Category: Press Release

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Nyxoah Reports First Quarter 2024 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2024 Financial and Operating Results
Announced DREAM U.S. pivotal study achieved primary endpoints
On track for FDA approval as early as end of 2024

Mont-Saint-Guibert, Belgium – May 14, 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), today reported financial and operating results for the first quarter of 2024.

Recent Financial and Operating Highlights

  • Reported the DREAM U.S. pivotal study achieved co-primary endpoints on an intent-to-treat (ITT) basis and demonstrated strong AHI reductions in supine and non-supine sleep positions.
  • The DREAM study achieved a median AHI reduction of 70.8%, a 12-month AHI responder rate, per the Sher criteria, of 63.5% (p=0.002) on an ITT basis and a 12-month ODI responder rate of 71.3% (p<0.001) on an ITT basis.
  • Preparing the fourth and final PMA module for submission this quarter.
  • Appointed Dr. Maurits S. Boon, MD as Chief Medical Officer.
  • Advanced patient access strategy through partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF).
  • Achieved quarterly sales of €1.2 million, showing 170% growth vs Q1 2023.
  • Total cash position of €44.3 million at the end of the quarter.

“The DREAM U.S. study achieving its primary endpoints is a pivotal milestone for Nyxoah and further differentiates Genio as the only HGNS therapy to demonstrate strong efficacy in supine and non-supine OSA. With the DREAM data in hand, our U.S. launch preparations are focused on attracting commercial talent to set us up for success when we introduce Genio,” commented Olivier Taelman, Nyxoah Chief Executive Officer. “With continued European commercial traction, positive DREAM data and a highly differentiated, patient centric HGNS solution, I could not be more excited for Nyxoah’s future.”

First Quarter 2024 Results

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

For the three months ended March 31, 
2024 2023
Revenue € 1,221 € 441
Cost of goods sold (455) (175)
Gross profit € 766 € 266
Research and Development Expense (7,199) (6,157)
Selling, General and Administrative Expense (5,972) (5,551)
Other income/(expense) 192 46
Operating loss for the period € (12,213) € (11,396)
Financial income 1 408 625
Financial expense ( 991) ( 958)
Loss for the period before taxes € (11,796) € (11,729)
Income taxes ( 110) ( 182)
Loss for the period € (11,906) € (11,911)
Loss attributable to equity holders € (11,906) € (11,911)
Other comprehensive income/(loss)
Items that may not be subsequently reclassified to profit or loss (net of tax)
Currency translation differences 60 (28)
Total comprehensive loss for the year, net of tax € (11,846) € (11,939)
Loss attributable to equity holders € (11,846) € (11,939)
Basic loss per share (in EUR) € (0.415) € (0.460)
Diluted loss per share (in EUR) € (0.415) € (0.460)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

(in thousands)

As at
March 31
2024		 December 31 2023
ASSETS
Non-current assets
Property, plant and equipment €4,379 €4,188
Intangible assets 48,501 46,608
Right of use assets 3,597 3,788
Deferred tax asset 134 56
Other long-term receivables 1 333 1,166
€ 57,944 € 55,806
Current assets
Inventory 3,418 3,315
Trade receivables 2,971 2,758
Other receivables 3,149 3,212
Other current assets 1,232 1,318
Financial assets 22,225 36,138
Cash and cash equivalents 22,077 21,610
€ 55,072 € 68,351
Total assets € 113,016 € 124,157
EQUITY AND LIABILITIES
Capital and reserves
Capital 4,927 4,926
Share premium 246,188 246,127
Share based payment reserve 8,440 7,661
Other comprehensive income 197 137
Retained loss (172,555) (160,829)
Total equity attributable to shareholders € 87,197 € 98,022
LIABILITIES
Non-current liabilities
Financial debt 8,616 8,373
Lease liability 2,933 3,116
Pension liability 22 9
Provisions 273 185
Deferred tax liability − 9
€ 11,844 € 11,692
Current liabilities
Financial debt 346 364
Lease liability 852 851
Trade payables 7,316 8,108
Current tax liability 2,091 1,988
Other payables 3,370 3,132
€ 13,975 € 14,443
Total liabilities € 25,819 € 26,135
Total equity and liabilities € 113,016 € 124,157

Revenue
Revenue was €1.2 million for the first quarter ending March 31, 2024, compared to €441,000 for the first quarter ending March 31, 2023. The increase in revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

Cost of Goods Sold

Cost of goods sold was €455,000 for the three months ending March 31, 2024, representing a gross profit of €0.8 million, or gross margin of 62.7%. This compares to total cost of goods sold of €175,000 in the first quarter of 2023, for a gross profit of €266,000, or gross margin of 60.3%.

Research and Development
For the first quarter ending March 31, 2024, research and development expenses were €7.2 million, versus €6.2 million for the first quarter ending March 31, 2023.

Operating Loss
Total operating loss for the first quarter ending March 31, 2024 was €12.2 million versus €11.4 million in the first quarter ending March 31, 2023. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash Position
As of March 31, 2024, cash and financial assets totaled €44.3 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €4.5 million per month during the first quarter 2024.

First Quarter 2024
Nyxoah’s financial report for the first quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah’s Q1 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah’s Q1 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

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 is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

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; 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, 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
David DeMartino, Chief Strategy Officer
IR@nyxoah.com

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GlobeNewswire Distribution ID 1000950825

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Workvivo by Zoom is named preferred migration partner for Workplace from Meta

Meta is discontinuing Workplace and will partner with Workvivo to assist with customer transitions.

SAN JOSE, Calif., May 14, 2024 (GLOBE NEWSWIRE) — Today, Workvivo by Zoom was named Meta’s only preferred migration partner for its customers as it retires Workplace from Meta.

Meta is discontinuing Workplace from Meta – its employee engagement platform. To assist with customer transitions, Meta will partner with Workvivo as its only preferred migration partner.

Workplace from Meta and Workvivo plan to provide migration tools for customers migrating to Workvivo and Workvivo will also offer additional implementation services at no further cost to support customers’ transition.

Workplace from Meta customers can find more information about migrating to Workvivo here.

John Goulding, CEO and founder of Workvivo, said: “We know that the news today may be disruptive for Workplace from Meta customers, but we’re so excited about the opportunity to support and help them. Meta has made a huge impact in this market, and we believe that Workvivo is the natural choice for Workplace from Meta customers to transition their employee experience platform.

“It’s our top priority to support customers through this transition, and our team is working to make this process as frictionless as possible. We put our customers first, and this will be no different for the Workplace from Meta customers. We are excited to welcome Workplace from Meta customers into our incredible customer community and see the amazing things they can do with Workvivo.”

Eric S. Yuan, CEO and founder of Zoom said: “Since Workvivo joined the Zoom family, we’ve seen how powerful this platform is at engaging workforces and bringing culture to life – especially for frontline employees who may not have a desk or even an email address. Workvivo has seen momentous growth as organizations around the world are increasingly prioritizing the employee experience. We are excited to support Workplace from Meta’s customers and help them reach their goals of reaching and engaging employees – whether they’re desk or frontline workers.”

Workvivo by Zoom is the employee experience platform that simplifies communication and increases engagement by empowering employees to be heard and helping everyone feel included, no matter where they work.

Acquired by Zoom in 2023, Workvivo extends the Zoom Workplace platform to offer its customers new ways to keep employees informed, engaged, and connected. Workvivo is working with some of the world’s best-known brands to help them boost employee engagement and bring their culture to life digitally, including Dollar General, the Virgin Group, Bupa, Ryanair, Lululemon and Amazon.

About Workvivo by Zoom

Workvivo is an employee experience platform that simplifies communication and increases engagement by empowering employees to be heard and helping everyone feel included, no matter where they work. The platform unifies employee communications, engagement, intranet, and measurement features into one modern employee app that captures the heartbeat of the organization and brings its culture to life.

Founded in 2017, Workvivo has seen momentous growth, which led to its acquisition by Zoom in 2023. Workvivo powers the employee experience at companies all over the world across all industries, including Amazon, Motherson, White Castle, Bupa and Ryanair. Workvivo regularly tops software review sites, including Gartner Digital, with a #1 spot on G2 for internal communications, intranet and engagement tool categories. For more information, visit www.workvivo.com.

Public Relations
Eleanor O’Mahony
eleanor.omahony@zoom.us

GlobeNewswire Distribution ID 9117415

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Mitsumi Distribution spearheading Technological Advancement at GITEX Africa 2024.

DUBAI, UAE – African Media Agency – 14 May 2024 – Mitsumi Distribution, a leading IT, Telco, Value and AI distributor in the Middle East and Africa, proudly announces its participation in GITEX Africa 2024. With a widespread presence spanning 28 countries and strategic partnerships with over 27+ vendors, Mitsumi Distribution is poised to showcase front-line technological advancements and innovations at this esteemed event.

Mr. Mitesh Shah – Managing Director

Mitsumi’s focus at GITEX Africa 2024 revolves around the theme of “Pioneering Future Solutions Today.” Reflecting this commitment, Mitsumi will unveil an extensive array of pioneering technologies and innovative solutions that are reshaping the landscape of IT, Telco, AI, and value-driven solutions. In the realm of AI, Mitsumi will showcase advancements such as machine learning, generative AI, computer vision, and AI-driven chatbots, among others. In the Value Division section, emphasis will be placed on cloud solutions, security, infrastructure solutions, and more. Seasoned experts from Mitsumi, alongside key principals, will be on hand to provide insights and facilitate direct engagement with the latest industry innovations. The prestigious vendors showcased at Mitsumi’s booth are industry giants such as Acer, Array Networks, Asus, Canon, DellTechnologies, HPE, HP, Infinix, Lenovo, Lexar, Oppo, Samsung, Seagate, Techno, and VIVO.

We are thrilled to announce our participation in GITEX Africa 2024,” exclaimed Mr. Mitesh Shah, Managing Director at Mitsumi Distribution. “In this ever-evolving landscape of innovation, AI stands out as one of the most prominent topics, continually expanding its reach and impact. We are excited to seize this opportunity to unveil new partnerships and business plans, further propelling our commitment to driving technological advancement and empowering businesses across Middle East & Africa and showcasing our solutions from the top vendors”.

Visit Mitsumi Distribution at Stand 5B-20, Hall No.5, CLOUD X IOT X AI, from the 29th of May to the 31st of May 2024 to experience firsthand the advanced technologies and solutions shaping the future. Engage with Mitsumi’s team of experts, explore the latest projects and developments, and discover how Mitsumi can empower your organization to thrive in the digital age.

About Mitsumi Distribution

Mitsumi Distribution is a leading technology provider specializing in distribution channels in Africa, the Middle East and African French-speaking countries. With over two decades of experience, Mitsumi Distribution has firmly established itself as a trusted authority in the region. The company offers a wide range of innovative technology products & solutions, with a focus on IT, Telco, AI, cloud computing, networking, servers and storage. Mitsumi Distribution is committed to providing superior quality products, exceptional service and unparalleled value to its valued partners. www.mitsumidistribution.com

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MedSource Labs Announces Innovation in Safety, Accuracy and Functionality of IV Catheters

MedSource Labs Unveils ClearSafe Comfort® and TrueSafe Comfort® Blood Control Safety IV Catheters to protect medical staff and patients

[Minneapolis, Minnesota, Chanhassen], May 14, 2024 (GLOBE NEWSWIRE) — MedSource Labs moves the needle in the peripheral safety IV market with the announcement of ClearSafe Comfort and TrueSafe Comfort Blood Control IV Catheters with groundbreaking active blood control check valve technology.

ClearSafe Comfort and TrueSafe Comfort Blood Control IV catheters provide significant benefits over other IV catheters.

  1. Safety: A new blood control device to significantly reduce the risk of exposure to bloodborne pathogens to the caregiver and patient.
  2. Precision: A translucent flashback chamber confirms vessel entry and ensures accuracy.
  3. Front-line functionality: The ergonomic design and non-slip grip ensure easy handling for healthcare workers.

 

“Healthcare professionals subject themselves to the risks associated with needlestick injuries and exposure to bloodborne pathogens every time they access a vein,” said Dave Kunelius, President at MedSource Labs. “ClearSafe Comfort and TrueSafe Comfort Blood Control Safety IV Catheters have been engineered to minimize these risks, allowing medical staff to better serve their patients without distraction or worry.”

These devices conform to the U.S. Needlestick Safety and Prevention Act.

MedSource Labs is a leading medical product developer and supplier specializing in high-quality products and innovative medical product development. The ClearSafe Comfort and TrueSafe Comfort Blood Control Safety IV Catheters are part of MedSource Labs’ high-performing IV catheter lines focused on caring for the caregiver. See the TrueSafe Animations and ClearSafe Animations for a detailed view.

“Quality has always been a key component of our IV catheter products, and the ClearSafe Comfort and TrueSafe Comfort blood control products raise the bar for medical staff safety and patient care,” said Kunelius.

MedSource Labs is ISO 13485:2016 certified for quality management in medical device manufacturing, registered with the FDA, and the blood control catheters are 510(k) Cleared Products.

ABOUT MEDSOURCE LABS

MedSource Labs is a leading provider of quality medical products, specializing in high-quality products, equipment and innovative class II medical product development. For over two decades, MedSource Labs has been a trusted provider of quality medical products at a superb value. Recently, MedSource Labs has expanded into new markets and grown its international services and offerings, including a focus on the EMERGE product imagine/design/build process.

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Jeremy Belloit
MedSource Labs
(952) 472-0131
jbelloit@medsourcelabs.com

GlobeNewswire Distribution ID 9116905

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‫ميتسومي للتوزيع تقود التقدم التكنولوجي في معرض جيتكس أفريقيا 2024

دبي، الإمارات العربية المتحدة – 14 مايو 2024 – تعلن شركة ميتسومي للتوزيع، الشركة الرائدة في مجال توزيع تكنولوجيا المعلومات والاتصالات وعروض القيمة والذكاء الاصطناعي في الشرق الأوسط وإفريقيا، بفخر عن مشاركتها في معرض جيتكس أفريقيا 2024. ومع تواجد واسع النطاق يشمل 28 دولة فضلاً عن الشراكات الاستراتيجية مع أكثر من 27 بائعًا، تستعد شركة ميتسومي للتوزيع لعرض التطورات والابتكارات التكنولوجية المتقدمة في هذا الحدث المرموق.

يتمحور تركيز ميتسومي في معرض جيتكس أفريقيا 2024 حول موضوع “ريادة الحلول المستقبلية اليوم”. وتجسيدًا لهذا الالتزام، ستكشف ميتسومي النقاب عن مجموعة متنوعة من التقنيات الرائدة والحلول المبتكرة التي تعيد تشكيل مشهد تكنولوجيا المعلومات، والاتصالات، والذكاء الاصطناعي، والحلول القائمة على القيمة. وفي مجال الذكاء الاصطناعي، ستعرض ميتسومي التطورات مثل تعلم الآلة، والذكاء الاصطناعي التوليدي، ورؤية الحاسوب، وروبوتات الدردشة التي تعتمد على الذكاء الاصطناعي، وغيرها. وفي قسم عروض القيمة، سيتم التركيز على الحلول السحابية والأمن وحلول البنية التحتية والمزيد. سيكون الخبراء المتمرسون من ميتسومي، جنبًا إلى جنب مع المديرين الرئيسيين، على استعداد لتقديم رؤى وتسهيل المشاركة المباشرة مع أحدث ابتكارات الصناعة. ويضم جناح ميتسومي عمالقة الصناعة من البائعين المرموقين مثل آيسر، وآيري نتوركس، وآسوس، وكانون، وديل تكنولوجيز، وإتش بي إي، وإتش بي، وإنفينيكس، وليكسار، وأوبو، وسامسونج، وسيجيت، وتكنو، وفيفو.

صرح السيد ميتيش شاه، المدير العام لشركة ميتسومي للتوزيع، قائلاً: “يسعدنا أن نعلن عن مشاركتنا في معرض جيتكس أفريقيا 2024”. “في هذا المشهد الابتكاري المتطور باستمرار، يبرز الذكاء الاصطناعي كواحد من أهم المواضيع، ويتوسع باستمرار في نطاقه وتأثيره. ونحن متحمسون لاغتنام هذه الفرصة للكشف عن شراكات وخطط عمل جديدة، وتعزيز التزامنا بقيادة التقدم التكنولوجي، وتمكين الشركات في جميع أنحاء الشرق الأوسط وأفريقيا، وعرض حلولنا من كبار البائعين.

تفضلوا بزيارة ميتسومي للتوزيع في الجناح 5B-20، القاعة رقم 5، السحابة × إنترنت الأشياء × الذكاء الاصطناعي (Stand 5B-20, Hall No.5, CLOUD X IOT X AI)، في الفترة من 29 مايو إلى 31 مايو 2024 للتجربة المباشرة للتقنيات والحلول المتقدمة التي تشكل المستقبل، وللتفاعل مع فريق خبراء ميتسومي، ولاستكشاف أحدث المشاريع والتطورات، ولاكتشاف كيف يمكن لشركة ميتسومي تمكين مؤسستكم من الازدهار في العصر الرقمي.

حول شركة ميتسومي للتوزيع:

ميتسومي للتوزيع هي شركة رائدة في مجال توفير التكنولوجيا المتخصصة في قنوات التوزيع في أفريقيا والشرق الأوسط والدول الأفريقية الناطقة بالفرنسية. رسخت شركة ميتسومي للتوزيع مكانتها بقوة كسلطة موثوقة في المنطقة بفضل ما لديها من أكثر من عقدين من الخبرة. تقدم الشركة مجموعة متنوعة من المنتجات والحلول التقنية المبتكرة، مع التركيز على تكنولوجيا المعلومات والاتصالات والذكاء الاصطناعي والحوسبة السحابية والشبكات والخوادم والتخزين، كما تلتزم شركة ميتسومي للتوزيع بتقديم منتجات فائقة الجودة وخدمة استثنائية وقيمة لا مثيل لها إلى شركائها الكرام. www.mitsumidistribution.com

للاستفسارات الإعلامية، يُرجى التواصل عبر البريد الإلكتروني:

marketing@mitsumidistribution.com

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Nyxoah to Release First Quarter 2024 Financial Results on May 14, 2024

Mont-Saint-Guibert, Belgium – May 13, 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 release financial results for the first quarter 2024 on Tuesday, May 14, 2024, after market close. Company management will host a conference call to discuss financial results that day beginning at 10:30pm CET / 4:30pm ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah’s Q1 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah’s Q1 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

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

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

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; 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, 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
David DeMartino, Chief Strategy Officer
IR@nyxoah.com

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