastoralists, Arid Zone Primary is one of the oldest schools in Kenya’s Turkana West. It opened its doors to learners in 1986 with 300 learners.

Decades later, the school has 2,500 learners, with just 20 teachers.

An aspiring medical doctor and a climate change warrior from way back in Sudan, where he planted over 50 trees before fleeing, Baballa has planted more trees in this part of Kenya.

His message to the world is clear.

“I urge other young people to conserve the environment by planting trees because trees are important for air purification, and they are also sources of medicine,” he said.

Edukon Joseph, the principal at Arid Zone School, says, “The beneficiaries of tree planting are definitely the learners.”

“Learners take the knowledge to their parents, spreading tree planting outside this institution,” said Joseph.

Attending the same school with Baballa is Patrice Namwar, a 15-year-old Kenyan boy in Grade 9.

Namwar said he has planted 30 trees and 10 more at his homestead.

“We were taught by our teachers that one tree alone absorbs 25 kilograms of carbon and I asked myself, what if I plant 100 trees at home? Global warming will be reduced, because let’s say 25 kilograms multiplied by those 10 trees I have planted in my home—that means 250 kilograms of carbon would be reduced. When we plant more trees, this place will be a place to live in,” Namwar said.

Like Baballa, 16-year-old Grade 9 learner Sharon Ayanae at the Arid Zone School said since 2023 she has planted 35 trees at school, with six more at her homestead.

“When we plant trees, we reduce the temperatures caused by the sun here in Turkana and some trees help us with food,” Ayanae, who is Kenyan, said. In total, 900 trees have been planted at Arid Zone School alone.

At the boarding school, firewood is used for cooking for the learners; however, the tree planting has helped balance the losses.

That has had a growing impact on Kakuma’s arid conditions, according to Virginia Wanjiku, a teacher at Arid Zone school.

“Nowadays in Turkana, we have rains because of the tree-planting initiative. Tree planting has really helped us,” said Wanjiku.

Girl Child Network’s Mutiso said that currently in the Kakuma region, “We have managed to plant 645,352 trees, and we hope to have planted about 850,215 by the end of this year.”

Some deeply traumatized learners, who have been affected by raging wars in their countries, say that tree planting serves as therapy.

Najila Luka Ibrahim, 16, hails from Sudan and is currently in Form 3 at Blue State Secondary school in Kakuma.

She does not know whether or not her parents are alive after she fled from the conflict.

“Before, I just kept to myself, but when I joined the environmental club at school, I interacted with many people I didn’t know before. Tree planting changed me,” said Najila.

Attending the same school with Najila is also 22-year-old Nema John Zechariah, who eight years ago arrived in Kenya fleeing from conflict in Sudan.

For Nema, tree planting is not new to her, as she started it in Sudan, planting fruit trees and fending off hunger amidst a raging war, as there was hardly enough to eat.

“What drove me to plant trees was the hunger caused by war. There was no food. The trees provided fruits, which I sold at the market. Here in Kenya, I started planting trees in 2022,” said Nema.

Refugee learners like 25-year-old Augustino Kuot Bol, a South Sudanese national, said they want peace to plant trees.

A Form 3 learner at Blue State secondary school, Augustino has planted 20 trees at the Kenyan school since arriving in 2022.

“We want peace in the world. Without peace, we cannot have time to plant trees,” Augustino said.

IPS UN Bureau Report

 


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