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Nyxoah to Participate in Upcoming Investor Conferences

Nyxoah to Participate in Upcoming Investor Conferences

Mont–Saint–Guibert, Belgium – September 5, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will participate in three upcoming investor conferences in New York City.

Olivier Taelman, Nyxoah’s Chief Executive Officer, will deliver corporate updates at the Baird Global Healthcare Conference on Tuesday, September 10, 2024, at 12:15pm ET, the H.C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11, 2024, at 11:00am ET and the Cantor Global Healthcare Conference on Wednesday, September 18, 2024 at 1:55pm ET. Webcasts of the presentations will be available on the Events section of Nyxoah’s Investor Relations website. The Company will also be available for 1×1 meetings with institutional investors attending the events.

Nyxoah’s Investor Presentation can be accessed on the Shareholder Information section of the Company’s Investor Relations page.

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. 

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 entry into of the loan facility agreement and the synthetic warrant agreement with the EIB; the use of proceeds from the loan facility agreement; 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
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

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

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GLOBENEWSWIRE (Distribution ID 1000990281)

Lantronix Announces 2024 SmartEdge Channel Partner Program Award Winners

IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global leader of compute and connectivity IoT solutions, today announced the winners of its 2024 SmartEdge™ Partner Program Awards, highlighting its top channel partners in North America; Asia Pacific; and Europe, Middle East and Africa.

“This year’s SmartEdge Partner Program winners are driving worldwide sales and developing relationships with our mutual customers, contributing to Lantronix’s position as a global compute and connect leader that is enabling edge intelligence with award–winning solutions for AI, Embedded, IoT and IT applications,” said Kurt Hoff, VP of Worldwide Sales at Lantronix. “We applaud their efforts and look forward to many more years of continued mutual success.”

Lantronix’s 2024 SmartEdge award winners are:

North America
SmartEdge Partner of the Year: TD Synnex
SmartEdge Innovation Partner: WWT
SmartEdge Software & Services Partner: Charter

Asia Pacific (APAC)
SmartEdge Partner of the Year: Nexty
SmartEdge Innovation Partner: Shanghai Scopecon Technology Co., Ltd.
SmartEdge Software & Services Partner: Sheeltron Digital Pvt. Ltd.
SmartEdge Newcomer: EDOM

Europe/Middle East/Africa (EMEA)
SmartEdge Partner of the Year: Atlantik Elektronik GmbH
SmartEdge Innovation Partner: Linkwave
SmartEdge Software & Services Partner: SOL
SmartEdge Newcomer: Netsecurity

For over two decades Lantronix has been providing its channel partners with a suite of reliable, secure and easy–to–deploy solutions, including out–of–band management, switches, system of modules (SoM) and trackers. As a global leader, Lantronix helps its customers increase productivity, all while supported by the exceptional Lantronix service team. Lantronix’s channel partners serve as an important part of the Lantronix customer support ecosystem.

“Winning the Lantronix SmartEdge channel partner award signifies our exceptional success as a valued channel partner for the EMEA region, bringing advanced solutions to leading organizations throughout the world,” stated Albert Windmeisser, line manager at Atlantik Elektronik GmbH.

“We are honored to win the prestigious SmartEdge award from Lantronix, a global leader in technology,” stated Steven Chaung, senior director at EDOM Technology Co Ltd. “Validating our position as one of Lantronix’s top channel partners in the APAC region, we are grateful to partner with Lantronix in bringing its innovative, award–winning solutions to the world’s leading organizations.”

“We are very proud to win Lantronix’s SmartEdge award, which acknowledges our success as a top channel partner for North America,” stated Ryan Abel, chief revenue officer at Charter Communications. “We are pleased to bring Lantronix’s exceptional AI, Embedded, IoT and IT solutions to the world.”

Lantronix’s SmartEdge Partner Program is designed to help Value–Added Resellers (VARs) and Systems Integrators (SIs) drive revenues by differentiating their offerings with Lantronix’s innovative Industrial Internet of Things (IoT), Out–of–Band Management (OOBM) and Mobility/Connectivity solutions.

For more information on the Lantronix SmartEdge Partner Program, visit https://www.lantronix.com/partners/.

About Lantronix

Lantronix Inc. is a global leader of compute and connectivity IoT solutions that target high–growth industries including Smart Cities, Automotive and Enterprise. Lantronix’s products and services empower companies to succeed in the growing IoT markets by delivering customizable solutions that address each layer of the IoT Stack. Lantronix’s leading–edge 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.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward–looking statements within the meaning of federal securities laws, including without limitation statements related to the 2024 SmartEdge Channel Partner Program, including statements about their reliability, security and flexibility industry position. These forward–looking statements are based on our current expectations and are subject to substantial risks and uncertainties that could cause our actual results, future business, financial condition, or performance to differ materially from our historical results or those expressed or implied in any forward–looking statement contained in this news release. The potential risks and uncertainties include, but are not limited to, such factors as the effects of negative or worsening regional and worldwide economic conditions or market instability on our business, including effects on purchasing decisions by our customers; our ability to mitigate any disruption in our and our suppliers’ and vendors’ supply chains due to the COVID–19 pandemic or other outbreaks, wars and recent tensions in Europe, Asia and the Middle East, or other factors; future responses to and effects of public health crises; cybersecurity risks; changes in applicable U.S. and foreign government laws, regulations, and tariffs; our ability to successfully implement our acquisitions strategy or integrate acquired companies; difficulties and costs of protecting patents and other proprietary rights; the level of our indebtedness, our ability to service our indebtedness and the restrictions in our debt agreements; and any additional factors included in our Annual Report on Form 10–K for the fiscal year ended June 30, 2023, filed with the Securities and Exchange Commission (the “SEC”) on Sept. 12, 2023, including in the section entitled “Risk Factors” in Item 1A of Part I of such report; in our Quarterly Report on Form 10–Q for the fiscal quarter ended March 31, 2024, filed with the SEC on May 2, 2024, including in the section entitled “Risk Factors” in Item 1A of Part II of such report; as well as in our other public filings with the SEC. Additional risk factors may be identified from time to time in our future filings. The forward–looking statements included in this release speak only as of the date hereof, and we do not undertake any obligation to update these forward–looking statements to reflect subsequent events or circumstances.

© 2024 Lantronix, Inc. All rights reserved. Lantronix is a registered trademark. Other trademarks and trade names are those of their respective owners.

Lantronix Media Contact:        
Gail Kathryn Miller
Corporate Marketing &
Communications Manager
media@lantronix.com
949–212–0960

Lantronix Analyst and Investor Contact:        
Jeremy Whitaker
Chief Financial Officer
investors@lantronix.com
949–450–7241


GLOBENEWSWIRE (Distribution ID 9224975)

Recursion Announces Phase 2 Data of REC-994, a First-in-Disease Investigational Treatment for Symptomatic Cerebral Cavernous Malformation (CCM), has Met its Primary Endpoint of Safety and Tolerability

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, today announced top–line results of the SYCAMORE trial, a 12–month Phase 2 randomized double–blind, placebo–controlled, safety, tolerability and exploratory efficacy study for REC–994 in symptomatic CCM patients.

REC–994 met its primary endpoint of safety and tolerability, demonstrating a similar profile across placebo and both 200mg and 400mg dosage–arms with regard to the frequency and severity of adverse events after 12 months of treatment. Magnetic resonance imaging–based secondary efficacy endpoints showed a trend towards reduced lesion volume and hemosiderin ring size in patients at the highest dose (400mg) as compared to placebo. Time–dependent improvement in these trends at the 400mg dose was also observed in this signal–finding study. Improvements in either patient or physician–reported outcomes were not yet seen at the 12 month time point. A meeting with the FDA is anticipated as soon as practical to discuss plans for an additional clinical study. Recursion plans to present data from this trial at a forthcoming medical conference and intends to submit these data for publication in a peer reviewed scientific journal.

“These studies are making significant strides in the development of therapeutics for CCM. The data from this readout is an impressive start and will provide a valuable contribution to the existing CCM literature and strongly supports the need for a future study, with a longer duration and a larger patient cohort,” said Dr. Jan–Karl Burkhardt, MD, Division Head, Cerebrovascular Surgery, University of Pennsylvania and Principal Investigator of the study. Connie Lee, Psy.D., founder and CEO of the Alliance to Cure Cavernous Malformation added: “I speak for the patients who have participated in the trial and those who have been cheering from the sidelines while waiting for news. This promising start is a critical step forward and will bring hope to thousands of families who currently have no options but brain or spinal cord surgery. The Alliance to Cure Cavernous Malformation looks forward to partnering with Recursion as they move to the next stage of the REC–994 program.”

“We are encouraged by the recent data from our signal–finding Phase 2 study in CCM, where the trial successfully met its primary safety endpoint and became the first investigational therapy to demonstrate safety alongside some promising trends in exploratory efficacy endpoints. These results provide critical insights that will inform our next study design, including exploring study duration, higher doses, and a larger cohort of patients,” said Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer of Recursion. “This is the first of several key clinical readouts for the company and represents an early proof–of–platform milestone for our constantly evolving Recursion OS, as we build upon our success in drug discovery with expertise and execution in mid–phase development. We are deeply grateful to the patients and investigators, and we are committed to advancing potential transformational therapies for CCM and beyond.”

Background on Cerebral Cavernous Malformation (CCM)

CCM is a neurovascular condition that impacts approximately 360,000 symptomatic individuals in the US and EU5. The disease is often underdiagnosed and potentially affects over 1 million patients worldwide. CCM manifests as vascular malformations of the spinal cord and brain characterized by abnormally enlarged capillary cavities without intervening brain parenchyma. Patients with CCM lesions are at substantial risk for seizures, headaches, progressive neurological deficits, and potentially fatal hemorrhagic stroke. Currently, only non–pharmacologic treatments including microsurgical resection and stereotactic radiosurgery are available options for this high unmet need patient population. However, surgical resection or stereotactic radiosurgery is not always feasible because of location and may not be curative.

About REC–994

REC–994 is an orally bioavailable, superoxide scavenger small molecule under development for the treatment of symptomatic CCM. The potential of REC–994 in CCM was demonstrated using the earliest version of what would become the foundational technology underlying the Recursion OS. Subsequently, REC–994 demonstrated preclinical activity in models for CCM and tolerability and suitability for chronic dosing in Phase 1 single ascending dose escalation (SAD) and multiple ascending dose escalation (MAD) trials in healthy volunteers directed and executed by Recursion. Recursion has sought and received Orphan Drug Designation for REC–994 in symptomatic CCM in the US and Europe.

About the Trial

Our Phase 2 SYCAMORE clinical trial is a randomized, double–blind, placebo–controlled study of two doses of REC–994 in participants with CCM. The primary endpoint of the study is safety and tolerability. Secondary efficacy endpoints include MRI–based endpoints, clinician and patient reported outcomes, as well as selected biomarkers. This trial was fully enrolled in June 2023 with 62 participants, and 80% of participants who completed 12 months of treatment have entered the long–term extension study. This signal–finding study was not powered to demonstrate statistical significance.

About Recursion

Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, London, and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward–Looking Statements

This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s anticipated meeting with the FDA; Recursion’s plans to present SYCAMORE trial data at a medical conference and submit the data for publication; the clinical relevance of the SYCAMORE trial data and obtaining additional confirmatory data; promising trends in REC–994 efficacy endpoints; advancing potential transformational therapies for CCM and beyond; subsequent REC–994 studies and their results and advancing Recursion’s REC–994 program further; the size of the potential CCM patient population; Recursion OS and other technologies potential and advancement of the future of medicine; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10–K, our subsequent Quarterly Reports on Form 10–Q, and our Current Reports on Form 8–K. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.


GLOBENEWSWIRE (Distribution ID 9223929)

Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device

Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device

FDA regulatory submission for the Company’s Genio® device is complete, U.S. approval on track for the end of 2024

U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised

Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024

Mont–Saint–Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), rang the Nasdaq Closing Bell on August 29, 2024 to recognize the Company’s recent progress and highlight upcoming milestones on its path to the U.S. market launch of its innovative patient–centric Genio® hypoglossal nerve stimulation technology for OSA, a prevalent and severe sleep–related breathing disorder associated with increased mortality risk and cardiovascular comorbidities.

“We are honored to ring the Closing Bell and to celebrate our recent clinical and regulatory achievements in the U.S. We look forward with excitement to the upcoming U.S. launch of our lead product, Genio,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “The U.S. is the largest healthcare market globally and therefore of strategic importance for us. With robust clinical evidence from our pivotal DREAM study, solid funding in place and our strengthened US commercial team, we feel well positioned to enter the US market. We have submitted the final module of our PMA submission to the FDA and are on track for U.S. approval by the end of 2024. If approved, Genio could become available in the U.S. as early as the beginning of 2025.”

Olivier Taelman, CEO of Nyxoah – NASDAQ Closing Bell Ceremony 29 august 2024

Recent Highlights and Upcoming Milestones of Nyxoah’s U.S. Commercialization Strategy

  • Announcement of positive data from the pivotal U.S. study, DREAM, regarding Nyxoah’s Genio® system, an innovative hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA) in spring 2024.
  • Final module submitted in the modular PMA submission, initiating FDA interactive review.
  • Building a U.S. commercial organization, headed by Scott Holstine as the new Chief Commercial Officer along with key sales, marketing and market access leaders.
  • The U.S. market launch of Genio® is fully funded following the successful raising of over €85 million in growth capital through a €48.5 million equity offering and a €37.5 million loan facility agreement with the European Investment Bank (EIB).
  • FDA approval expected approval by US Food and Drug Administration by the end of 2024.
  • U.S. market launch of Genio® planned for the beginning of 2025.

To view the broadcast of the Nasdaq Closing Bell ceremony, please visit: https://www.nasdaq.com/news–and–insights/nasdaq–stock–market–bell–ceremonies

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 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 entry into of the loan facility agreement and the synthetic warrant agreement with the EIB; the use of proceeds from the loan facility agreement; 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
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

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

 

 

 

 

 

 

 

 

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GLOBENEWSWIRE (Distribution ID 1000989628)

Nyxoah Sonne la Cloche de Clôture sur le Nasdaq alors qu'elle se Prépare à Lancer sa Technologie Innovante pour l'Apnée du Sommeil sur le Marché Américain

Nyxoah Sonne la Cloche de Clôture sur le Nasdaq alors qu'elle se Prépare à Lancer sa Technologie Innovante pour l'Apnée du Sommeil sur le Marché Américain

L'entreprise a complété la demande d'enregistrement réglementaire auprès de la FDA pour le système Genio®. L'approbation aux États–Unis est prévue pour fin 2024

Le lancement commercial aux États–Unis attendu début 2025 et entièrement financé avec plus de 85 millions d'euros de nouveaux capitaux

Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024

Mont–Saint–Guibert, Belgique – 2 septembre 2024 22:05 CET / 16h05 ET – Nyxoah SA (Euronext Bruxelles/Nasdaq : NYXH) (“Nyxoah” ou la “Société”), une entreprise de technologie médicale axée sur le développement et la commercialisation de solutions innovantes pour le traitement de l'Apnée Obstructive du Sommeil (AOS), a sonné la cloche de clôture au Nasdaq le 29 août 2024 pour reconnaître les progrès récents de l'entreprise et pour souligner les prochaines étapes importantes vers le lancement sur le marché américain de sa technologie innovante et centrée sur le patient Genio® pour la stimulation du nerf hypoglosse dans le traitement de l'AOS, un trouble respiratoire du sommeil courant et grave associé à un risque accru de mortalité et de comorbidités cardiovasculaires.

” Nous sommes honorés de sonner la cloche de clôture et de célébrer nos récentes réalisations cliniques et réglementaires aux États–Unis. Nous attendons avec enthousiasme le lancement imminent de notre produit phare, Genio, aux États–Unis”, a déclaré Olivier Taelman, Chief Executive Officer de Nyxoah. “Les États–Unis sont le plus grand marché de soins de santé au monde et sont donc d'une importance stratégique pour nous. Avec des preuves cliniques solides issues de notre étude clé DREAM, un financement solide et notre équipe commerciale renforcée aux États–Unis, nous nous sentons bien positionnés pour entrer sur le marché américain. Nous avons soumis le dernier module de notre demande PMA à la FDA et nous attendons une décision d'ici fin 2024. Si elle est approuvée, Genio pourrait être disponible aux États–Unis dès le début de 2025.”

Olivier Taelman, CEO de Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024

Faits marquants récents et étapes futures de la stratégie de commercialisation de Nyxoah aux États–Unis

  • Annonce de données positives de l'étude américaine pivot, DREAM, concernant le système Genio® de Nyxoah, une thérapie innovante de neurostimulation hypoglosse pour l'apnée obstructive du sommeil (AOS) au printemps 2024.
  • Soumission du dernier module de la demande d'autorisation de mise sur le marché (PMA) modulaire, initiant l'examen interactif par la FDA.
  • Mise en place d'une organisation commerciale aux États–Unis, dirigée par Scott Holstine en tant que nouveau Chief Commercial Officer, avec des experts clés dans les domaines de la vente, du marketing et de l'accès au marché.
  • Le lancement de Genio® sur le marché américain a été entièrement financé suite à la levée réussie de plus de 85 millions d'euros de capital de croissance par le biais d'une émission d'actions de 48,5 millions d'euros et d'un accord de prêt de 37,5 millions d'euros avec la Banque européenne d'investissement (BEI).
  • L'approbation par la Food and Drug Administration (FDA) américaine est attendue pour la fin de l'année 2024.
  • Le lancement de Genio® sur le marché américain est prévu pour le début de l'année 2025.

Pour regarder la diffusion de la cérémonie de la cloche de clôture du Nasdaq, rendez–vous sur :
https://www.nasdaq.com/news–and–insights/nasdaq–stock–market–bell–ceremonies

À propos de Nyxoah

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

Pour plus d’informations, visitez http://www.nyxoah.com/

Attention – Marquage CE depuis 2019. Dispositif expérimental aux États–Unis. Limité par la loi fédérale américaine à une utilisation expérimentale 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®, 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 pour l'obtention éventuelle de l'approbation du système Genio® par la FDA ; et 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 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 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 sincérité 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 énoncés prospectifs sont exemptes d'erreurs et n'acceptent aucune responsabilité quant à l'exactitude future des énoncés prospectifs contenus dans le présent communiqué de presse ou à la survenance réelle 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
Belgique / France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

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

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1000989628)

Blue Hat Announced Execution of $66.49 Million Gold Acquisition

HONG KONG, Aug. 29, 2024 (GLOBE NEWSWIRE) — Blue Hat Interactive Entertainment Technology (“BHAT” or the “Company”) (NASDAQ: BHAT) announced the execution of a 1,000–kilogram (approximately 2,204.62 pounds) gold delivery, officially marking the launch of its gold supply chain business. This delivery follows the framework agreement signed in October 2023 with Macau Rongxin Precious Metals Technology Co., Ltd. (“Macau Rongxin”), a company registered in Macau with registration number: 86918(SO) registered with the Macau Commercial Register.

The spot price for gold at the time of the October 2023 framework agreement was approximately $61.14 per gram, while the spot price for gold as of August 28, 2024 is approximately $80.61 per gram. The purchase price of the gold delivered to BHAT is approximately $66.49 per gram, for a total purchase price of approximately $66.49 million. This acquisition is a strategic move to develop a gold supply chain business. BHAT plans to leverage this gold in gold supply chain business, providing gold to refineries, wholesalers, and retailers, thereby generating revenue and establishing a robust presence in the gold business.

Chen Xiaodong, CEO of BHAT, commented, “The completion of this significant gold delivery represents a crucial advancement for BHAT in the bulk commodity trading sector. This milestone not only underscores our commitment to expanding our presence in the international market but also strengthens our financial position. We anticipate that this success will drive further growth and unlock additional opportunities for the Company.”

The Company believes that the proceeds from this delivery will enhance its financial flexibility, enabling further expansion within the precious metals market. BHAT remains focused on innovation and operational efficiency as it continues to explore new market opportunities to bolster its competitive standing.

Forward–Looking Statements:

This release contains forward–looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward–looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the Company. Readers are cautioned not to place undue reliance on these forward–looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the Company's SEC filings, including its Annual Report on Form 20–F. These risks and uncertainties could cause the Company's actual results to differ materially from those indicated in the forward–looking statements.

Contacts:

Blue Hat Interactive Entertainment Technology
Phone: +86 (592) 228–0010
Email: ir@bluehatgroup.net
IR Website: https://ir.bluehatgroup.com


GLOBENEWSWIRE (Distribution ID 9222445)

Volt Mobility Enters into $210 Million Contract with Mullen Automotive to Purchase 3,000 Class 1 and Class 3 EV Cargo Vans and Trucks

Mullen to receive initial $3 million deposit and will begin shipping first vehicles immediately

Volt, a leading UAE–based commercial leasing company with clients including UPS, DHL and FedEx, to purchase 3,000 EV cargo vans and trucks over the next 16 months

BREA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) — via IBN – Mullen Automotive, Inc. (NASDAQ: MULN) (“Mullen” or the “Company”), an electric vehicle (“EV”) manufacturer, announced today that Volt Mobility (“Volt”), based in the United Arab Emirates (“UAE”), has entered into a purchase agreement for approximately $210 million to acquire 3,000 Class 1 and Class 3 EV cargo vans and trucks over a 16–month period. Mullen will receive an initial $3 million deposit within 60 days and additional payments as the vehicles are delivered. The Company will begin shipping the first vehicles immediately.

Mullen expects to recognize approximately $210 million in revenue over the next 16 months of the agreement. Volt intends to lease these vehicles to its corporate customers based in the Middle East and Gulf States. Current Volt clients include UPS, DHL and FedEx throughout the Gulf Cooperation Council (“GCC”) region, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates (UAE).

Volt’s vehicle order will be assembled at Mullen’s Tunica, Mississippi–based Commercial Vehicle Facility, which is capable of producing 20,000 Class 1 and 6,000 Class 3 vehicles annually with two production shifts.

Founded in 2020, Volt quickly established itself as one of the largest and most influential commercial EV leasing companies in the region. Volt’s vehicle portfolio includes 17 models with focus on light, medium and heavy–duty electric vehicles. Volt leases vehicles to corporate customers providing first to last–mile delivery for fast moving goods and provides heavy duty trucks for shuttling service across the region, serving clients including large transport businesses under a long–term secured leasing model

The UAE has identified e–mobility as a priority policy area and is now seven years into an ambitious plan to decarbonize its infrastructure and energy production. The Emirate’s Clean Energy Strategy 2050 and Net Zero Carbon Emissions Strategy 2050 seek to generate 100% power from clean energy sources by 2050. Furthermore, Dubai's Roads and Transport Authority (“RTA”) has rolled out a long–term strategy to migrate towards net–zero emission public transport by 2050.

“At Volt, we don’t just follow trends; we set them. Our mission is clear: lead the transformation to sustainable, efficient and cutting–edge transportation,” said Sophia Nau, managing director and CFO for Volt Mobility.

“Volt is reshaping the way people and businesses move across the UAE and GCC,” said David Michery, CEO and chairman of Mullen Automotive. “This landmark agreement provides Mullen with exposure to leading global transportation companies and the opportunity for utilizing Mullen EVs across the UAE and other areas of the Middle East.”

Additional details, including the related agreement, can be found in the Company’s Form 8–K to be filed with the SEC.

Mullen’s commercial EV lineup includes the Mullen ONE Class 1 EV cargo van, the Mullen THREE Class 3 EV cab chassis truck, and the Bollinger B4 Class 4 and Bollinger B5 Class 5 EV cab chassis trucks from its subsidiary, Bollinger Motors. Mullen’s full lineup of commercial EVs is purpose–built to meet the demands of urban last–mile delivery; available for sale and in full compliance with U.S. Federal Motor Vehicle Safety Standards, the Environmental Protection Agency and the California Air Resources Board (“CARB”) certifications, denoting strict adherence to clean air emissions standards. The Bollinger B4 begins Start of Production (“SOP”) on Sept. 16, 2024, with deliveries beginning in October 2024.

About Volt Mobility
We are unwavering in our commitment to sustainability, and we firmly believe in the potential of electric mobility to revolutionize industrial transportation. Our steadfast commitment aligns seamlessly with the transformative potential of electric mobility in the industrial sector. By leveraging the latest technologies, we strive to create a cleaner, more efficient and seamlessly connected transportation network tailored for industrial applications. Whether you operate in logistics, manufacturing or any industrial sector, Volt Industrial Mobility is your partner in driving positive change. Join us as we work towards a future where industrial electric vehicles play a pivotal role in creating environmentally conscious, high–performance and cost–effective transportation solutions.

To learn more about Volt, visit www.VoltMobility.group.

About Mullen
Mullen Automotive (NASDAQ: MULN) is a Southern California–based automotive company building the next generation of commercial electric vehicles (“EVs”) with two United States–based vehicle plants located in Tunica, Mississippi, (120,000 square feet) and Mishawaka, Indiana (650,000 square feet). In August 2023, Mullen began commercial vehicle production in Tunica. In September 2023, Mullen received IRS approval for federal EV tax credits on its commercial vehicles with a Qualified Manufacturer designation that offers eligible customers up to $7,500 per vehicle. As of January 2024, both the Mullen ONE, a Class 1 EV cargo van, and Mullen THREE, a Class 3 EV cab chassis truck, are California Air Resource Board (“CARB”) and EPA certified and available for sale in the U.S. Recently, CARB issued HVIP approval on the Mullen THREE, Class 3 EV truck, providing up to a $45,000 cash voucher at time of vehicle purchase. The Company has also recently expanded its commercial dealer network with the addition of Pritchard EV, National Auto Fleet Group, Ziegler Truck Group, Range Truck Group and Eco Auto, providing sales and service coverage in key Midwest, West Coast and Pacific Northwest and New England markets. The Company also recently announced Foreign Trade Zone (“FTZ”) status approval for its Tunica, Mississippi, commercial vehicle manufacturing center. FTZ approval provides a number of benefits, including deferment of duties owed and elimination of duties on exported vehicles.

To learn more about the Company, visit www.MullenUSA.com.

Forward–Looking Statements
Certain statements in this press release that are not historical facts are forward–looking statements within the meaning of Section 27A of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward–looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential” and similar expressions are intended to identify such forward–looking statements. These forward–looking statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the purchase agreement with Volt, the anticipated purchase and delivery of vehicles and expected revenue. All forward–looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward–looking statements, many of which are generally outside the control of Mullen and are difficult to predict. These forward–looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward–looking statements are subject to a number of risks and uncertainties, including but are not limited to, uncertainty that Volt will abide by its contractual obligations, including payment of the deposit and order of vehicles as expected, the timing and dates for receipt of payments pursuant to the agreement, successful certification of the vehicles in the GCC region,  delays in production and delivery of vehicles, unanticipated returns of vehicles, delayed commercial product launches and the achievement of operational milestones,  and changes in domestic and foreign business, market, financial, political and legal conditions that may affect incentives and the general market for EVs.. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward–looking statements can be found in the most recent annual report on Form 10–K, quarterly reports on Form 10–Q and current reports on Form 8–K filed by Mullen with the Securities and Exchange Commission. Mullen anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Mullen assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward–looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law. Forward–looking statements speak only as of the date they are made and should not be relied upon as representing Mullen’s plans and expectations as of any subsequent date.

Contact:
Mullen Automotive, Inc.
+1 (714) 613–1900
www.MullenUSA.com

Corporate Communications:
IBN
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com

Attachments


GLOBENEWSWIRE (Distribution ID 9220336)

Zoom Appoints Mike Fenger to Board of Directors

SAN JOSE, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) — Zoom Video Communications, Inc. (NASDAQ: ZM) announced that it has appointed Mike Fenger, vice president Worldwide Sales, Apple, as an independent director on Zoom’s Board of Directors effective immediately.

“Zoom plays an important role connecting people around the world, and I’m excited to join the Board and contribute to its future success,” said Mike Fenger, vice president Worldwide Sales, Apple. “Eric Yuan has built a great team and the company’s dedication to driving innovative technology is inspiring. I’m really looking forward to working with them.”

“On behalf of Zoom’s Board of Directors, I am thrilled to welcome Mike to the team,” said Zoom founder and CEO Eric S. Yuan. “Mike’s experience at Apple, and companies including GE, and his proven track record of global leadership bring valuable insights that align perfectly with our vision. We’re excited to see the fresh perspective and innovative ideas he’ll contribute as we continue driving our growth and success.”

About Mike Fenger

Mike oversees global product sales for Apple, and his team plays an important part in helping customers discover products they love. Since joining Apple in 2008, he has also had a key role in strengthening telecommunications and consumer electronic reseller partnerships, and deepening connections with customers in enterprise, education, and government. He began his Apple career as vice president of Global iPhone Sales, where he led the expansion of iPhone distribution to customers around the globe.

Mike has over 20 years of experience building and leading sales teams for global companies. Before joining Apple, he held senior positions at General Electric and Motorola, where he helped develop and execute strategy for sales, operations, marketing, and supply chain management in the Americas, Europe, and Greater China. Mike is a graduate of Miami University, where he earned a bachelor’s degree in Economics.

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 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 PR
Colleen Rodriguez
Head of Global PR
press@zoom.us


GLOBENEWSWIRE (Distribution ID 9220130)

DigiAsia Corp. Appoints Andreas Gregori to its AI Strategic Advisory Board

~ The Addition Strengthens the Delivery of Meaningful AI Fintech Solutions for its Enterprise Clients ~

NEW YORK, Aug. 20, 2024 (GLOBE NEWSWIRE) — DigiAsia Corp. (NASDAQ: FAAS) (“DigiAsia” or the “Company”), a leading Fintech as a Service (“FaaS”) ecosystem provider, today announced that Andreas Gregori, a current member of DigiAsia’s board of directors and highly experienced business executive and entrepreneur, has been appointed as an advisor to its recently established AI strategic advisory board. Mr. Gregori is a seasoned commercial leader with a digital and customer–first mindset. His deep knowledge of leveraging technology and AI in meaningful ways will propel the Company as it rapidly integrates AI solutions to enhance its Fintech offerings for enterprise clients and partners in Indonesia and beyond.

Mr. Gregori has over 15 years of global C–suite experience within leading technology and telecommunications companies with vast experience driving growth through bold commercial and technology programs for multi–billion–dollar organizations and start–ups in both mature and emerging markets. Since 2019, Mr. Gregori has served as President of Axiom D Inc., where he devises new digital revenue streams and business models around innovative value propositions, customer value management and data monetization. Previously, Mr. Gregori served as Chief Marketing Officer and Chief Digital Officer of Indosat Ooredoo, Indonesia’s second largest telecommunications provider, where he led the successful company transformation to establish itself as a leading digital telco in Indonesia. Mr. Gregori has a Ph.D. in Computer Science and Artificial Intelligence from Technische Universitat Berlin, Germany, and an M.S. in Computer Science from Technische Universitat Darmstadt, Germany.

Prashant Gokarn, CEO of DigiAsia, commented, “We are honored that industry veteran Andreas has further dedicated his time and experience to our AI advisory team. Andreas’ leadership, technological acumen and customer–first mindset have proven to drive operational growth through bold innovations. His expertise will be instrumental as we accelerate the development and deployment of innovative AI fintech solutions that deliver significant value to our clients and contribute to sustained economic growth.”

Andreas Gregori added, “I am excited to deepen my involvement with DigiAsia as a member of its AI strategic advisory board. DigiAsia already powers significant parts of the digital value chain for Indonesia’s leading enterprises, and I am eager to contribute to the development of its next generation fintech solutions. By leveraging AI and our access to Nvidia’s cutting–edge GPUs, we can create powerful tools to drive enterprise growth across the region.”

About DigiAsia

DigiAsia is a leading Fintech as a Service (FaaS) provider in Indonesia and nearby emerging markets and digitizing finance across the commerce ecosystem operating as a B2B2X model. DigiAsia’s fintech architecture offers municipalities and small and medium enterprise business (SME) comprehensive embedded finance APIs to streamline processes across the commerce value chain. DigiAsia’s embedded fintech solutions equally address democratizing digital finance access that supports financial inclusion of underbanked merchants and consumers in emerging markets resulting in growth for enterprise business. The suite of B2B2X solutions provided by DigiAsia include, but are not limited to, cashless payments, digital wallets, digital banking, remittances and banking licenses. DigiAsia has recently established a strategic initiative to develop its embedded FaaS enterprise solution with AI capabilities in Southeast Asia, India, and the Middle East, with plans for global expansion. For more information, please visit DigiAsia’s Corporate website here or Investor Relations website here.

Forward–Looking Statements:

This press release may contain forward–looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “believe”, “expect”, “anticipate”, “project”, “targets”, “optimistic”, “confident that”, “continue to”, “predict”, “intend”, “aim”, “will” or similar expressions are intended to identify forward–looking statements. All statements other than statements of historical fact are statements that may be deemed forward–looking statements. These forward–looking statements including, but not limited to, statements concerning DigiAsia and the Company’s operations, financial performance and condition are based on current expectations, beliefs and assumptions which are subject to change at any time. DigiAsia cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors such as government and stock exchange regulations, competition, political, economic and social conditions around the world including those discussed in DigiAsia’s Form 20–F under the headings “Risk Factors”, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business Overview” and other reports filed with the Securities and Exchange Commission from time to time. All forward–looking statements are applicable only as of the date it is made and DigiAsia specifically disclaims any obligation to maintain or update the forward–looking information, whether of the nature contained in this release or otherwise, in the future.

DigiAsia Company Contact:
Subir Lohani
Chief Financial Officer and Chief Strategy Officer
646–480–0142

Investor Contact:
MZ North America
Email: FAAS@mzgroup.us


GLOBENEWSWIRE (Distribution ID 9217207)

Entera Bio to Participate in Upcoming Investor and Scientific Conferences

JERUSALEM, Aug. 20, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that management will be participating in the following investor and scientific conferences:

H.C. Wainwright 26th Annual Global Investment Conference (Presentation and 1×1)

Date and Time: September 9, 2024 at 7am ET
Location: Virtual, September 9–11, 2024

American Society for Bone and Mineral Research 2024 Annual Meeting (Poster and 1×1)

Date and Time: Saturday, September 28, 2024, 2:15 – 3:45PM 
Location: In person, September 26–29, 2024 Toronto, Canada

7th Annual Evercore ISI HealthCONx Conference (Fireside Chat and 1×1)

Date and Time: December 4, 2024 at 3:25–3:45PM in Track 2 – Sevilla A
Location: In person, December 3–5, 2024 Coral Gables, Florida

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 on 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 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 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. 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 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 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 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 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 Statements 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 the company’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 press release. The information in this press release is provided only as of the date of this press release, 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.


GLOBENEWSWIRE (Distribution ID 9217620)