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Nyxoah Reports Third Quarter 2025 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports Third Quarter 2025 Financial and Operating Results

US launch off to a strong start. First commercial Genio implants completed with widespread payer coverage drives initial revenue.

Mont–Saint–Guibert, Belgium – November 13, 2025, 10:10pm CET / 4:10 pm 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 third quarter of 2025.

Recent Financial and Operating Highlights

  • Completed the first commercial implants of U.S. patients, and generated first U.S. revenue as early as September
  • Reimbursement secured with Medicare and private payers, achieving 100% approval rate on prior authorization submissions from United Healthcare, Blue Cross Blue Shield, and Anthem. In all these approvals, the CPT code 64568 was accepted
  • Revenue for the third quarter of 2025 was €2.0 million, representing 56% year over year growth, compared to €1.3 million in the third quarter of 2024
  • Cash, cash equivalents and financial assets were €22.5 million on September 30, 2025, compared to €43.0 million at the end of June 30, 2025.

“The first weeks post FDA approval have been a huge success. We already completed the first implants in September. The response from physicians has been overwhelmingly positive, driven by the excitement of finally having real optionality in hypoglossal nerve stimulation for OSA patients,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We also secured reimbursement and generate the first U.S. revenue within the first month post FDA approval. The financing transaction announced today will support our sustained growth in the U.S. market. The momentum and enthusiasm couldn’t be greater.”

Strong Initial U.S. Commercial Launch

The Company is executing its focused two–pronged launch strategy, targeting high–volume hypoglossal nerve stimulation implanting centers while developing strong referral networks with sleep physicians. The first commercial Genio devices were implanted at Townsend Memorial Health System in Houston, Texas, where the surgeon completed five procedures in the first week.

As of October 31, the Company has trained 111 surgeons on the Genio system, and 9 accounts implanted Genio. The Company has completed 102 value analysis committee submissions, with 35 approvals received, and has submitted 63 prior authorizations through their Genio Access Program (GAP), of which 21 approvals have been received. These metrics reflect the strong early traction the Company is seeing in the market and demonstrate the execution of its focused launch strategy.

Reimbursement Progress

The Company continues to make significant progress towards widespread reimbursement coverage with major payor policy updates and strategic partnerships that streamline patient access to the Genio system. Health Care Service Corporation (HCSC) operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan have updated their hypoglossal nerve stimulation medical policies to include CPT Code 64568 as a referenced procedure code. While coverage for hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payors, which the Company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across six states.

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

 

 

    For the three months ended September 30   For the nine months ended September 30
      2025   2024   2025   2024
Revenue     1 972   1 266   4 376   3 258
Cost of goods sold     ( 779)   ( 482)   (1 675)   (1 217)
Gross profit     € 1 193   € 784   € 2 701   € 2 041
Research and Development Expense     (12 911)   (7 902)   (31 959)   (22 573)
Selling, General and Administrative Expense     (12 702)   (8 042)   (35 765)   (20 396)
Other income/(expense)     51   180   166   430
Operating loss for the period     € (24 369)   € (14 980)   € (64 857)   € (40 498)
Financial income     1 082   1 138   6 561   4 615
Financial expense     ( 583)   (3 043)   (8 162)   (5 480)
Loss for the period before taxes     € (23 870)   € (16 885)   € (66 458)   € (41 363)
Income taxes     290   ( 173)   ( 114)   ( 724)
Loss for the period     € (23 580)   € (17 058)   € (66 572)   € (42 087)
                   
Loss attributable to equity holders     € (23 580)   € (17 058)   € (66 572)   € (42 087)
Other comprehensive loss                  
Items that may be subsequently reclassified to profit or loss (net of tax)                  
Currency translation differences     ( 33)   ( 209)   197   ( 221)
Total comprehensive loss for the year, net of tax     € (23 613)   € (17 267)   € (66 375)   € (42 308)
Loss attributable to equity holders     € (23 613)   € (17 267)   € (66 375)   € (42 308)
                   
Basic Loss Per Share (in EUR)     € (0.630)   € (0.496)   € (1.778)   € (1.346)
Diluted Loss Per Share (in EUR)     € (0.630)   € (0.496)   € (1.778)   € (1.346)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)

    As Of  
      September 30
2025		   December 31 2024      
ASSETS                
Non–current assets                
Property, plant and equipment     4 471   4 753      
Intangible assets     50 108   50 381      
Right of use assets     1 891   3 496      
Deferred tax asset     25   76      
Other long–term receivables     1 759   1 617      
      € 58 254   € 60 323      
Current assets                
Inventory     6 075   4 716      
Trade receivables     1 356   3 382      
Contract assets     1 384   −      
Other receivables     3 026   2 774      
Other current assets     1 026   1 656      
Financial assets     11 609   51 369      
Cash and cash equivalents     10 869   34 186      
      € 35 345   € 98 083      
Total assets     € 93 599   € 158 406      
                 
EQUITY AND LIABILITIES                
Share capital and reserves                
Share capital     6 450   6 430      
Share premium     314 417   314 345      
Share based payment reserve     11 765   9 300      
Other comprehensive income     1 111   914      
Retained loss     (282 789)   (217 735)      
Total equity attributable to shareholders     € 50 954   € 113 254      
                 
LIABILITIES                
Non–current liabilities                
Financial debt     18 787   18 725      
Lease liability     1 382   2 562      
Provisions     1 106   1 000      
Deferred tax liability     30   19      
Contract liability     581   472      
Other liability     −   845      
      € 21 886   € 23 623      
Current liabilities                
Financial debt     248   248      
Lease liability     742   1 118      
Trade payables     9 559   9 505      
Current tax liability     3 376   4 317      
Contract liability     342   117      
Other liability     6 492   6 224      
      € 20 759   € 21 529      
Total liabilities     € 42 645   € 45 152      
Total equity and liabilities     € 93 599   € 158 406      

Revenue
Revenue was €2.0 million for the third quarter ending September 30, 2025, compared to €1.3 million for the third quarter ending September 30, 2024, representing a 56% year over year increase.

Cost of Goods Sold
Cost of goods sold was €0.8 million for the third quarter ending September 30, 2025, representing a gross profit of €1.2 million, or gross margin of 60.5%. This compares to cost of goods sold of €482,000 in the third quarter ending September 30, 2024, for a gross profit of €0.8 million, or gross margin of 62.0%.

Research and Development
For the third quarter ending September 30, 2025, research and development (“R&D”) expenses were €12.9 million, versus €7.9 million for the third quarter ending September 30, 2024. The increase in research and development expenses was primarily due to higher R&D activities. Additionally, following FDA approval in August 2025, the amortization of the related intangible assets commenced leading to an increase in depreciation and amortization expenses.

Selling, General and Administrative
For the third quarter ending September 30, 2025, selling, general and administrative expenses were €12.7 million, versus €8.0 million for the third quarter ending September 30, 2024. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system and the Company’s overall scale–up preparations for the commercialization of the Genio® system in the U.S. following receipt of FDA approval.

Operating Loss
Total operating loss for the third quarter ending September 30, 2025, was €24.4 million, versus €15.0 million in the third quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, including the Company’s overall scale–up preparations for the commercialization of the Genio system in the US in connection with the receipt of FDA approval, and increased R&D and manufacturing activities, in addition to higher depreciation and amortization expenses.

Cash Position
As of September 30, 2025, cash, cash equivalents and financial assets totaled €22.5 million, compared to €43.0 million at the end of June 30, 2025.

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

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, November 13, 2025, beginning at 10:30pm CET / 4:30pm ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q3 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 Q3 2025 Earnings Call Q&A Line. 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 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 FDA for a subset of adult patients with moderate to severe OSA with an 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 Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and 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. 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]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

Attachment


GLOBENEWSWIRE (Distribution ID 1001138769)

Nyxoah Présente ses Résultats Financiers et d’Exploitation pour le Troisième Trimestre 2025

INFORMATIONS RÉGLEMENTÉES

Nyxoah Présente ses Résultats Financiers et d’Exploitation
pour le Troisième Trimestre 2025

Lancement réussi aux États–Unis. Les premières implantations commerciales de Genio, largement prises en charge par les organismes payeurs, génèrent les premiers revenus.

Mont–Saint–Guibert, Belgique – 13 novembre 2025, 22h10 CET / 16h10 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 rapporté aujourd’hui ses résultats financiers et d’exploitation pour le troisième trimestre 2025.

Temps Forts Financiers et d’Exploitation

  • Réalisation des premières implantations commerciales chez des patients américains et génération des premiers revenus aux États–Unis dès le mois de septembre
  • Remboursement sécurisé auprès de Medicare et des assureurs privés, avec un taux d'approbation de 100 % des demandes d'autorisation préalable soumises à United Healthcare, Blue Cross Blue Shield et Anthem. Dans toutes ces approbations, le code CPT 64568 a été accepté
  • Le chiffre d'affaires du troisième trimestre 2025 s'est élevé à 2,0 millions d'euros, soit une croissance de 56 % par rapport à l'année précédente, contre 1,3 million d'euros au troisième trimestre 2024
  • La trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 22,5 millions d'euros au 30 septembre 2025, contre 43,0 millions d'euros à la fin du 30 juin 2025.

“Les premières semaines qui ont suivi l'autorisation de la FDA ont été couronnées de succès. Nous avons déjà réalisé les premières implantations en septembre. Les réactions des médecins ont été extrêmement positives, motivées par l'enthousiasme suscité par la possibilité d'avoir enfin une véritable option en matière de stimulation du nerf hypoglosse pour les patients atteints d'AOS”, a commenté Olivier Taelman, CEO de Nyxoah. “Nous avons également obtenu le remboursement et généré les premiers revenus aux États–Unis dès le premier mois suivant l'autorisation de mise sur le marché délivrée par la FDA. L'opération de financement annoncée aujourd'hui soutiendra notre croissance durable sur le marché américain. La dynamique et l'enthousiasme ne pourraient être plus grands.”

Lancement Commercial Initial Solide aux États–Unis
La Société met en œuvre sa stratégie de lancement à deux volets, ciblant les centres d'implantation de stimulateurs du nerf hypoglosse à grand volume tout en développant de solides réseaux de référents auprès des médecins spécialistes du sommeil. Les premiers dispositifs Genio ont été implantés au Townsend Memorial Health System à Houston, au Texas, où le chirurgien a réalisé cinq interventions au cours de la première semaine.

Au 31 octobre, la Société avait formé 111 chirurgiens au système Genio et 9 établissements avaient implanté Genio. La Société a soumis 102 demandes auprès de comités d'analyse de la valeur (Value Analysis Committee – “VAC”), dont 35 ont été approuvées, et a soumis 63 autorisations préalables dans le cadre de son programme Genio Access Program (GAP), dont 21 ont été approuvées. Ces chiffres reflètent la forte traction initiale que la Société observe sur le marché et démontrent la bonne exécution de sa stratégie de lancement ciblée.

Progrès en Matière de Remboursement

La Société continue de réaliser des progrès significatifs en matière de couverture de remboursement généralisée grâce à des mises à jour importantes des politiques des principaux payeurs et à des partenariats stratégiques qui rationalisent l'accès des patients au système Genio. Health Care Service Corporation (HCSC) gère les régimes Blue Cross Blue Shield dans l'Illinois, au Texas, en Oklahoma, au Nouveau–Mexique et au Montana. HCSC et Blue Cross Blue Shield of Michigan ont mis à jour leurs politiques médicales en matière de stimulation du nerf hypoglosse afin d'inclure le code CPT 64568 comme code de procédure de référence. Bien que la couverture de la stimulation du nerf hypoglosse était déjà établie, l'inclusion de ce code apporte une clarification supplémentaire pour les prestataires et les payeurs, ce qui, selon la Société, contribuera à réduire les obstacles administratifs et à rationaliser l'accès des patients. HCSC et BCBS of Michigan représentent plus de 26 millions de membres dans six États.

ÉTATS CONSOLIDÉS DES PERTES ET AUTRES ÉLÉMENTS DU RÉSULTAT GLOBAL

(non audités) (en milliers)

      Pour la période de trois mois clôturée le 30 septembre   Pour la période de neuf mois clôturée le 30 septembre
      2025   2024   2025   2024
Chiffre d'affaires     € 1 972   € 1 266   € 4 376   € 3 258
Coût des biens vendus     ( 779)   ( 482)   (1 675)   (1 217)
Bénéfice brut     € 1 193   € 784   € 2 701   € 2 041
Frais de recherche et de développement     (12 911)   (7 902)   (31 959)   (22 573)
Frais de vente, dépenses administratives et autres frais généraux     (12 702)   (8 042)   (35 765)   (20 396)
Autres revenus / (frais) d'exploitation     51   180   166   430
Perte d'exploitation de la période     € (24 369)   € (14 980)   € (64 857)   € (40 498)
Produits financiers     1 082   1 138   6 561   4 615
Charges financières     ( 583)   (3 043)   (8 162)   (5 480)
Perte de la période avant impôts     € (23 870)   € (16 885)   € (66 458)   € (41 363)
Impôts sur le revenu     290   ( 173)   ( 114)   ( 724)
Perte de la période     € (23 580)   € (17 058)   € (66 572)   € (42 087)
                   
Perte attribuable aux actionnaires     € (23 580)   € (17 058)   € (66 572)   € (42 087)
Autres éléments du résultat global                  
Eléments pouvant être reclassifiés en bénéfices ou en pertes (nets d'impôts)                  
Différences de conversion de devises     ( 33)   ( 209)   197   ( 221)
Perte globale totale de la période, nette d'impôts     € (23 613)   € (17 267)   € (66 375)   € (42 308)
Perte attribuable aux actionnaires     € (23 613)   € (17 267)   € (66 375)   € (42 308)
                   
Perte de base par action (en €)     € (0,630)   € (0,496)   € (1,778)   € (1,346)
Perte diluée par action (en €)     € (0,630)   € (0,496)   € (1,778)   € (1,346)

ÉTAT DE LA SITUATION FINANCIÈRE CONSOLIDÉ (non audité) (en milliers)

      Au
      30 septembre
2025		   31 décembre
2024
ACTIFS          
Actifs non courants          
Immobilisations corporelles     4 471   4 753
Immobilisations incorporelles     50 108   50 381
Droit d'utilisation des actifs     1 891   3 496
Actif d'impôts différés     25   76
Autres créances à long terme     1 759   1 617
      € 58 254   € 60 323
Actifs courants          
Stocks     6 075   4 716
Créances commerciales     1 356   3 382
Actifs liés à des contrats     1 384   −
Autres créances     3 026   2 774
Autres actifs courants     1 026   1 656
Actifs financiers     11 609   51 369
Trésorerie et équivalents de trésorerie     10 869   34 186
      € 35 345   € 98 083
Total de l'actif     € 93 599   € 158 406
           
CAPITAUX PROPRES ET PASSIFS          
Capital et réserves          
Capital     6 450   6 430
Prime d'émission     314 417   314 345
Réserve pour paiement fondé sur des actions     11 765   9 300
Autres éléments du résultat global     1 111   914
Résultats reportés     (282 789)   (217 735)
Total des capitaux propres attribuables aux actionnaires     € 50 954   € 113 254
           
PASSIFS          
Passifs non courants          
Dettes financières     18 787   18 725
Passifs locatifs     1 382   2 562
Provisions     1 106   1 000
Passif d'impôts différés     30   19
Responsabilité contractuelle     581   472
Autres passifs     −   845
      € 21 886   € 23 623
Passifs courants          
Dettes financières     248   248
Passifs locatifs     742   1 118
Dettes commerciales     9 559   9 505
Passif d'impôts exigibles     3 376   4 317
Responsabilité contractuelle     342   117
Autres passifs     6 492   6 224
      € 20 759   € 21 529
Total du passif     € 42 645   € 45 152
Total des capitaux propres et du passif     € 93 599   € 158 406

Revenus
Le chiffre d'affaires s'est élevé à 2,0 millions d'euros pour le troisième trimestre clos le 30 septembre 2025, contre 1,3 million d'euros pour le troisième trimestre clos le 30 septembre 2024, soit une augmentation de 56 % en comparaison annuelle.

Coût des marchandises vendues
Le coût des marchandises vendues s'est élevé à 0,8 million d'euros pour le troisième trimestre clos le 30 septembre 2025, ce qui représente une marge brute de 1,2 million d'euros, soit une marge brute de 60,5 %. À titre de comparaison, le coût des marchandises vendues s'élevait à 482 000 € au troisième trimestre clos le 30 septembre 2024, pour une marge brute de 0,8 million d'euros, soit une marge brute de 62,0 %.

Recherche et développement
Pour le troisième trimestre clos le 30 septembre 2025, les dépenses de recherche et développement (« R&D ») se sont élevées à 12,9 millions d'euros, contre 7,9 millions d'euros pour le troisième trimestre clos le 30 septembre 2024. L'augmentation des dépenses de recherche et développement est principalement due à l'intensification des activités de R&D. En outre, à la suite de l'autorisation de mise sur le marché délivrée par la FDA en août 2025, l'amortissement des actifs incorporels associés a commencé, entraînant une augmentation des charges d'amortissement.

Frais commerciaux, généraux et administratifs
Pour le troisième trimestre clos le 30 septembre 2025, les frais commerciaux, généraux et administratifs se sont élevés à 12,7 millions d'euros, contre 8,0 millions d'euros pour le troisième trimestre clos le 30 septembre 2024. L'augmentation des frais de vente, généraux et administratifs est principalement due à une augmentation des coûts liés à la commercialisation du système Genio® et aux préparatifs généraux de la Société en vue de la commercialisation du système Genio® aux États–Unis après l'obtention de l'autorisation de la FDA.

Perte d'exploitation
La perte d'exploitation totale pour le troisième trimestre clos le 30 septembre 2025 s'est élevée à 24,4 millions d'euros, contre 15,0 millions d'euros au troisième trimestre 2024. Cette augmentation s'explique par la hausse des frais commerciaux, généraux et administratifs liés à la commercialisation du système Genio, notamment les préparatifs généraux de la Société en vue de la commercialisation du système Genio aux États–Unis suite à l'obtention de l'autorisation de la FDA, ainsi que par l'intensification des activités de R&D et de fabrication, en plus de la hausse des charges d'amortissement.

Position de trésorerie

Au 30 septembre 2025, la trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 22,5 millions d'euros, contre 43,0 millions d'euros à la fin du 30 juin 2025.

Troisième trimestre 2025

Le rapport financier de Nyxoah pour troisième trimestre 2025, y compris les détails des résultats consolidés, sont disponibles sur la page investisseurs du site web de Nyxoah (https://investors.nyxoah.com/financials).

Conférence téléphonique et webcast

Le management de la Société organisera une conférence téléphonique pour discuter ses résultats financiers le même jour, à 22h30 CET / 16h30 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 Q3 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 Q3 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 et l'obtention de l'autorisation de la FDA pour un sous–groupe de patients adultes atteints d'AOS modérée à sévère avec un 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 prescription médicale.

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.

Contact :

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

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شركة Profound Medical توقع اتفاقية توزيع حصرية لمنتجات TULSA-PRO®وSonalleve® مع شركة Al Faisaliah Medical Systems في المملكة العربية السعودية

الاتفاقية تفتح المجال أمام علاجات Profound التي لا تستلزم أي جراحة أو إشعاع لاستئصال الأنسجة المريضة، لتخترق بذلك أكبر سوق للرعاية الصحية في الشرق الأوسط

تم الحصول بالفعل على جميع الموافقات التنظيمية اللازمة لاستيراد وبيع تقنيتي الاستئصال المتقدمتين من شركة Profound في المملكة العربية السعودية

تورنتو والرياض، المملكة العربية السعودية, Nov. 13, 2025 (GLOBE NEWSWIRE) —

يسر شركة Profound Medical (NASDAQ:PROF; TSX:PRN) (“Profound” أو “الشركة”)، وهي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة، أن تُعلن أنها أبرمت اتفاقية توزيع وتوريد حصرية لتقنيتي TULSA–PRO® و Sonalleve®في المملكة العربية السعودية مع شركة Al Faisaliah Medical Systems (“FMS”)، وهي شركة تابعة لإحدى أبرز تكتلات الأعمال في المملكة، مجموعة Al Faisaliah Group (“AFG”).

وتعد Profound الشركة الوحيدة التي تجمع بين قدرات التصوير في الوقت الحقيقي والتصوير الحراري للرنين المغناطيسي (“MR”) مع تصميمات العلاج التي تعتمد على الذكاء الاصطناعي للسماح للأطباء بمعالجة الأنسجة المريضة بدقة ولطف دون أي جراحة أو غلي أو كي الأنسجة المرتبطة أو فقدان الدم أو الألم الشديد/ المُطوَّل أو الحاجة إلى الإقامة في المستشفى لليلة واحدة.

يظل التسويق التجاري لدواء TULSA–PRO، المُصمم خصيصًا لعلاج أمراض البروستاتا (سرطان البروستاتا وتضخم البروستاتا الحميد “BPH” أو أيٍ منهما) في الولايات المتحدة هو الأولوية القصوى لفريق المبيعات المباشرة للشركة. يمثل TULSA Procedure™، الذي يتم إجراؤه باستخدام نظام TULSA–PRO من Profound، تقدمًا كبيرًا في علاج البروستاتا. بدلاً من الجراحة أو الإشعاع، يتم تطبيق إجراء TULSA داخل جناح التصوير بالرنين المغناطيسي لتسخين أنسجة البروستاتا بدقة ولطف “وصولًا لدرجة الحرارة اللازمة للقضاء على الأنسجة المريضة” (55–57 درجة مئوية) باستخدام الموجات فوق الصوتية الاتجاهية، مع حماية الأعصاب المحيطة والبنية التشريحية. من حيث نية العلاج، في حين أن TULSA–PRO يتمتع بالمرونة التي تمكننا من استخدامه في جميع عمليات الاستئصال، بما في ذلك الاستئصال البؤري واستئصال نصف الغدة، فإن غالبية إجراءات TULSA هي إما استئصال الغدة بالكامل أو استئصال الغدة بالكامل تقريبًا. في أواخر عام 2024، أصدرت مراكز الرعاية الطبية والخدمات الطبية (CMS) في الولايات المتحدة القاعدة النهائية لنظام الدفع المستقبلي للمرضى الخارجيين (OPPS) (“القاعدة النهائية”) لرموز الفئة 1 الجديدة CPT® وأوصافها التي تغطي إجراء TULSA، والتي دخلت حيز التنفيذ في 1 يناير 2025. بموجب القاعدة النهائية، تم وضع سداد تكاليف TULSA في تصنيف الدفع الخارجي لمستوى 7 في طب المسالك البولية (APC). حتى الآن، خضع أكثر من 4000 رجل لإجراء TULSA، واعتبارًا من آخر تقرير (أكتوبر 2025)، بلغ عدد أنظمة TULSA–PRO المثبتة لدى Profound 67 نظامًا.

ويحظى المنتج الثاني لشركة Profound، وهو Sonalleve، والذي يُقدّم يتم في المقام الأول كعملية بيع رأسمالية لمرة واحدة، باهتمام تجاري متزايد، وخاصة خارج الولايات المتحدة. يستخدم Sonalleve نفس تقنية التصوير بالرنين المغناطيسي والتصوير الحراري مثل TULSA–PRO، ويجمع ذلك مع الموجات فوق الصوتية المركزة من خارج الجسم لعلاج الأمراض. توجد حاليًا عشرة أجهزة Sonalleve عاملة في أجزاء من أوروبا والصين وجنوب شرق آسيا – حيث تم بالفعل علاج أكثر من 4000 امرأة باستخدام هذه التكنولوجيا لعلاج الانتباذ البطاني الرحمي والأورام الليفية الرحمية، وهي أمراض تصيب الرحم ويمكن أن تسبب آلامًا مزمنة وحيضًا ثقيلًا وطويلًا أو أيًا منهما. وقد أثبت العلاج باستخدام Sonalleve تخفيف الألم والأعراض دون التأثير على احتياطي المبيض، كما تشير تقارير إلى محافظة النساء على خصوبتهن بعد العلاج. ويُستخدم Sonalleve الآن أيضًا في الأبحاث والتجارب السريرية في أوروبا لاستئصال أنسجة سرطان البنكرياس وأمراض الأورام الأخرى. على مدى السنوات الخمس الماضية، قدمت منظمات الأبحاث في أوروبا وكندا ما يقرب من 10 مليون دولار أمريكي لإجراء المزيد من الأبحاث السريرية باستخدام Sonalleve لعلاج أمراض متعددة تهدد الحياة في كثيرٍ من الأحيان.

مع استمرار تزايد اهتمام المستخدمين بتقنيات Profound، تنشر الشركة فريق المبيعات المباشرة الخاص بها في أمريكا الشمالية، في حين تتعاون مع شركاء توزيع استراتيجيين مختارين لدعم إمكانات الأعمال وقاعدة العملاء في أجزاء أخرى من العالم.

وصرح Arun Menawat، الرئيس التنفيذي ورئيس مجلس إدارة شركة Profound، قائلاً: “يشرفنا أن نتعاون مع شركة FMS، إحدى شركات توزيع الأجهزة الطبية الرائدة في المملكة العربية السعودية، لتوزيع كل من TULSA–PRO وSonalleve”. “إن التسويق والتوزيع الناجحين لعلاجاتنا الخالية التي لا تستلزم جراحة لاستئصال الأنسجة المريضة يتطلب فهمًا عميقًا لديناميكيات السوق الإقليمية والاحتياجات المحددة للأطباء والمرضى المحليين. وبفضل سجلها الحافل في تقديم إجراءات الأورام المتقدمة وغيرها من التقنيات الطبية في المملكة، فإننا على ثقة بأن شركة FMS هي الشريك المثالي لنا”.

قال المدير العام لشركة FMS، السيد Abdullah Al Melik: “مع توجه المملكة العربية السعودية نحو التنوع الاقتصادي في إطار رؤية 2030، تلتزم كل من FMS وشركتنا الأم، AFG، بالقيام بدور حاسم في تشكيل مستقبل البلاد. وتعد المجموعة من أهم مُقدمي المعدات والخدمات للمستشفيات القائمة، كما تمتلك وتدير مرافقها الطبية المتخصصة بفعاليةٍ. بفضل شراكتنا مع شركة Profound، نحن متحمسون للغاية لتقديم تقنياتها الفريدة التي لا تستلزم الجراحة أو الإشعاع إلى المستشفيات ومراكز العلاج السعودية التي تهدف إلى أن تكون رائدة عالميًا في نتائج المرضى. نتطلع إلى العمل بشكل وثيق مع فريق Profound.”

نبذة عن شركة Al Faisaliah Medical Systems

تأسست شركة FMS في عام 1973، وكانت في البداية قسم الرعاية الصحية التابع لشركة AFG، حتى تأسيسها كشركة مستقلة في عام 1993. بفضل سابقة أعمالها الضخمة التي تضم العديد من الشركاء والمنتجات، تتمكن الشركة من تقديم حلول متكاملة ومعقدة لمعدات الرعاية الصحية من مصدر واحد لأكبر مقدمي الرعاية الصحية في المنطقة. تعد شركة FMS مزودًا رئيسيًا لحلول الرعاية الصحية المتنوعة، وذلك من خلال انتشار عملياتها في جميع أنحاء المملكة العربية السعودية، حيث توفر أحدث المعدات والحلول لمختلف الاستخدامات مثل الأورام والعمليات والملاحظة والرعاية الحرجة وأمراض القلب والأوعية الدموية وغيرها. لمزيد من المعلومات، يُرجى زيارة www.tibbiyah.com/fms.

نبذة عن Al Faisaliah Group

AFG هي شركة قابضة مملوكة للقطاع الخاص يقع مقرها الرئيسي في الرياض، المملكة العربية السعودية، وتعمل في جميع أنحاء الشرق الأوسط. وقد اشتق اسم الشركة من اسم مؤسسها عبدالله الفيصل الابن الأكبر للملك الراحل فيصل بن عبد العزيز. تأسست المجموعة في عام 1971، وتلعب أدوارًا قياديةً في العديد من الصناعات بما في ذلك منتجات الألبان والإلكترونيات والرعاية الصحية وخدمات الطعام. وتدير AFG أيضًا ذراع رأس المال الاستثماري لشركات (Al Faisaliah Ventures) التي تستثمر في الشركات الرائدة عالميًا وإقليميًا. وتحظى المجموعة بتقدير كبير في مختلف أنحاء المنطقة بفضل قيمها الراسخة وإدارتها المحترفة وشراكاتها الاستراتيجية التي تمتد لعقود من الزمن مع شركات محلية وعالمية رائدة بما في ذلك Sony وDanone وPhilips. لمزيد من المعلومات، يُرجى زيارة www.alfaisaliah.com.

نبذة عن شركة Profound Medical

Profound هي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة.

تعمل شركة Profound على تسويق TULSA–PRO® وهي تقنية تجمع بين التصوير بالرنين المغناطيسي في الوقت الفعلي والتخطيط المعزز بالذكاء الاصطناعي والموجات فوق الصوتية عبر مجرى البول التي يتم تشغيلها آليًا والتحكم في درجة الحرارة ذات الحلقة المغلقة. إن إجراء TULSA Procedure™‎، الذي يتم إجراؤه باستخدام نظام TULSA–PRO، لديه القدرة على أن يصبح طريقة علاج رئيسية في جميع أنوع أمراض البروستاتا؛ بدءًا من سرطان البروستاتا منخفض أو متوسط أو عالي الخطورة؛ إلى المرضى الهجينين الذين يعانون من سرطان البروستاتا وفرط تنسج البروستاتا الحميد (“BPH”)؛ إلى الرجال المصابين بتضخم البروستاتا الحميد فقط؛ وأيضًا، إلى المرضى الذين يحتاجون إلى علاج إنقاذي لسرطان البروستاتا الموضعي المتكرر بالإشعاع. يستخدم إجراء TULSA توجيهات التصوير بالرنين المغناطيسي في الوقت الفعلي لضمان الدقة في الحفاظ على القدرة على التحكم في البول والوظيفة الجنسية لدى المرضى، مع قتل أنسجة البروستاتا المستهدفة من خلال تقنية امتصاص الصوت الدقيقة التي تسخنها بلطف حتى تصل إلى 55–57 درجة مئوية. إجراء TULSA هو إجراء جراحي لا يستلزم جراحة أو إشعاع ويتم إجراؤه في جلسة واحدة تستغرق بضع ساعات. يمكن علاج جميع أشكال وأحجام البروستاتا تقريبًا بأمان وفعالية وكفاءة باستخدام إجراء TULSA. لا ينطوي الإجراء على نزيف؛ ولا يتطلب الأمر البقاء في المستشفى؛ ويبلغ معظم مرضى TULSA عن تعافيهم السريع وعودتهم إلى روتينهم الطبيعي. تم وضع علامة CE على منتج TULSA–PRO، وتمت الموافقة عليه من قبل وزارة الصحة الكندية، وتمت الموافقة عليه بموجب 510(k) من قبل Food and Drug Administration (“FDA”).

تقوم شركة  Profoundبتسويق Sonalleve®، وهي منصة علاجية مبتكرة حاصلة على علامة CE لعلاج الأورام الليفية الرحمية، والانتباذ العضلي الليفي، وتخفيف آلام نقائل العظام، والأورام الليفية العضلية، وأورام العظام العظمية. كما تمت الموافقة على Sonalleve من قبل إدارة المنتجات الطبية الوطنية الصينية لعلاج الأورام الليفية الرحمية غير الجراحية، وحصل على موافقة FDA بموجب الإعفاء الإنساني للجهاز لعلاج ورم العظم العظمي. وتجري شركة Profound حالياً المراحل الأولى من استكشاف أسواق علاجية محتملة إضافية لجهاز Sonalleve حيث ثبت أن هذه التقنية لها تطبيقات سريرية، مثل الاستئصال غير الجراحي لسرطانات البطن والحرارة العالية لعلاج السرطان.

البيانات التطلعية

يتضمن هذا البيان الصحفي بيانات تطلعية بشأن شركة Profound وأعمالها والتي قد تشمل، على سبيل المثال لا الحصر، التوقعات المتعلقة بفعالية تقنية Profound في علاج سرطان البروستاتا، وتضخم البروستاتا الحميد، والأورام الليفية الرحمية، وعلاج الألم التلطيفي، وورم العظام العظمي؛ ومدى وتوقيت استكمال Profound لمبيعات نظام TULSA–PRO®‎ من قنوات المبيعات المؤهلة؛ وتوقعات Profound للإيرادات المستقبلية؛ ونجاح إستراتيجية Profound التجارية وأنشطتها فيما يتعلق بـ TULSA–PRO. في كثير من الأحيان، ولكن ليس دائمًا، يمكن التعرف على البيانات التطلعية من خلال استخدام كلمات مثل “يخطط”، “من المتوقع”، “يتوقع”، “مجدول”، “ينوي”، “يتأمل”، “يتوقع”، “يعتقد”، “يقترح” أو الاختلافات (بما في ذلك الاختلافات السلبية) لهذه الكلمات والعبارات، أو تنص على أن بعض الإجراءات أو الأحداث أو النتائج “قد” أو “يمكن” أو “سوف” يتم اتخاذها أو حدوثها أو تحقيقها. وتستند مثل هذه البيانات إلى التوقعات الحالية لإدارة شركة Profound. قد لا تقع الأحداث والظروف التطلعية التي تمت مناقشتها في هذا البيان الصحفي بحلول تواريخ محددة أو قد لا تقع على الإطلاق وقد تختلف ماديًا نتيجة لعوامل الخطر المعروفة وغير المعروفة وعدم اليقين الذي يؤثر على الشركة، بما في ذلك المخاطر المتعلقة بصناعة الأجهزة الطبية، والموافقات التنظيمية، والسداد، والعوامل الاقتصادية، وأسواق الأسهم بوجهٍ عامٍ والمخاطر المرتبطة بالنمو والمنافسة. على الرغم من أن Profound حاولت تحديد العوامل المهمة التي قد تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج الفعلية بشكل مادي عن تلك الموصوفة في البيانات التطلعية، إلا أنه قد تكون هناك عوامل أخرى تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج عن تلك المتوقعة أو المقدرة أو المقصودة. لا يمكن ضمان أي بيان تطلعي. تم وصف العوامل والمخاطر الأخرى التي قد تؤدي إلى اختلاف النتائج الفعلية بشكل مادي عن تلك المنصوص عليها في البيانات التطلعية في التقرير السنوي لشركة Profound على النموذج 10–K والملفات الأخرى المقدمة إلى هيئات تنظيم الأوراق المالية الأمريكية والكندية، والمتاحة على www.sedarplus.ca وwww.sec.gov. باستثناء ما تقتضيه قوانين الأوراق المالية المعمول بها، فإن البيانات التطلعية تتحدث فقط اعتبارًا من تاريخ إصدارها، ولا تتعهد Profound بأي التزام بتحديث أو مراجعة أي بيان تطلعي علنًا، سواء نتيجة لمعلومات جديدة أو أحداث مستقبلية أو غير ذلك، بخلاف ما يقتضيه القانون.

لمزيد من المعلومات، يرجى التواصل مع:

Stephen Kilmer
علاقات المستثمرين
[email protected]
هاتف: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9575020)

NeOnc Technologies Reports Updated Clinical Results

CALABASAS, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) — NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a multi–Phase 2 clinical–stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers today announced updated clinical results from its current Phase 1/2a and compassionate care studies involving a cohort of 24 patients with recurrent WHO Grade III/IV isocitrate dehydrogenase 1 (IDH1)–mutant astrocytoma treated with its investigational intranasal agent, NEO100.

Clinical results provided support that treatment with intranasally delivered NEO100 resulted in a significant radiographic response, confirmed by contrast–enhanced and perfusion MRI, in 5 of 24 patients (21%)—a rate that markedly exceeds the <8% response typically observed with salvage therapies for recurrent gliomas. Additionally, results indicated that 44% of patients in this Phase 2a study achieved six–month progression–free survival (PFS–6), surpassing the 21–31% benchmark reported in historical datasets for IDH1–mutant recurrent high–grade gliomas. Furthermore, 8 of 24 patients (33%) remained alive ≥18 months after initiation of NEO100, demonstrating long term survival.

In addition, no significant toxicity was reported with intranasal administration of NEO100, even with prolonged, chronic intranasal administration, underscoring its potential utility as a therapeutic option for this patient population.

Amir F. Heshmatpour, Executive Chairman, President & CEO of NeOnc Technologies Holdings, Inc., stated: “With these data, we believe NeOnc stands at the threshold of a true game–changer for one of medicine’s greatest unmet needs—recurrent IDH1–mutant hi grade gliomas. For the first time, we’re witnessing evidence of meaningful radiographic responses and support for durable survival in patients who previously had few, if any, options. As we approach full enrollment of the NEO100 trial—and our full data readout six months post–enrollment—we believe this may represent a potential paradigm shift in the treatment of brain cancer. The data will speak for itself—and for the patients whose lives we are determined to transform.”

Mr. Heshmatpour added: “We view this trial as a pivotal value inflection point for NeOnc and for the broader neuro–oncology field signaling a potential move beyond palliation toward measurable, durable disease control and a possible new standard of care in malignant gliomas.”

Founder, Dr. Thomas Chen, Vice–Chairman and Chief Medical Officer noted that, “The data suggest that intranasal NEO100 may be the first central nervous system (CNS)–penetrant metabolic therapy capable of inducing durable response and multi–year survival in recurrent IDH1 mutant gliomas.”

Dr. Henry Friedman of Duke University emphasized the implications of these findings, stating, “The results from NEO100 signify a potential paradigm shift in the treatment of recurrent IDH1–mutant gliomas.”

Key Data Highlights:

  • Radiographic Response: 21% (5 of 24 patients) achieved significant radiographic remission confirmed by contrast–enhanced, T2–FLAIR, and perfusion MRI. This response rate exceeds the <8% typically observed with salvage therapies for recurrent gliomas.
  • Progression–Free Survival (PFS–6): 44% of patients achieved 6–month progression–free survival (PFS–6), outperforming historical benchmarks of 21–31% for IDH1–mutant recurrent high–grade gliomas.
  • Long Term Survival: 33% (8 of 24) demonstrated durable survival ≥18 months post–initiation of NEO100.
  • Tolerability: No significant toxicity observed even with prolonged, chronic intranasal administration.

Study Context: All patients in the combined analysis (1 compassionate–use case, 5 from Phase 1, and 18 from Phase 2a) had confirmed WHO recurrent Grade III/IV IDH1–Mutant Astrocytoma and were included in the analysis if they had been enrolled in the study for at least six months prior to data cutoff. Patients received intranasal NEO100, and results were assessed using Response Assessment in Neuro–Oncology (RANO) criteria.

Collectively, these findings indicate that NEO100 could represent a first–in–class, CNS–penetrant metabolic therapy potentially inducing significant radiographic response and extending survival in patients with recurrent Grade III/IV IDH1–Mutant Astrocytoma, thereby potentially offering a major advancement over past approaches predominantly limited to palliative care.

ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical–stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood–brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast–Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.

For more about NeOnc and its pioneering technology, visit neonc.com.

Important Cautions Regarding Forward Looking Statements
This press release contains “forward–looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward–looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward–looking information.

Examples of forward–looking statements include, among others, statements regarding whether a definitive agreement will be reached with Quazar. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated.

The “Risk Factors” section of our most recent Annual Report on Form 10–K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward–looking statements herein, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds.

We assume no obligation to revise or update any forward–looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.

“NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Company Contact:
[email protected]

Investor Contact:
James Carbonara
Hayden IR
(646)–755–7412
[email protected]


GLOBENEWSWIRE (Distribution ID 9573872)

Profound Medical Inks Exclusive Distribution Agreement for TULSA-PRO® and Sonalleve® with Al Faisaliah Medical Systems in Saudi Arabia

Agreement creates runway for Profound’s incision–free and radiation–free therapies for the ablation of diseased tissue, to penetrate the largest healthcare market in the Middle East

All required regulatory approvals to import and sell Profound’s two advanced ablative technologies in Saudi Arabia are already in place

TORONTO and RIYADH, Saudi Arabia, Nov. 11, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial–stage medical device company that develops and markets artificial intelligence (“AI”)–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into an exclusive distribution and supply agreement for its TULSA–PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. (“FMS”), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (“AFG”).

Profound is the only company that combines the real–time imaging and thermography capabilities of magnetic resonance (“MR”) with AI–driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay.

U.S. commercialization of TULSA–PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, “BPH”), remains the top priority for the Company’s direct sales team. The TULSA Procedure™, performed using Profound’s TULSA–PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55–57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention–to–treat, while TULSA–PRO has the flexibility to be used for all ablations, including focal and hemi–gland, the majority of TULSA Procedures are either whole–gland or near–whole–gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (“Final Rule”) for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To–date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (October 2025), Profound’s TULSA–PRO installed base stood at 67 systems.

Profound’s second product, Sonalleve, which is offered primarily as a one–time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA–PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life–threatening, diseases.

As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.

“We’re honored to partner for the distribution of both TULSA–PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia,” commented Profound’s CEO and Chairman, Arun Menawat. “Successfully marketing and distributing our incision–free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients. With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we’re confident that FMS is the ideal partner for us.”

FMS’ GM, Mr. Abdullah Al Melik, said, “As Saudi Arabia moves toward economic diversification under Vision 2030, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country’s future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities. With our partnership with Profound, we're extremely excited to bring its unique, incision– and radiation–free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team.”

About with Al Faisaliah Medical Systems Co.

Founded in 1973, FMS was initially the healthcare division of AFG, until its establishment as an independent company in 1993. Its broad portfolio of partners and products enables it to deliver complex, integrated, single–source healthcare equipment solutions to the largest healthcare providers in the region. With operations across the Kingdom of Saudi Arabia, FMS is a major provider of diversified healthcare solutions, supplying state–of–the–art equipment and solutions for various uses such as oncology, operations, monitoring and critical care, cardiovascular and others. For further information, visit www.tibbiyah.com/fms.

About Al Faisaliah Group

AFG is a privately held holding company headquartered in Riyadh, Saudi Arabia, operating across the wider Middle East. Its name is derived from the name of its founder, Abdullah Al Faisal, eldest son of the late King Faisal. Founded in 1971, the Group holds leading positions in multiple industries including Dairy, Electronics, Healthcare and Food Service. AFG also operates a corporate venture capital arm (Al Faisaliah Ventures) that invests in global and regional disruptive players. The Group is recognized across the region for its strongly–held values, professional management and decades–long strategic partnerships with leading local and global firms including notably Sony, Danone and Philips. For further information, visit www.alfaisaliah.com.

About Profound Medical Corp.

Profound is a commercial–stage medical device company that develops and markets AI–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA–PRO®, a technology that combines real–time MRI, AI–enhanced planning, robotically–driven transurethral ultrasound and closed–loop temperature feedback control. The TULSA Procedure™, performed using the TULSA–PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low–, intermediate–, or high–risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio–recurrent localized prostate cancer. The TULSA Procedure employs real–time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55–57°C. The TULSA Procedure is an incision– and radiation–free “one–and–done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA–PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non–invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non–invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward–Looking Statements

This release includes forward–looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; the extent and timing of Profound’s completion of TULSA–PRO® system sales from its qualified sales pipeline; Profound’s expectations for future revenues; and the success of Profound’s commercialization strategy and activities for TULSA–PRO. Often, but not always, forward–looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward–looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward–looking statements are described in Profound's Annual Report on Form 10–K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward–looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward–looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9573632)

Namib Minerals – Production and Operational Update

HARARE, Zimbabwe, Nov. 10, 2025 (GLOBE NEWSWIRE) — Namib Minerals (Nasdaq: NAMM) (“Namib Minerals” or the “Company”) today provided an operational update, including production guidance for 2025 and an overview of its mandate to WSP Global Inc. (“WSP”).

2025 Operational Guidance

The Company expects 2025 to continue as a year of grade consolidation and optimization at its flagship How Mine operation. Based on current mine plans and market conditions, the Company anticipates the following ranges:

Metric 2025 Guidance Range
Production (oz) 24,000 – 25,000
Adjusted EBITDA (US$ millions) 22 – 26
All–in Sustaining Cost (AISC US$/oz) 2,700 – 2,800

The 2025 focus at How Mine remains on stabilizing grade performance and completing throughput–capacity improvements. These improvements are expected to yield geared production and grades in the upcoming year. Furthermore, the Company continues advancing early–stage restart preparation work at Redwing Mine and Mazowe Mine.

Pathway to Resource and Production Expansion
Namib Minerals is pursuing a phased, technically driven growth plan designed to transform the Company from a single–asset producer into a multi–asset operator. The Company has in the past informed investors of its objective to recommence operations at Mazowe Mine and Redwing Mine. These restarts represent the first phase of the Company’s pathway to expansion and have commenced with the appointment of WSP. WSP has been appointed to begin feasibility studies at both mines simultaneously.

The Company appointed WSP not only for its expertise but also the firm’s understanding and familiarity with the Company’s assets. The Company’s objective is to align the future production levels of Redwing Mine and Mazowe Mine with their respective resource sizes therein increasing their production capacities.

WSP have been mandated to verify the Company’s ability to meet this strategic objective. WSP have been mandated to execute a SK–1300 compliant feasibility study on the following terms, amongst others –

Feasibility Studies — 12 to 18 Months

  • These studies will validate our exploration program to increase, convert and upgrade these resources.
  • The program is expected to be completed over 12 to 18 months and will provide the technical foundation for reserve conversion, permitting, and financing discussions.

In conjunction with the feasibility studies, the Company shall execute on phase two, namely the following strategic objectives –

Dewatering and Infrastructure Preparation

  • Dewatering at Redwing is scheduled to commence during the Feasibility–study phase and is expected to take approximately eight months to reach the targeted mining levels.
  • Concurrently, surface–infrastructure and power–supply upgrades will be planned to align with the restart timeline.

The third phase of the Company’s expansion will be to proceed with financing of its CAPEX –

CAPEX Financing

  • Upon completion of the Feasibility Studies, Namib Minerals intends to initiate the procurement process for major equipment and plant components required for the restart of the Redwing and Mazowe Mines.
  • The Company’s preliminary estimate is that the total funding requirement for the expansion program is expected to fall within a range of US $300 million to $400 million, with the majority allocated to the Redwing Mine. However, such estimate is preliminary and subject to the completion of the feasibility studies and final engineering outcomes as well as a number of assumptions, risks and uncertainties, including the timing of the completion of the feasibility studies, market conditions, and the cost of equipment and construction, many of which are beyond the Company’s control and subject to change.
  • The Company plans to pursue a balanced funding mix that may include project debt, strategic partnerships, and internally–generated cash flows to help minimize shareholder dilution.

Forward–Looking Statements
This update includes forward–looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained in this update are forward–looking statements. Any statements that refer to estimates, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward–looking statements. Forward–looking statements include, without limitation, our management teams’ expectations concerning future operational and cost performance, the anticipate timeline and costs of the restart of the Mazowe and Redwing Mines, and related assumptions. The forward–looking statements are based on our current expectations and are inherently subject to uncertainties and changes in circumstance and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward–looking statements involve a number of risks and uncertainties which include, but are not limited to, (i) market risks, including the price of gold; (ii) the inability to maintain the listing of Namib Minerals’ securities on Nasdaq; (iii) the inability to remediate the identified material weaknesses in the Company’s internal control over financial reporting, which, if not corrected, could adversely affect the reliability of Namib Minerals’ financial reporting; (iv) the risk that the Company may not be able to successfully develop its assets, including expanding the How mine, restarting and expanding the Redwing and Mazowe Mines; (v) the risk that Namib Minerals will be unable to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; and (vi) political and social risks of operating in Zimbabwe and the DRC. The foregoing list is not exhaustive. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the filings we make with Securities and Exchange Commission (the “SEC”). We caution you against placing undue reliance on forward–looking statements, which reflect current beliefs and are based on information currently available as of the date a forward–looking statement is made.

Non–IFRS Information
References to non–IFRS financial measures, including Adjusted EBITDA and AISC, are presented as supplementary information and should not be considered substitutes for IFRS results. Definitions and reconciliations are available in the Company’s public filings with the SEC.

Contacts:

Investor Relations:
[email protected]  

Lamiaa Maniar:
VP of Communications
[email protected]


GLOBENEWSWIRE (Distribution ID 9572442)

NeOnc Technologies (Nasdaq: NTHI) to Host Investor Conference Call to Present Data Updates from Ongoing NEO100-1 Phase 1/2a Clinical Trial and Compassionate Use Program

CALABASAS, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a clinical–stage biopharmaceutical company developing novel brain–penetrant therapeutics for patients with malignant brain tumors and central nervous system (CNS) disorders, today announced that it will host an investor conference call and webcast on Wednesday, November 12, 2025, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time (prior to market open).

During the call, members of the NTHI management team and independent members of the company’s Scientific Advisory Board (SAB) will present data updates from the Company’s ongoing Phase 1/2a NEO100–1 clinical trial and compassionate use program, evaluating intranasal delivery of NEO100 (high–purity perillyl alcohol) in patients with recurrent high grade malignant glioma.

The discussion will highlight MRI–based radiographic response data, progression–free survival (PFS), and overall survival (OS) trends observed to date, providing important insights into long–term clinical outcomes for patients treated with NEO100.

Featured Participants:

  • Dr. Henry S. Friedman, MD – Deputy Director, Preston Robert Tisch Brain Tumor Center, Duke University; Independent Member, NTHI Scientific Advisory Board
  • Dr. Alexander Miller, MD – Chief Neuro–oncology, Brain Tumor Program, NYU Langone Health; Independent Member, NTHI Scientific Advisory Board
  • NTHI Management Team:
    • Amir Heshmatpour – Chief Executive Officer, Executive Chairman and President
    • Dr. Thomas C. Chen, MD, PhD – Chief Medical Officer and Chief Scientific Officer
    • Dr. Josh Neman, PhD – Chief Clinical Officer
    • Keith Garnett – Chief Financial Officer

Conference Call Details:

  • Date: Wednesday, November 12, 2025
  • Time: 6:00 a.m. PT / 9:00 a.m. ET
  • Webcast: A live webcast can be accessed by visiting https://investors.neonc.com

ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical–stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood–brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast–Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.

For more about NeOnc and its pioneering technology, visit neonc.com.

Important Cautions Regarding Forward–Looking Statements
This press release contains “forward–looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward–looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward–looking information.

Examples of forward–looking statements include, among others, statements regarding whether a definitive agreement will be reached with Quazar. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated.

The “Risk Factors” section of our most recent Annual Report on Form 10–K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward–looking statements herein, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds.

We assume no obligation to revise or update any forward–looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.

“NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Company Contact:
[email protected]

Investor Contact:
James Carbonara
Hayden IR
(646)–755–7412
[email protected]


GLOBENEWSWIRE (Distribution ID 9571142)

WeRide Lists on Hong Kong Stock Exchange, Becoming World's First Publicly Traded Robotaxi Company in Hong Kong and US

HONG KONG, Nov. 06, 2025 (GLOBE NEWSWIRE) — WeRide (HKEX: 0800.HK, NASDAQ: WRD), a global leader in autonomous driving technology, today announced its successful listing on the Stock Exchange of Hong Kong Limited (HKEX) under the stock code 0800.HK, becoming the world's first Robotaxi company to be publicly traded on both Hong Kong and US exchanges.

With that, WeRide also becomes the world's first Robotaxi and autonomous driving technology company to achieve a dual primary listing on both HKEX and NASDAQ.

Under its Hong Kong listing, WeRide issued a total of 88.25 million shares (pre–greenshoe), with 17.65 million shares offered publicly and 70.60 million shares for international placement. The offer price was set at HKD 27.1 per share, raising a total of approximately HKD 2.39 billion (pre–greenshoe).

Dr. Tony Han, Founder and CEO of WeRide, had voluntarily committed to a three–year lock–up on October 28, 2025, pledging not to sell any of his shares for the next three years. This demonstrated the founder's and management team's confidence in WeRide's fundamentals and growth, as well as their full commitment to the company's long–term vision and global expansion.

“We are deeply grateful to our partners, investors, customers, and every member of the WeRide team. Your trust and dedication have helped turn our vision of autonomous driving into reality. Over the past eight years, WeRide has evolved from technological innovation to commercial operation, becoming the only company worldwide with products holding autonomous driving permits in seven countries, and deployments in over 30 cities across 11 countries. We firmly believe that safe and reliable autonomous driving technology will deliver huge economic and social benefits. Our Hong Kong listing marks a new beginning, and we will continue to lead with technology, drive global commercial deployment, and deliver long–term, sustainable value for our shareholders and society,” said Dr. Tony Han, Founder and CEO of WeRide, at the listing ceremony.

Founded in 2017, WeRide was listed on the NASDAQ Stock Exchange on October 25, 2024, becoming the world's first publicly listed Robotaxi and universal autonomous driving technology company. The HKEX listing broadens its investor base and access to capital markets, enabling deeper investment in technology R&D and accelerating the global deployment of its autonomous vehicle fleet.

Powered by its proprietary WeRide One universal autonomous driving technology platform, WeRide offers Level 2 to Level 4 (L4) products and services across smart mobility, smart logistics, and smart sanitation, including the Robotaxi, Robobus, Robosweeper, Robovan and ADAS (Advanced Driver–Assistance Systems). With WeRide GENESIS, its self–developed, closed–loop simulation engine, WeRide has also significantly lowered road testing costs and safety risks, accelerating product iteration efficiency, market expansion speed, and commercial deployment scale.

Currently, WeRide is the only technology company in the world with products holding autonomous driving permits in seven countries – China, the UAE, Singapore, Saudi Arabia, France, Belgium, and the US. The company operates a fleet of more than 1,500 L4 vehicles, including over 700 Robotaxis. Partnering with Uber in Abu Dhabi, WeRide operates the largest commercial Robotaxi fleet outside of China and the US. Looking ahead, WeRide plans to deploy tens of thousands of Robotaxis by 2030.

On industry collaboration, WeRide continues to attract leading global investors and ecosystem partners, building a strategic network with companies such as NVIDIA, Bosch, Uber, Grab, and Renault–Nissan. It is also the only autonomous driving company to receive investment commitments from ride–hailing giants Uber and Grab, highlighting its strategic position and leading role in the industry.

WeRide has achieved multiple key milestones in the global commercial deployment of L4 autonomous vehicles. In China, fully driverless WeRide Robotaxis are now commercially operating in Guangzhou and Beijing, with 24–hour autonomous services extended to major transport hubs such as airports and train stations. In core markets such as the Middle East and Singapore, WeRide maintains a first–mover advantage of at least 1.5 years over its competitors. In European countries such as France, Switzerland, and Belgium, WeRide is the only autonomous driving company to have commercially deployed an L4 vehicle fleet.

In the ADAS sector, WeRide and Bosch’s jointly developed one–stage end–to–end assisted driving solution has successfully reached SOP and is set to enter mass production in 2025. These developments demonstrate the global adaptability and competitiveness of WeRide’s technology and business model across various regions.

With strong technology competence and a global commercial footprint, WeRide has been recognized internationally, including twice on Fortune's Change the World list – the only autonomous driving company to date – and twice on Fortune's Global Future 50, ranking 16th this year, the highest among Chinese companies.

Following its dual primary listing on HKEX and NASDAQ, WeRide remains committed to its mission of transforming urban living with autonomous driving. The company will continue to advance autonomous driving technology, expand global commercial operations, and work with partners worldwide to build a safer, more efficient, comfortable, and sustainable smart mobility ecosystem.

About WeRide
WeRide is a global leader and a first mover in the autonomous driving industry, as well as the first publicly traded Robotaxi company. Our autonomous vehicles have been tested or operated in over 30 cities across 11 countries. We are also the first and only technology company whose products have received autonomous driving permits in seven markets: China, the UAE, Singapore, France, Saudi Arabia, Belgium, and the US. Empowered by the smart, versatile, cost–effective, and highly adaptable WeRide One platform, WeRide provides autonomous driving products and services from L2 to L4, addressing transportation needs in the mobility, logistics, and sanitation industries. WeRide was named to Fortune's 2025 Change the World and 2025 Future 50 lists.

Media Contact
[email protected]

Safe Harbor Statement
This press release contains statements that may constitute “forward–looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward–looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. Statements that are not historical facts, including statements about WeRide’s beliefs, plans, and expectations, are forward–looking statements. Forward–looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in WeRide’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of this press release. WeRide does not undertake any obligation to update any forward–looking statement, except as required under applicable law.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cf56fe7e–50f7–4346–a4b9–6f973a0a51a9


GLOBENEWSWIRE (Distribution ID 9569559)

Nyxoah to Participate in the Stifel 2025 Healthcare Conference

Nyxoah to Participate in the Stifel 2025 Healthcare Conference

Mont–Saint–Guibert, Belgium – November 3, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that the Company will participate in the Stifel 2025 Healthcare Conference on Tuesday, Nov. 11, 2025. The Company is scheduled to present at 9:20am Eastern Time the same day via webcast.

A live webcast of the event can be accessed by visiting Nyxoah’s Investor Relations website and will be available for replay following the events. The Company will also be available for 1×1 meetings with institutional investors attending the event.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat 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 U.S. FDA approval of a Premarket Approval application.

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 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; the Company's commercialization strategy and entrance to the U.S. market; the Company’s intellectual property portfolio; 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, or adverse litigation outcomes 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.

Investor and Media Contact:

Rémi Renard

Chief Investor Relations and Corporate Communication Officer

[email protected]

Attachment


GLOBENEWSWIRE (Distribution ID 1001136656)

Nyxoah Participera à la Conférence Stifel Healthcare 2025

Nyxoah Participera à la Conférence Stifel Healthcare 2025

Mont–Saint–Guibert, Belgique – 3 novembre 2025, 22h05 CET / 16h05 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 que la Société participera à la conférence Stifel Healthcare 2025 le mardi 11 novembre 2025. La Société fera une présentation à 9h20 ET, le même jour, via webdiffusion.

La webdiffusion en direct de l’évènement sera accessible sur le site web Investor Relations de Nyxoah et pourra être visionnée en rediffusion après les événements. La Société sera également disponible pour des rencontres individuelles avec les investisseurs institutionnels participant à l'événement.

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'approbation par la FDA américaine d'une demande d'autorisation préalable à la mise sur le marché.

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 prescription médicale.

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.

Contact Medias et Investisseurs :

Rémi Renard

Chief Investor Relations and Corporate Communication Officer

[email protected]

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1001136656)