A Natural Disaster that Has Affected More People Worldwide Than Any Other

Livestock in eastern Mauritania are dying due to drought. Credit: UNHCR/Caroline Irby

By Danielle Nierenberg
BALTIMORE, Maryland, May 14 2025 – Here’s a question: Over the past 40 years, what natural disaster has affected more people around the globe than any other?

The answer, according the U.N. Food and Agriculture Organization (FAO), is drought.

The past 10 years have been the hottest 10 years on record, and higher temperatures and drier conditions are making more regions vulnerable to drought and arid land degradation, or desertification. This process is “a silent, invisible crisis that is destabilizing communities on a global scale,” according to the U.N. Office for Disaster Risk Reduction.

Globally, the nearly 2 billion people who live in dryland areas are often the first to face hunger, thirst, and the devastating effects of poor soil and environmental decline, says Dr. ML Jat, the Director of Resilient Farm and Food Systems at the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT).

And the next generations will feel the effects: UNICEF predicts that, by 2040, one in four children will live in areas of extremely high water stress. But there is a path toward a better future—there are farming and food-system solutions that allow us to nourish communities in hotter, drier climates.

Indigenous crops, for example, are naturally adapted to the extreme weather in desert regions and can strengthen food security, community health, and local ecosystems. I’ve long admired the work of organizations like Native Seeds/SEARCH, which conserves seeds so they can continue to benefit the peoples in the Southwest and Mexico, and the Arizona Alliance for Climate-Smart Crops, which supports farmers in adopting climate-smart crops and practices that conserve water.

“Wild desert plants have a remarkable number of adaptations to cope with heat, drought, unpredictable rainfall, and poor soils—the sorts of stressful growing conditions we are already seeing and expect to see more of in the future,” Dr. Erin Riordan of the University of Arizona told Food Tank.

And at the same time, there are innovative solutions we can elevate to restore degraded landscapes and combat further desertification! The UN Convention to Combat Desertification (UNDP) is supporting several amazing projects in Africa, including the Great Green Wall Initiative, which works across 22 countries to revitalize fertile land and transform lives.

And in Somalia, UNDP is partnering with local leaders to construct reservoirs and dams to improve water access and address deforestation and desertification.

We can’t solve these challenges alone. A fascinating new ICRISAT report looks at the power of microbes to boost crop yields and restore soil health in dryland farming systems. These microbes could include bacteria that improve nitrogen-fixation, which can improve soil fertility, and other microorganisms that can control diseases and crop pests.

And we need a whole-of-society approach to combating desertification—especially in parts of the world that have not traditionally struggled with arid landscapes and water scarcity, because, as we know, natural disasters like drought are affecting more and more people as the climate crisis deepens.

As he always does, author and agro-ecologist Gary Paul Nabhan writes powerfully about what all of us across the entire food system must do to prioritize Indigenous crops and adapt to changing environments.

“If farmers shift what crops they grow, they will need consumers, cooks, and chefs to adapt what they are willing to prepare and eat in the new normal,” he wrote in a great op-ed for us at Food Tank. “It is time to turn the corner from corn and soy monocultures to the sesames, prickly pear cactus, garbanzos, millets and mulberries of the world that desert dwellers have eaten in delicious dishes for millennia.”

How are food and agriculture system leaders in your community working to protect land from becoming degraded? I love hearing stories of creative solutions, like the ones I’ve highlighted here, so please say hello at [email protected] and tell me about the microbes, Indigenous crops, and land management techniques that will help us nourish our neighbors and adapt our food systems in hotter, drier climates.

Food Tank is a registered 501(c)(3), and all donations are tax-deductible. Danielle Nierenberg has served as President since the organization began and Bernard Pollack is the Chair of the Board of Directors.

IPS UN Bureau

 


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Nyxoah Présente ses Résultats Financiers et Opérationnels du Premier Trimestre

INFORMATIONS RÉGLEMENTÉES

Nyxoah Présente ses Résultats Financiers et Opérationnels du Premier Trimestre
La Société est en bonne voie pour obtenir l'autorisation de mise sur le marché
au deuxième trimestre 2025
Les exigences de validation de la FDA ont été remplies avec succès,
l'inspection finale du site est en cours

Mont–Saint–Guibert, Belgique – 14 mai 2025, 07h00 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 publié aujourd’hui ses résultats financiers et opérationnels pour le premier trimestre 2025.

Temps Forts Financiers et d’Exploitation

  • A reçu une lettre d'approuvabilité (“Approvable Letter) de la FDA indiquant que la FDA approuvera la demande de mise sur le marché américain (PMA) du système Genio, sous réserve de l'achèvement satisfaisant d'un examen des installations de fabrication, des méthodes et des contrôles
  • Achèvement avec succès des exigences de validation de la FDA, inspection finale du site en cours sur le site de fabrication américain
  • Le chiffre d'affaires du premier trimestre 2025 s'élève à 1,1 million d'euros, contre 1,2 million d'euros au premier trimestre 2024
  • Lancement de la mise à jour du logiciel patient Genio 2.1 sur les marchés commerciaux
  • La trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 63,0 millions d'euros au 31 mars 2025, contre 85,6 millions d'euros à la fin de l'année 2024

“Nous sommes ravis d’avoir atteint le stade final de la procédure d’examen par la FDA de notre système Genio® aux États–Unis”, a commenté Olivier Taelman, CEO de Nyxoah. “La lettre d'approbation de la FDA que nous avons reçue précédemment confirme que notre demande répond en grande partie aux exigences de la loi fédérale sur les aliments, les médicaments et les cosmétiques, y compris la biocompatibilité et l'acceptation de nos données cliniques démontrant la sécurité et l'efficacité du système Genio®. Nous avons complété avec succès la validation finale du processus demandée par la FDA. Nous savons que la dernière étape vers l'approbation de la FDA est une inspection sur le site de fabrication américain, qui devrait être achevée sous peu. Dans le cadre du processus de PMA, ce site a déjà passé avec succès une inspection sur place sans aucune anomalie, ce qui nous donne confiance dans la réalisation de cette étape réglementaire. Nous continuons à penser que notre demande pourrait être approuvée au cours du deuxième trimestre 2025.”

COMPTE DE RESULTATS CONSOLIDÉS (NON–AUDITÉS)
(en milliers)

      Pour la période de trois mois clôturée le 31 mars
      2025   2024
Chiffre d'affaires     € 1 064   € 1 221
Coût des biens vendus     ( 406)   ( 455)
Bénéfice brut     € 658   € 766
Frais de recherche et de développement     (8 989)   (7 199)
Frais de vente, dépenses administratives et autres frais généraux     (12 392)   (5 972)
Autres revenus / (frais) d'exploitation     84   192
Perte d'exploitation de la période     € (20 639)   € (12 213)
Produits financiers     2 622   1 408
Charges financières     (4 242)   ( 991)
Perte de la période avant impôts     € (22 259)   € (11 796)
Impôts sur le revenu     ( 125)   ( 110)
Perte de la période     € (22 384)   € (11 906)
           
Perte attribuable aux actionnaires     € (22 384)   € (11 906)
Autres éléments du résultat global          
Eléments pouvant être reclassifiés en bénéfices ou en pertes (nets d'impôts)          
Différences de conversion de devises     ( 2)   60
Perte globale totale de la période, nette d'impôts     € (22 386)   € (11 846)
Perte attribuable aux actionnaires     € (22 386)   € (11 846)
           
Perte par action (en €)     € (0,598)   € (0,415)
Perte diluée par action (en €)     € (0,598)   € (0,415)

ÉTAT DE LA SITUATION FINANCIÈRE CONSOLIDÉ (non audité)
(en milliers)
 
      Au
      31 mars
2025
  31 décembre
2024
ACTIFS          
Actifs non courants          
Immobilisations corporelles     4 696   4 753
Immobilisations incorporelles     50 977   50 381
Droit d'utilisation des actifs     3 152   3 496
Actif d'impôts différés     78   76
Autres créances à long terme     1 790   1 617
      € 60 693   € 60 323
Actifs courants          
Stocks     4 981   4 716
Créances commerciales     2 604   3 382
Autres créances     3 128   2 774
Autres actifs courants     1 450   1 656
Actifs financiers     40 653   51 369
Trésorerie et équivalents de trésorerie     22 394   34 186
      € 75 210   € 98 083
Total de l'actif     € 135 903   € 158 406
           
CAPITAUX PROPRES ET PASSIFS          
Capital et réserves          
Capital     6 430   6 430
Prime d'émission     314 345   314 345
Réserve pour paiement fondé sur des actions     11 256   9 300
Autres éléments du résultat global     912   914
Résultats reportés     (240 100)   (217 735)
Total des capitaux propres attribuables aux actionnaires     € 92 843   € 113 254
           
PASSIFS          
Passifs non courants          
Dettes financières     18 519   18 725
Passifs locatifs     2 316   2 562
Provisions     548   1 000
Passif d'impôts différés     27   19
      277   472
      401   845
      € 22 088   € 23 623
Passifs courants          
Dettes financières     244   248
Passifs locatifs     1 010   1 118
Dettes commerciales     9 316   9 505
Passif d'impôts exigibles     4 300   4 317
Responsabilité contractuelle     368   117
Autres dettes     5 734   6 224
      € 20 972   € 21 529
Total du passif     € 43 060   € 45 152
Total des capitaux propres et du passif     € 135 903   € 158 406

Revenus
Le chiffre d'affaires s'est élevé à 1,1 million d'euros pour le premier trimestre se terminant le 31 mars 2025, contre 1,2 million d'euros pour le premier trimestre se terminant le 31 mars 2024.

Coût des Marchandises Vendues
Le coût des marchandises vendues s'est élevé à 406 000 € pour le premier trimestre se terminant le 31 mars 2025, soit un bénéfice brut de 0,7 million d'euros, ou une marge brute de 61,8 %. À titre de comparaison, le coût des marchandises vendues était de 455 000 € pour le premier trimestre se terminant le 31 mars 2024, soit un bénéfice brut de 0,8 million €, ou une marge brute de 62,7 %.

Frais de Recherche et de Développement
Pour le premier trimestre se terminant le 31 mars 2025, les frais de recherche et développement se sont élevés à 9,0 millions d'euros, contre 7,2 millions d'euros pour le premier trimestre se terminant le 31 mars 2024. L'augmentation des frais de recherche et développement est principalement due à l'augmentation des activités de R&D et des dépenses liées aux études cliniques.

Frais commerciaux, Généraux et Administratifs
Pour le premier trimestre se terminant le 31 mars 2025, les frais commerciaux, généraux et administratifs se sont élevés à 12,4 millions d'euros, contre 6,0 millions d'euros pour le premier trimestre se terminant le 31 mars 2024. L'augmentation des frais commerciaux, généraux et administratifs est principalement due à une augmentation des coûts pour soutenir la commercialisation du système Genio®, les préparations globales de mise à l'échelle de la Société pour la commercialisation prochaine du système Genio® aux États–Unis après réception de l'approbation de la FDA.

Perte d'Exploitation
La perte d'exploitation totale pour le premier trimestre se terminant le 31 mars 2025 s'est élevée à 20,6 millions d'euros, contre 12,2 millions d'euros au premier trimestre 2024, respectivement. Cette évolution s'explique par une augmentation des frais commerciaux, généraux et administratifs pour soutenir la commercialisation du système Genio, les préparatifs globaux de mise à l'échelle de la Société en vue de la commercialisation prochaine du système Genio® aux États–Unis après réception de l'approbation de la FDA, et l'augmentation des activités de R&D et des dépenses liées aux études cliniques.

Position de Trésorerie
Au 31 mars 2025, la trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 63,0 millions d'euros, contre 85,6 millions d'euros à la fin de l'année 2024.

Premier Trimestre 2025
Le rapport financier de Nyxoah pour le premier trimestre 2025, y compris les détails des résultats consolidés, est disponible sur la page : https://investors.nyxoah.com/financials.

Progrès vers l'approbation PMA de la FDA

Le 26 mars 2025, Nyxoah a annoncé que la Food and Drug Administration (FDA) des États–Unis a émis une lettre d'approbation concernant la demande d'approbation préalable à la mise en marché (PMA) de la société pour le système Genio®. La lettre d'approbation signifie que la demande de Nyxoah pour la commercialisation du dispositif aux États–Unis répond en grande partie aux exigences de la loi fédérale sur les aliments, les médicaments et les cosmétiques (Federal Food, Drug and Cosmetic Act) et aux règlements d'application de la FDA en matière d'approbation préalable à la mise sur le marché (Pre–Market Approval).

La FDA a accepté toutes les autres données fournies avec la demande d'autorisation de mise sur le marché, y compris et surtout le fait que l'étude clinique démontre la sécurité et l'efficacité du système Genio®. Nyxoah a terminé avec succès le travail de validation demandé par la FDA pour le processus de fabrication utilisé pour un composant du système Genio sur le site de fabrication américain.. La société a soumis la documentation requise à la FDA, qui a examiné ce travail de validation et a confirmé qu'elle n'avait pas d'autres questions. Nous pensons que la dernière étape avant l'approbation complète de la PMA est une inspection sur place du site de fabrication américain par la FDA, qui devrait être achevée prochainement. Dans le cadre du processus de PMA, ce site a déjà passé une inspection sur place sans aucune déficience, ce qui donne à la société la confiance nécessaire pour franchir cette étape réglementaire. Nyxoah prévoit que sa demande pourrait être approuvée au cours du deuxième trimestre 2025.

Conférence téléphonique et webcast de présentation

Le management de la Société organisera une conférence téléphonique pour discuter ses résultats financiers le même jour à 14h00 CET / 8h00 ET.

La retransmission de la conférence téléphonique sera accessible sur la page Investor Relations du site web de Nyxoah ou par le biais de ce lien : Nyxoah's Q1 2025 Earnings Call Webcast. Pour ceux qui n'ont pas l'intention de poser une question au Management, la Société recommande d'écouter la webdiffusion.

Si vous avez l'intention de poser une question, veuillez utiliser le lien suivant : Nyxoah's Q1 2025 Earnings Call. Après l'inscription, un courriel sera envoyé, comprenant les détails de la connexion et un code d'accès unique à la conférence téléphonique nécessaire pour rejoindre l'appel en direct. Pour s'assurer que vous êtes connecté avant le début de la conférence, la Société suggère de s'inscrire au moins 10 minutes avant le début de l'appel.

Le webcast archivé pourra être réécouté peu après la clôture de la conférence.

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.

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

Attention – Marquage CE depuis 2019. Dispositif de recherche aux États–Unis. Limité à un usage expérimental aux États–Unis par la loi fédérale américaine.

Déclarations Prospectives

Certaines déclarations, croyances et opinions contenues dans le présent communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la Société ou, le cas échéant, des administrateurs ou de la direction de la Société 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 concernant le développement, la voie réglementaire et l'utilisation potentielle du système Genio®, l'obtention de l'approbation de la FDA, l'achèvement satisfaisant de l'examen des installations de fabrication, des méthodes et des contrôles, et le calendrier prévu pour ce qui précède, l'entrée sur le marché américain, ainsi que les résultats d'exploitation, la situation financière, les liquidités, les performances, les perspectives, la croissance et les stratégies de la Société. De par leur nature, les déclarations prévisionnelles impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou les événements réels diffèrent matériellement de ceux exprimés ou sous–entendus dans les déclarations prévisionnelles. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence négative sur les résultats et les effets financiers des plans et des 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 des 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 de manière significative de tout développement anticipé. Les déclarations prospectives contenues dans le présent communiqué de presse concernant des tendances ou des activités passées ne constituent pas des garanties de performances futures et ne doivent pas être considérées comme une déclaration selon laquelle 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 peuvent ne pas être représentatifs des résultats ou développements des périodes futures. Aucune déclaration ou garantie n'est donnée quant à l'exactitude ou à la justesse de ces déclarations prospectives. En conséquence, la Société décline expressément toute obligation ou tout 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 des attentes ou d'un changement des événements, conditions, hypothèses ou circonstances sur lesquels ces déclarations prospectives sont basées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni les 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 ce communiqué de presse ou quant à la survenance effective des développements prévus. Vous ne devriez pas accorder une confiance excessive 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]

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1001096431)

Nyxoah Reports First Quarter Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter Financial and Operating Results
Company On Track for Anticipated PMA Approval in the Second Quarter of 2025
Successfully Completed FDA Validation Requirements, Final Site Inspection in Progress

Mont–Saint–Guibert, Belgium – May 14, 2025, 7am CET / 1am 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) through neuromodulation, today reported financial and operating results for the first quarter of 2025.

Recent Financial and Operating Highlights

  • Received an FDA Approvable Letter indicating the FDA will approve the Company’s PMA application for its Genio® system subject to satisfactory completion of a manufacturing facilities, methods and controls review
  • Successfully completed FDA validation requirements, final site inspection in progress at the U.S. contract manufacturing site
  • Revenue for the first quarter of 2025 was €1.1 million, compared to €1.2 million in the first quarter of 2024
  • Launched Genio® 2.1 patient software upgrade in international commercial markets
  • Cash, cash equivalents and financial assets were €63.0 million at March 31, 2025, compared to €85.6 million at the end of 2024

“We are excited that we are in the final stage of the FDA review process of our Genio® system in the United States,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “The FDA Approvable Letter we received previously confirms that our application substantially meets the requirements of the Federal Food, Drug and Cosmetic Act, including biocompatibility and acceptance of our clinical data demonstrating the safety and effectiveness of the Genio® system. We have successfully completed the final process validation requested by the FDA. We understand that the last step toward FDA approval is an on–site inspection at the U.S. manufacturing site which we expect to be completed shortly. As part of the PMA process, this site has already successfully passed an on–site inspection with no deficiencies, which gives us confidence in completing this regulatory step. We continue to anticipate that our application could potentially be approved in the second quarter of 2025.”

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)

      For the three months ended March 31
      2025   2024
Revenue     € 1 064   € 1 221
Cost of goods sold     ( 406)   ( 455)
Gross profit     € 658   € 766
Research and Development Expense     (8 989)   (7 199)
Selling, General and Administrative Expense     (12 392)   (5 972)
Other income/(expense)     84   192
Operating loss for the period     € (20 639)   € (12 213)
Financial income     2 622   1 408
Financial expense     (4 242)   ( 991)
Loss for the period before taxes     € (22 259)   € (11 796)
Income taxes     ( 125)   ( 110)
Loss for the period     € (22 384)   € (11 906)
           
Loss attributable to equity holders     € (22 384)   € (11 906)
Other comprehensive (loss)          
Items that may be subsequently reclassified to profit or loss (net of tax)          
Currency translation differences     ( 2)   60
Total comprehensive loss for the year, net of tax     € (22 386)   € (11 846)
Loss attributable to equity holders     € (22 386)   € (11 846)
           
Basic Loss Per Share (in EUR)     € (0.598)   € (0.415)
Diluted Loss Per Share (in EUR)     € (0.598)   € (0.415)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

(in thousands)

        As at
        March 31 2025   December 31 2024
ASSETS            
Non–current assets            
Property, plant and equipment       4 696   4 753
Intangible assets       50 977   50 381
Right of use assets       3 152   3 496
Deferred tax asset       78   76
Other long–term receivables       1 790   1 617
        € 60 693   € 60 323
Current assets            
Inventory       4 981   4 716
Trade receivables       2 604   3 382
Other receivables       3 128   2 774
Other current assets       1 450   1 656
Financial assets       40 653   51 369
Cash and cash equivalents       22 394   34 186
        € 75 210   € 98 083
Total assets       € 135 903   € 158 406
             
EQUITY AND LIABILITIES            
Share capital and reserves            
Share capital       6 430   6 430
Share premium       314 345   314 345
Share based payment reserve       11 256   9 300
Other comprehensive income       912   914
Retained loss       (240 100)   (217 735)
Total equity attributable to shareholders       € 92 843   € 113 254
             
LIABILITIES            
Non–current liabilities            
Financial debt       18 519   18 725
Lease liability       2 316   2 562
Provisions       548   1 000
Deferred tax liability       27   19
Contract liabilities       277   472
Other liabilities       401   845
        € 22 088   € 23 623
Current liabilities            
Financial debt       244   248
Lease liability       1 010   1 118
Trade payables       9 316   9 505
Current tax liability       4 300   4 317
Contract liability       368   117
Other liabilities       5 734   6 224
        € 20 972   € 21 529
Total liabilities       € 43 060   € 45 152
Total equity and liabilities       € 135 903   € 158 406

Revenue
Revenue was €1.1 million for the first quarter ending March 31, 2025, compared to €1.2 million for the first quarter ending March 31, 2024.

Cost of Goods Sold
Cost of goods sold was €406,000 for the first quarter ending March 31, 2025, representing a gross profit of €0.7 million, or gross margin of 61.8%. This compares to cost of goods sold of €455,000 in the first quarter ending March 31, 2024, for a gross profit of €0.8 million, or gross margin of 62.7%.

Research and Development
For the first quarter ending March 31, 2025, research and development expenses were €9.0 million, versus €7.2 million for the first quarter ending March 31, 2024. The increase in research and development expenses was primarily due to higher R&D activities and clinical study expenses.

Selling, General and Administrative
For the first quarter ending March 31, 2025, selling, general and administrative expenses were €12.4 million, versus €6.0 million for the first quarter ending March 31, 2024. The increase in selling, general and administrative expenses was primarily due to an increase in costs to support the commercialization of Genio® system, the Company’s overall scale–up preparations for the upcoming commercialization of Genio® system in the US upon receipt of FDA approval.

Operating Loss
Total operating loss for the first quarter ending March 31, 2025 was €20.6 million, versus €12.2 million in the first quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, the Company’s overall scale–up preparations for the upcoming commercialization of Genio® system in the US upon receipt of FDA approval and increased R&D activities and clinical study expenses.

Cash Position
As of March 31, 2025, cash, cash equivalents and financial assets totaled €63.0 million, compared to €85.6 million at the end of 2024.

First Quarter 2025
Nyxoah’s financial report for the first quarter of 2025, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Progress Toward FDA PMA Approval
On March 26, 2025, Nyxoah announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre–Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations.

The FDA has accepted all other data provided with the PMA submission, including most importantly that the clinical study demonstrates the safety and effectiveness of the Genio® system. Nyxoah has successfully completed the validation work requested by the FDA for the manufacturing process used for a component of the Genio system at the U.S. manufacturing site. The Company submitted the required documentation to the FDA, which has reviewed this validation work and confirmed they have no further questions. We believe that the last step before full PMA approval is an on–site FDA inspection of the U.S. manufacturing site which we expect to be completed shortly. As part of the PMA process, this site already passed an on–site inspection with no deficiencies, giving the Company confidence in completing this regulatory step. Nyxoah anticipates that its application could potentially be approved in the second quarter of 2025.

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Wednesday, May 14, 2025, beginning at 2:00pm CET / 8:00am ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2025 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah's Q1 2025 Earnings Call. After registering, an email will be sent, including dial–in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

The archived webcast will be available for replay shortly after the close of the call.

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.

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 Genio® system; planned 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; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; 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. 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, 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 – Glenn Silver
[email protected]

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

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

Attachment


GLOBENEWSWIRE (Distribution ID 1001096431)

Noted Vaccine Researcher and Leader Kate O’Brien Awarded Sabin’s Gold Medal; Physician Livancliff Mbianke of Cameroon Receives Rising Star Award

WASHINGTON, May 13, 2025 (GLOBE NEWSWIRE) — The Sabin Vaccine Institute today awarded the Albert B. Sabin Gold Medal to pediatrician Katherine O’Brien, MD, MPH, for her research on the pneumococcal vaccine and leadership in global vaccine research and access, and its Rising Star Award to dedicated physician and public health specialist Livancliff Mbianke, MD, MPH, of Cameroon. The awards were presented at a ceremony in the National Academy of Sciences building in Washington D.C.

O’Brien is a pioneering global health leader whose innovative work in vaccine access and policy has transformed immunization programs worldwide.

“I am honored to award the Sabin Gold Medal to Dr. O’Brien for her extensive scientific and humanitarian work, which has significantly contributed to the development, licensure, and global distribution of critical immunizations,” says Amy Finan, Sabin’s chief executive officer. “The breadth and scope of her work — in addition to her leadership in advancing the availability of vaccines for everyone, everywhere — has saved millions of lives around the world.”

O’Brien’s interest in vaccines and preventable illness began during her early career as a research pediatrician in Port–au–Prince, Haiti, where almost a third of children admitted to the hospital she worked at died, often from vaccine–preventable diseases. Returning to the U.S. to pursue her infectious disease fellowship, Master of Public Health, and training as an epidemiologist, she then worked for the Johns Hopkins Center for American Indian Health and led groundbreaking clinical trials on the pneumococcal vaccine to establish the vaccine’s performance and impact on both disease and on colonization to achieve both individual and population–level protection. O’Brien was appointed Director of Infectious Disease at the Center and led research on vaccine development and implementation for vaccine–preventable diseases disproportionately affecting Indigenous populations. Her work in large–scale vaccine impact studies and clinical trials has been instrumental in the licensure, introduction and global use of vaccines against pneumococcal disease, rotavirus, influenza, and respiratory syncytial virus (RSV).
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O’Brien continued her leadership in vaccine development, access, and research in her position as the Executive Director of the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health. She has served on WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and on the board of Gavi, the Vaccine Alliance, where she has influenced vaccine financing, policy development, and global immunization strategies.

In her current role as Director, Immunization, Vaccines and Biologicals for the World Health Organization (WHO), O’Brien leads the global vaccine and immunization strategy. She oversees WHO’s work across the vaccine continuum by accelerating new vaccine research and development, advancing vaccine access and equity, introducing new vaccines into country programs, identifying and responding to outbreaks including as WHO’s vaccine technical lead during the COVID–19 pandemic, and strengthening immunization program reach in order to maximize the impact of vaccines, even in the most fragile and vulnerable settings.

O’Brien earned her medical degree from McGill University and a Master of Public Health from Johns Hopkins University. She completed her pediatric and infectious disease training at Johns Hopkins Medical Institutions and served as an Epidemic Intelligence Service officer at the U.S. Centers for Disease Control and Prevention (CDC).

“I am deeply grateful for a career working with incredible people around the world, and through them to have life–saving impact,” says O’Brien. “Vaccines are truly one of science’s greatest achievements. It is immensely fulfilling to work on vaccines all the way from development through licensure and dissemination, and to then see them protect the lives and well–being of families. This award is a huge honor, and a tribute to those who have taught me the value of evidence–based courage.”

Sabin’s Rising Star Award is intended to encourage and recognize the next generation of vaccine and immunization leaders. Mbianke is a dedicated physician and public health specialist whose work in vaccine access and strengthening health systems has made a profound impact on underserved communities. With expertise in immunization, maternal and child health, and community engagement, Mbianke has played a pivotal role in expanding vaccine coverage and improving health outcomes in Cameroon.

“With his recognized achievements in reducing maternal and child mortality by 50% in remote areas and increasing accessibility of vaccines, Dr. Mbianke is leading innovations around immunization in fragile settings,” says Finan. “Whether he is delivering vaccines to displaced populations or creating health clinics out of village councils, his creative solutions serve as a model for those working in challenging settings and makes him a Rising Star in global health.”

As Program Country Manager for the COMBAT Project (Community–Based Tracking for Immunization) at the International Vaccine Access Center (IVAC), Mbianke leads efforts to enhance immunization delivery by improving community–based monitoring, engagement, and service delivery strategies. He also serves as Technical Advisor for the World Health Organization’s “Big Catch–Up,” a global initiative aimed at restoring vaccine coverage following pandemic–related disruptions.

Beyond his advisory roles, Mbianke is the CEO of Empower Women Foundation, where he champions maternal and child health initiatives in Cameroon, advocating for sustainable and locally driven health care solutions. His leadership extends to past roles with WHO, Gavi, USAID, and other global health organizations, where he has contributed to immunization policy formulation and innovative strategies to reach zero–dose and under–immunized children.

A graduate of Université de la Montagne Bagante (MD) and Mountain University for Sustainable Studies (MPH), Mbianke combines medical expertise with public health leadership to promote vaccine confidence and equitable access.

“This award is so meaningful,” says Mbianke. “When you work in settings with such a high burden, sometimes you feel you are not doing enough because you want to improve as many lives as possible. But recognition like the Rising Star award really motivates you. It says you are creating an impact. You are creating a change.”

Awarded annually since 1993 and 2020 respectively, the Albert B. Sabin Gold Medal and Rising Star Award honor individuals who have made extraordinary contributions to immunization and global health. These awards commemorate the legacy of the late Dr. Albert B. Sabin, who discovered the oral polio vaccine and dedicated his life to ensuring everyone in the world had access to vaccines.

Watch the 2025 Albert B. Sabin Gold Medal and Rising Star ceremony on Sabin’s YouTube channel.

About the Sabin Vaccine Institute 
  
The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X @SabinVaccine. 

Media Contact:
Monika Guttman
Senior Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 621–1691
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c995d1e5–eae3–4d74–b2fa–6e7914d38549


GLOBENEWSWIRE (Distribution ID 9451069)