Les Données de l'Étude Pivot DREAM Présentées lors de l'International Surgical Sleep Society 2024 Educational Update

Les Données de l'Étude Pivot DREAM Présentées lors de l'International Surgical Sleep Society 2024 Educational Update

Des données cliniques supplémentaires sur des patients souffrant d'apnée obstructive du sommeil (AOS) démontrent une réduction médiane cliniquement significative de 71,0 % de l'indice d'apnée–hypopnée (IAH) en position couchée sur le dos à 12 mois par rapport à la valeur de référence.

82,0 % des patients ayant passé une polysomnographie à 12 mois avaient un IAH inférieur à 15, et 67,4 % des patients ayant passé une polysomnographie à 12 mois avaient un IAH inférieur à 10.

Mont–Saint–Guibert, Belgique – 27 septembre 2024, 10h30 CET / 16h30 ET – Nyxoah SA (Euronext Bruxelles/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 présenté aujourd'hui les données de l'étude pivot DREAM U.S. lors d'une séance orale lors de l’International Surgical Sleep Society (ISSS) 2024 Educational Update qui a eu lieu les 26 et 27 septembre à Miami, en Floride.

Des données supplémentaires ont été présentées pour la réduction de l'IAH en position dorsale et non latérale. La stimulation bilatérale Genio a entraîné une réduction médiane cliniquement significative de 71,0 % de l'IAH en position dorsale à 12 mois par rapport à la valeur de référence. Cette réduction se compare à une réduction médiane de l'IAH à 12 mois de 70,8 % dans toutes les positions de sommeil.

En ce qui concerne les critères d'évaluation secondaires rapportés à l'ISSS, les sujets ont montré des améliorations significatives de la qualité de vie. Plus précisément, une augmentation moyenne de 2,3 points a été observée dans l'évaluation du questionnaire Functional Outcomes of Sleep Questionnaire (FOSQ). En outre, le score de somnolence d'Epworth a été réduit de 3,4 points en moyenne par rapport à la situation initiale.

La présentation comprenait des données précédemment annoncées montrant que l'étude avait atteint ses critères d'évaluation co–principaux du taux de réponse à l'IAH à 12 mois, selon les critères Sher, et du taux de réponse à l'indice de désaturation en oxygène (ODI), tous deux sur la base de l'intention de traiter (ITT ). Dans l'étude principale DREAM, 115 patients ont reçu l'implant Genio et ont été inclus dans l'analyse de sécurité. Ces patients avaient un IAH moyen de 28,0 au départ, un ODI moyen de 27,0 et un indice de masse corporelle moyen de 28,5. Après 12 mois, 73 sujets se sont révélés être des répondeurs IAH selon les critères Sher*, ce qui a donné un taux de réponse IAH ITT de 63,5 % (p=0,002), de plus, 82 sujets ont été identifiés comme répondeurs ODI, ce qui a donné un taux de réponse ODI de 71,3 % (p<0,001). Les résultats d'innocuité étaient conformes à ceux d'autres thérapies de neuromodulation, avec 11 événements indésirables graves, ou EIG, chez dix sujets, entraînant un taux d'EIG de 8,7 %. Sur les 11 SAE, trois étaient liés à des dispositifs, et trois étaient des explants.

« L'étude DREAM a démontré l'efficacité de la stimulation bilatérale du nerf hypoglosse à l'aide de Genio pour le traitement de l'apnée obstructive du sommeil. Des améliorations cliniquement significatives des critères d'évaluation primaires et secondaires ont été observées », a déclaré B. Tucker Woodson, MD, Chef, Professeur – Medical College of Wisconsin et Investigateur principal de l'étude DREAM. « Genio a le potentiel de nous aider à faire progresser la thérapie de neuromodulation pour le traitement du SAOS. »
« L'obtention de réductions significatives de l'IAH, quelle que soit la position de sommeil, est une validation clinique de notre approche centrée sur le patient », a déclaré Olivier Taelman, CEO de Nyxoah. « La stimulation bilatérale Genio a également permis à plus de 80 % des patients d'atteindre 12 mois avec un IAH inférieur à 15, ce qui a eu un impact positif sur leur qualité de vie globale et a réduit la somnolence. Nyxoah entre maintenant dans la phase réglementaire finale et progresse vers l'approbation de la FDA. Il s'agira d'une étape importante dans notre mission qui consiste à mettre Genio à la disposition des patients souffrant d'AOS aux États–Unis. »

À propos de Nyxoah
Nyxoah réinvente le sommeil pour le milliard de personnes qui souffrent d'apnée obstructive du sommeil (AOS). Nous sommes une société de technologie médicale qui développe des alternatives de traitement révolutionnaires pour l'AOS grâce à la neuromodulation. Notre première innovation est Genio®, un dispositif de neuromodulation hypoglosse sans pile, inséré par une simple incision sous le menton et contrôlé par un dispositif portable. Grâce à notre engagement en faveur de l'innovation et des preuves cliniques, nous avons obtenu les meilleurs résultats de sa catégorie en matière de réduction du fardeau du SAOS.

Suite à l'achèvement réussi de l'étude BLAST OSA, le système Genio® a reçu son marquage CE européen en 2019. Nyxoah a réalisé deux introductions en bourse réussies : sur Euronext Bruxelles en septembre 2020 et sur le NASDAQ en juillet 2021. Suite aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu l'approbation du marquage CE pour l'élargissement de ses indications thérapeutiques aux patients atteints d'effondrement concentrique complet (CCC), actuellement contre–indiqués dans la thérapie des concurrents. En outre, la société a annoncé les résultats positifs de l'étude pivot DREAM IDE en vue de l'approbation de la FDA et de la commercialisation aux États–Unis.

Pour plus d'informations, veuillez consulter le rapport annuel de la société pour l'exercice 2023 et visiter le site http://www.nyxoah.com/.

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

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® et les études cliniques 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'utilité des données cliniques pour l'obtention éventuelle de l'approbation de la FDA pour le système Genio® ; la communication des données de l'essai pivot DREAM U. U. de Nyxoah ; la demande d'approbation de la FDA ; et l'entrée sur le marché américain. De par leur nature, les déclarations prospectives impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs susceptibles d'entraîner une différence matérielle entre les résultats ou événements réels et ceux exprimés ou sous–entendus dans les déclarations prospectives. 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 2023, déposé auprès de la Securities and Exchange Commission (” SEC ») le 20 mars 2024, 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
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com

Media
Etats–Unis
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

Belgique/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

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

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DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update

DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update

Additional clinical data on patients suffering from Obstructive Sleep Apnea (OSA) demonstrate a clinically significant 71.0% median reduction in Apnea–Hypopnea index (AHI) while sleeping supine
at 12 months compared with baseline.

82.0% of patients who completed a polysomnography at 12 months had an AHI below 15, and 67.4% of patients who completed a polysomnography at 12 months had an AHI below 10.

Mont–Saint–Guibert, Belgium – September 27, 2024, 10:30pm CET / 4:30pm 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, announced that data from the DREAM U.S. pivotal study were presented in an oral session at the International Surgical Sleep Society (ISSS) 2024 Educational Update, taking place from September 26 –27 in Miami, Florida.

Additional data were presented for AHI reduction in supine and non–supine positions. Genio bilateral stimulation resulted in a clinically meaningful 71.0% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12–month AHI reduction of 70.8% across all sleeping positions.

With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality–of–life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.

The presentation included previously announced data demonstrating that the study achieved its co–primary endpoints of 12–month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent–To–Treat (ITT) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001). Safety results were in line with other neuromodulation therapies, with 11 serious adverse events, or SAEs, in ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related, and there were three explants.

“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea. Clinically significant improvements in primary and secondary endpoints were observed,” said B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM study. “Genio has the potential of helping us advance neuromodulation therapy for the treatment of OSA.”

“Achieving meaningful AHI reductions regardless of sleep position is a clinical validation of our patient–centric approach,” said Olivier Taelman, CEO of Nyxoah. “Genio bilateral stimulation also enabled more than 80% of patients to hit 12 months with an AHI below 15, positively impacting their overall quality of life and reducing sleepiness. Nyxoah is now entering the final regulatory phase and is progressing toward FDA approval. This will be a huge milestone in our mission to make Genio available to OSA patients in the US.”

About Nyxoah

Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery–free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best–in–class outcomes for reducing OSA burden.

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 FDA and U.S. commercialization approval.

For more information, please see the Company’s annual report for the financial year 2023 and 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 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 utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com

For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

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

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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), September 27, 2024, 08:05 am CET / 2:05 am 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 5,907,711.21
  • Total number of securities carrying voting rights: 34,389,015 (all ordinary shares)
  • Total number of voting rights (= denominator): 34,389,015 (all relating to ordinary shares)
  • Number of rights to subscribe to securities carrying voting rights not yet issued: 2,040,231 (all granted subscription rights; this number excludes 643,394 subscription rights that were issued but not yet granted)

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Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com

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GLOBENEWSWIRE (Distribution ID 1000994258)

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 27 septembre 2024, 8:05 CET / 2:05h 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 5.907.711,21
  • Nombre total de titres avec droits de vote: 34.389.015 (tous des actions ordinaires)
  • Nombre total de droits de vote (= dénominateur): 34.389.015 (tous liés aux actions ordinaires)
  • Nombre de droits de souscrire à des titres avec droits de vote non encore émis: 2.040.231 (tous des droits de souscription octroyés; ce nombre exclut 643.394 droits de souscription émis mais pas encore octroyés)

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Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com

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Publication relative à des notifications de transparence

  

INFORMATION RÉGLEMENTÉE

Publication relative à des notifications de transparence

Mont–Saint–Guibert (Belgique), le 27 septembre 2024, 08:00h CET / 2:00h ET Conformément à l'article 14 de la loi du 2 mai 2007 relative à la publicité des participations importantes, Nyxoah SA (Euronext Brussels/Nasdaq : NYXH) annonce qu’elle a reçu une notification de transparence comme détaillé ci–dessous.

BlackRock, Inc.

Le 24 septembre 2024, Nyxoah a reçu une notification de transparence de BlackRock, Inc. et de personnes liées indiquant que BlackRock Advisors, LLC est passée en dessous du seuil de 3% en date du 20 septembre 2024. A cette date, BlackRock, Inc. (avec ses entreprises contrôlées) détenait 1.116.421 droits de vote, soit 1.043.221 actions et 73.200 instruments financiers assimilés, représentant 3,25% du nombre total des droits de vote en date du 20 septembre 2024 (34.373.015).

La notification datée du 23 septembre 2024 contient les informations suivantes :

  • Motif de la notification : acquisition ou cession de titres conférant le droit de vote ou de droits de vote
  • Notification par : une entreprise mère ou une personne détenant le contrôle
  • Personnes tenues à la notification :
    • BlackRock, Inc. (avec adresse à 50 Hudson Yards, New York, NY, 10001, Etats–Unis)
    • BlackRock Advisors, LLC (avec adresse à 50 Hudson Yards, New York, NY, 10001, Etats–Unis)
    • BlackRock Fund Advisors (avec adresse à 400 Howard Street, San Francisco, CA, 94105, Etats–Unis)
    • BlackRock Investment Management (UK) Limited (avec adresse à 12 Throgmorton Avenue, London, EC2N 2DL, Royaume–Uni)
    • BlackRock Investment Management, LLC (avec adresse à 1 University Square Drive, Princeton, NJ, 8540, Etats–Unis)
  • Date du dépassement de seuil : le 20 septembre 2024
  • Seuil franchi : 3%
  • Dénominateur : 34.373.015
  • Détails de la notification :
A) Droits de vote Notification précédente Après la transaction
  # droits de vote # droits de vote % de droits de vote
Détenteurs de droits de vote   Attachés à des titres Non liés à des titres Attachés à des titres Non liés à des titres
BlackRock, Inc. 0 0   0,00%  
BlackRock Advisors, LLC 1.071.561 1.016.861   2,96%  
BlackRock Fund Advisors 46 46   0,00%  
BlackRock Investment Management (UK) Limited 1.080 1.080   0,00%  
BlackRock Investment Management, LLC 25.242 25.234   0,07%  
Sous–total 1.097.929 1.043.221   3,03%  
  TOTAL 1.043.221 0 3,03% 0,00%

B) Instruments financiers assimilés Après la transaction
Détenteurs d’instruments financiers assimilés Type d’instrument financier Date d’échéance Date ou délai d’exercice ou de conversion # droits de vote pouvant être acquis en cas d’exercice de l’instrument % de droits de vote Règlement
BlackRock Advisors, LLC Prêt d’actions     72.300 0,21% physique
BlackRock Fund Advisors Prêt d’actions     900 0,00% physique
  TOTAL     73.200 0,21%  

  TOTAL (A & B) # droits de vote % de droits de vote  
        1.116.421 3,25%  
  • Chaine des entreprises contrôlées par l'intermédiaire desquelles la participation est effectivement détenue :

BlackRock, Inc.
Trident Merger, LLC
BlackRock Investment Management, LLC

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock International Holdings, Inc.
BR Jersey International Holdings L.P.
BlackRock Holdco 3, LLC
BlackRock Cayman 1 LP
BlackRock Cayman West Bay Finco Limited
BlackRock Cayman West Bay IV Limited
BlackRock Group Limited
BlackRock Finance Europe Limited
BlackRock Investment Management (UK) Limited

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Holdco 4, LLC
BlackRock Holdco 6, LLC
BlackRock Delaware Holdings Inc.
BlackRock Fund Advisors

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Capital Holdings, Inc.
BlackRock Advisors, LLC

  • Information supplémentaire : L'obligation d'information est née du fait que les droits de vote attachés aux actions de BlackRock Advisors, LLC ont passés en dessous de 3%.

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Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com

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Publication relating to transparency notifications

               

REGULATED INFORMATION

Publication relating to transparency notifications

Mont–Saint–Guibert (Belgium), September 27, 2024, 8.00am CET / 2.00am ET In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below.

BlackRock, Inc.

On September 24, 2024, Nyxoah received a transparency notification from BlackRock, Inc. and related persons indicating that BlackRock Advisors, LLC went below the 3% threshold on September 20, 2024. As of such date, BlackRock, Inc. (together with its controlled undertakings) held 1,116,421 voting rights, consisting of 1,043,221 shares and 73,200 equivalent financial instruments, representing 3.25% of the total number of voting rights on September 20, 2024 (34,373,015).

The notification dated September 23, 2024 contains the following information:

  • Reason for the notification: acquisition or disposal of voting securities or voting rights
  • Notification by: a parent undertaking or a controlling person
  • Persons subject to the notification requirement:
    • BlackRock, Inc. (with address at 50 Hudson Yards, New York, NY, 10001, U.S.A.)
    • BlackRock Advisors, LLC (with address at 50 Hudson Yards, New York, NY, 10001, U.S.A.)
    • BlackRock Fund Advisors (with address at 400 Howard Street, San Francisco, CA, 94105, U.S.A.)
    • BlackRock Investment Management (UK) Limited (with address at 12 Throgmorton Avenue, London, EC2N 2DL, U.K.)
    • BlackRock Investment Management, LLC (with address at 1 University Square Drive, Princeton, NJ, 8540, U.S.A.)
  • Date on which the threshold was crossed: September 20, 2024
  • Threshold that is crossed: 3%
  • Denominator: 34,373,015
  • Notified details:
A) Voting rights Previous notification After the transaction
  # of voting rights # of voting rights % of voting rights
Holders of voting rights   Linked to securities Not linked to the securities Linked to securities Not linked to the securities
BlackRock, Inc. 0 0   0.00%  
BlackRock Advisors, LLC 1,071,561 1,016,861   2.96%  
BlackRock Fund Advisors 46 46   0.00%  
BlackRock Investment Management (UK) Limited 1,080 1,080   0.00%  
BlackRock Investment Management, LLC 25,242 25,234   0.07%  
Subtotal 1,097,929 1,043,221   3.03%  
  TOTAL 1,043,221 0 3.03% 0.00%

B) Equivalent financial instruments After the transaction
Holders of equivalent financial instruments Type of financial instrument Expiration date Exercise period or date # of voting rights that may be acquired if the instrument is exercised % of voting rights Settlement
BlackRock Advisors, LLC Securities Lent     72,300 0.21% physical
BlackRock Fund Advisors Securities Lent     900 0.00% physical
  TOTAL     73,200 0.21%  

  TOTAL (A & B) # of voting rights % of voting rights  
        1,116,421 3.25%  
  • Full chain of controlled undertakings through which the holding is effectively held:

BlackRock, Inc.
Trident Merger, LLC
BlackRock Investment Management, LLC

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock International Holdings, Inc.
BR Jersey International Holdings L.P.
BlackRock Holdco 3, LLC
BlackRock Cayman 1 LP
BlackRock Cayman West Bay Finco Limited
BlackRock Cayman West Bay IV Limited
BlackRock Group Limited
BlackRock Finance Europe Limited
BlackRock Investment Management (UK) Limited

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Holdco 4, LLC
BlackRock Holdco 6, LLC
BlackRock Delaware Holdings Inc.
BlackRock Fund Advisors

BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Capital Holdings, Inc.
BlackRock Advisors, LLC

  • Additional information: The disclosure obligation arose due to voting rights attached to shares for BlackRock Advisors, LLC going below 3%.

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Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com

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GLOBENEWSWIRE (Distribution ID 1000994257)

Bitdeer Completes Testing of its Latest SEAL02 Bitcoin Mining Chip

SINGAPORE, Sept. 26, 2024 (GLOBE NEWSWIRE) — Bitdeer Technologies Group (NASDAQ: BTDR) (“Bitdeer” or the “Company”), a world–leading technology company for blockchain and high–performance computing, today announced the successful testing of its latest Bitcoin mining chip, SEAL02, following tape–out.

SEAL02 uses one of the most advanced process nodes in partnership with TSMC, a world–leading semiconductor foundry. An exceptional power efficiency ratio of 13.5 J/TH – while running at low voltage, ultra power–saving mode – was indicated in SEAL02 chip’s verification and prototype tests, achieving the power efficiency milestone outlined in the SEALMINER technology roadmap announced in June 2024.

Linghui Kong, Chief Business Officer of Bitdeer, commented, “We are thrilled about achieving SEALMINER’s power efficiency target as reflected in our roadmap. Our ongoing commitment to R&D is making possible innovative and superior solutions that will set new benchmarks for efficiency and transparency to benefit the wider mining ecosystem.”

SEAL02 will be integrated into the Company’s upcoming SEALMINER A2 mining machines, with mass production scheduled to commence in November 2024.

Additionally, R&D work on the Company’s upcoming chip, SEAL03, is ongoing and the Company’s product release milestone is on track.

Bitdeer has a full–fledged team of professional engineers dedicated to R&D across key domains, including ASIC design, algorithm development, platform architecture, software and hardware. The Company will continue to work alongside its customers in contributing to the security of the Bitcoin decentralized network.

About Bitdeer Technologies Group

Bitdeer is a world–leading technology company for blockchain and high–performance computing. Bitdeer is committed to providing comprehensive computing solutions for its customers. The Company handles complex processes involved in computing such as equipment procurement, transport logistics, datacenter design and construction, equipment management, and daily operations. The Company also offers advanced cloud capabilities to customers with high demand for artificial intelligence. Headquartered in Singapore, Bitdeer has deployed datacenters in the United States, Norway, and Bhutan. To learn more, visit https://www.bitdeer.com/ or follow Bitdeer on X @ BitdeerOfficial and LinkedIn @ Bitdeer Group.

Investors and others should note that Bitdeer may announce material information using its website and/or on its accounts on social media platforms, including X, formerly known as Twitter, Facebook, and LinkedIn. Therefore, Bitdeer encourages investors and others to review the information it posts on the social media and other communication channels listed on its website.

Forward–Looking Statements

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward–looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “look forward to,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward–looking statements, although not all forward–looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward–looking statements as a result of various important factors, including factors discussed in the section entitled “Risk Factors” in Bitdeer’s annual report on Form 20–F, as well as discussions of potential risks, uncertainties, and other important factors in Bitdeer’s subsequent filings with the U.S. Securities and Exchange Commission. Any forward–looking statements contained in this press release speak only as of the date hereof. Bitdeer specifically disclaims any obligation to update any forward–looking statement, whether due to new information, future events, or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Contact:

Public Relations
Wachsman
Bee Shin
bitdeer@wachsman.com


GLOBENEWSWIRE (Distribution ID 9237034)

Montana Technologies Establishes International Office in the United Arab Emirates

RONAN, Mont., Sept. 25, 2024 (GLOBE NEWSWIRE) — Montana Technologies Corporation (NASDAQ: AIRJ) (“Montana Technologies” or the “Company”), the developer of the transformational AirJoule® technology for atmospheric water generation, today announced that it has established its first international office in the United Arab Emirates (“UAE”) to accelerate the deployment of AirJoule® in the region.

“Establishing an office in the UAE will help us to efficiently address the significant demand for AirJoule®’s advanced dehumidification and atmospheric water harvesting capabilities from potential customers in the fast–growing markets of the UAE, the Gulf Cooperation Council countries, and India. Our UAE presence also bolsters the Company’s efforts to strategically calibrate the rollout of our transformative technology globally,” said Ramdas Rao, President, International of Montana Technologies who heads this new office.

“AirJoule®’s market–leading efficiency when delivering distributed water security and power–efficient comfort cooling is our key differentiator and has the potential to support responsible decarbonization while supporting this region’s rapid development trajectory and critical infrastructure growth. The UAE government leadership is very proactive in attracting and supporting the growth of cutting–edge technologies that enable sustainable development. We look forward to working closely with our local and strategic partners and using the UAE as a hub to fine–tune our international go–to–market strategies, thereby further catalyzing sustainable development for communities here and around the world,” Mr. Rao added.

Montana Technologies previously announced the signing of a Memorandum of Understanding with TenX Investment in Energy Enterprises & Management Co. LLC to address water security and energy efficiency opportunities in the UAE.

Pat Eilers, Executive Chairman of Montana Technologies, said, “UAE’s Vision 2030 places a strong emphasis on water security as one of the critical aspects of its sustainable development goals. The deployment of AirJoule®’s industry–leading capabilities for water harvesting is expected to meaningfully contribute to efforts by the UAE government and corporations to strengthen water security. We are excited to be expanding our presence in the country and bolstering our global reach with the establishment of our international office.”

In conjunction with establishing its international office, Montana Technologies will showcase AirJoule® at the WETEX conference in Dubai on October 1–3. Organized by the Dubai Electricity and Water Authority, WETEX provides a platform to display technological advancements in energy, water and natural resources in support of Dubai’s vision to build a sustainable future. The Company encourages WETEX attendees to visit its exhibition booth (Booth #7–F2) to see a demonstration AirJoule® unit and to meet the Company’s senior executives. 

As the most advanced dehumidification and water harvesting technology in the market, AirJoule® can harvest water directly from the air to mitigate water scarcity. AirJoule® can also be paired with vapor compression refrigeration systems to reduce power consumption for air conditioning by up to 75%.

About Montana Technologies Corporation

Montana Technologies Corporation (NASDAQ: AIRJ) is the developer of AirJoule®, an atmospheric thermal energy and water harvesting technology that provides efficient and sustainable air dehumidification and pure water from air. Designed to reduce energy consumption and generate material cost efficiencies, AirJoule® is being commercialized through a joint venture with GE Vernova and through partnerships with Carrier Global Corporation and BASF. For more information, visit www.mt.energy.

Forward–Looking Statements

The information in this press release includes “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. All statements, other than statements of present or historical fact included in this press release are forward–looking statements. These forward–looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Readers are cautioned not to put undue reliance on forward–looking statements, and the Company assumes no obligation and, except as required by law, does not intend to update or revise these forward–looking statements, whether as a result of new information, future events or otherwise.

Contacts

Montana Technologies Corporation
Tom Divine – Vice President, Investor Relations and Finance
investors@mt.energy


GLOBENEWSWIRE (Distribution ID 9236360)

Entera Bio and OPKO Health Provide Update on PK/PD Results of Oral Oxyntomodulin (GLP-1/Glucagon) Peptide Tablet Candidate for Obesity and Metabolic Disorders

JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long–acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N–Tab™ technology. The program is focused on developing the first oral dual agonist GLP–1/glucagon peptide as a potential once–daily treatment for patients with obesity, metabolic and fibrotic disorders. OXM is a naturally occurring peptide hormone found in the small intestine that acts to suppress appetite and induce weight loss.

Entera and OPKO have completed in vivo proof–of–concept PK/PD studies in rodent and pig models. The studies’ objectives were met with oral OXM exhibiting significant systemic exposure following a single dose in both models. Furthermore, a favorable PK profile and bioavailability were shown with oral OXM. In the pig model, oral OXM achieved high plasma concentrations with prolonged systemic exposure, which is consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog.

To assess the pharmacologic effect of oral OXM, a glucose tolerance test was performed in rats. Oral OXM showed a statistically significant reduction in plasma glucose levels post–glucose administration compared with placebo. Entera and OPKO plan to present these data at an upcoming clinical conference.

“We are very pleased with the progress we are making in our collaboration with OPKO. These bioavailability and pharmacological data support continuing toward IND–enabling efforts for the program,” said Miranda Toledano, Entera Chief Executive Officer.

OPKO previously reported that weekly injections of pegylated OXM demonstrated significant weight loss and reduction in HbA1, triglyceride and cholesterol levels in 113 obese and diabetic patients in a Phase 2B study. The OXM agonist peptide has since been modified to maintain its long–acting profile while increasing its potential potency. Currently, there are no approved OXM agonists available, and those in development by others are small molecules or require subcutaneous injections.

About Entera Bio

Entera is a clinical–stage company focused on developing oral peptide or 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 a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), 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 (BMD) endpoints. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH (1–34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP–1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry–leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release 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 press release 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 and OPKO’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 or OPKO 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 our product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera and OPKO’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; 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 and OPKO’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s and OPKO’s most recent Annual Report on Form 10–K filed with the SEC, as well as the companies’ 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward–looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and Entera and OPKO undertake 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.


GLOBENEWSWIRE (Distribution ID 9236250)

Zoom introduces new advanced enterprise offerings to boost efficiency, reliability, security, and compliance for enterprise organizations

SAN JOSE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) — Today, Zoom announced several new add–on products and functionalities to further strengthen its advanced enterprise offerings portfolio for the Zoom platform. Zoom advanced enterprise offerings consist of a comprehensive portfolio of Zoom products and features that help organizations meet their compliance, security, privacy, survivability, and manageability requirements.

“Zoom’s advanced enterprise offerings reflect our commitment to empowering businesses and providing them with offerings that enable them to be more efficient, secure, compliant, and reliable,” said Smita Hashim, chief product officer, Zoom. “Our advanced enterprise products and features are essential tools built for Zoom Workplace and Zoom Business Services like Zoom Events and Zoom Contact Center that work behind the scenes as part of the Zoom network infrastructure to provide exceptional experiences to our customers. Our goal is to make communication and collaboration on Zoom foolproof, future–proof, and fail–proof.”

New offerings for enterprise customers

In 2023 alone, over $549 million in non–compliance penalties were issued globally, more than 353 million individuals were impacted by security breaches, and 31 percent of enterprises experienced unstable network or bandwidth constraints. Companies face urgent pressures to manage often complex compliance obligations, avoid hefty fines, safeguard their reputations against security threats, and prevent user dissatisfaction stemming from unreliable connectivity. Zoom’s newest additions to its advanced enterprise offerings are poised to help companies overcome these challenges.

  • Zoom Compliance Manager Plus: Launched in March and powered by Theta Lake, Zoom Compliance Manager (ZCM) is an all–in–one offering that provides archiving, eDiscovery, legal hold, and information protection offerings for enterprises. Zoom Compliance Manager Plus enhances ZCM with advanced features such as risk detection, data loss protection, and advanced trends analysis. These enhanced capabilities will further help organizations fulfill regulatory obligations and mitigate organizational communications compliance risks.
  • Zoom Meeting Survivability: Introduces a new level of network redundancy and enables business continuity, helping to ensure uninterrupted Zoom meeting service even during internet disruption due to outages from a storm, natural disaster, or carrier failure. Utilizing Zoom Node, a central hub for hosting Zoom workloads on premises, this functionality keeps meetings running smoothly via a failover to data centers where meetings are hosted on your local servers with minimal disruption to the end users.
  • Zoom Mesh for Meetings: With Zoom Mesh, companies can optimize bandwidth usage and save up to 60 percent on internet bandwidth and associated costs. Already available for Zoom Webinars and Zoom Events, this capability now extends to Zoom Meetings for an exceptional user experience regardless of bandwidth constraints.
  • Zoom Customer Managed Key (CMK) Hybrid: CMK Hybrid enhances Zoom’s current CMK data privacy offering by providing customers with more options to manage the encryption keys used to protect data maintained by Zoom. CMK Hybrid allows customers to control the entire encryption/decryption process on premises. Zoom Team Chat messages, for example, can be encrypted locally by the Zoom Workplace app (some Zoom cloud–based Team Chat functionalities will not be available as a result). Zoom CMK Hybrid will be available for Zoom Workplace starting with the support of Zoom Team Chat in Q4 2024.

An enterprise–grade offerings portfolio designed to meet organizations’ needs

The new advanced enterprise products and features introduced today bolster the existing robust portfolio of Zoom’s enterprise offerings, which are specifically designed to address the complex needs of large organizations and those in regulated industries such as finance, healthcare, and government agencies. These offerings are included with Zoom Workplace Enterprise licenses, help improve business continuity, optimize bandwidth, enhance security, simplify manageability, and support communications compliance. The advanced enterprise offerings are organized across six key categories:

  • Communications compliance: Archiving, Data Loss Prevention, Information Barrier, and Chat Etiquette solutions help address communications compliance requirements for regulated industries worldwide.
  • Data residency & privacy compliance: Tools to help meet local and regional customer data residency and privacy compliance requirements such as Customer Managed Key.
  • Policy & deployment management: Zoom Device Management, policy provisioning, and deployment tools to help ease implementation and support.
  • Security & access control: Encryption and virtual desktop infrastructure (VDI) offerings to provide enhanced security protection for data at rest and in transit.
  • Analytics & insights: A robust set of dashboards, monitoring, reporting, and alerting tools to improve overall operational visibility.
  • Network optimization & survivability: Zoom Mesh, Zoom Node, and Zoom survivability solutions help reduce bandwidth, optimize performance, and improve business continuity.

Several Zoom advanced enterprise offerings including end–to–end encryption, GDPR and privacy controls, management dashboards, and other capabilities are already available with Zoom Workplace Enterprise licenses while other features, including these new products, are available as paid add–ons. For more information on Zoom’s advanced enterprise offerings, please visit the Zoom advanced enterprise website. Zoom will also host technical sessions on its enterprise offerings at Zoomtopia 2024 for those interested in learning more.

About Zoom
Zoom’s mission is to provide one platform that delivers limitless human connection. Reimagine teamwork with Zoom Workplace — Zoom’s open collaboration platform with AI Companion that empowers teams to be more productive. Together with Zoom Workplace, Zoom’s Business Services for sales, marketing, and customer care 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.

Zoom Public Relations
Travis Isaman
press@zoom.us


GLOBENEWSWIRE (Distribution ID 9235289)