Day: May 17, 2023

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Nyxoah Reports First Quarter 2023 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2023 Financial and Operating Results

Mont-Saint-Guibert, Belgium – May 16, 2023 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 2023.

Recent Financial and Operating Highlights

  •  Completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected in the first quarter of 2024.
  •  Initiated the modular PMA submission with the filing of the first module.
  •  Submitted 12-month data1 on the first 34 DREAM patients as a late-breaking abstract to SLEEP 2023 demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. The abstract will be presented in a late-breaking poster session on June 6th. These data are preliminary and not conclusive of final DREAM success.
  •  Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC). Implant completion expected in 2024.
  •  Hired Christoph Eigenmann as Chief Commercial Officer.
  •  Raised €19 million from new and historical shareholders including ResMed, Cochlear and Robert Taub, Nyxoah’s Chairman and Founder.
  •  Ended the quarter with 40 active German accounts and quarterly sales of €441 thousand.
  •  Expanded European market access with first implants in Austria.
  •  Strengthened the supply chain with the Belgium manufacturing facility receiving clearance from the EU notified body.

“In 2023, our focus is in the U.S. on DREAM patient follow up resulting in reaching the primary endpoints. I am excited by the data on the first 34 patients and look forward to sharing the full abstract results at SLEEP 2023 next month. Our increasing conviction in DREAM outcomes is accelerating investment in our commercial organization, starting with the addition of Christoph as Chief Commercial Officer,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Christoph’s hire, along with the €19 million raised from key investors, puts us in a strong position as we embark on our next stage of growth.”

First Quarter 2023 Results

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2023  (in thousands)

        For the three months ended March 31
2023   2022
Revenue €441 €660
Cost of goods sold   (175) (289)
Gross profit €266 €371
Research and Development Expense   (6,157) (3,595)
Selling, General and Administrative Expense (5,551) (4,193)
Other income/(expense) 46 136
Operating loss for the period   €(11,396) €(7,281)
Financial income 625 1,576
Financial expense   (958) (788)
Loss for the period before taxes €(11,729) €(6,493)
Income taxes   (182) (208)
Loss for the period €(11,911) €(6,701)
     
Loss attributable to equity holders €(11,911) €(6,701)
Other comprehensive loss  
Items that may be subsequently reclassified to profit or
loss (net of tax)
Currency translation differences   (28) ( 102)
Total comprehensive loss for the year, net of tax €(11,939) €(6,803)
Loss attributable to equity holders   €(11,939) €(6,803)
Basic Loss Per Share (in EUR) €(0.460) €(0.260)
Diluted Loss Per Share (in EUR) €(0.460) €(0.260)

 UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF MARCH 31, 2023 (in thousands)

    As at
March 31
2023		   December 31 2022
ASSETS
Non-current assets      
Property, plant and equipment €2,721 €2,460
Intangible assets 42,447   39,972
Right of use assets 3,669 3,159
Deferred tax asset     50   47
Other long-term receivables 169 173
    €49,056   €45,811
Current assets      
Inventory     1,249   882
Trade receivables 1,499 1,463
Other receivables     1,419   1,775
Other current assets 1,663 1,284
Financial assets 62,403 76,968
Cash and cash equivalents 33,664 17,888
  €101,897 €100,260
Total assets €150,953 €146,071
   
EQUITY AND LIABILITIES
Capital and reserves    
Capital 4,859 4,440
Share premium 243,488   228,275
Share based payment reserve   6,582 5,645
Other comprehensive income 148   176
Retained loss   (130,051) (118,212)
Total equity attributable to shareholders €125,026 €120,324
     
LIABILITIES
Non-current liabilities    
Financial debt 8,381   8,189
Lease liability   3,112 2,586
Pension liability 25   −
Provisions   74 59
Deferred tax liability −   −
€11,592 €10,834
Current liabilities    
Financial debt 390   388
Lease liability   711 719
Trade payables 5,012   4,985
Current tax liability 3,619   3,654
Other payables 4,603   5,167
  €14,335 €14,913
Total liabilities €25,927 €25,747
Total equity and liabilities €150,953 €146,071

Revenue

Revenue was €441,000 for the first quarter ending March 31, 2023, compared to €660,000 for first quarter ending March 31, 2022.

Cost of Goods Sold

Cost of goods sold was €175,000 for the three months ending March 31, 2023, representing a gross profit of €266,000, or gross margin of 60.3%. This compares to total cost of goods sold of €289,000 in the first quarter ending March 31, 2022, for a gross profit of €371,000, or gross margin of 56.2%.

Research and Development Expenses

Research and development expenses were €6.2 million for the three months ending March 31, 2023, versus €3.6 million for the prior year period, driven by an acceleration in clinical activities, notable the start of the ACCCESS study.

Selling, General and Administrative Expenses

Selling, general and administrative expenses rose to €5.6 million for the first quarter of 2023, up from €4.2 million in the first quarter of 2022. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.

Operating Loss

Total operating loss for the first quarter 2023 was €11.4 million versus €7.3 million in the first quarter of 2022. 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, 2023, cash and financial assets totaled €96.1 million, compared to €94.9 million on December 31, 2022.  Total cash burn was approximately €4.9 million per month during the first quarter of 2023.

First Quarter 2023 Report
Nyxoah’s financial report for the first quarter of 2023, 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 
Nyxoah will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number: https://edge.media-server.com/mmc/p/imeku8f7

A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. The archived webcast will be available for replay shortly after the close of the call.

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

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, 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
david.demartino@nyxoah.com
+1 310 310 1313

1 For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

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SC Land and Planning Manager Considers FIFA World Cup Qatar 2022’s Exceptional Hosting an Unprecedented Historical Achievement

Land & Planning Manager for the Supreme Committee for Delivery & Legacy (SC) Allison Taylor considered that the exceptional success in hosting the FIFA World Cup Qatar 2022 was an unprecedented historical achievement, expressing her pride in having participated in the work team for more than nine years, on the road to preparing to host the first ever FIFA World Cup tournament in the Arab world and the Middle East.

Speaking to the Qatar2022.qa website, part of its Amazing: Delivered series,”It was an exciting, mega project that had global reach and working on it was a once-in-a-lifetime opportunity. I had been working in Qatar for a couple of years before taking the role and this offered a chance to really contribute to the development of the country. Who wouldnt say yes to a project like this?!” She wondered.

Regarding her role during the tournament, Taylor said: “During the World Cup, I was in the Main Operations Centre, representing the non-official sites team. Effectively, the Main Operations Centre was a collection of representatives from several different projects, including stakeholders like KAHRAMAA and Ashghal, and featured a number of other command centres. We dealt with different issues that would arise during the tournament and worked towards making sure everything went smoothly.” She expressed that her proudest achievement was the delivery of this amazing project successfully. To achieve that goal, not only for herself as a professional, but for the State of Qatar and all her colleagues, that was a great achievement.

She then elaborated by adding: “In terms of the project itself, I feel so proud to have been involved. I met an amazing amount of wonderful people and had so many great experiences. I feel very privileged to have been part of this project since almost the start. To see all these stadiums become reality, seeing everything operational and people having a great time, it feels wonderful.” In her interview with the Qatar2022.qa website, Allison Taylor touched on the key lesson she learned during her FIFA World Cup Qatar 2022 experience, and that was coordination and teamwork, saying: “I cant say that enough. There were situations that weve gone through where things were done in silos and not in a coordinated fashion. I always recommend to communicate with everyone as a team. Also, be kind to each other. Even in our most stressful times, keep the kindness and keep the respect.” Urban planner Allison Taylor has overseen a multitude of roles during her nine-year stint supporting Qatars preparations for the FIFA World Cup .

she was involved in pre-tournament planning, construction, and event operations.

Source: Qatar News Agency

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QDB, Microsoft Qatar Partner to Accelerate Startups, SMEs Digital Transformation

Qatar Development Bank and Microsoft Qatar have established a partnership aiming to accelerate the digital transformation of startups and SMEs and to foster innovation as part of QDB’s integrated efforts to bolster the local entrepreneurship ecosystem and talent pool as well as Qatar’s position as a regional innovation and technology hub.

The partnership will enable SMEs to benefit from emerging technologies, leveraging Microsoft Cloud to improve performance, boost productivity, reduce costs, and develop innovative solutions.

The initiative will also provide SMEs with the opportunity to build their digital skills through the Microsoft Learn platform, which equips entrepreneurs, leaders and employees with the necessary skills to leverage cloud technology to accelerate digital transformation and achieve growth in a knowledge-based economy.

Startups under Qatar Development Bank’s umbrella will also now have access to Microsoft’s Founders Hub, a platform that brings together people, knowledge, and technology to help founders solve challenges in every stage of their ambitious journey.

Microsoft will also offer access to learning tools to enable entrepreneurs and startups to leverage cloud technology such as artificial intelligence, data analytics and the Internet of Things to launch a successful business.

Commenting on this partnership, Abdulrahman Hesham Al Sowaidi, Acting CEO of QDB said: “This partnership provides access to an advanced set of digital platforms, and guarantees the readiness of our innovators and startups to pursue aspirations that fall in line with our goals of developing Qatar’s entrepreneurship ecosystem and strengthening the country’s position as a center for innovation and technological excellence.” Lana Khalaf, General Manager, Microsoft Qatar, expressed her enthusiasm about the partnership with Qatar Development Bank which aligns with the company’s investments to empower in the startups and SMEs ecosystem in Qatar. She said, “Startups and SMEs play a pivotal role in accelerating Qatar’s digital economy and its position as an innovation hub for investment. Through this initiative, businesses will have access to the latest cloud technologies and digital skills needed to achieve their business goals and contribute to Qatar’s economic growth and development. This partnership supports our efforts to be the preferred and trusted partner for cloud innovation for all sectors of the economy in Qatar.” QDB’s partnership with Microsoft is the latest in a series of initiatives to bolster capacity development and build a diversified entrepreneurship ecosystem that drives economic development.

Source: Qatar News Agency

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Human Resources Minister Heads Meeting of ARADO Executive Council

The Minister of Human Resources and Social Development, Eng. Ahmed bin Sulaiman Al-Rajhi, virtually today headed the 115th meeting of the Executive Council of the Arab Administrative Development Organization (ARADO), which was held in Cairo with the participation of several ministers and representatives of member states of the council.

Al-Rajhi delivered the opening speech during the meeting in which he emphasized the ongoing efforts to activate the ARADO’s role and achieve sustainable administrative development in the Arab world to contribute to ARADO’s ambitions and aspirations at the Arab and international levels.

During the meeting, attendees reviewed the organization’s achievements and financial results for 2022, followed up on implementing previous decisions of the council and discussed the importance of implementing the recommendations of the organization’s strategy team to ensure the implementation of the strategy and the achievement of its objectives.

Source: Saudi Press Agency

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Foreign Minister Meets with Syrian Foreign Minister

Prince Faisal bin Farhan bin Abdullah, the Minister of Foreign Affairs, met in Jeddah today with Dr. Fayssal Mikdad, the Minister of Foreign Affairs and Expatriates of the Syrian Arab Republic, on the sidelines of the Preparatory Ministerial Meeting of the Arab League Council at the Summit Level in its 32nd session.

During the meeting, they discussed the latest developments in the Syrian arena and the region, exchanging views on matters of common concern.

Additionally, the two sides exchanged perspectives on the agenda items of the Preparatory Ministerial Meeting of the Arab League Council at the Summit Level in its 32nd session.

Source: Saudi Press Agency

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Discovery of an archaeological site dating back to the Roman era in Sabratha.

The GNU-Ministry of Interior announced the discovery of an archaeological site dating back to the Roman era in Sabratha.

The Ministry stated on its SMS page that a report was received to the tourist police branch and the protection of antiquities in the western region from a citizen stating that an archaeological site was found while he was surveying and bulldozing his land near Sabratha Hospital.

The Ministry confirmed that a record was opened in this regard, and the Western Public Order Prosecution Office and the Sabratha Antiquities Office were notified.

It indicated that a member of the Public Order Prosecution, accompanied by the head of the Investigation Unit, members of the investigation in the branch, and two antiquities experts, went to the location of the site to inspect the place based on an assignment issued by the Director of the Western Public Order Prosecution when the site was discovered and later found to be archaeological dating back to the Roman era.

The ministry said that all legal measures have been taken, including stopping the survey, placing an insulating tape, and assigning members of the tourist police to protect the site from tampering and theft.

Source: Libyan News Agency