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Nyxoah Obtient l'Autorisation de la FDA pour le Système Genio® Destiné au Traitement de l'Apnée Obstructive du Sommeil

INFORMATIONS PRIVILÉGIÉES
INFORMATIONS RÉGLEMENTÉES

Nyxoah Obtient l'Autorisation de la FDA pour le Système Genio® Destiné au Traitement de l'Apnée Obstructive du Sommeil
Lancement Officiel de la Commercialisation aux États–Unis

Mont–Saint–Guibert, Belgique – 8 juillet 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 annoncé aujourd'hui que la Food and Drug Administration (FDA) des États–Unis a approuvé le système Genio pour un groupe de patients atteints d'AOS modérée à sévère avec un index d'apnée–hypopnée (IAH) supérieur ou égal à 15 et inférieur ou égal à 65.

Genio est une approche différente de la stimulation du nerf hypoglosse (HGNS) pour le traitement de l'AOS. La conception unique de Genio utilise une stimulation bilatérale et offre aux patients une solution sans sonde, compatible avec l'IRM 1,5 T et 3 T pour le corps entier, sans batterie implantée, alimentée et contrôlée par un composant portable. Le composant portable est entièrement évolutif, ce qui permet aux patients Genio d'accéder à cette technologie sans avoir à subir d'autres interventions chirurgicales pour les mises à jour technologiques ou les remplacements de batterie.

“Aujourd'hui marque un moment charnière pour Nyxoah et pour les patients américains souffrant d'AOS. Avec l'autorisation de mise sur le marché du système Genio par la FDA, nous sommes fiers d'introduire cette thérapie innovante sur le marché américain”, a commenté Olivier Taelman, CEO de Nyxoah. “Notre mission a toujours été de simplifier le sommeil des patients atteints d'AOS en leur offrant une solution qui leur permet de mieux dormir. Nous sommes impatients de mettre en œuvre avec succès notre stratégie de commercialisation aux États–Unis.”
        
L'autorisation de mise sur le marché du système Genio par la FDA s'appuie sur les données de haute qualité, distinctives en matière de sécurité et d'efficacité, issues de L'étude pivot DREAM menée par la Société. L'étude DREAM a atteint ses critères d'évaluation principaux et secondaires, démontrant un taux de réponse de 63,5 % pour l'IAH et de 71,3 % pour l'index de désaturation en oxygène, avec une réduction médiane globale de l'IAH de 70,8 %. De plus, 82,0 % de tous les sujets de l'étude DREAM ont vu leur score IAH passer en dessous de 15.

Il est important de noter que l'étude DREAM a démontré que Genio est efficace quelle que soit la position de sommeil du patient et, à notre connaissance, il s'agit du seul traitement bénéficiant d'une telle preuve clinique dans le cadre d'une vaste étude clinique prospective multicentrique utilisant les données d'une polysomnographie complète. Il s'agit là d'un facteur de différenciation essentiel, car en moyenne, les gens dorment en position couchée sur le dos entre 35 % et 40 % de la nuit. L'étude DREAM a mesuré les résultats spécifiques à chaque position et a démontré une réduction médiane de 66,6 % de l'IAH lorsque les patients dormaient en position dorsale, malgré le fait que le nombre d'obstructions des voies respiratoires puisse doubler dans cette position. Cette réduction est comparable à la réduction de 71,0 % de l'IAH observée lorsque les patients dormaient dans une position autre que dorsale.

“L'autorisation du système Genio représente un ajout majeur aux options thérapeutiques dont disposent les médecins traitant les patients atteints d'AOS “, a déclaré le Dr Colin Huntley, Associate Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University. “Cette technologie unique de stimulation bilatérale a démontré une efficacité constante dans toutes les positions de sommeil, y compris la position couchée sur le dos, qui est difficile à traiter, tout en conservant un excellent profil de sécurité.”

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. Dispositif de recherche aux États–Unis. Limité à un usage expérimental aux États–Unis par la loi fédérale américaine.

Déclarations Prospectives

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

Contacts :

Nyxoah
John Landry, CFO
[email protected]

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

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

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

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1001122077)

Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea

INSIDE INFORMATION
REGULATED INFORMATION

Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea
U.S. Commercialization Officially Launched

Mont–Saint–Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm 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 announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea–Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. Genio’s unique design utilizes bilateral stimulation, and offers patients a leadless, full–body 1.5T and 3T MRI compatible, non–implanted battery solution, powered and controlled by a wearable component. The wearable component is fully upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.

“Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. commercialization strategy.”
        
The Genio system’s FDA approval was supported by the high–quality, differentiated safety and efficacy data from the Company's DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints demonstrating an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%, with an overall median AHI reduction of 70.8%. Additionally, 82.0% of all DREAM subjects saw their AHI scores drop below 15 or lower.

Importantly, the DREAM study demonstrated that Genio is efficacious regardless of a patient's sleeping position and, to our knowledge the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography. This is a critical differentiator as on average, people sleep in a supine position between 35% and 40% of the night. The DREAM study measured position–specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non–supine position.

“The Genio system's approval represents a major addition to the treatment options available to physicians treating patients with OSA,” said Colin Huntley MD, Associate Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University. “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”

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.

For more information, please visit http://www.nyxoah.com/.

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; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20–F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward–looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

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

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

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

Attachment


GLOBENEWSWIRE (Distribution ID 1001122077)

Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates

  • FDA provides pivotal agreement on EB613 Phase 3 design, confirming Bone Mineral Density (BMD) as primary endpoint and clearing streamlined pathway for first oral anabolic osteoporosis treatment
  • Significant regulatory and pipeline advancements achieved including FDA waiver of additional safety studies and next–gen EB613 expected to enter Phase 1 in November 2025
  • Strong momentum across OPKO collaboration with obesity program showing promising preclinical data; and EB612 oral PTH directed hypoparathyroidism program candidate validation
  • Strong balance sheet provides runway through mid–Q3 2026, including dedicated OPKO collaboration funding

JERUSALEM, Aug. 08, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported financial results and key business updates for the quarter ended June 30, 2025.

“Last week's FDA agreement on using BMD as the primary endpoint for EB613's Phase 3 program represents a pivotal milestone in our journey to bring the first oral anabolic osteoporosis tablet treatment to market,” said Miranda Toledano, Chief Executive Officer of Entera. “This unprecedented regulatory alignment validates both the strength of our clinical data and our strategic vision that began taking shape in July 2022. The concurrence opens the door to addressing a massive unmet need – with less than 25% of the world's 200 million osteoporotic women having access to safe, effective, and affordable treatment options, and no new therapies approved in this space since 2019. Beyond EB613, throughout Q2, we continued building momentum across our entire pipeline, including presenting promising pharmacokinetic data for our oral GLP–1/glucagon dual agonist program with OPKO. With our strengthened cash position of $18.9 million, including dedicated OPKO collaboration funding, we are well–positioned to execute on multiple value–creating milestones across 2025 and beyond.”

Key Recent Highlights

EB613: First Oral PTH(1–34) Anabolic Treatment for Osteoporosis

  • FDA Agreement that BMD Primary Endpoint Would Support NDA: In a July Type A meeting, FDA provided written concurrence on our Phase 3 study design – a single multinational, randomized, double–blind, placebo–controlled, 24–month study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. As a 505(b)(2) application, the submission will rely on FDA's previous findings of effectiveness and safety for the Reference Listed Drug Forteo®, where the correlation between BMD and fracture has been well–established. The study is designed and powered to demonstrate a statistically significant increase in total hip BMD, coupled with a positive trend on vertebral fracture reduction as key secondary endpoint to provide substantial evidence of effectiveness. This FDA decision is independent of the Agency's qualification of the SABRE BMD Initiative which is still expected within 2025.
  • Regulatory Burden Significantly Reduced: In May and June, Entera received written agreements from FDA that dedicated oral carcinogenicity studies and comprehensive nonclinical developmental and reproductive toxicity (DART) studies are not warranted given the totality of evidence generated fromForteo® literature and nonclinical studies conducted with EB613.
  • Strong Clinical Data Gains Scientific Recognition: In April, Dr. Rachel B Wagman presented early effects of EB613 on trabecular and cortical bone using 3D–DXA at the 2025 WCO–IOF–ESCEO Congress. Additionally, 3D Shaper Phase 2 data was selected for oral presentation at ASBMR 2025 in September.
  • Next–Generation EB613 Advancing: “Advancing Oral Anabolic Treatments for Osteoporosis: Pre–Clinical Data for Next Gen EB613 Tablet Utilizing N–Tab™ Proprietary Technology” was selected for poster presentation at ASBMR 2025. Next Gen EB613 is being developed with a new generation of Entera's N–TAB™ platform and is expected to enter the clinic in a Phase 1 Safety and PK Study in November 2025.
  • Strategic Regulatory Engagement: In June, CEO Miranda Toledano participated in the Boston “CEO Forums: An FDA Listening Tour to Engage Pharma and Bio CEOs” and presented a one–minute brief on osteoporosis and potential regulatory reform to spur innovation.

First PTH (1–34) Tablet Protein Replacement Therapy for Hypoparathyroidism

  • First pre–clinical PK/PD data from undisclosed collaborative research with long–acting PTH agonist as a once–daily tablet format is expected by end of year.

OPKO Health Collaboration Programs

  • First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity: In June, a poster at ENDO2025 reported PK data from a mini–pig study of oral OPK–88006 (dual GLP–1/glucagon receptor agonist in partnership with OPKO Health, Nasdaq: “OPK”) which showed plasma levels consistent with those reported in humans for the highest subcutaneous dose of Wegovy™ (semaglutide) weekly injection, a standard of care for the treatment of obesity. The reported pharmacological data supports a once–daily tablet regimen of this first–in–class oral dual agonist. A Phase 1 study is being planned and IND filing is expected in H1 2026.
  • First GLP–2 Peptide Tablets for Short Bowel Syndrome: In June, Entera in partnership with OPKO's “First–in–Class Oral GLP–2 Analog for Treatment of Short Bowel Syndrome” abstract was selected for poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress.

Financial Results for the Quarter Ended June 30, 2025

Cash and cash equivalents were $18.9 million as of June 30, 2025, including $8.0 million in restricted cash designated to fund the OPKO collaboration through Phase 1 studies of oral GLP–1/glucagon candidate OPK–88006. Cash on hand is expected to support operations through mid–third quarter 2026.

Net loss was $2.7 million, or $0.06 per ordinary share, for the three months ended June 30, 2025, compared to $2.1 million, or $0.06 per ordinary share, for the three months ended June 30, 2024.

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024, an increase of $0.4 million. The increase was primarily due to regulatory activities and Phase 3 planning for EB613.

General and administrative expenses were $1.1 million for the three months ended June 30, 2025, compared to $1.1 million for the three months ended June 30, 2024.

Total operating expenses were $2.7 million for the three months ended June 30, 2025, compared to $2.2 million for the three months ended June 30, 2024.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and a pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 with alignment from FDA on the use of BMD as its primary endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

 
ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
       
  June 30,   December 31,
  2025   2024
  (Unaudited)   (Audited)
   
Cash and cash equivalents 10,858   8,660
Accounts receivable and other current assets 438   312
Restricted cash 8,015   –
Property and equipment, net 79   57
Other assets 277   361
Total assets 19,667   9,390
 
 
Accounts payable and other current liabilities 1,844   1,176
Total non–current liabilities 567   134
Total liabilities 2,411   1,310
Total shareholders' equity 17,256   8,080
       
Total liabilities and shareholders' equity 19,667   9,390

   
ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

(Unaudited)

  
  Three Months Ended
June 30,
  2025   2024
REVENUES –   57
COST OF REVENUES –   49
GROSS PROFIT –   9
OPERATING EXPENSES:    
Research and development 1,520   1,086
General and administrative 1,148   1,088
TOTAL OPERATING EXPENSES 2,668   2,174
OPERATING LOSS 2,668   2,165
FINANCIAL INCOME, NET (12)   (20)
NET LOSS 2,656   2,145
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.06
       
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 46,836,700   37,090,160
     


GLOBENEWSWIRE (Distribution ID 9509020)

Zoom to Release Financial Results for the Second Quarter of Fiscal Year 2026

SAN JOSE, Calif., July 31, 2025 (GLOBE NEWSWIRE) — Zoom Communications, Inc. (NASDAQ: ZM) today announced it will release its financial results for the second quarter of fiscal year 2026 on Thursday, August 21, 2025, after the market closes.

A live Zoom Webinar of the event can be accessed at 2:00 pm PT / 5:00 pm ET through Zoom’s investor relations website at https://investors.zoom.com. A replay will be available approximately two hours after the conclusion of the live event.

About Zoom
Zoom’s mission is to provide an AI–first work platform for human connection. Reimagine teamwork with Zoom Workplace — Zoom’s open collaboration platform with AI Companion empowers teams to be more productive. Together with Zoom Workplace, Zoom’s Business Services for sales, marketing, and customer experience teams, including Zoom Contact Center, strengthen customer relationships throughout the customer lifecycle. Founded in 2011, Zoom is publicly traded (NASDAQ:ZM) and headquartered in San Jose, California. Get more information at zoom.com.

Public Relations
Colleen Rodriguez
Head of Global PR for Zoom
[email protected]

Investor Relations
Charles Eveslage
Head of Investor Relations for Zoom
[email protected]


GLOBENEWSWIRE (Distribution ID 9503211)

Zoom to Release Financial Results for the Second Quarter of Fiscal Year 2026

SAN JOSE, Calif., July 31, 2025 (GLOBE NEWSWIRE) — Zoom Communications, Inc. (NASDAQ: ZM) today announced it will release its financial results for the second quarter of fiscal year 2026 on Thursday, August 21, 2025, after the market closes.

A live Zoom Webinar of the event can be accessed at 2:00 pm PT / 5:00 pm ET through Zoom’s investor relations website at https://investors.zoom.com. A replay will be available approximately two hours after the conclusion of the live event.

About Zoom
Zoom’s mission is to provide an AI–first work platform for human connection. Reimagine teamwork with Zoom Workplace — Zoom’s open collaboration platform with AI Companion empowers teams to be more productive. Together with Zoom Workplace, Zoom’s Business Services for sales, marketing, and customer experience teams, including Zoom Contact Center, strengthen customer relationships throughout the customer lifecycle. Founded in 2011, Zoom is publicly traded (NASDAQ:ZM) and headquartered in San Jose, California. Get more information at zoom.com.

Public Relations
Colleen Rodriguez
Head of Global PR for Zoom
[email protected]

Investor Relations
Charles Eveslage
Head of Investor Relations for Zoom
[email protected]


GLOBENEWSWIRE (Distribution ID 9503211)

Namib Minerals Provides Corporate Update

NEW YORK, July 31, 2025 (GLOBE NEWSWIRE) — Namib Minerals (“Namib Minerals” or “the Company”), (Nasdaq: NAMM), an established African gold producer with a portfolio of mining and exploration assets in Zimbabwe and the Democratic Republic of Congo, is pleased to provide a corporate update after closing the business combination with Hennessy Capital Investment Corp. VI and listing on the Nasdaq Stock Exchange under the ticker symbol NAMM. The Company also recently rang the Closing Bell at the Nasdaq Stock Exchange on July 25, 2025.

Namib Minerals Rings the Nasdaq Closing Bell
Photo Courtesy of Nasdaq, Inc.

Ibrahima Sory Tall, Chief Executive Officer, stated “This achievement marks more than a change in our corporate structure – it is a validation of our vision. The transaction facilitates access to strategic partnerships necessary to advance our mission of becoming a leading, multi–asset producer of gold and green minerals. We believe Namib Minerals is ready to become a leader of Africa’s next generation of globally significant mineral producers.”

Strategic Growth and Asset Development

Namib Minerals’ foundation is built on a portfolio of cash–generating assets. Its anchor operation, How Mine in Zimbabwe, is a fully producing underground gold mine that generated 36.6 koz of gold and approximately US$86 million in revenue in 2024. With a strong operational track record and existing infrastructure, and assuming sufficient funding is obtained, Namib Minerals believes How Mine is well positioned for expansion. The Company is actively planning to increase the current production capacity to unlock additional value.

Alongside How Mine, the Company is advancing restart plans for the Mazowe and Redwing mines in Zimbabwe. These assets are undergoing enabling works, with the expectation of returning both to production in the near term. Dewatering at Redwing is expected to begin this fiscal year, with parallel infrastructure upgrades continuing at Mazowe.

As of December 31, 2023, Namib Minerals’ three gold assets have a substantial mineral endowment of 1.6Moz of gold in measured and indicated reserves at an average grade of 3.92 g/t Au, and an additional 2.4Moz in inferred resources at 3.57 g/t Au.

In addition to optimizing and restarting existing operations, Namib Minerals expects to organize a series of feasibility studies to facilitate discovery of increased reserves and resources across all three projects. These studies are expected to form the technical foundation for future expansion and help underpin the Company’s long–term production profile.

The Company’s exploration portfolio in the Democratic Republic of Congo comprises an interest in 13 exploration permits targeting copper and cobalt – two critical minerals essential to the global energy transition. This marks an important part of diversifying Namib Minerals’ commodity base while maintaining exposure to structurally robust markets.

Commitment to Operational Excellence, and Shared Prosperity

Namib Minerals operates according to leading international standards, with ISO 14001, 9001, and 45001 certifications for environmental responsibility, quality, and occupational health and safety. The Company is committed to maintaining these standards as it expands, helping to ensure that all new sites operate under its established Operational Excellence framework aligned with these ISO certifications.

Such framework also includes Sustainability, with environmental best practices, and Shared Prosperity, through continuous partnerships with our local communities and governments.

About Namib Minerals

Namib Minerals (NASDAQ:NAMM) is a gold producer, developer and explorer with operations focused in Zimbabwe. Namib Minerals is a significant player in Africa’s mining industry, driving sustainable growth and innovation across the sector. Currently Namib Minerals operates the How Mine, an underground gold mine in Zimbabwe, and aims to restart two assets in Zimbabwe, with additional exploration assets in the DRC. For additional information, please visit namibminerals.com.

Contacts:

Namib Minerals:
Ibrahima Sory Tall
CEO & Director
[email protected]

Investor Relations:
Kaitlin Taylor & Chris Santa Cruz
[email protected] 

Forward–Looking Statements

All statements other than statements of historical facts contained in this press release, including statements regarding Namib Minerals’ future financial position, results of operations, business strategy, and plans and objectives of its management team for future operations, are forward–looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward–looking statements. In some cases, you can identify forward–looking statements by words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “strategy,” “future,” “opportunity,” “may,” “target,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “preliminary,” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward–looking. Forward–looking statements include, without limitation, Namib Minerals’ or its respective management team’s expectations concerning the outlook for Namib Minerals’ business, productivity, plans, and goals for future operational improvements, growth and capital investments, operational and cost performance, future market conditions, economic performance and developments in the capital and credit markets, expected future financial performance, the restart of the Mazowe mine and Redwing mine and related expansion plans, capital expenditure plans and timeline, the development and goals of the prospective exploration licenses in the DRC, mineral reserve and resource estimates, production and other operating results, productivity improvements, expected additional funding, growth prospects and outlook of Namib Minerals’ operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Namib Minerals’ exploration and production projects, as well as any information concerning possible or assumed future results of operations of Namib Minerals. Forward–looking statements also include statements regarding the expected benefits of the Business Combination. The forward–looking statements are based on the current expectations of the management team of Namib Minerals, 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, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward–looking statements. These risks and uncertainties include, but are not limited to, (i) market risks, including the price of gold; (ii) the effect of the announcement or consummation of the Business Combination on Namib Minerals’ business relationships, performance, and business generally; (iii) the outcome of any legal proceedings that may be instituted against Namib Minerals or its subsidiaries related to the Business Combination; (iv) the failure to realize the anticipated benefits of the Business Combination; (v) the inability to maintain the listing of Namib Minerals’ securities on Nasdaq; (vi) the inability to remediate the identified material weaknesses in Namib Minerals’ subsidiary’s internal control over financial reporting, which, if not corrected, could adversely affect the reliability of Namib Minerals’ or its subsidiaries’ financial reporting; (vii) the risk that the price of Namib Minerals’ securities may be volatile due to a variety of factors, including changes in the highly competitive industries in which Namib Minerals plans to operate, variations in performance across competitors, changes in laws, regulations, technologies, natural disasters or health epidemics/pandemics, national security tensions, and macro–economic and social environments affecting its business, and changes in the combined capital structure; (viii) the inability to implement business plans, forecasts, and other expectations, identify and realize additional opportunities, and manage growth and expanding operations; (ix) the risk that Namib Minerals may not be able to successfully develop its assets, including expanding the How mine, restarting and expanding its other mines in Zimbabwe or developing its interests in exploration permits in the DRC; (x) 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; (xi) political and social risks of operating in Zimbabwe and the DRC; (xii) the operational hazards and risks that Namib Minerals and its subsidiaries face; and (xiii) potential volatile and sporadic trading of Namib’s securities. The foregoing list is not exhaustive, and there may be additional risks that Namib Minerals presently does not know or that it currently believes are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the registration statement on Form F–4 (together with all amendments thereto, the “Registration Statement”) initially filed on December 6, 2024, and the definitive proxy statement / prospectus contained therein, in each case, under the heading “Risk Factors,” and other documents of Namib Minerals’ subsidiaries filed, or to be filed, with the U.S. Securities and Exchange Commission (“SEC”). Namib Minerals cautions 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. Forward–looking statements set forth in this press release speak only as of the date of this press release. Neither Namib Minerals nor its subsidiaries undertakes any obligation to revise forward–looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward–looking statement is updated, no inference should be made that Namib Minerals or its subsidiaries will make additional updates with respect to that statement, related matters, or any other forward–looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward–looking statements, including discussions of significant risk factors, may appear, from subsequent events and developments, in Namib Minerals’ public filings with the SEC, which are or will be (as appropriate) accessible at www.sec.gov, and which you are advised to review carefully.

Cautionary Note Regarding Mineral Resources

Estimates of “measured”, “indicated” and “inferred” mineral resources as well as “proven” and “probable” mineral reserves shown in this communication are defined in Subpart 1300 of Regulation S–K promulgated by the SEC (“S–K 1300”). The estimation of measured resources and indicated resources involves greater uncertainty as to their existence and economic feasibility than the estimation of proven and probable mineral reserves. The estimation of inferred resources involves far greater uncertainty as to their existence and economic viability than the estimation of other categories of resources. Investors are cautioned not to assume that any or all of the mineral resources are economically or legally mineable or that these mineral resources will ever be converted into mineral reserves. You are cautioned that mineral resources do not have demonstrated economic viability.

No Offer or Solicitation

This press release shall not constitute an offer to sell or exchange, the solicitation of an offer to buy or a recommendation to purchase, any securities, or a solicitation of any vote, consent or approval, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale may be unlawful under the laws of such jurisdiction.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/209aa0b1–f756–4d9c–ba4a–085af921ebc5


GLOBENEWSWIRE (Distribution ID 9503757)

Information on the total number of voting rights and shares

REGULATED INFORMATION

Information on the total number of voting rights and shares

Mont–Saint–Guibert (Belgium), July 29, 2025, 10:45 pm CET / 4:45 pm ET – In accordance with article  15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publishes the below information following the issue of new shares.

  • Share capital: EUR 6,432,066.28
  • Total number of securities carrying voting rights: 37,441,140 (all ordinary shares)
  • Total number of voting rights (= denominator): 37,441,140 (all relating to ordinary shares)
  • Number of rights to subscribe to securities carrying voting rights not yet issued: 2,793,941 (all granted subscription rights; this number excludes 493,057 subscription rights that were issued but not yet granted)

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Contact:
Nyxoah
John Landry, CFO
[email protected]

Attachment


GLOBENEWSWIRE (Distribution ID 1001120306)

Informations sur le nombre total de droits de vote et d'actions

INFORMATION RÉGLEMENTÉE

Informations sur le nombre total de droits de vote et d'actions

Mont–Saint–Guibert (Belgique), le 29 juillet 2025, 22:45h CET / 16:45h ET – Conformément à l'article 15 de la loi du 2 mai 2007 relative à la publicité des participations importantes, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publie les informations ci–dessous suite à l'émission de nouvelles actions.

  • Capital: EUR 6.432.066,28
  • Nombre total de titres avec droits de vote: 37.441.140 (tous des actions ordinaires)
  • Nombre total de droits de vote (= dénominateur): 37.441.140 (tous liés aux actions ordinaires)
  • Nombre de droits de souscrire à des titres avec droits de vote non encore émis: 2.793.941 (tous des droits de souscription octroyés; ce nombre exclut 493.057 droits de souscription émis mais pas encore octroyés)

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Contact:
Nyxoah
John Landry, CFO
[email protected]

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GLOBENEWSWIRE (Distribution ID 1001120306)

Nyxoah to Release Second Quarter 2025 Financial Results on August 18, 2025

Nyxoah to Release Second Quarter 2025 Financial Results on August 18, 2025

Mont–Saint–Guibert, Belgium – Tuesday July 29, 2025, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the second quarter of 2025 on Monday, August 18, 2025. Company management will host a conference call to discuss financial results that day beginning 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 Q2 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 Q2 2025 Earnings Call. After registering, an email will be sent, including dial–in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

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

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient–centered, leadless and battery–free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States

FORWARD–LOOKING STATEMENTS

Certain statements, beliefs and opinions in this press release are forward–looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20–F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward–looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward– looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.
Contacts: Nyxoah
John Landry, CFO
[email protected]

For Media

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

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

Attachment


GLOBENEWSWIRE (Distribution ID 1001120298)

Nyxoah Publiera ses Résultats Financiers du Second Trimestre 2025 le 18 Août 2025

Nyxoah Publiera ses Résultats Financiers du Second Trimestre 2025 le 18 Août 2025

Mont–Saint–Guibert, Belgique – Mardi 29 juillet 2025, 22h30 CET / 16h30 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 a annoncé aujourd'hui que la Société publiera ses résultats financiers pour le second trimestre le lundi 18 août 2025. 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 Q2 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 Q2 2025 Earnings Call. Après l'inscription, un courriel sera envoyé, comprenant les détails de la connexion et un code d'accès unique à la conférence téléphonique nécessaire pour rejoindre l'appel en direct. Pour s'assurer que vous êtes connecté avant le début de la conférence, la Société suggère de s'inscrire au moins 10 minutes avant le début de l'appel.

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

A propos de Nyxoah

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

À la suite de la finalisation probante de l’étude BLAST OSA, le système Genio® a reçu le marquage européen CE en 2019. Nyxoah a réalisé avec succès deux IPO : l’une sur Euronext Bruxelles en septembre 2020 et l’autre sur le NASDAQ en juillet 2021. Grâce aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu le marquage CE pour l’extension de ses indications thérapeutiques aux patients souffrant de collapsus concentrique complet (CCC), pour lesquels les thérapies concurrentes sont actuellement contre–indiquées. En outre, la Société a annoncé les résultats positifs de l'étude pivot DREAM IDE.

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

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

Déclarations Prospectives
Certaines déclarations, croyances et opinions contenues dans le présent communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la Société ou, le cas échéant, des administrateurs ou de la direction de la Société concernant le système Genio®, les études cliniques prévues et en cours sur le système Genio®, les avantages potentiels du système Genio®, les objectifs de Nyxoah concernant le développement, la voie réglementaire et l'utilisation potentielle du système Genio®, l'obtention de l'approbation de la FDA, l'achèvement satisfaisant de l'examen des installations de fabrication, des méthodes et des contrôles, et le calendrier prévu pour ce qui précède, l'entrée sur le marché américain, ainsi que les résultats d'exploitation, la situation financière, les liquidités, les performances, les perspectives, la croissance et les stratégies de la Société. De par leur nature, les déclarations prévisionnelles impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou les événements réels diffèrent matériellement de ceux exprimés ou sous–entendus dans les déclarations prévisionnelles. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence négative sur les résultats et les effets financiers des plans et des événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la Société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2024, déposé auprès de la Securities and Exchange Commission (« SEC ») le 20 mars 2025, et des rapports ultérieurs que la Société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent de manière significative de tout développement anticipé. Les déclarations prospectives contenues dans le présent communiqué de presse concernant des tendances ou des activités passées ne constituent pas des garanties de performances futures et ne doivent pas être considérées comme une déclaration selon laquelle ces tendances ou activités se poursuivront à l'avenir. En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements peuvent ne pas être représentatifs des résultats ou développements des périodes futures. Aucune déclaration ou garantie n'est donnée quant à l'exactitude ou à la justesse de ces déclarations prospectives. En conséquence, la Société décline expressément toute obligation ou tout engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement des attentes ou d'un changement des événements, conditions, hypothèses ou circonstances sur lesquels ces déclarations prospectives sont basées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni les dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans ce communiqué de presse ou quant à la survenance effective des développements prévus. Vous ne devriez pas accorder une confiance excessive aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contacts :

Nyxoah
John Landry, CFO
[email protected]

Medias

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

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

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GLOBENEWSWIRE (Distribution ID 1001120298)