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Nyxoah Reports Third Quarter 2022 Financial and Operating Results

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Nyxoah Reports Third Quarter 2022 Financial and Operating Results

DREAM US pivotal 12–month clinical data expected in fall of 2023

Mont–Saint–Guibert, Belgium "" November 8, 2022, 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 quarter ended September 30, 2022.

Third Quarter 2022 Financial and Operating Highlights

  • Completed 110 of 115 implants in the DREAM U.S. pivotal trial to date, with 12–month clinical data expected in the fall of 2023 and regulatory approval in the second quarter of 2024
  • Activated the first clinical sites in the ACCCESS U.S. pivotal trial to treat complete concentric collapse (CCC) patients in the U.S., with first implants expected in the fourth quarter of 2022
  • Reported revenue of 182,000 from the commercialization of Genio ; sales during the third quarter were impacted by a temporary inventory shortage in Germany due to a disruption at a component supplier, resulting in unfulfilled third quarter orders of approximately 700,000 in Germany; this supply disruption has subsequently been remedied and the vast majority of the open orders have since been filled
  • Ended the third quarter with 32 active sites in Germany, up from 26 sites at the end of the second quarter 2022; expects to have up to 40 active sites by the end of 2022
  • Launched the "Care4" program, using the AcuPebble home sleep test at selected centers of excellence in Germany to accelerate the time from CPAP failure to our Genio solution
  • Received CE Mark for the next–generation Genio system, Genio 2.1

"With 110 implants in the DREAM trial, we believe we are within weeks of completion of the implants, keeping us on track for 12–month data next fall," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "Additionally, ACCCESS, our second US pivotal trial is launched, and first patients are expected to be implanted before year end. This trial is focused on addressing the unmet need of approximately 30% of OSA patients contra–indicated in the U.S. to hypoglossal nerve stimulation due to their complete concentric collapse."

Mr. Taelman continued, "Commercially in Germany, where we have both CCC and non–CCC indications already, we continue to build on our momentum, as patients and clinicians increasingly recognize the unique benefits of the Genio solution. While third quarter sales reflected a temporary supply disruption, the fourth quarter is off to a strong start, as we are filling both open orders from the third quarter and new ones. This gives us confidence that we can be the German market leader exiting 2022."

Third Quarter 2022 Results

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION "" INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS"FOR THE THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30,"2022"(in thousands)

For the three months ended September 30 For the nine months ended September 30
2022 2021 2022 2021
Revenue 182 203 1 777 557
Cost of goods sold ( 63) ( 82) ( 685) ( 198)
Gross profit 119 121 1 092 359
Research and Development Expense (4 221) (3 517) (11 286) (9 009)
Selling, General and Administrative Expense (4 763) (4 496) (13 492) (10 775)
Other income/(expense) 87 ( 178) 237 ( 274)
Operating loss for the period (8 778) (8 070) (23 449) (19 699)
Financial income 5 127 29 11 372 72
Financial expense (2 524) ( 585) (5 473) (1 484)
Loss for the period before taxes (6 175) (8 626) (17 550) (21 111)
Income taxes ( 65) ( 136) ( 379) ( 260)
Loss for the period (6 240) (8 762) (17 929) (21 371)
Loss attributable to equity holders (6 240) (8 762) (17 929) (21 371)
Other comprehensive loss
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences 100 ( 54) ( 14) 138
Total comprehensive loss for the year, net of tax (6 140) (8 816) (17 943) (21 233)
Loss attributable to equity holders (6 140) (8 816) (17 943) (21 233)
Basic Loss Per Share (in EUR) (0.242) (0.348) (0.695) (0.923)
Diluted Loss Per Share (in EUR) (0.242) (0.348) (0.695) (0.923)

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION "" INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS AT SEPTEMBER 30, 2022 (in thousands)

As at
September 30, 2022 December 31, 2021
ASSETS
Non–current assets
Property, plant and equipment 2 216 2 020
Intangible assets 36 488 25 322
Right of use assets 3 413 3 218
Deferred tax asset 2 423 46
Other long–term receivables 188 164
44 728 30 770
Current assets
Inventory 594 346
Trade receivables 757 226
Other receivables 2 022 2 286
Other current assets 587 1 693
Financial assets 25 505 '
Cash and cash equivalents 89 877 135 509
119 342 140 060
Total assets 164 070 170 830

EQUITY AND LIABILITIES
Capital and reserves
Capital 4 440 4 427
Share premium 228 275 228 033
Share based payment reserve 5 225 3 127
Other comprehensive income 188 202
Retained loss (105 058) (87 167)
Total equity attributable to shareholders 133 070 148 622
LIABILITIES
Non–current liabilities
Financial debt 8 035 7 802
Lease liability 2 831 2 737
Pension liability 80 80
Provisions 47 12
Deferred tax liability ' 5
10 993 10 636
Current liabilities
Financial debt 656 554
Lease liability 722 582
Trade payables 5 346 3 995
Current tax liability 5 391 2 808
Other payables 7 892 3 633
20 007 11 572
Total liabilities 31 000 22 208
Total equity and liabilities 164 070 170 830

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION – INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS AS AT SEPTEMBER 30, 2022 (in thousands)

For the nine months ended September 30
2022 2021
CASH FLOWS FROM OPERATING ACTIVITIES
Loss before tax for the year (17 550) (21 111)
Adjustments for
Finance income (11 372) ( 72)
Finance expenses 5 473 1 484
Depreciation and impairment of property, plant and equipment and right–of–use assets 832 558
Amortization of intangible assets 607 653
Share–based payment transaction expense 2 136 784
Increase/(Decrease) in provisions 36 4
Other non–cash items ( 353) 247
Cash generated before changes in working capital (20 191) (17 453)
Changes in working capital
Decrease/(Increase) in inventory ( 248) ( 33)
(Increase)/Decrease in trade and other receivables 1 100 (2 876)
Increase/(Decrease) in trade and other payables 1 265 2 563
Cash generated from changes in operations (18 074) (17 799)
Income tax paid ( 314) ( 205)
Net cash used in operating activities (18 388) (18 004)

CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment ( 484) (1 257)
Capitalization of intangible assets (11 774) (7 219)
Purchase of financial assets – current (44 032) '
Proceeds from sale of financial assets – current 24 582 '
Interest income on financial assets 63 '
Net cash used in investing activities (31 645) (8 476)
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of principal portion of lease liabilities ( 497) ( 358)
Repayment of other loan ( 62) ( 63)
Interests paid ( 185) ( 324)
Repayment of recoverable cash advance ( 220) ( 280)
Proceeds from issuance of shares, net of transaction costs 255 76 070
Other financial costs ( 55) ( 7)
Net cash used in financing activities ( 764) 75 038
Movement in cash and cash equivalents (50 797) 48 558
Effect of exchange rates on cash and cash equivalents 5 165 56
Cash and cash equivalents at January 1 135 509 92 300
Cash and cash equivalents at September 30 89 877 140 914

Revenue

Revenue was 182,000 for the third quarter of 2022, compared to 203,000 for the prior year period. The decrease in revenue was attributable to the temporary supply disruption that caused a delay in order fulfillment.

Cost of Goods Sold

Cost of goods sold was 63,000 for the three months ending September 30, 2022, representing a gross profit of 119,000, or gross margin of 65.3%. This compares to total costs of goods sold of 82,000 in the third quarter of 2021, for a gross profit of 121,000, or gross margin of 59.6%.

Research and Development Expenses

Research and development expenses were 4.2 million for the three months ending September 30, 2022, versus 3.5 million for the prior year period, reflecting the Company's investments in the development of next generation versions of the Genio system as well as ongoing clinical studies, most notably DREAM in the U.S.

Selling, General and Administrative Expenses

General and administrative expenses rose to 4.8 million for the third quarter of 2022, up from 4.5 million in the third quarter of 2021. 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 U.S. commercial launch.

Operating Loss

Total operating loss for the third quarter of 2022 was 8.8 million versus 8.1 million in the third quarter of 2021. This was driven by the delay of third quarter revenue due to the temporary supply disruption, the acceleration in the Company's R&D spending, and ongoing commercial and clinical activities. Nyxoah realized a net loss of 6.2 million for the third quarter of 2022, compared to a net loss of 8.8 million for the third quarter.

Cash Position

As of September 30, 2022, cash and financial assets totaled 115.4 million, compared to 135.5 million on December 31, 2021. Total cash burn was approximately 3.0 million per month during the third quarter of 2022, and is expected to increase going forward to account for the ACCCESS IDE trial in the U.S.

Third Quarter 2022 Report

Nyxoah's financial report for the third quarter of 2022, including details of the unaudited 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 to open to the public today at 10:30 p.m. CET / 4:30 p.m. 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://register.vevent.com/register/BI0d7e0daed6e34e548b85e51146400c1a

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; future financial performance and market position; 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
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

Attachment


GLOBENEWSWIRE (Distribution ID 1000755751)

CryptoDATA Tech becomes RNF MotoGP Team majority and strategic shareholder

BUCHAREST, Romania, Nov. 08, 2022 (GLOBE NEWSWIRE) — CryptoDATA Tech, a blockchain–applied technologies pioneer and developer of hardware and software cybersecurity solutions, is pleased to announce the acquisition of a majority stake in RNF Racing Ltd. This strategic investment marks a significant milestone and a beginning of a new era for the fifteen months old RNF MotoGP team and the Romanian holding.

After previously announcing the cybersecurity company as the Official Premium Partner for the final three races of the season, CryptoDATA's became a partner who shared the same passion, values and recognised the potential value of a MotoGP team in the long term.

With CryptoDATA as the majority shareholder, the vision and strategy is to go beyond racing and expand the business and services into motorsports mainly in MotoGP and taking the role of the business and branding aspects of the team. RNF MotoGP Team will continue participating as an Independent Team in the premier class of the FIM MotoGP World Championship with Team Principal Razlan Razali remaining at the helm focusing on the sporting and technicality side of the team.

In conjunction with the final race of the season and to mark the start of this historical milestone, RNF MotoGP Team and CryptoDATA will be unveiling a special livery design on race day at the Valencia Grand Prix.

Razlan Razali, Founder and Team Principal, RNF Racing Ltd,
“Today marks a historical milestone for the team. I'd like to thank CryptoDATA for putting their trust in me and the team for the future.”

“In a short period of time, discussions have evolved into a long term commitment. We have extended our partnership, and as I previously stated, this is a fantastic collaboration. The union of the two companies will drive the team to not just perform in racing, but also to grow the business aspects of the team, and this is where both parties join forces to share expertise and experience. My main focus is to ensure the team fights for the championship while CryptoDATA's team consisting of young, smart, innovative, and ambitious individuals will develop strategies to strengthen our position off track.”

“With the experience from our previous successes, the same strong and passionate crew from our MotoGP garage, and a solid rider line–up, we are set for a competitive comeback with CryptoDATA for the next season.”

Ovidiu TOMA, Chief Executive Officer and Founder, CryptoDATA Tech,
"We are delighted to extend our partnership and become the majority shareholder of the RNF MotoGP Team. The MotoGP World Championship is an exclusive and international showcase, a special universe where the starting grid is a stage for heroes in which CryptoDATA has found its space by sharing its values and objectives. We became the first Romanian company to Title Sponsor a Moto Grand Prix at the Red Bull track this year, and we are now more excited and motivated than ever to become the majority shareholder in the RNF Team. This represents not only a historical milestone for CryptoDATA, but also a new beginning and a significant incentive.

"We look to 2023 with optimism and confidence as our team is led by trained, serious, and experienced managers. We will do our best to support the team to achieve their goals and to reach their highest potential in MotoGP."

Bogdan Mruni, Global Strategy and Founder, CryptoDATA Tech,
"We are glad to announce our partnership with the RNF team, and we are confident that we can help the team set strategic goals for the upcoming season and long–term performance goals both on and off–track. We want to start the team's transformation into a successful business that will provide unique experiences to our fans and partners while promoting our brand values in the top series of global racing."

"As CryptoDATA representatives, we will be in charge of the business's strategic management and will work to provide stability and further strengthen the team's position in the MotoGP world and in the business world."

Carmelo Ezpeleta, Chief Executive Officer, Dorna Sports S.L,
"The agreement that Razlan Razali has reached with CryptoDATA allows him to maintain the viability and presence of his project in MotoGP. We are delighted to see a new sponsor supporting a team, especially one that Dorna brought to the championship. We were happy with the relationship with CryptoDATA at the Austrian Grand Prix, they have the idea to develop and the idea to put things together with Aprilia next year which is the stability needed for MotoGP, it's a very warm welcome for CryptoDATA to MotoGP. The fact that they are not just limiting their participation in the sponsorship area but in an entire team shows the importance of Motorsport and of MotoGP in particular. We know that Razlan had many requests, and we believe he has chosen the best option for the future and to consolidate his structure."

About RNF MotoGP Team

A new beginning, a collaboration that goes beyond racing. The RNF MotoGP Team will debut in the premier class of the 2023 FIM MotoGP World Championship grid as the first–ever satellite team for Aprilia showcasing Portuguese MotoGP rider and 5–times race winner Miguel Oliveira with promising Spanish youngster and 2021 Moto2 Vice World Champion, Raul Fernandez.

The addition of CryptoDATA to the RNF MotoGP Team brings sustainability on and off track, as it sets the tone for further developing and improving performance in the upcoming season. The team will collaborate on two missions for the team with CryptoDATA spearheading the business side while RNF MotoGP Team focuses on the sports itself.

Our shared passion for performance, innovations and technology will bring a fresh and unique value to the world of motorsports.

About CryptoDATA Tech

CryptoDATA Tech is a global ambassador for promoting the importance of data security and digital privacy worldwide. The company has pioneered the development of services and products based on blockchain technology that enables private and secure communication, satisfying the requirements of its collaborators as well as tech users worldwide. Wispr, one of its major products, is an online messaging app that allows motorsport fans to exchange messages without constraints from anywhere in the world, thereby fueling the passion and determination of the motorsport community.

Contact details:
Cosmin Bidileci
Email: cosmin.bidileci@cryptodata.com
Phone: +40750803241

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2edbe83b–3def–4c0b–9b14–5bc24d38858e


GLOBENEWSWIRE (Distribution ID 1000755737)