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NeOnc Technologies Holdings, Inc. Executive Chairman, Amir Heshmatpour, Assumes Expanded Leadership Role as Company’s New President

CALABASAS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI), a clinical–stage biopharmaceutical company focused on innovative treatments for central nervous system (CNS) cancers and disorders, today announced that Executive Chairman Amir Heshmatpour has been appointed to serve as President of the Company. Heshmatpour will retain his role as Executive Chairman, while taking on day–to–day leadership responsibilities to accelerate the Company’s strategic and clinical initiatives.

“Amir’s appointment as President reflects our commitment to strong, visionary leadership as NeOnc advances its clinical programs,” said Dr. Thomas Chen, CEO of NeOnc. “His extensive experience in building and scaling companies, coupled with his deep understanding of capital markets and business development, will be instrumental as we move forward.”

Heshmatpour brings over 25 years of senior executive and board–level experience in business development, operations, finance, and M&A. He is the founder, chairman, and managing director of AFH Holdings & Advisory, where he has led IPO transactions totaling over $1.5 billion, and private funding and M&A transactions exceeding $5 billion in aggregate value.

Previously, Heshmatpour served as Chairman and CEO of Metrophone Telecommunications, which he founded in 1994. Under his leadership, Metrophone completed 17 acquisitions and grew annual revenues to over $100 million during a decade of sustained expansion. He has served on the board of the UCLA Anderson School of Management for more than 12 years, and is a board member of the Make–A–Wish Foundation for the Central Coast and Southern Central Valley of California.

“I’m honored to step into the role of President at such a pivotal time in NeOnc’s evolution. By formalizing my day–to–day oversight of Company operations, we’re enabling Dr. Chen to focus fully on driving our clinical trials forward, with a specific emphasis on patient enrollment for our lead drug candidates — NEO212, our TMZ bio–conjugate, and NEO100,” said Heshmatpour. “With our promising drug candidates advancing through clinical development, I’m confident in our ability to deliver significant value to patients, providers, and shareholders alike.”

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

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

Important Cautions Regarding Forward Looking Statements
All statements other than statements of historical facts included in this press release are “forward–looking statements” (as defined in the Private Securities Litigation Reform Act of 1995). Generally, such forward–looking statements include statements regarding expectations, possible or assumed future actions, business strategies, events or results of operations, including statements regarding expectations or predictions or future financial or business performance or conditions and those statements that use forward–looking words such as “projected,” “expect,” “possibility” and “anticipate,” or similar expressions. The achievement or success of the matters covered by such forward–looking statements involve significant risks, uncertainties, and assumptions. Actual results could differ materially from current projections or implied results. The Company cautions that statements and assumptions made in this news release constitute forward–looking statements and make no guarantee of future performance. Forward–looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward–looking statements following the date of this news release, whether because of new information, future events or otherwise, except as required by law.

“NEO100” is a registered trademark of NeOnc Technologies Holdings, Inc.

Company Contact:
Patrick Walters
Chief Operations Officer
NeOnc Technologies Holdings, Inc.
[email protected]

Investor Relations:
Roger Pondel / Laurie Berman
PondelWilkinson Inc.
(310) 279–5980
[email protected]/[email protected]


GLOBENEWSWIRE (Distribution ID 9419859)

Nyxoah Provides Update on FDA Approvable Letter for Genio System

Nyxoah Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full PMA approval in the second quarter

Mont–Saint–Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system.

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre–Market Approval (PMA) application for the Genio® system.

The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system.

Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.

“We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.”

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 United States
FINN Partners – Alyssa Paldo
[email protected]

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

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

Attachment


GLOBENEWSWIRE (Distribution ID 1001078888)

Nyxoah Présente une Mise à Jour Concernant la Lettre d'Approuvabilité de la FDA pour le Système Genio

Nyxoah Présente une Mise à Jour Concernant la Lettre d'Approuvabilité de la FDA pour le Système Genio
Prévoit de satisfaire aux exigences finales de la FDA pour obtenir l'approbation PMA complète au cours du deuxième trimestre

Mont–Saint–Guibert, Belgique – 8 avril 2025, 07h00 CET / 01h00 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques innovantes pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a annoncé aujourd'hui une mise à jour sur le processus d'approbation du système Genio par la FDA.

Le 26 mars 2025, la Société a annoncé que la Food and Drug Administration (FDA) des États–Unis avait émis une lettre d'approuvabilité (“Approvable Letter) concernant la demande d'approbation préalable à la mise sur le marché (PMA) de la Société pour le système Genio®.

La lettre d'approuvabilité (“Approvable Letter) signifie que la demande de Nyxoah pour la commercialisation du dispositif aux États–Unis répond en grande partie aux exigences de la loi fédérale sur les aliments, les médicaments et les cosmétiques (Federal Food, Drug and Cosmetic Act) et aux règlements d'application de la PMA de la FDA codifiés à la section 814 du 21 C.F.R., et que la FDA approuvera la demande sous réserve de l'achèvement satisfaisant d'un examen des installations de fabrication, des méthodes et des contrôles. La FDA a accepté toutes les autres données fournies avec la demande de PMA, y compris et surtout l'étude clinique qui démontre la sécurité et l'efficacité du système Genio®.

Nyxoah s'occupe activement d'un point restant avant que l'approbation de la FDA ne soit éventuellement accordée, à savoir la validation d'un processus utilisé avec un composant du système Genio sur son site de fabrication aux États–Unis. La Société est convaincue qu'elle sera en mesure de mener à bien cette validation à court terme. Ainsi, Nyxoah prévoit que sa demande pourrait être approuvée au cours du deuxième trimestre et prévoit de fournir une mise à jour sur le processus d'examen lors de sa conférence téléphonique sur les résultats du premier trimestre 2025, qui aura lieu en mai.

“Nous sommes heureux d'annoncer que la lettre d'approuvabilité de la FDA confirme que nous sommes très proches de l'approbation PMA,” a commenté Olivier Taelman, Chief Executive Officer de Nyxoah. “Nous pensons que la dernière étape restante est l'achèvement de la validation d’un processus sur notre site de production aux États–Unis – une mesure prise en réponse à la dernière série de questions spécifiques de validation envoyées par la FDA – que nous sommes convaincus de pouvoir traiter rapidement et avec succès. Nous sommes impatients de lancer Genio aux États–Unis dès que nous aurons reçu l'approbation de la FDA.”

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 visions de Nyxoah est que les patients souffrant de SAOS doivent pouvoir profiter de nuits réparatrices et vivre pleinement leur vie.

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

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

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

Déclarations Prospectives

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

Contacts :

Nyxoah
John Landry, CFO
[email protected]

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

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

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

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1001078888)

Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates

JERUSALEM, March 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, today reported financial results and key business achievements for the year ended December 31, 2024.

 “2024 was a truly transformational year for Entera. We delivered key data read–outs and advanced each of our oral peptide PTH(1–34), GLP1/Glucagon and GLP2 tablet programs, significantly increased our stockholder value, and efficiently strengthened our balance sheet. To our core team with whom I started this journey in late 2022 as a board member, and to our rapidly expanding ecosystem of premier global advisors, I thank you for your commitment and dedication. To our existing and new shareholders, we are grateful for your belief and support of our thesis. To our collaborators, especially, the formidable team at OPKO Health, Inc., we are grateful for your partnership and the opportunity to expand our N–Tab™ platform to additional high value peptides,” said Miranda Toledano, Chief Executive Officer of Entera.

 “To our potential patient base for whom we are developing EB613: the majority of the estimated 200 million women with osteoporosis who wish to preserve their bone health, who remain underserved with current treatments and who have not been able to access a new therapy since 2019, our dedication to you is firm and unwavering. Osteoporosis is one of the foremost underserved health issues globally which disproportionally afflicts women. Most women experience menopause between the ages of 45 and 55 years. One in three women over age 50 will develop osteoporosis, and one in two of those women will develop an osteoporosis–related fracture. The morbidity and mortality risk of osteoporosis fractures to women outpaces that of breast cancer, stroke and heart attack combined. Nevertheless, most patients remain untreated. Furthermore, existing regulatory guidelines requiring fracture outcomes have curtailed innovation in this significant disease due to ethical, time and sizing of studies required to evaluate new treatments. The SABRE (Study to Advance Bone Mineral Density as a Regulatory Endpoint), based on a statistical meta–analysis of over 170,000 patients across 53 randomized clinical studies and 7 osteoporosis drug classes correlating total hip BMD to fracture outcomes, is undergoing review at FDA. This is analogous to prior initiatives that qualified LDL cholesterol as a surrogate marker for CV outcomes and HBA1C as a surrogate for the risk of future diabetes complications, both of which enabled the advancement of many important new therapies for those conditions. We look forward to potential updates from FDA and SABRE on this important ruling and to potentially initiating our pivotal Phase 3 study of EB613 promptly thereafter. Our EB613, the first oral PTH(1–34) peptide treatment candidate is being developed to close the treatment gap in osteoporosis with a validated anabolic mechanism of action in tablet form. We plan to continue our mission to add value to Entera in 2025, with humility and a focus on execution,” said Miranda Toledano, Chief Executive Officer of Entera.

2024 Key Achievements:

EB613: First Oral PTH(1–34), teriparatide Anabolic Tablet Treatment Candidate for Women with Osteoporosis

  • In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment–related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months 
  • In April 2024, Entera announced that the Journal of Bone and Mineral Research (JBMR) published EB613 placebo controlled Phase 2 Trial results, highlighting its dual mechanism of action and rapid increases in BMD at trabecular and cortical skeletal sites
  • In June 2024, an independent editorial was published by the JBMR “A Novel Oral PTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”
  • In September 2024, Entera presented new comparative pharmacological data for EB613 vs. Forteo® at the ASBMR September 2024 Annual Meeting in Toronto. The abstract was previewed by Dr. Serge Ferrari of Geneva University Hospital in Switzerland in his sneak–peak highlights of cutting–edge clinical abstracts on osteoporosis therapy at ASBMR2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity

  • In September 2024, Entera and OPKO Health jointly announced topline pharmacokinetic/pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program
  • 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 and metabolic disorders combining OPKO’s proprietary long–acting oxyntomodulin analog (OPK–88006) and Entera’s proprietary N–Tab™ platform
  • Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half–life for semaglutide (Rybelsus®), the only approved oral GLP–1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo
  • In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro–rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • During 2024, Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents. Oral GLP–2 tablets exhibited significant systemic exposure. Furthermore, plasma levels achieved with the oral tablet form of the GLP–2 analogue were about 10–fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex®)
  • The pharmacokinetic analysis of the data obtained following the IV injections of the GLP–2 peptide showed the plasma half–life in rats to be about six times longer than the half–life reported for teduglutide in the same animal model. This data is consistent with previously reported PK data relating to OPKO’s GLP–2 peptide’s long–acting profile, which had initially been developed as a weekly subcutaneous injection
  • Given the challenging compliance rates attributed to injectable GLP–2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets Candidate for Hypoparathyroidism

  • In June 2024, Entera presented Phase 1 clinical data for EB612, which is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for patients with hypoparathyroidism, at the Endocrine Society ENDO 2024 Annual Meeting. This Phase 1 data supports potentially moving the BID tablet dose to Phase 2 development in patients with hypoparathyroidism
  • Entera continues to collaborate productively with a third party on the oral tablet development of another PTH replacement treatment for hypoparathyroidism

Financial Results for the Year Ended December 31, 2024

As of December 31, 2024, Entera had cash and cash equivalents of $8.7 million. As of March 28, 2025, Entera had cash and cash equivalents of $21 million, largely attributable to at–market direct investments from existing and new institutional shareholders and our partner, OPKO. The cash is expected to be sufficient to fund our operations into the third quarter of 2026, including ongoing work related to the planned EB613 phase 3 study, regulatory expenses, research and development, patent prosecution, the completion of an additional Phase 1 PK study related to our new generation platform and our share of projected oral GLP1/Glucagon tablet Phase 1 study expenses in collaboration with OPKO.

  • Research and development expenses for the years ended December 31, 2024 and December 31, 2023 were each $4.5 million. There was a decrease of $0.8 million related to the completion of the first cohorts of a Phase 1 PK study, which occurred in 2023. The decrease was offset by an increase of $0.8 million in 2024 related to optimization related to the preparation of the EB613 phase 3 study
  • General and administrative expenses for the year ended December 31, 2024 were $5.1 million, compared to $4.4 million for the year ended December 31, 2023. The increase of $0.7 million was mainly attributable to expanding our intellectual property position and advisor compensation. The increase was partially offset by a decrease of $0.2 million in D&O insurance costs and other costs
  • Operating expenses for the year ended December 31, 2024 were $9.6 million, as compared to $8.9 million for the year ended December 31, 2023

Net loss was $9.5 million, or $0.25 per ordinary share (basic and diluted), for the year ended December 31, 2024, as compared to 8.9 million, or $0.31 per ordinary share (basic and diluted), for the year ended December 31, 2023.

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 its pipeline includes five differentiated, 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)), 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 pursuant to the FDA’s qualification of a quantitative BMD 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)
       
  December 31,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 8,660   11,019
Accounts receivable and other current assets 312   238
Property and equipment, net 57   100
Other assets, net 361   408
Total assets 9,390   11,765
     
     
Accounts payable and other current liabilities 1,176   1,091
Total non–current liabilities 134   288
Total liabilities 1,310   1,379
Total shareholders' equity 8,080   10,386
       
Total liabilities and shareholders' equity 9,390   11,765

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
  Year Ended
December 31,
  2024   2023
REVENUES 181   –
COST OF REVENUES 172   –
GROSS PROFIT 9   –
OPERATING EXPENSES:    
Research and development 4,499   4,510
General and administrative 5,095   4,430
Other income –   (49)
TOTAL OPERATING EXPENSES 9,594   8,891
OPERATING LOSS 9,585   8,891
FINANCIAL INCOME, NET (58)   (31)
INCOME TAX 14   29
NET LOSS 9,541   8,889
     
LOSS PER SHARE BASIC AND DILUTED 0.25   0.31
WEIGHTED AVERAGE NUMBER OF SHARES      
OUTSTANDING USED IN COMPUTATION OF      
BASIC AND DILUTED LOSS PER SHARE  37,650,179    29,007,794 


GLOBENEWSWIRE (Distribution ID 9412734)

Lantronix lance le nouveau System on module Open-Q 8550CS conçu pour répondre aux besoins de l’IA en périphérie du réseau

IRVINE, Californie, 28 mars 2025 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ : LTRX), un leader mondial du calcul et de la connectivité pour les solutions d’IdO intégrant l’intelligence en périphérie du réseau (AI Edge), a annoncé aujourd’hui l’arrivée de son nouveau System on module (SOM) Open–Q™ 8550CS. Alimenté par le processeur Qualcomm Dragonwing™ QCS8550, ce module prêt à la production offre des capacités d’intelligence artificielle (IA) et d’apprentissage automatique (ML) sur appareil et à faible consommation d’énergie, simplifiant ainsi la conception et permettant aux développeurs de mettre plus rapidement sur le marché des produits de périphérie innovants.

L’Open–Q 8550 de Lantronix est spécialement conçu pour répondre aux exigences d’IA / d’apprentissage automatique plus strictes de l’informatique en périphérie, y compris les applications vidéo et d’IA avancées, telles que la collaboration vidéo, le transcodage vidéo, les applications de caméra et l’intégration avec les passerelles d’IA en périphérie de réseau. Comme toutes les technologies informatiques intégrées de Lantronix, cette plateforme offre une solution complète unique comprenant du matériel, des logiciels, une gestion des périphériques et des services, ce qui permet aux clients de mettre plus rapidement leurs produits sur le marché. C’est une plateforme idéale pour le développement de produits d’IA en périphérie de réseau industriels, notamment des drones, des contrôleurs, des outils de robotique et des appareils portables industriels pour divers secteurs, dont l’entreposage intelligent, la fabrication, le transport, la logistique et la vente au détail.

« La collaboration stratégique de Qualcomm Technologies avec Lantronix, qui perdure depuis 15 ans, soutient notre objectif commun de fournir des solutions intégrées et collaboratives afin d’accroître le succès des technologies d’IdO, d’IA en périphérie de réseau et d’IA / apprentissage automatique pour faciliter le développement d’applications de pointe », a déclaré Suri Maddhula, vice–président de la gestion des produits pour les solutions d’IdO chez Qualcomm Technologies Inc.

« Avec l’appui de Qualcomm Technologies, Lantronix favorise l’innovation dans le domaine de l’IA en périphérie de réseau, permettant ainsi aux développeurs de tirer pleinement parti de l’informatique embarquée et de l’IdO pour mettre au point des solutions industrielles de pointe. Ensemble, nous faisons de l’impossible une réalité », a déclaré Mathi Gurusamy, directeur de la stratégie chez Lantronix.

Le SOM Open–Q8550CS haute performance répond aux exigences d’IA / d’apprentissage automatique de l’informatique en périphérie de réseau

Le SOM Open–Q 8550CS est doté d’un moteur d’IA sur l’appareil offrant des performances de premier ordre et répondant aux exigences plus élevées en matière d’IA / d’apprentissage automatique pour l’informatique en périphérie extrême, y compris pour les appareils en périphérie, les serveurs en périphérie et les boîtiers d’IA en périphérie.

Les principales caractéristiques sont les suivantes :

  • Faible consommation d’énergie grâce à un procédé 4 nm
  • Processeur Kryo à 8 cœurs jusqu’à 3,2 GHz et GPU Adreno A740
  • Double eNPU fournissant 48 TOPs INT8 et 12 TOPs FP16
  • Les fonctions de sécurité comprennent l’architecture Trusted Management Engine, l’hyperviseur, l’unité de traitement sécurisée et le chiffrement DDR
  • Connectivité de niveau entreprise avec Wi–Fi 7 MU–MIMO prenant en charge jusqu’à 5,8 Go/s
  • Meilleure performance de sa catégorie pour le traitement de données informatique, la photo, l’IA, la sécurité et l’audio.
  • Jusqu’à 8 Go de RAM LPDDR5 + 128 Go de mémoire Flash UFS
  • Android™ 13 et Linux Yocto Kirkstone
  • Moteur de vision par ordinateur dédié
  • Plusieurs ports MIPI pour caméras et écrans
  • Plusieurs options de connectivité à haut débit
  • Prise en charge de Qualcomm Sensing Hub 3.0

Voici quelques–uns de ses avantages :

  • Amélioration des expériences de visioconférence, de la trajectoire des véhicules à guidage automatique, de la qualité des images des caméras intelligentes et de l’évolutivité des boîtiers d’IA en périphérie de réseau grâce à son processeur à huit cœurs et à ses performances de tenseur de 48 TOPS ;
  • Réalisation de tâches complexes de synthèse 3D et de vision par ordinateur grâce à un puissant GPU Adreno 740 capable de prendre en charge le lancer de rayons, les profils Open GL ES, Vulkan et Open CL, le décodage vidéo 4K240/8K60 et l’encodage 4K120/8K30 ; et
  • Connexion aux boîtiers d’IA en périphérie de réseau grâce à des ports Ethernet 2,5 Go et 10 Go à haut débit.

Le kit de développement Open–Q 8550 permet d’accélérer le développement et de réduire le délai de mise sur le marché

Le kit de développement du SOM Open–Q 8550CS de Lantronix est la solution idéale pour évaluer le module SOM Open–Q 8550CS. Il est conçu pour faciliter l’évaluation des principales caractéristiques du SOM, telles que le sous–système d’IA basse consommation avec un DSP dédié et un accélérateur d’IA prenant en charge l’audio en continu, les capteurs, les flux de données contextuelles et la caméra en continu.

Le kit permet d’évaluer les caméras C–PHY et D–PHY MIPI CSI et GMSL, la double interface MIPI DSI, le DisplayPort, l’audio, les capteurs, le GNSS, le Gigabit Ethernet et de nombreuses autres fonctionnalités. Il est fourni avec le SOM Open–Q™ 8550CS de Lantronix, une carte porteuse ouverte exposant toutes les E/S disponibles, et avec un ensemble d’accessoires permettant d’accélérer le développement produit.

Solutions conformes aux normes TAA et NDAA

Les solutions de développement Open–Q de Lantronix sont conformes aux normes TAA et NDAA, ce qui garantit une pérennité d’au moins 10 ans grâce à des nomenclatures strictes et à un contrôle qualité rigoureux. Avec plus de 20 ans d’expertise et plus de 1 200 projets matériels et logiciels menés à bien, Lantronix s’impose comme une référence en matière de fiabilité et d’innovation.

Services d’ingénierie de Lantronix

Les services d’ingénierie de Lantronix offrent une assistance au développement de produits clés en main pour ses plateformes Open–Q et ses kits de développement. Grâce à une expertise reconnue ayant contribué au développement de plus de 1 500 produits performants, notre équipe est spécialiste du développement et de l’optimisation des caméras, du contrôle vocal, de l’apprentissage automatique, de la conception mécanique et RF, ainsi que de l’optimisation thermique et énergétique. En proposant des solutions rentables, nous permettons aux développeurs de mettre plus rapidement leurs produits sur le marché, tout en alliant innovation et efficacité.

À propos de Lantronix

Lantronix Inc. est un leader mondial des solutions IoT de calcul et de connectivité destinées aux secteurs à forte croissance, notamment l’urbanisme intelligent, les entreprises et les transports. Les produits et services de Lantronix permettent aux entreprises de se démarquer sur les marchés de l’IoT en plein essor en proposant des solutions personnalisables qui exploitent l’intelligence artificielle en périphérie (AI Edge Intelligence). Les solutions de pointe développées par Lantronix comprennent une infrastructure de sous–stations intelligentes, des systèmes d’infodivertissement et de surveillance vidéo, mais également une administration hors bande (OOB) avancée adaptée au cloud et à l’informatique en périphérie.

Pour en savoir plus, rendez–vous sur le site Internet de Lantronix.

Contact médias :
Gail Kathryn Miller
Responsable du marketing et de la
communication
[email protected]

Contact analystes et investisseurs de Lantronix :
[email protected]

© 2025 Lantronix, Inc. Tous droits réservés. Lantronix est une marque déposée. Les autres marques et noms commerciaux appartiennent à leurs détenteurs respectifs.

Les produits de la marque Qualcomm sont des produits de Qualcomm Technologies, Inc. et/ou de ses filiales. Qualcomm, Kryo, Adreno et Qualcomm Dragonwing sont des marques commerciales ou des marques déposées de Qualcomm Incorporated.

Une photo accompagnant le présent communiqué est disponible à l’adresse suivante : https://www.globenewswire.com/NewsRoom/AttachmentNg/208b6cd7–8503–4deb–97d2–5953513dde52


GLOBENEWSWIRE (Distribution ID 9412579)

Lantronix bringt neues Open-Q 8550CS System-On-Module auf den Markt, das die Anforderungen von Edge-KI-Computing optimal erfüllt

IRVINE, Kalifornien, March 28, 2025 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), ein weltweit führender Anbieter von Rechen– und Konnektivitätslösungen für das Internet der Dinge (IoT), der Edge–KI–Intelligence ermöglicht, kündigte heute sein neues Open–Q™ 8550CS System–on–Module (SOM) an. Dieses serienreife Modul mit dem Qualcomm Dragonwing™ QCS8550–Prozessor bietet stromsparende On–Device–Funktionen für künstliche Intelligenz (KI) und maschinelles Lernen (ML), die das Design vereinfachen und es Entwicklern ermöglichen, innovative Edge–Produkte schneller auf den Markt zu bringen.

Der Open–Q 8550 von Lantronix wurde speziell für die höheren KI/ML–Anforderungen des Extreme Edge Computing entwickelt, einschließlich fortschrittlicher Video– und KI–Anwendungen wie Video–Collaboration, Video–Transcoding, Kameraanwendungen und Integration mit Edge–KI–Gateways. Wie alle integrierten Computertechnologien von Lantronix bietet auch diese Plattform eine Komplettlösung aus Hardware, Software, Gerätemanagement und Dienstleistungen, die Kunden eine schnellere Markteinführung ermöglicht. Sie ist die ideale Plattform für die Entwicklung industrieller Edge–KI–Produkte, einschließlich Drohnen, Steuerungen, Robotik und tragbarer Industriegeräte für eine Vielzahl von Branchen, darunter intelligente Lagerhaltung, Fertigung, Transport, Logistik und Einzelhandel.

„Die 15–jährige strategische Zusammenarbeit von Qualcomm Technologies mit Lantronix unterstützt unser gemeinsames Ziel, integrierte und kooperative Lösungen bereitzustellen, um den Erfolg von IoT–, Edge–KI– und KI/ML–Technologien zu steigern und die Entwicklung fortschrittlicher Anwendungen voranzutreiben“, so Suri Maddhula, Vice President of IoT Solutions Product Management bei Qualcomm Technologies Inc.

„Mit der Unterstützung von Qualcomm Technologies treibt Lantronix die nahtlose KI–Innovation am Edge voran und ermöglicht es Entwicklern, Embedded Computing und IoT für hochmoderne, industrietaugliche Lösungen zu nutzen. Gemeinsam machen wir das Unmögliche möglich“, erklärt Mathi Gurusamy, Chief Strategy Officer bei Lantronix.

Leistungsstarkes Open–Q 8550CS SOM erfüllt KI/ML–Anforderungen für Edge Computing

Das Open–Q 8550CS SOM verfügt über eine „On–Device“ KI–Engine mit erstklassiger Leistung und unterstützt die höheren KI/ML–Anforderungen für extremes Edge–Computing, einschließlich Edge–Geräte, Edge–Server und Edge–KI–Boxen.

Die Hauptmerkmale sind:

  • Niedriger Energieverbrauch durch 4nm–Prozess
  • Kryo Octa–Core CPU mit bis zu 3,2 GHz und Adreno A740 GPU
  • Dual eNPU mit 48 INT8, 12 FP16 TOPs
  • Zu den Sicherheitsfunktionen gehören Trusted Management Engine, Hypervisor, Secure Processing Unit und DDR–Verschlüsselung
  • Konnektivität der Enterprise–Klasse mit Wi–Fi 7 MU–MIMO, das bis zu 5,8 Gbit/s unterstützt
  • Erstklassige Leistung in den Bereichen Compute Processing, Kamera, KI, Sicherheit und Audio.
  • Bis zu 8GB LPDDR5 RAM + 128GB UFS Flash
  • Android™ 13 und Linux Yocto Kirkstone
  • Dedizierte Computer Vision Engine
  • Mehrere MIPI–Kamera– und Display–Anschlüsse
  • Mehrere Hochgeschwindigkeits–Konnektivitätsoptionen
  • Unterstützung von Qualcomm Sensing Hub 3.0

Zu den Vorteilen gehören:

  • Verbesserte Videokonferenz–Meetings, automatisierte Routenführung, intelligente Kamerabildqualität und Skalierbarkeit der Edge–KI–Box mit Octal–Core–Rechenleistung und 48 AI TOPS Tensor–Leistung;
  • Durchführung komplexer 3D–Rendering– und Computer–Vision–Aufgaben mit einem leistungsstarken Adreno 740–Grafikprozessor, der Raytracing, Open GL ES–, Vulkan– und Open CL–Profile sowie 4K240/8K60–Videodekodierung und 4K120/8K30–Kodierung unterstützt; und
  • Anschluss von Edge–KI–Boxen über Hochgeschwindigkeits–2,5G– und 10G– Ethernet–Anschlüsse.

Open–Q 8550 Dev Kit beschleunigt die Entwicklung und verkürzt die Markteinführungszeit

Das Open–Q 8550CS SOM Development Kit von Lantronix ist ein idealer Ausgangspunkt für die Evaluierung des Open–Q 8550CS SOM. Es wurde entwickelt, um eine einfache Evaluierung der Hauptfunktionen des SOMs zu ermöglichen, wie z.B. das stromsparende AI–Subsystem mit dediziertem DSP und AI–Beschleuniger, das Always–on–Audio, Sensoren, kontextbezogene Datenströme und eine Always–on–Kamera unterstützt.

Das Kit unterstützt die Evaluierung von C–PHY und D–PHY MIPI CSI und GMSL Kameras, Dual MIPI DSI, DisplayPort, Audio, Sensoren, GNSS, Gigabit Ethernet und vieles mehr. Es wird mit dem Open–Q™ 8550CS SOM von Lantronix geliefert, einem Open–Frame–Trägerboard, das alle verfügbaren I/Os offenlegt, sowie einer Reihe von Zubehör für eine schnelle Produktentwicklung.

TAA– und NDAA–konforme Lösungen

Die Open–Q–Entwicklungslösungen von Lantronix sind TAA– und NDAA–konform und garantieren eine Lebensdauer von mindestens 10 Jahren mit strikten Materiallisten und strengen Qualitätskontrollen. Mit über 20 Jahren Erfahrung hat Lantronix mehr als 1.200 Hardware– und Software–Projekte erfolgreich durchgeführt und dabei den Standard für Zuverlässigkeit und Innovation gesetzt.

Lantronix Engineering Services

Lantronix Engineering Services bietet schlüsselfertigen Produktentwicklungssupport für seine Open–Q–Plattformen und Entwicklungskits. Unser Entwicklungsteam verfügt über unübertroffenes technisches Know–how, das für mehr als 1.500 erfolgreiche Produkte verantwortlich ist, und hat sich auf die Entwicklung und das Tuning von Kameras, Sprachsteuerung, maschinelles Lernen, mechanisches und HF–Design sowie die Optimierung von Wärme– und Stromversorgung spezialisiert. Mit kosteneffizienten Lösungen beschleunigen wir die Time–to–Market für Entwickler und stellen sicher, dass Innovation und Effizienz Hand in Hand gehen.

Über Lantronix

Lantronix Inc. ist ein weltweit führender Anbieter von IoT–Lösungen für Rechenleistung und Konnektivität, die auf wachstumsstarke Märkte wie Smart Cities, Unternehmen und Transportwesen abzielen. Die Produkte und Dienstleistungen von Lantronix ermöglichen es Unternehmen, auf den wachsenden IoT–Märkten erfolgreich zu sein, indem sie anpassbare Lösungen bereitstellen, die KI–Edge–Intelligenz ermöglichen. Zu den fortschrittlichen Lösungen von Lantronix gehören die Infrastruktur für intelligente Umspannwerke, Infotainmentsysteme und Videoüberwachung, ergänzt durch fortschrittliches Out–of–Band–Management (OOB) für Cloud– und Edge–Computing.

Weitere Informationen finden Sie auf der Website von Lantronix.

Medienkontakt bei Lantronix:
Gail Kathryn Miller
Corporate Marketing &
Communications Manager
[email protected]

Kontakt für Analysten und Anleger bei Lantronix:        
[email protected]

©2025 Lantronix, Inc. Alle Rechte vorbehalten. Lantronix ist eine eingetragene Marke. Andere Marken und Markennamen sind Eigentum der jeweiligen Inhaber.

Produkte mit der Marke Qualcomm sind Produkte der Qualcomm Technologies, Inc. und/oder ihren Tochtergesellschaften. Qualcomm, Kryo, Adreno und Qualcomm Dragonwing sind Marken oder eingetragene Marken von Qualcomm Incorporated.

Ein Foto zu dieser Pressemitteilung finden Sie unter https://www.globenewswire.com/NewsRoom/AttachmentNg/208b6cd7–8503–4deb–97d2–5953513dde52


GLOBENEWSWIRE (Distribution ID 9412579)

Lantronix Lança Novo System-On-Module Open-Q 8550CS Projetado para Atender às Necessidades de Edge AI Computing

IRVINE, Califórnia, March 27, 2025 (GLOBE NEWSWIRE) — A Lantronix Inc.(NASDAQ: LTRX), líder global de computação e conectividade para soluções de IoT que habilitam Edge AI Intelligence, anunciou hoje o lançamento do seu novo System–on–Module (SOM) Open–Q™ 8550CS. Alimentado pelo processador Qualcomm Dragonwing™ QCS8550, este módulo pronto para produção fornece recursos de Inteligência Artificial (IA) e Aprendizado de Máquinas (AM) de baixo consumo de energia e no dispositivo, simplificando o design e capacitando os desenvolvedores a levar mais rapidamente produtos inovadores de ponta para o mercado.

O Open–Q 8550 da Lantronix foi projetado exclusivamente para atender aos mais altos requisitos de IA/ML da computação Edge extrema, incluindo aplicativos avançados de vídeo e IA, como colaboração de vídeo, transcodificação de vídeo, aplicativos de câmera e integração com gateways Edge AI. Como toda a tecnologia de computação incorporada da Lantronix, esta plataforma fornece exclusivamente uma solução completa composta por hardware, software, Gerenciamento de Dispositivos e Serviços, permitindo que os clientes cheguem ao mercado mais rapidamente. É uma plataforma ideal para o desenvolvimento de produtos industriais Edge AI, incluindo drones, controladores, robótica e dispositivos portáteis industriais para uma variedade de indústrias, incluindo armazenamento inteligente, fabricação, transporte, logística e varejo.

“A colaboração estratégica de 15 anos da Qualcomm Technologies com a Lantronix apoia nosso objetivo mútuo de fornecer soluções integradas e colaborativas para elevar o sucesso das tecnologias de IoT, Edge AI e IA/ML para impulsionar o desenvolvimento de aplicativos de ponta”, disse Suri Maddhula, vice–presidente de Gerenciamento de Produtos de Soluções de IoT da Qualcomm Technologies Inc.

“Com o apoio da Qualcomm Technologies, a Lantronix está impulsionando a inovação contínua da IA no Edge, capacitando os desenvolvedores a aproveitar a computação incorporada e a IoT para soluções de ponta de nível industrial. Juntos, estamos transformando o impossível em realidade”, disse Mathi Gurusamy, diretor de estratégia da Lantronix.

O SOM Open–Q 8550CS de Alto Desempenho Atende aos Requisitos de IA/ML de Edge Computing

O SOM Open–Q 8550CS apresenta um mecanismo de IA no dispositivo com desempenho premium, com suporte para os mais altos requisitos de IA/ML para computação Edge extrema, incluindo dispositivos Edge, servidores Edge e caixas Edge AI.

Principais características incluem:

  • Baixo consumo de energia com um processo de 4nm
  • CPU Octa–core Kryo de até 3,2 GHz e GPU Adreno A740
  • Dupla eNPU fornecendo 48 INT8, 12 FP16 TOPs
  • Os recursos de segurança incluem Mecanismo de Gerenciamento Confiável, Hipervisor, Unidade de Processamento Seguro e criptografia DDR
  • Conectividade de nível empresarial com Wi–Fi 7 MU–MIMO com suporte para até 5,8 Gbps
  • O melhor desempenho da categoria em processamento de computação, câmera, IA, segurança e áudio.
  • Até 8 GB de RAM LPDDR5 + 128 GB de Flash UFS
  • Android™ 13 e Linux Yocto Kirkstone
  • Mecanismo de Visão de Computador Dedicado
  • Várias câmeras MIPI e portas de exibição
  • Várias opções de conectividade de alta velocidade
  • Suporte para Qualcomm Sensing Hub 3.0

Benefícios incluem a capacidade de:

  • Aprimorar experiências de reuniões de videoconferência, caminho automatizado do veículo guiado, qualidade de imagem da câmera inteligente e escalabilidade da caixa Edge AI com seus recursos de computação de núcleo octal e desempenho de tensor 48 AI TOPS;
  • Executar tarefas complexas de renderização 3D e visão computacional com uma poderosa GPU Adreno 740 com suporte para ray tracing, perfis Open GL ES, Vulkan e Open CL e decodificação de vídeo 4K240/8K60 e codificação 4K120/8K30; e
  • Conexão de caixas Edge AI aproveitando portas Ethernet de alta velocidade de 2,5G e 10G.

O kit de Desenvolvimento Open–Q 8550 Acelera o Desenvolvimento, Reduz o Tempo de Colocação no Mercado

Fornecendo um ponto de partida ideal para avaliar o SOM Open–Q 8550CS, o Kit de Desenvolvimento SOM Open–Q 8550CS da Lantronix foi projetado para facilitar a avaliação fácil dos principais recursos do SOM, como o subsistema de IA de baixa potência com um DSP dedicado e acelerador de IA com suporte para áudio sempre ligado, sensores, fluxos de dados contextuais e uma câmera sempre ligada.

Kit com suporte para avaliação de câmeras C–PHY e D–PHY MIPI CSI e GMSL, dual MIPI DSI, DisplayPort, áudio, sensores, GNSS, Gigabit Ethernet e muitos outros recursos. Ele vem com o SOM Open–Q™ 8550CS da Lantronix, uma placa transportadora de estrutura aberta que expõe toda a E/S disponível e uma gama de acessórios para o desenvolvimento rápido de produtos.

Soluções em Conformidade com TAA e NDAA

As soluções de desenvolvimento Lantronix Open–Q são compatíveis com TAA e NDAA, garantindo pelo menos 10 anos de longevidade com rigoroso Bill–of–Materials e rigoroso controle de qualidade. Com mais de 20 anos de experiência, a Lantronix entregou com sucesso mais de 1.200 projetos de hardware e software, definindo o padrão de confiabilidade e inovação.

Lantronix Engineering Services

A Lantronix Engineering Services oferece suporte completo ao desenvolvimento de produtos para suas plataformas Open–Q e kits de desenvolvimento. Com o apoio de uma experiência de engenharia incomparável por trás de mais de 1.500 produtos de sucesso, nossa equipe de desenvolvimento é especializada no desenvolvimento e ajuste de câmeras, controle de voz, aprendizado de máquina, design mecânico e de RF, bem como otimização térmica e de energia. Com soluções econômicas, aceleramos os cronogramas de entrada dos desenvolvedores no mercado, garantindo que a inovação atinja a eficiência.

Sobre a Lantronix

A Lantronix Inc. é líder global de soluções de IoT de computação e conectividade que visam mercados de alto crescimento, incluindo Smart Cities, Enterprise e Transportation. Os produtos e serviços da Lantronix capacitam as empresas a alcançar o sucesso nos mercados de IoT em crescimento, fornecendo soluções personalizáveis que capacitam AI Edge Intelligence. As soluções avançadas da Lantronix incluem infraestrutura de Subestações Inteligentes, sistemas de Infotainment e Vigilância por Vídeo, complementados com o avançado Out–of–Band Management (OOB) para Cloud e Edge Computing.

Para mais informação, visite Site da Lantronix.

Contato de Mídia da Lantronix:
Gail Kathryn Miller
Gerente de Marketing e
Comunicações Corporativas
[email protected]

Contato para Analista e Investidor da Lantronix:        
[email protected]

©2025 Lantronix, Inc. Todos os direitos reservados. Lantronix é uma marca comercial registrada. Todas as outras marcas comerciais são de propriedade de seus respectivos proprietários.

Produtos Qualcomm são produtos da Qualcomm Technologies, Inc. e/ou de suas subsidiárias. Qualcomm, Kryo, Adreno e Qualcomm Dragonwing são marcas comerciais ou marcas comerciais registradas da Qualcomm Incorporated.

Foto deste comunicado disponível em https://www.globenewswire.com/NewsRoom/AttachmentNg/208b6cd7–8503–4deb–97d2–5953513dde52


GLOBENEWSWIRE (Distribution ID 9412579)

Lantronix Launches New Open-Q 8550CS System-On-Module Designed to Meet the Needs of Edge AI Computing

IRVINE, Calif., March 27, 2025 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global leader of compute and connectivity for IoT solutions enabling Edge AI Intelligence, today announced its new Open–Q™ 8550CS System–on–Module (SOM). Powered by the Qualcomm Dragonwing™ QCS8550 processor, this production–ready module provides low–power, on–device Artificial Intelligence (AI) and Machine Learning (ML) capabilities, simplifying design and empowering developers to more quickly bring innovative edge products to market.

Lantronix’s Open–Q 8550 is uniquely designed to meet the higher AI/ML requirements of extreme Edge computing, including advanced video and AI applications such as video collaboration, video transcoding, camera applications and integration with Edge AI gateways. Like all Lantronix’s embedded compute technology, this platform uniquely provides a complete solution comprised of hardware, software, Device Management and Services, enabling customers to get to market faster. It is an ideal platform for the development of industrial Edge AI products, including drones, controllers, robotics and industrial handheld devices for a variety of industries, including smart warehousing, manufacturing, transportation, logistics and retail.

“Qualcomm Technologies’ 15–year strategic collaboration with Lantronix supports our mutual goal of delivering integrated, collaborative solutions to elevate the success of IoT, Edge AI and AI/ML technologies to drive the development of advanced–edge applications,” said Suri Maddhula, vice president of IoT Solutions Product Management at Qualcomm Technologies Inc.

“With the support of Qualcomm Technologies, Lantronix is driving seamless AI innovation at the Edge, empowering developers to harness embedded computing and IoT for cutting–edge, industrial–grade solutions. Together, we're transforming the impossible into reality,” said Mathi Gurusamy, chief strategy officer at Lantronix.

High–Performance Open–Q 8550CS SOM Meets AI/ML Requirements for Edge Computing

The Open–Q 8550CS SOM features an on–device AI engine with premium performance, supporting the higher AI/ML requirements for extreme Edge computing, including Edge devices, Edge servers and Edge AI boxes.

Key features include:

  • Low power consumption with a 4nm process
  • Kryo Octa–core CPU up to 3.2 GHz and Adreno A740 GPU
  • Dual eNPU delivering 48 INT8, 12 FP16 TOPs
  • Security features include Trusted Management Engine, Hypervisor, Secure Processing Unit, and DDR encryption
  • Enterprise–level connectivity with Wi–Fi 7 MU–MIMO supporting up to 5.8Gbps
  • Best–in–class performance across compute processing, camera, AI, security and audio.
  • Up to 8GB LPDDR5 RAM + 128GB UFS Flash
  • Android™ 13 and Linux Yocto Kirkstone
  • Dedicated Computer Vision Engine
  • Multiple MIPI camera and display ports
  • Multiple high speed connectivity options
  • Support for Qualcomm Sensing Hub 3.0

Benefits include the ability to:

  • Enhance video conferencing meeting experiences, automated guided vehicle pathing, smart camera image quality and Edge AI box scalability with its octal–core computing capabilities and 48 AI TOPS tensor performance;
  • Perform complex 3D rendering and computer vision tasks with a powerful Adreno 740 GPU supporting ray tracing, Open GL ES, Vulkan and Open CL profiles and 4K240/8K60 video decoding and 4K120/8K30 encoding; and
  • Connect Edge AI boxes leveraging high–speed 2.5G and 10G Ethernet ports.

Open–Q 8550 Dev Kit Speeds Development, Reduces Time–to–Market

Providing an ideal starting point for evaluating the Open–Q 8550CS SOM, Lantronix’s Open–Q 8550CS SOM Development Kit is designed to facilitate easy evaluation of the SOM’s key features, such as the low–power AI subsystem with a dedicated DSP and AI accelerator supporting always–on audio, sensors, contextual data streams and an always–on camera.

The kit supports the evaluation of C–PHY and D–PHY MIPI CSI and GMSL cameras, dual MIPI DSI, DisplayPort, audio, sensors, GNSS, Gigabit Ethernet and many more features. It comes with Lantronix’s Open–Q™ 8550CS SOM, an open–frame carrier board exposing all the available I/O, and a range of accessories to fast–track product development.

TAA and NDAA Compliant Solutions

Lantronix Open–Q development solutions are TAA and NDAA compliant, ensuring at least 10 years of longevity with strict Bill–of–Materials and rigorous quality control. Backed by more than 20 years of expertise, Lantronix has successfully delivered more than 1,200 hardware and software projects, setting the standard for reliability and innovation.

Lantronix Engineering Services

Lantronix Engineering Services delivers turn–key product development support for its Open–Q platforms and development kits. Backed by unparalleled engineering expertise behind 1,500+ successful products, our development team specializes in camera development and tuning, voice control, machine learning, mechanical and RF design, as well as thermal and power optimization. With cost–effective solutions, we accelerate developers' go–to–market timelines, ensuring innovation meets efficiency.

About Lantronix

Lantronix Inc. is a global leader of compute and connectivity IoT solutions that target high–growth markets, including Smart Cities, Enterprise and Transportation. Lantronix’s products and services empower companies to succeed in the growing IoT markets by delivering customizable solutions that enable AI Edge Intelligence. Lantronix’s advanced solutions include Intelligent Substations infrastructure, Infotainment systems and Video Surveillance, supplemented with advanced Out–of–Band Management (OOB) for Cloud and Edge Computing.

For more information, visit the Lantronix website.

Lantronix Media Contact:
Gail Kathryn Miller
Corporate Marketing &
Communications Manager
[email protected]

Lantronix Analyst and Investor Contact:        
[email protected]

©2025 Lantronix, Inc. All rights reserved. Lantronix is a registered trademark. Other trademarks and trade names are those of their respective owners.

Qualcomm–branded products are products of Qualcomm Technologies, Inc. and/or its subsidiaries. Qualcomm, Kryo, Adreno and Qualcomm Dragonwing are trademarks or registered trademarks of Qualcomm Incorporated.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/208b6cd7–8503–4deb–97d2–5953513dde52


GLOBENEWSWIRE (Distribution ID 9411811)

La FDA Délivre à Nyxoah une Lettre d'Approuvabilité pour son système Genio®

 

INFORMATIONS PRIVILÉGIÉES
INFORMATIONS RÉGLEMENTÉES

La FDA Délivre à Nyxoah une Lettre d'Approuvabilité pour son Système Genio®

Mont–Saint–Guibert, Belgique – 26 mars 2025, 8h00 CET / 3h00 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques innovantes 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 émis une lettre d'approuvabilité (Approvable Letter) concernant la demande d'autorisation préalable à la mise sur le marché (PMA) de la société pour le système Genio®.

La lettre d'approuvabilité (Approvable Letter) signifie que la demande de Nyxoah pour la commercialisation du dispositif aux États–Unis répond en grande partie aux exigences de la loi fédérale sur les aliments, les médicaments et les cosmétiques (Federal Food, Drug and Cosmetic Act) et aux règlements d'application de la PMA de la FDA codifiés à la section 814 du 21 C.F.R., et que la FDA approuvera la demande sous réserve de l'achèvement satisfaisant d'un examen des installations de fabrication, des méthodes et des contrôles. La Société travaillera en étroite collaboration avec la FDA pour répondre à ces demandes et s'engage à mettre cette thérapie innovante à la disposition des patients américains.

“La FDA a examiné notre demande et a déterminé qu'elle répondait en grande partie aux exigences d'approbation : la lettre d'approuvabilité de la FDA ne comportait aucune autre question sur les données cliniques ou la biocompatibilité qui soutiennent la demande,” a commenté Olivier Taelman, CEO de Nyxoah. “Nous sommes toujours sur la bonne voie pour mettre Genio à la disposition des patients américains souffrant de SAOS.”

Cette décision n'a pas d'impact sur le marquage CE de Genio ni sur les activités commerciales en cours en Europe, où le dispositif est approuvé pour les patients souffrant de collapsus concentrique complet (CCC) et pour ceux qui n'en souffrent pas.

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 visions 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 en ce qui concerne le développement, la voie réglementaire et l'utilisation potentielle du système Genio® ; l'utilité des données cliniques dans l'obtention potentielle de l'approbation de la FDA pour le système Genio® ; l'achèvement satisfaisant d'un examen des installations de fabrication, des méthodes et des contrôles et l'obtention de l'approbation de la FDA ; l'entrée sur le marché américain ; et les attentes actuelles des administrateurs ou de la direction de la Société concernant le système Genio® ; les résultats d'exploitation, la situation financière, les liquidités, les performances, les perspectives, la croissance et les stratégies de la Société. De par leur nature, les déclarations prévisionnelles impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou les événements réels diffèrent matériellement de ceux exprimés ou sous–entendus dans les déclarations prévisionnelles. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence négative sur les résultats et les effets financiers des plans et des événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la Société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2024, déposé auprès de la Securities and Exchange Commission (« SEC ») le 20 mars 2025, et des rapports ultérieurs que la Société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent de manière significative de tout développement anticipé. Les déclarations prospectives contenues dans le présent communiqué de presse concernant des tendances ou des activités passées ne constituent pas des garanties de performances futures et ne doivent pas être considérées comme une déclaration selon laquelle ces tendances ou activités se poursuivront à l'avenir.

En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements peuvent ne pas être représentatifs des résultats ou développements des périodes futures. Aucune déclaration ou garantie n'est donnée quant à l'exactitude ou à la justesse de ces déclarations prospectives. En conséquence, la société décline expressément toute obligation ou tout engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement des attentes ou d'un changement des événements, conditions, hypothèses ou circonstances sur lesquels ces déclarations prospectives sont basées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni les dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans ce communiqué de presse ou quant à la survenance effective des développements prévus. Vous ne devriez pas accorder une confiance excessive aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contacts :

Nyxoah
John Landry, CFO
[email protected]

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

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

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

 

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GLOBENEWSWIRE (Distribution ID 1001076080)

FDA Issues Nyxoah an Approvable Letter for its Genio® System

INSIDE INFORMATION
REGULATED INFORMATION

FDA Issues Nyxoah an Approvable Letter for its Genio® System

Mont–Saint–Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am 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 U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre–Market Approval (PMA) application for the Genio® system.

The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.

“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are still on the right track to make Genio available to U.S. patients suffering from OSA.”

This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non–CCC patients.

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; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; 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
nyxoah@mc–services.eu

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

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GLOBENEWSWIRE (Distribution ID 1001076080)