Nyxoah (NASDAQ: NYXH) lifts H1 2026 revenue to €14.0M as U.S. launch scales
Rhea-AI Filing Summary
Nyxoah reported second-quarter and first-half 2026 results, with H1 2026 revenue of €14.0 million, up from €2.4 million a year earlier, as U.S. commercialization of its Genio system accelerated. U.S. revenue grew 22% sequentially in Q2 2026 over Q1 2026 and reached €9.5 million for the first half, alongside €4.6 million from international markets.
Despite higher gross profit of €8.2 million, heavy investment in growth led to a net loss of €48.9 million versus €43.0 million in H1 2025, while basic loss per share improved to €0.976 from €1.149 on a larger share base. Cash and financial assets totaled €97.8 million at June 30, 2026, supported by a Q2 equity raise and additional drawdown under the European Investment Bank term loan, providing liquidity for continued U.S. launch and clinical programs.
Positive
- H1 2026 revenue increased to €14.0 million from €2.4 million, reflecting rapid uptake of the Genio system as U.S. and international commercialization expanded.
- Cash and financial assets reached €97.8 million at June 30, 2026, aided by an equity raise and term-loan funding, giving Nyxoah substantial liquidity to support operations and growth initiatives.
Negative
- Nyxoah’s net loss widened to €48.9 million in H1 2026 from €43.0 million a year earlier, as higher selling, general and administrative spending and financing costs outpaced gross profit.
- The net negative financial result deepened to €7.0 million, driven mainly by a €5.4 million fair value loss on convertible bond and synthetic warrant liabilities and €1.5 million amortization of the day 1 loss.
Filing Explained
Completed share issuance increased Nyxoah’s share count to 100,072,815 by June 30, 2026, reducing existing holders’ percentage ownership absent offsets.
Form 6-K furnishes material information published by a foreign private issuer; this filing reports Nyxoah’s completed first-half financing and interim results as of
The equity financing was completed through the issuance of
The EIB financing also included a completed
As of
Management states that the
Key Figures
Key Terms
Obstructive Sleep Apnea medical
hypoglossal neurostimulation medical
Complete Concentric Collapse (CCC) medical
Breakthrough Device Designation regulatory
synthetic warrants financial
recoverable cash advances financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
How did Nyxoah (NYXH) perform financially in the first half of 2026?
What drove Nyxoah (NYXH) revenue growth in H1 2026?
What is Nyxoah (NYXH)'s cash position as of June 30, 2026?
How are Nyxoah (NYXH)'s operating expenses evolving?
What key clinical and regulatory milestones support Nyxoah (NYXH)'s Genio system?
What is Nyxoah (NYXH)'s outlook for the rest of 2026?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2026
Commission File Number: 001-40552
(Translation of registrant’s name into English)
Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
On August 5, 2026, Nyxoah SA (the “Company”) issued a press release announcing its financial and operating results for the second quarter and first half of 2026. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Additionally, on August 5, 2026, the Company announced its unaudited first half-year results for 2026, which are further described in an H1 2026 report.
The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
The information in the attached Exhibit 99.2 shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-261233, 333-269410, 333-283103, 333-285960 and 333-294644) and Form F-3 (Registration Number 333-285982) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
2
Exhibits
99.1 | | Press Release, dated August 5, 2026 |
99.2 | H1 Report 2026 |
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NYXOAH SA | ||
|
| |
Date: August 5, 2026 | By: | /s/ John Landry |
Name: | John Landry | |
Title: | Chief Financial Officer | |
4
Exhibit 99.1
REGULATED INFORMATION
Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results
U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026
Mont-Saint-Guibert, Belgium – August 5, 2026, 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 second quarter and first half of 2026.
Financial and Operating Highlights
| ● | Financials |
o | U.S. net revenue for the second quarter of 2026 was €5.2 million, 22% sequential growth over U.S. net revenue for the first quarter of 2026 |
o | Global net revenue for the second quarter of 2026 was €7.7 million, 21% sequential growth over global net revenue for the first quarter of 2026 |
o | Global net revenue for the first half of 2026 was €14.0 million, as compared to €2.4 million for the first half of 2025 |
o | Secured $110 million in aggregate financing during the second quarter of 2026. As of June 30, 2026, cash and cash equivalents and financial assets totaled €97.8 million |
| ● | Leading U.S. commercial indicators |
o | 40 active sales reps, focused on covering 200 high volume HGNS accounts |
o | 55 new surgeons trained in Q2, bringing the total to 262 surgeons trained |
o | 89 new accounts activated in Q2, bringing the total to 180 active high-volume accounts |
o | 427 patients actively under prior authorization entering Q3 2026, a 77% increase over the number of patients actively under prior authorization entering Q2 2026 |
| ● | U.S. reimbursement landscape |
o | 100% approval rate on reviewed prior authorization submissions |
o | Clarity for Genio, with Medicare C-code 8011 and existing commercial payers CPT codes |
o | CMS proposed reimbursement increases in both hospital outpatient and ambulatory surgical centers of 12% and 15% respectively for 2027 |
o | Upcoming CPT editorial panel meetings to involve AAO-HNS and industry discussing comprehensive HGNS coding |
| ● | Hosted investor day on July 8 – Link to the replay |
o | Featured independent perspectives from ENT and Sleep physicians, who highlighted Genio’s differentiated clinical profile and their intent to expand utilization across their patient populations |
o | Reimbursement expert group confirmed the strength and durability of long-term HGNS coverage, with Genio well positioned across future coding scenarios |
1
“The doubling of active accounts in Q2 and the strong acceleration of our patient pipeline, demonstrate the growing acceptance and excitement around Genio by physicians and patients,” commented Olivier Taelman, Chief Executive Officer of Nyxoah. “With a dedicated Genio C-code for Medicare patients and another quarter of 100% prior-authorization approval for commercial and WISeR patients, we are confident that the current reimbursement landscape supports our accelerating U.S. revenue growth. The recent closing of our $110 million financing provides the capital needed to further invest in Genio’s U.S. commercial organization in the second half of 2026.”
Results for the Three and Six Months Ended June 30, 2026
Revenue
| ● | Net revenue in the second quarter of 2026 was €7.7 million, compared to €1.3 million in the second quarter of 2025. Net revenue in the first half of 2026 was €14.0 million, as compared to €2.4 million for the first half of 2025. The increases in net revenue were primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets. |
Cost of Goods Sold
| ● | Cost of goods sold was €3.1 million for the second quarter of 2026, resulting in gross profit of €4.6 million and a gross margin of 60% for the second quarter of 2026, compared to cost of goods sold of €0.5 million in the second quarter of 2025, resulting in gross profit of €0.9 million and a gross margin of 63% in the second quarter of 2025. The increase in cost of goods sold was primarily driven by an increase in revenue. The decrease in gross margin was primarily due to a higher mix of U.S. revenue. |
| ● | Cost of goods sold in the first half of 2026 was €5.8 million, as compared to €0.9 million for the first half of 2025, resulting in gross profit of €8.2 million and a gross margin of 59% in the first half of 2026, compared to gross profit of €1.5 million and a gross margin of 63% in the first half of 2025. The decrease in gross margin was primarily due to production yield issues in the first quarter of 2026 and higher mix of U.S. revenue. |
Research and Development
| ● | For the second quarter of 2026, research and development expenses were €9.5 million, versus €10.1 million for the second quarter of 2025. For the first half of 2026, research and development expenses were €18.3 million, versus €19.0 million for the first half of 2025. The decreases in research and development expenses were primarily due to a decrease in product development expenses. |
Selling, General and Administrative
| ● | For the second quarter of 2026, selling, general and administrative expenses were €15.6 million, versus €10.7 million for the second quarter of 2025. For the first half of 2026, selling, general and administrative expenses were €31.0 million, versus €23.1 million for the first half of 2025. The increases in selling, general and administrative expenses were primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions. |
Operating Loss
| ● | Total operating loss for the second quarter of 2026 was €20.6 million, versus €19.9 million in the second quarter of 2025. Total operating loss for the first half of 2026 was €41.1 million, versus €40.5 million in the first half of 2025. The increases in operating loss reflect increased net revenue offset by increased investments to support the build-out of the Company’s U.S. commercial organization. |
Cash Position
Cash and cash equivalents and financial assets totaled €97.8 million at June 30, 2026, compared to €48.0 million at December 31, 2025.
2
Financial Guidance for the full year 2026
| ● | The Company continues to expect worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million. |
| ● | The Company continues to expect gross margin for the full year 2026 to be in the range of 60% to 62%. |
| ● | The Company now expects total operating expenses for the full year 2026 to be in the range of €99 million to €102 million. This increase of approximately €1 million is due to the one-time share-based compensation expense of approximately €0.9 million associated with the repricing of employee equity incentive arrangements recorded in the second quarter. |
| ● | The Company continues to expect non-GAAP cash operating expenses for the full year 2026 to be in the range of €88 million to €90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less non-cash expenses such as depreciation, amortization, and share-based compensation. |
Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Wednesday, August 5, 2026, 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 Q2 Earnings Call Webcast. For those not planning to ask a question to management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah’s Q2 2026 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.
Non-GAAP financial measures
This press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expense items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company’s operating performance and for planning purposes, including the preparation of the Company’s annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. The Company’s definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat 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
3
Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and receipt of approval from the FDA in August 2025.
For more information, please visit http://www.nyxoah.com.
Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.
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 management’s current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, future revenue, future operating expenses, future gross margins 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. 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, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 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.
4
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited) (in thousands)
| | For the three months ended | | For the six months ended | ||||||||
| | June 30 | | June 30 | ||||||||
| | 2026 | | 2025 | | 2026 | | 2025 | ||||
Revenue | | | 7,675 | | | 1,340 | | | 14,047 | | | 2,404 |
Cost of goods sold | |
| (3,091) | |
| (490) | |
| (5,826) | |
| (896) |
Gross profit | | € | 4,584 | | € | 850 | | € | 8,221 | | € | 1,508 |
Research and Development Expense | |
| (9,543) | |
| (10,059) | |
| (18,347) | |
| (19,048) |
Selling, General and Administrative Expense | |
| (15,618) | |
| (10,672) | |
| (30,992) | |
| (23,063) |
Other income/(expense) | |
| (11) | |
| 31 | |
| 29 | |
| 115 |
Operating loss for the period | | € | (20,588) | | € | (19,850) | | € | (41,089) | | € | (40,488) |
Financial income | |
| 1,179 | |
| 2,858 | |
| 2,468 | |
| 5,480 |
Financial expense | |
| (13,078) | |
| (3,337) | |
| (9,421) | |
| (7,579) |
Loss for the period before taxes | | € | (32,487) | | € | (20,329) | | € | (48,042) | | € | (42,587) |
Income taxes | |
| (477) | |
| (278) | |
| (868) | |
| (404) |
Loss for the period | | € | (32,964) | | € | (20,607) | | € | (48,910) | | € | (42,991) |
| |
| | |
| | |
| | |
| |
Loss attributable to equity holders | | € | (32,964) | | € | (20,607) | | € | (48,910) | | € | (42,991) |
Other comprehensive loss | |
| | |
| | |
| | |
| |
Items that may be subsequently reclassified to profit or loss (net of tax) | |
| | |
| | |
| | |
| |
Currency translation differences | |
| 310 | |
| 232 | |
| 1 | |
| 230 |
Total comprehensive loss for the year, net of tax | | € | (32,654) | | € | (20,375) | | € | (48,909) | | € | (42,761) |
Loss attributable to equity holders | | € | (32,654) | | € | (20,375) | | € | (48,909) | | € | (42,761) |
| |
| | |
| | |
| | |
| |
Basic Loss Per Share (in EUR) | | € | (0.578) | | € | (0.551) | | € | (0.976) | | € | (1.149) |
Diluted Loss Per Share (in EUR) | | € | (0.578) | | € | (0.551) | | € | (0.976) | | € | (1.149) |
5
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2026 – Interim consolidated statement of financial position (unaudited) (in thousands)
| | As at | ||||
| | June 30 | | December 31 | ||
| | 2026 | | 2025 | ||
ASSETS | | | | | | |
Non-current assets |
| | |
| | |
Property, plant and equipment |
| | 4,159 |
| | 4,052 |
Intangible assets |
| | 48,016 |
| | 50,108 |
Right of use assets |
| | 1,775 |
| | 1,293 |
Deferred tax asset |
| | 10 |
| | 87 |
Other long-term receivables |
| | 1,831 |
| | 1,718 |
|
| € | 55,791 |
| € | 57,258 |
Current assets |
| | |
| | |
Inventory |
| | 3,706 |
| | 4,660 |
Trade receivables |
| | 6,849 |
| | 5,254 |
Contract assets | | | 100 | | | 261 |
Other receivables |
| | 3,432 |
| | 2,209 |
Other current assets |
| | 803 |
| | 828 |
Financial assets |
| | 33,670 |
| | 18,000 |
Cash and cash equivalents |
| | 64,115 |
| | 30,001 |
|
| € | 112,675 |
| € | 61,213 |
Total assets |
| € | 168,466 |
| € | 118,471 |
| | | | | | |
EQUITY AND LIABILITIES | | | | | | |
Share capital and reserves | | | | | | |
Share capital | | | 7,075 | | | 6,505 |
Share premium | | | 415,011 | | | 335,134 |
Share based payment reserve | | | 13,468 | | | 12,395 |
Other comprehensive income | | | 1,125 | | | 1,124 |
Retained loss | | | (353,570) | | | (306,029) |
Total equity attributable to shareholders | | € | 83,109 | | € | 49,129 |
| | | | | | |
LIABILITIES | | | | | | |
Non-current liabilities | | | | | | |
Financial debt | | | 34,976 | | | 17,670 |
Lease liability | | | 1,326 | | | 637 |
Provisions | | | 1,022 | | | 1,396 |
Deferred tax liability | | | 45 | | | — |
Contract liability | | | 722 | | | 681 |
| | € | 38,091 | | € | 20,384 |
Current liabilities | | | | | | |
Financial debt | | | 23,135 | | | 22,990 |
Lease liability | | | 551 | | | 779 |
Trade payables | |
| 12,638 | |
| 13,727 |
Current tax liability | |
| 4,020 | |
| 3,939 |
Contract liability | | | 1,000 | | | 894 |
Other liability | |
| 5,922 | |
| 6,629 |
| | € | 47,266 | | € | 48,958 |
Total liabilities | | € | 85,357 | | € | 69,342 |
Total equity and liabilities | | € | 168,466 | | € | 118,471 |
6
Non-GAAP Financial Measures
The following table contains a reconciliation of GAAP operating expenses to non-GAAP cash operating expenses for the three and six months ended June 30, 2026 and 2025, respectively.
| | Three Months Ended | | Six Months Ended | ||||||||
| | June 30, | | June 30, | ||||||||
Unaudited – In thousands | | 2026 | | 2025 | | 2026 | | 2025 | ||||
GAAP R&D Operating Expenses |
| € | 9,543 |
| € | 10,059 |
| € | 18,347 |
| € | 19,048 |
Depreciation and amortization |
| | (1,470) |
| | (418) |
| | (2,746) |
| | (829) |
Impairment of intangibles |
| | — |
| | — |
| | — |
| | — |
Share-based compensation |
| | (254) |
| | (105) |
| | (332) |
| | (415) |
Capitalized R&D |
| | — |
| | 690 |
| | 159 |
| | 1,554 |
Non-GAAP Cash R&D Operating Expenses |
| € | 7,819 |
| € | 10,226 |
| € | 15,428 |
| € | 19,358 |
| | | | | | | | | | | | |
GAAP SG&A Operating Expenses |
| € | 15,618 |
| € | 10,672 |
| € | 30,992 |
| € | 23,063 |
Depreciation |
| | (342) |
| | (356) |
| | (782) |
| | (719) |
Share-based compensation |
| | (1,308) |
| | (782) |
| | (2,111) |
| | (2,447) |
Non-GAAP Cash SG&A Operating Expenses |
| € | 13,968 |
| € | 9,534 |
| € | 28,099 |
| € | 19,898 |
Contacts:
Nyxoah
John Landry, CFO
IR@nyxoah.com
Rémi Renard
Head of Investor Relations & Corporate Communication
IR@nyxoah.com
7
Table of Contents
Exhibit 99.2
INTERIM FINANCIAL REPORT
FIRST HALF 2026
TABLE OF CONTENTS
Interim financial report | 2 | |
1. BUSINESS UPDATE | 2 | |
2. FINANCIAL HIGHLIGHTS | 3 | |
3. 2026 OUTLOOK | 4 | |
4. RISK FACTORS | 4 | |
5. FORWARD-LOOKING STATEMENTS | 4 | |
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2026 – Interim consolidated statement of financial position | 5 | |
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2026 - Interim consolidated statements of loss and other comprehensive loss | 6 | |
Unaudited condensed consolidated interim financial information as at and for the six months ended, June 30, 2026 - Interim consolidated statements of changes in equity | 7 | |
Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2026 – Interim consolidated statements of cash flows | 8 | |
Notes to the unaudited condensed interim consolidated financial information | 9 | |
1. General information | 9 | |
2. Material accounting policies | 9 | |
3. Critical accounting estimates and assumptions | 10 | |
4. Segment reporting | 10 | |
5. Fair Value | 11 | |
6. Subsidiaries | 12 | |
7. Property, Plant and Equipment | 12 | |
8. Intangible assets | 13 | |
9. Right of use assets and lease liabilities | 13 | |
10. Other long-term receivables | 13 | |
11. Inventory | 14 | |
12. Trade receivables, Contract assets and Other receivables | 14 | |
13. Other current assets | 14 | |
14. Cash and cash equivalents | 15 | |
15. Financial assets | 15 | |
16. Share Capital, Share Premium, Reserves | 15 | |
17. Share-Based compensation | 17 | |
18. Financial Debt | 20 | |
19. Provisions | 24 | |
20. Trade payables | 25 | |
21. Income taxes and deferred taxes | 25 | |
22. Other liabilities | 25 | |
23. Foreign currency swaps and forwards | 26 | |
24. Results of operation | 26 | |
25. Employee benefits | 30 | |
26. Financial income | 30 | |
27. Financial expense | 31 | |
28. Earnings/(Loss) Per Share (EPS) | 31 | |
29. Other commitments | 32 | |
30. Related Party Transactions | 32 | |
31. Events after the Balance-Sheet Date | 34 | |
Responsibility statement | 35 |
1
Table of Contents
INTERIM FINANCIAL REPORT
FIRST HALF 2026
1.BUSINESS UPDATE
A. CLINICAL UPDATE
DREAM US: IDE PIVOTAL STUDY
Nyxoah initiated its pivotal DREAM IDE trial in the United States in December 2020 to support an application seeking FDA marketing authorization and, ultimately, reimbursement in the U.S. for bilateral hypoglossal nerve stimulation for the treatment of moderate-to-severe obstructive sleep apnea (“OSA”). The DREAM trial is a multicenter, prospective, open-label trial in which patients who undergo implantation of the Genio system will be followed for five years post-implantation to assess the safety and efficacy of the Genio system in patients with moderate-to-severe OSA.
The trial was initially expected to enroll 134 patients who will undergo the implantation procedure with 12-month effectiveness and safety primary endpoints across 18 centers in the United States and six international sites. In April 2022, the FDA approved the Company’s request to reduce the trial’s sample size to 115 patients from 134 after reviewing data from the BETTER SLEEP trial.
The primary safety endpoint is incidence of device-related severe adverse events (“SAEs”) at 12-months post implantation. The co-primary effectiveness endpoints are the percentage of responders with at least a 50% reduction on the apnea-hypopnea index (“AHI”) with hypopneas associated with a 4% oxyhemoglobin desaturation and a remaining AHI with hypopneas associated with a 4% oxyhemoglobin desaturation less than 20, and a 25% reduction on the oxygen desaturation index (“ODI”) between baseline and 12-month visits. Patients with moderate to severe OSA (AHI score between 15 and 65) and aged between 22 and 75 years are eligible for enrolment if they failed, did not tolerate or refused positive airway pressure (“PAP”) treatment. Patients with a body mass index above 32 kg/m2, a complete concentric collapse (“CCC”) observed during a drug induced sleep endoscopy and combined central and mixed AHI above 25% at baseline polysomnography are to be excluded.
On March 19th, 2024, the Company reported the DREAM study met its primary endpoints on an intent-to-treat (ITT) basis, with an Apnea-Hypopnea Index (AHI) responder rate of 63.5% (p=0.002) and an Oxygen Desaturation Index (ODI) responder rate of 71.3% (p<0.001). Additionally, the study demonstrated a median 12-month AHI reduction of 70.8%. There were 11 serious adverse events, or SAEs, in ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related and there were three explants. The Company filed the fourth and final module of the modular premarket approval (PMA) application at the end of the second quarter 2024 and received FDA approval on August 8, 2025.
ACCCESS U.S. IDE STUDY SEEKING APPROVAL TO TREAT CCC PATIENTS
In the United States, supported by the BETTER SLEEP study data, the FDA in September 2021 granted Breakthrough Device Designation for the Genio system in order to shorten the approval path to treat CCC patients. Following a series of sprint discussions with the FDA regarding the design of a trial called ACCCESS to assess the safety and efficacy of the Genio system on CCC patients, the FDA approved the Company’s IDE application in July 2022.
In this study, Nyxoah initially intended to implant up to 106 patients across up to 40 implant sites with co-primary efficacy endpoints of AHI responder rate, per the Sher criteria, and ODI responder rate, both assessed at 12 months post-implant. However, in the meantime, as announced on August 11, 2025, the Company closed patient enrolment in this study prior to enrolling all 106 potential patients. The study will continue with the patients already enrolled, with said co-primary endpoints assessed at 12 months post implant and followed for five years. The Company closed enrolment prior to reaching 106 patients as it believes that the patient population already enrolled in the study will provide statistically significant results, which along with the outcomes from prior clinical evidence, will provide meaningful data with respect to the safety and efficacy of using Genio therapy in the patient population suffering from CCC.
B.COMMERCIALIZATION outside U.S.
During the first half of 2026, Nyxoah recognized net revenue of €4.6 million, primarily in Germany, which amounted to €2.6 million. After securing DRG reimbursement in Germany during the first quarter of 2021, Nyxoah built and expanded its German commercial organization to a total of 13 fulltime employees as of June 30, 2026.
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Nyxoah’s commercial strategy is focused on creating a Center of Excellence ecosystem, with a high level of clinical expertise between implanting ENT surgeons and sleep physicians who can provide more treatment options to their large patient pools.
The Company has also focused on entering new international markets:
The Company secured DRG reimbursement in Switzerland in 2021 and generated regular revenue ever since.
In Q4 2024, the Company entered the SSDP (Specialised Services Devices Program) with the NHS in the UK and generated its first revenue that same quarter.
In Q1 2025, the Company initiated commercialization in the Middle East region through a distributor agreement and generated its first revenue in Dubai that same quarter. In Q2 2025, the Company generated its first revenue in Kuwait and Abu Dhabi.
In Q4 2025, Nyxoah initiated commercialisation and generated first revenues in the Netherlands.
Nyxoah has also generated revenue in Austria, Spain and Italy and the Company expects to expand into other European countries and Middle East markets, pending feedback on submitted reimbursement dossiers.
C.FDA PMA APPROVAL AND US COMMERCIALIZATION
On August 8, 2025, the U.S. Food and Drug Administration (FDA) approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. The Company immediately commenced U.S. commercialization with a phased rollout at early-adopter centres, onboarding sites, shipping initial systems to hospitals/ambulatory surgery centres, and completing surgeon training. During the first half of 2026, the Company recognized net revenue of €9.5 million from sales in the U.S. As part of the FDA PMA approval, the Company will complete a post-PMA approval clinical study named BREATHE which is expected to enrol 229 patients (with a minimum of 160 evaluable patients).
2.FINANCIAL HIGHLIGHTS
Revenue was €14.0 million for the six months ended June 30, 2026, compared to €2.4 million for the six months ending June 30, 2025.
Cost of goods sold was €5.8 million for the six months ended June 30, 2026, compared to €0.9 million cost for the six months ended June 30, 2025.
Selling, general and administrative expenses increased by €7.9 million or 34.4 % from €23.1 million for the six months ended June 30, 2025 to €31.0 million for the six months ended June 30, 2026, due to an increase in costs to support the commercialization of the Genio system following FDA approval in August 2025 and an increase in legal costs related to IP litigation.
Research and development expenses decreased by €0.7 million or 3.7 %, from €19.0 million for the six months ended June 30, 2025, to €18.4 million for the six months ended June 30, 2026. The decrease is mainly due to a decrease in clinical study expenses and in R&D activities. Additionally, following FDA approval in August 2025, the amortization of the related intangible assets commenced leading to an increase in depreciation and amortization expenses.
Nyxoah realized a net negative financial result of €7.0 million for the six months ended June 30, 2026 primarily driven by a €5.4 million loss on the change in fair value of the convertible bond and synthetic warrant liabilities and by the amortization of the day 1 loss on the Company’s currently outstanding convertible bond for an amount of €1.5 million. This compares to a net negative financial result of €2.1 million for the six months ended June 30, 2025.
Nyxoah realized a net loss of €48.9 million for the six months ended June 30, 2026, compared to a net loss of €43.0 million for the six months ended June 30, 2025.
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Cash and cash equivalents
On June 30, 2026, cash and cash equivalents and financial assets totaled €97.8 million, compared to €48.0 million on December 31, 2025. The increase in financial assets is due to an equity raise completed in the second quarter of 2026 and the draw down of the second tranche of the Company’s term loan facility.
3.2026 OUTLOOK
The Company expects to continue ramping up sales primarily in the United States. In markets where we are already present such as Germany, Switzerland, the United Kingdom and the Middle East, and in other select international markets, we strive for further growth subject to the receipt of favourable reimbursement for the Company’s product in those markets.
4.RISK FACTORS
We refer to the description of risk factors in the Company’s 2025 annual report, pp. 81-101. In summary, the principal risks and uncertainties faced by us relate to our financial situation and need for additional capital, clinical development of our product candidates, commercialization and reimbursement of our product candidates, our dependence on third parties and on key personnel, the markets and countries in which we operate, the manufacturing of our product candidates, legal and regulatory compliance matters, our intellectual property, the outcome of intellectual property litigation, our organization and operations.
5.FORWARD-LOOKING STATEMENTS
This interim management report contains forward-looking statements. All statements other than present and historical facts and conditions contained in this report, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Nyxoah’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including Nyxoah’s expectations regarding the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements; Nyxoah’s reliance on collaborations with third parties; estimating the commercial potential of Nyxoah’s product candidates; Nyxoah’s ability to obtain and maintain protection of intellectual property for its technologies; the outcome of any intellectual property litigation; Nyxoah’s limited operating history; and Nyxoah’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Nyxoah’s 2025 annual report. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Nyxoah expressly disclaims any obligation to update any such forward-looking statements in this document, to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by applicable law or regulation.
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NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2026 –
INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(unaudited)
(in thousands)
As at | ||||||||
June 30, | December 31, | |||||||
| Notes | | 2026 | | 2025 | |||
ASSETS | ||||||||
Non-current assets |
| |
| |
| | ||
Property, plant and equipment |
| 7 |
| | | |||
Intangible assets |
| 8 |
| | | |||
Right of use assets |
| 9 |
| | | |||
Deferred tax asset |
|
| | | ||||
Other long-term receivables |
| 10 |
| | | |||
| |
| € | |
| € | | |
Current assets |
| |
|
| ||||
Inventory |
| 11 |
| | | |||
Trade receivables |
| 12 |
| | | |||
Contract assets | 12 | | | |||||
Other receivables |
| 12 |
| | | |||
Other current assets |
| 13 |
| | | |||
Financial assets |
| 15 |
| | | |||
Cash and cash equivalents |
| 14 |
| | | |||
| |
| € | |
| € | | |
Total assets |
| |
| € | |
| € | |
| |
|
| |||||
EQUITY AND LIABILITIES |
| |
|
| ||||
Share capital and reserves |
| |
|
| ||||
Share capital |
| 16 |
| |
| | ||
Share premium |
| 16 |
| |
| | ||
Share based payment reserve |
| 17 |
| |
| | ||
Other comprehensive income |
| 16 |
| |
| | ||
Retained loss |
| |
| ( |
| ( | ||
Total equity attributable to shareholders |
| |
| € | |
| € | |
| |
|
| |||||
LIABILITIES |
| |
|
| ||||
Non-current liabilities |
| |
|
| ||||
Financial debt |
| 18 |
| |
| |||
Lease liability |
| 9 |
|
| | |||
Provisions |
| 19 |
| |
| |||
Deferred tax liability | | — | ||||||
Contract liability |
| 24 |
| |
| | ||
| |
| € | |
| € | | |
| |
| |
| ||||
Current liabilities |
|
|
| |||||
Financial debt |
| 18 |
| |
| | ||
Lease liability |
| 9 |
| |
| | ||
Trade payables |
| 20 |
| |
| | ||
Current tax liability |
| 21 |
| |
| | ||
Contract liability | 24 | | | |||||
Other liability |
| 22 |
| |
| | ||
| |
| € | |
| € | | |
Total liabilities |
| |
| € | |
| € | |
Total equity and liabilities | € | | € | | ||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2026 -
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS
(unaudited)
(in thousands)
| For the three months | | For the six months | |||||||||||
ended June 30, | ended June 30, | |||||||||||||
| Notes | 2026 | | 2025 | | 2026 | | 2025 | ||||||
Revenue | 24 | | | | | |||||||||
Cost of goods sold |
| 24 | ( |
| ( |
| ( |
| ( | |||||
Gross profit |
| € | | € | | € | | € | | |||||
Research and Development Expense |
| 24 |
| ( |
| ( |
| ( |
| ( | ||||
Selling, General and Administrative Expense |
| 24 |
| ( |
| ( |
| ( |
| ( | ||||
Other income/(expense) |
|
| ( |
| |
| |
| | |||||
Operating loss for the period |
| € | ( | € | ( | € | ( | € | ( | |||||
Financial income |
| 26 |
| |
| |
| |
| | ||||
Financial expense |
| 27 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period before taxes |
| € | ( | € | ( | € | ( | € | ( | |||||
Income taxes |
| 21 |
| ( |
| ( |
| ( |
| ( | ||||
Loss for the period |
| € | ( | € | ( | € | ( | € | ( | |||||
|
|
|
|
| ||||||||||
Loss attributable to equity holders |
| € | ( | € | ( | € | ( | € | ( | |||||
Other comprehensive loss |
|
|
|
|
| |||||||||
Items that may be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
| |||||||||
Currency translation differences |
|
| |
| |
| |
| | |||||
Total comprehensive loss for the year, net of tax |
| € | ( | € | ( | € | ( | € | ( | |||||
Loss attributable to equity holders |
| € | ( | € | ( | € | ( | € | ( | |||||
|
|
|
|
| ||||||||||
Basic Loss Per Share (in EUR) |
| 28 | € | ( | € | ( | € | ( | € | ( | ||||
Diluted Loss Per Share (in EUR) |
| 28 | € | ( | € | ( | € | ( | € | ( | ||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements
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NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED, JUNE 30, 2026 -
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
(in thousands)
Attributable to owners of the parent | ||||||||||||||||||
Share | ||||||||||||||||||
based | Other | |||||||||||||||||
Common | Share | payment | comprehensive | Retained | ||||||||||||||
| shares | | premium | | reserve | | income | | loss | | Total | |||||||
Balance at January 1, 2026 | | € | | | € | | | € | | | € | | | € | ( | | € | |
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive loss for the period |
| — |
| — |
| — |
| |
| — |
| | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | | € | ( | € | ( | ||||||
Equity-settled share-based payments |
| |
|
|
| |
|
| | |||||||||
Granted during the period |
| — |
| — |
| |
| — |
| — |
| | ||||||
Expired during the period |
| — |
| — |
| ( |
| — |
| |
| — | ||||||
Exercised during the period | | | — | — | — | | ||||||||||||
Impact modification vested RSUs | — | — | ( | — | | — | ||||||||||||
Issuance of shares on conversion of convertible bond | | | — | — | — | | ||||||||||||
Issuance of shares for cash |
| |
| |
| — |
| — |
| — |
| | ||||||
Transaction cost | — | ( | — | — | — | ( | ||||||||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2026 | € | | € | | € | | € | | € | ( | € | | ||||||
Attributable to owners of the parent | ||||||||||||||||||
Share | ||||||||||||||||||
based | Other | |||||||||||||||||
Common | Share | payment | comprehensive | Retained | ||||||||||||||
| shares | | premium | | reserve | | income | | loss | | Total | |||||||
Balance at January 1, 2025 | € | | € | | € | | € | | € | ( | € | | ||||||
Loss for the period |
| — |
| — |
| — |
| — |
| ( |
| ( | ||||||
Other comprehensive income for the period |
| — |
| — |
| — |
| |
| — |
| | ||||||
Total comprehensive loss for the period |
| — |
| — |
| — | € | | € | ( | € | ( | ||||||
Equity-settled share-based payments |
|
| |
| |
|
| |
| | ||||||||
Granted during the period | — | — | | — | — | | ||||||||||||
Expired during the period |
| — |
| — |
| ( |
| — |
| |
| — | ||||||
Exercised during the period | | | ( | — | | | ||||||||||||
Total transactions with owners of the company recognized directly in equity |
| |
| |
| |
| — |
| |
| | ||||||
Balance at June 30, 2025 | € | | € | | € | | € | | € | ( | € | | ||||||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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NYXOAH SA
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION AS AT AND
FOR THE SIX MONTHS ENDED JUNE 30, 2026 –
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
| For the six months ended | |||||||
June 30, | ||||||||
| Notes | | 2026 | | 2025 | |||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Loss before tax for the year |
| | € | ( | € | ( | ||
Adjustments for |
| |
|
| ||||
Finance income |
| |
| ( |
| ( | ||
Finance expenses |
| |
| |
| | ||
Depreciation and impairment of property, plant and equipment and right-of-use assets |
| 7, 9 |
| |
| | ||
Amortization of intangible assets |
| 8 |
| |
| | ||
Share-based payment transaction expense |
| 17 |
| |
| | ||
Decrease in provisions |
|
| ( |
| ( | |||
Other non-cash items |
|
| |
| | |||
Cash used before changes in working capital |
| € | ( | € | ( | |||
(Increase)/Decrease in inventory |
| 11 |
| |
| ( | ||
(Increase)/Decrease in trade and other receivables |
| 12 |
| ( |
| | ||
Increase/(Decrease) in trade and other liabilities |
| 20,22 |
| ( |
| | ||
Cash used from changes in operations |
| € | ( | € | ( | |||
Income tax paid |
|
| ( |
| ( | |||
Net cash used in operating activities |
| € | ( | € | ( | |||
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
| |||||
Purchases of property, plant and equipment |
| 7 |
| ( |
| ( | ||
Capitalization of intangible assets |
| 8 |
| ( |
| ( | ||
Purchase of financial assets - current | 15 | ( | ( | |||||
Proceeds from sale of financial assets - current | 15 | | | |||||
Interest income on financial assets |
|
| |
| | |||
Net cash generated/(used) in investing activities |
| € | ( | € | | |||
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
| |||||
Payment of principal portion of lease liabilities |
| 9 |
| ( |
| ( | ||
Proceeds from other loan |
| |
| |
| — | ||
Transaction costs related to loans and borrowings | ( | — | ||||||
Interests paid |
| |
| ( |
| ( | ||
Repayment of recoverable cash advance |
|
| ( |
| — | |||
Proceeds from issuance of shares, net of transaction costs |
| 16 |
| |
| | ||
Other financial costs |
|
| ( |
| ( | |||
Net cash generated/(used) from financing activities |
| € | | € | ( | |||
Movement in cash and cash equivalents |
| € | | € | ( | |||
Effect of exchange rates on cash and cash equivalents |
|
| |
| ( | |||
Cash and cash equivalents at January 1 |
| 14 | € | | € | | ||
Cash and cash equivalents at June 30 |
| 14 | € | | € | | ||
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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NYXOAH SA
NOTES TO THE UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL INFORMATION
1.General information
Nyxoah SA (the “Company”) is a public listed company with limited liability (naamloze vennootschap/société anonyme) incorporated and operating under the laws of Belgium and is domiciled in Belgium. The Company is registered with the legal entities register (Brabant Walloon) under enterprise number 0817.149.675. The Company’s registered office is in Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium.
The Company is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea, or OSA. Obstructive sleep apnea is the world’s most common sleep disordered breathing condition. OSA occurs when the throat and tongue muscles and soft tissues relax and collapse. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or completely (apnea) blocked, limiting the amount of air that reaches the lungs. During an episode of apnea or hypopnea, the patient’s oxygen level drops, which leads to sleep interruptions.
Our lead solution is the Genio system, a CE-Marked, patient-centric, minimally invasive, next generation hypoglossal neurostimulations therapy for OSA. OSA is the world’s most common sleep disordered breathing condition and is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.
The Genio system is the first neurostimulation system for the treatment of OSA to include a battery-free and leadless neurostimulator capable of delivering bilateral hypoglossal nerve stimulation to keep the upper airway open. The product is intended to be used as a second-line therapy to treat moderate to severe OSA patients who have either not tolerated, failed or refused conventional therapy, including Continuous Positive Airway Pressure, or CPAP, which, despite its proven efficacy, is associated with many limitations, meaning compliance is a serious challenge. In addition, other second-line treatments are more suitable to treat mild to moderate OSA (such as oral devices) or highly invasive. Compared to other hypoglossal nerve stimulation technologies for the treatment of OSA, the Genio system is a disruptive, differentiating technology that targets a clear unmet medical need thanks to its minimally invasive and quick implantation technique, its external battery and its ability to stimulate the two branches of the hypoglossal nerve.
Nyxoah SA has established four wholly owned subsidiaries: Nyxoah Ltd, a subsidiary of the Company since October 21, 2009 (located in Israel and incorporated on January 10, 2008 under the name M.L.G. Madaf G. Ltd), Nyxoah Pty Ltd since February 1, 2017 (located in Australia) and Nyxoah Inc. since May 14, 2020 (located in the USA) and Nyxoah GmbH since July 26, 2023 (located in Germany).
The interim condensed consolidated financial statements of Nyxoah SA and its subsidiaries (collectively, the Group) as of June 30, 2026 and for the three and six months ended June 30, 2026, have been authorized for issue on August 5, 2026 by the Board of Directors of the Company.
2.Material accounting policies
Basis of Preparation of the interim condensed consolidated financial statements
The Company’s interim condensed consolidated financial statements have been prepared in accordance with International Accounting Standard 34 – Interim Financial Reporting (“IFRS”), as issued by the International Accounting Standards Board (IASB). They do not include all the information required for complete annual financial statements and should be read in conjunction with the Company’s last annual consolidated financial statements as at and for the year ended December 31, 2025.
Except for the application of standards, interpretations and amendments being mandatory as of January 1, 2026, the accounting policies used for the preparation of the interim condensed consolidated financial statements are consistent with those used for the preparation of the Company’s annual consolidated financial statements as of and for the year ended December 31, 2025.
The consolidated financial statements are presented in Euros (€) and all values are rounded to the nearest thousands, except when otherwise indicated (e.g. € million).
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The preparation of the interim condensed consolidated financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, are areas where assumptions and estimates are significant to the consolidated financial statements. The critical accounting estimates used in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements as of and for the year ended December 31, 2025.
Going concern principle
The Unaudited Interim Condensed Consolidated Financial Statements have been prepared under the assumption of going concern. As of June 30, 2026, the Company held cash and cash equivalents totaling €
The Company confirms that despite the conflict between Israel and Iran, operations are continuing with no major impact and the assets are currently safeguarded. The Company is not suffering impact of this conflict.
New and amended standards and interpretations applicable
Effective for the annual periods beginning on January 1, 2026
The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
The following amendment applies for the first time in 2026, but does not have an impact on the interim condensed consolidated financial statements of the Company:
-Amendments to IFRS 9 and IFRS 7 Classification and Measurement of Financial Instruments
-Annual Improvements – Volume 11
3.Critical accounting estimates and assumptions
The preparation of interim financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that may significantly affect the reported amounts of revenues, expenses, assets and liabilities, and the disclosure of contingent liabilities at the end of the reporting period.
Refer to the disclosure note 5.5.2 from the Group’s 2025 year-end consolidated financial statements for further details about the main critical accounting estimates and assumptions.
4.Segment reporting
Based on the organizational structure, as well as the nature of financial information available and reviewed by the Company’s chief operating decision makers to assess performance and make decisions about resource allocations, the Company has concluded that its total operations represent
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5.Fair Value
Financial assets
Cash guarantees are recorded in the consolidated statement of financial position under “Other long-term receivables”. Upon release of the guarantees, interest is received for the duration of the guarantee, whereby the carrying amount approximates the fair value.
The prepayment option, recorded in the consolidated statement of financial position under “Other long-term receivables”, related to the loan facility agreement with the European Investment Bank (“EIB”), is measured at fair value through profit and loss (see note 18.2).
The carrying amount of trade and other receivables, other current assets, cash and cash equivalents and financial assets approximate their value due to their short-term character.
The foreign currency forwards and swaps, recorded in the consolidated statement of financial position under “Other receivables”, are measured at fair value through profit and loss. Fair value is determined by the financial institution and is based on foreign currency swap rates and the maturity of the instrument. Refer to note 23.
Financial liabilities
The loan facility agreement with the EIB, recorded in the consolidated statement of financial position under “Financial debt”, is measured at amortized cost with a fixed interest rate. Refer to note 18.2. The fair value is evaluated based on the interest rates and maturity date. The instrument has a fixed interest rate and the fair value measurement is subject to changes in interest rates. The fair value measurement is classified as level 3.
The synthetic warrants, in connection with the loan facility agreement with the EIB and recorded in the consolidated statement of financial position under “Financial debt”, are measured at fair value through profit and loss (see note 18.2). The fair value is determined using a binomial tree with
| ● | Volatility of |
A
A
The convertible bonds, recorded in the consolidated statement of financial position under “Financial debt”, are measured at fair value through profit and loss (see note 18.3). The fair value is determined using the Longstaff-Schwartz Monte Carlo valuation model. We refer to note 18.3 for the overview of the key assumptions. A
The carrying value of trade and other liabilities approximates their fair value due to the short-term character of these instruments. The sensitivity on the fair value measurements of the recoverable cash advances are further detailed in note 18.1.
11
Table of Contents
There were no changes in the Group’s valuation processes, valuation techniques, and types of inputs used in the fair value measurements during the period. There were
Carrying value | Fair value | |||||||
As at | As at | As at | As at | |||||
June 30, | December 31, | June 30, | December 31, | |||||
(in EUR 000) | | 2026 | 2025 | | 2026 | | 2025 | |
Financial Assets |
| |
| |
| |
| |
Cash guarantees (level 3) |
| |
| |
| |
| |
Prepayment option (level 3) | | | | | ||||
Trade and other receivables (level 3) |
| |
| |
| |
| |
Foreign currency forwards and swaps (level 2) |
| — |
| |
| — |
| |
Other current assets (level 3) |
| |
| |
| |
| |
Cash and cash equivalents (level 1) |
| |
| |
| |
| |
Financial assets (level 1) |
| |
| |
| |
| |
Carrying value | Fair value | |||||||
As at | As at | As at | As at | |||||
June 30, | December 31, | June 30, | December 31, | |||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Financial liabilities |
| |
| |
| |
| |
Loan facility agreement (level 3) | | | | | ||||
Synthetic warrants (level 3) |
| |
| |
| |
| |
Convertible bonds (level 3) |
| |
| |
| |
| |
Recoverable cash advances (level 3) |
| |
| |
| |
| |
Trade and other liabilities (level 1 and 3) |
| |
| |
| |
| |
6.Subsidiaries
For all periods that are mentioned in this report, the Company owns 100% of the shares of:
| ● | , an Israeli company |
| ● | , an Australian company |
| ● | , a US- based company |
| ● | , a German company |
7.Property, Plant and Equipment
The total acquisitions for the six months ended June 30, 2026 amount to €
The main part of the acquisitions for the six months ended June 30, 2026 relate to leasehold improvements under construction. The leasehold improvements under construction relate to a new lease agreement that the Company entered into per January 1, 2026 for the setup of a new manufacturing line and cleanroom area in Belgium. The Company initially funds
The depreciation charge amounts to €
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8.Intangible assets
Development | Patents and | |||||
(in EUR 000) | | cost | | licenses | | Total |
Cost |
| |
| |
| |
Opening value at January 1, 2025 |
| |
| |
| |
Additions |
| |
| |
| |
Other movements | ( | — | ( | |||
Cost at June 30, 2025 |
| |
| |
| |
Opening value at January 1, 2026 |
| |
| |
| |
Additions |
| |
| |
| |
Cost at June 30, 2026 |
| |
| |
| |
Amortization |
| |
| |
| |
Opening amortization at January 1, 2025 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2025 |
| ( |
| ( |
| ( |
Opening amortization at January 1, 2026 |
| ( |
| ( |
| ( |
Amortization |
| ( |
| ( |
| ( |
Amortization at June 30, 2026 |
| ( |
| ( |
| ( |
Net book value at June 30, 2025 |
| |
| |
| |
Net book value at June 30, 2026 |
| |
| |
| |
The Company develops The Genio system. The Company started amortizing the first-generation Genio system in 2021. Following the FDA approval for the Genio system on August 8, 2025, the amortization of the related intangible assets commenced in Q3 2025. Due to the finalization of one of the clinical studies the amortization of the related intangible assets started in Q2 2026. Total amortization amounted to €
The Company continues to incur in 2026 development expenses with regard to the improved second-generation Genio system. The total capitalized development expenses amounted to €
9.Right of use assets and lease liabilities
For the six months ended June 30, 2026, the Company entered into new lease agreements for a total of €
The repayments of lease liabilities amounted to €
10.Other long-term receivables
As at | ||||
June 30, | December 31, | |||
(in EUR 000) | | 2026 | | 2025 |
R&D tax incentive |
| |
| |
Prepayment option |
| |
| |
Cash guarantees |
| |
| |
Total other long term receivables |
| |
| |
The other long-term receivables consist of cash guarantees for an amount of €
For further details regarding the prepayment options, refer to 18.2.
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The R&D tax incentive recorded as at June 30, 2026 relates to investments both on tangible and intangible assets for the years 2022 until 2026. The incentives are expected to be received 5 years after the investments are made. However, following the Law of May 12, 2024 (Belgian Gazette May 29, 2024), the Belgian R&D tax credit regime has been amended. As of 2024, the R&D tax incentive will be refunded after 4 years instead of 5 years. We refer to note 24.
11.Inventory
As at | ||||
June 30, | December 31, | |||
(in EUR 000) | | 2026 | | 2025 |
Raw materials | | | ||
Work in progress |
| |
| |
Finished goods |
| |
| |
Total Inventory |
| |
| |
The decrease in inventory is mainly due to a decrease in work in progress partly offset by an increase in finished goods.
12.Trade receivables, Contract assets and Other receivables
As at | ||||
June 30, | December 31, | |||
(in EUR 000) | | 2026 | | 2025 |
Trade receivables |
| |
| |
Contract assets | | | ||
Allowance for expected credit loss | ( | ( | ||
Advance payments | | | ||
R&D incentive receivable (Australia) |
| |
| |
VAT receivable |
| |
| |
Current tax receivable |
| |
| |
Foreign currency swaps and forwards |
| − |
| |
Other |
| |
| |
Total trade receivables, contract assets and other receivables |
| |
| |
The increase of €
The Company can include unbilled receivables in its accounts receivable balance. Generally, these receivables represent earned revenue from products delivered to customers, which will be billed in the next billing cycle. All amounts are considered collectible and billable. As at December 31, 2025 and June 30, 2026, there were
R&D incentive receivables relate to incentives received in Australia as a support to the clinical trials and the development of the Genio system.
We refer to note 23 for more details on the foreign currency swaps and forwards.
13.Other current assets
As at | ||||
June 30, | December 31, | |||
(in EUR 000) | | 2026 | | 2025 |
Deferred charges |
| |
| |
Accrued income |
| |
| |
Total other current assets |
| |
| |
14
Table of Contents
14.Cash and cash equivalents
| As at | |||
June 30, | | December 31, | ||
(in EUR 000) | 2026 | 2025 | ||
Short term deposit |
| |
| |
Current accounts |
| |
| |
Total cash and cash equivalents |
| |
| |
Cash and cash equivalents increased to €
15.Financial assets
Current financial assets relate to term accounts with an initial maturity longer than 3 months but less than 12 months measured at amortized costs.
As per June 30, 2026 the current financial assets consists of $
During the period ended June 30, 2026, the Company entered into USD Deposits and US treasury bills for a total amount of $
As at December 31, 2025 the current financial assets amounts €
16.Share Capital, Share Premium, Reserves
16.1. Share capital and share premium
The number of shares and the par value in the paragraph below take into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing preferred shares were converted into common shares, and then a share split of
As part of the IPO on September 21, 2020, the Company incurred direct-attributable transaction costs of €
As part of the IPO on July 7, 2021, the Company incurred direct-attributable transaction costs of €
As at June 30, 2026, the share capital of the Company amounts to €
15
Table of Contents
Evolution of the share capital and share premium over the six months ended June 30, 2026 and 2025:
| | | Share | | Share | | Share | |||
Common | Total of | capital per | capital (in | premium (in | ||||||
(Number of shares except otherwise stated) | shares | shares | share | EUR 000) | EUR 000) | |||||
January 1, 2025 |
| |
| |
| — |
| |
| |
May 12, 2025 - Exercise warrants | | | | — | | |||||
June 13, 2025 - Exercise warrants | | | | | | |||||
June 30, 2025 |
| |
| |
| — |
| |
| |
July 8, 2025 - Exercise warrants |
| |
| |
| |
| |
| |
September 26, 2025 - Exercise RSU warrants |
| |
| |
| |
| |
| — |
November 18, 2025 - Capital increase in cash | | | | | | |||||
Novermber 20, 2025 - Capital increase in cash | | | | | | |||||
December 31, 2025 | | | — | | | |||||
March 2, 2026 - Issuance of shares on conversion of convertible debt | | | | | | |||||
May 20, 2026 - Issuance of shares on conversion of convertible debt | | | | | | |||||
June 9, 2026 - Capital increase in cash | | | | | | |||||
June 10, 2026 - Capital increase in cash | | | | | | |||||
June 30, 2026 - Exercise RSU warrants | | | | | | |||||
June 30, 2026 | | | — | | |
On May 12, 2025, pursuant to the exercise of warrants, the Company issued
On June 13, 2025, pursuant to the exercise of warrants, the Company issued
On July 8, 2025, pursuant to the exercise of warrants, the Company issued
On September 26, 2025, pursuant to the exercise of RSU warrants, the Company issued
On November 18, 2025, the Company issued
On November 20, 2025, the Company issued
As part of above capital increases, the Company incurred direct-attributable transaction costs of €
On March 2, 2026, pursuant to the conversion of convertible debt, the Company issued
On May 20, 2026, pursuant to the conversion of convertible debt, the Company issued
On June 9, 2026, the Company issued
On June 10, 2026, the Company issued
16
Table of Contents
On June 30, 2026, pursuant to the exercise of RSU warrants, the Company issued
As part of above capital increase, the Company incurred direct-attributable transaction costs of €
16.2. Reserves
The reserves include the share-based payment reserve (see note 17), other comprehensive income and the retained loss. Retained loss is comprised of primarily accumulated losses, other comprehensive income is comprised of currency translation reserves and remeasurements of post-employment benefit obligations.
The movement in other comprehensive income for the six months ended June 30, 2026 and 2025 is detailed in the table below:
Post- | ||||||
Currency | employment | |||||
translation | benefit | |||||
(in EUR 000) | | reserve | | obligations | | Total |
Opening value at January 1, 2025 |
| |
| |
| |
Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||
Currency translation differences |
| |
| — |
| |
Total other comprehensive income at June 30, 2025 |
| |
| |
| |
Opening value at January 1, 2026 |
| |
| |
| |
Items that may be subsequently reclassified to profit or loss (net of tax) | ||||||
Currency translation differences |
| |
| — |
| |
Total other comprehensive income at June 30, 2026 |
| |
| |
| |
17.Share-Based compensation
Equity-settled share-based payment transactions
As of June 30, 2026, the Company has
The changes of the year for the equity-settled warrant plans are as follows:
Number of shares (after share split) warrants give right to across all plans | | 2026 | | 2025 |
Outstanding at January 1 |
| |
| |
Granted |
| |
| |
Forfeited |
| ( |
| ( |
Exercised |
| |
| ( |
Expired | ( | ( | ||
Outstanding as at June 30 |
| |
| |
Exercisable as at June 30 |
| |
| |
The following warrants were granted during 2025:
-On February 1, 2025,
-On February 1, 2025,
-On March 14, 2025,
-On April 8, 2025,
17
Table of Contents
-On May 5, 2025,
On January 18, 2026,
On June 26, 2026,
The table below provides the input to the Black-Scholes model for warrants granted in the second quarter of 2026.
| Plan 2024 | | Plan 2025 | | Plan 2025-2 |
| |
(grant Jun 26 | (grant Jun 26 | (grant Jun 26 |
| ||||
2026) | 2026) | 2026) |
| ||||
Return Dividend |
| | % | | % | | % |
Expected volatility |
| | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % |
Expected life |
| |
| |
| | |
Exercise price |
| |
| |
| | |
Stock price |
| |
| |
| | |
Fair value |
| |
| |
| |
On June 26, 2026, the Company reduced the exercise price of the outstanding warrants previously granted to warrant holders under all Warrants Plans to
The fair value of the modified warrants was determined using the same models and principles as described above, with the following model inputs:
| Plan 2021 | | Plan 2021 | | Plan 2021 | | Plan 2021 |
| |
(grant Sept 17 | (grant Oct 27 | (grant Feb 21 | (grant May 14 |
| |||||
2021) | 2021) | 2022) | 2022) |
| |||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility | | % | | % | | % | | % | |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| | |
Incremental Fair value |
|
|
|
|
*Incremental fair value of the warrants that were not repriced on March 24, 2023.
| Plan 2021 | | Plan 2022 | | Plan 2022 | | Plan 2022 |
| |
(grant March 24 | (grant Feb 01 | (grant Apr 21 | (grant Aug 2 |
| |||||
2023) | 2024) | 2024) | 2024) |
| |||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| | |
Incremental Fair value |
| |
| |
| |
| 0.53-0.55 |
18
Table of Contents
| Plan 2024 | | Plan 2024 | | Plan 2024 | | Plan 2025 |
| |
(grant Sept 18 | (grant Nov 25 | (grant Feb 1 | (grant Feb 1 | ||||||
2024) | 2024) | 2025) | 2025) |
| |||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| | |
Exercise price |
| |
| |
| |
| | |
Stock price |
| |
| |
| |
| | |
Fair value |
| |
| |
| |
| | |
Incremental Fair value | | | | |
| Plan 2025 | | Plan 2025 | | Plan 2025 | | 2024 Plan | ||
(grant Mar 14 | (grant Apr 8 | (grant May 5 | (grant Sept 6 | ||||||
| 2025) |
| 2025) |
| 2025) |
| 2025) |
| |
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| % | % | % | % | ||||
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| |
|
Exercise price |
| |
| |
| |
| |
|
Stock price |
| |
| |
| |
| |
|
Fair value |
| |
| |
| |
| | |
Incremental Fair value | | | | |
|
| 2025 Plan | | 2025 Plan | | 2025-2 Plan | | 2025-2 Plan |
| |
(grant Sept 6 | (grant Oct 13 | (grant Oct 13 | (grant Jan 18 | ||||||
2025) | 2025) | 2025) | 2026) | ||||||
Return Dividend |
| | % | | % | | % | | % |
Expected volatility |
| | % | | % | | % | | % |
Risk-free interest rate |
| | % | | % | | % | | % |
Expected life |
| |
| |
| |
| |
|
Exercise price |
| |
| |
| |
| |
|
Stock price |
| |
| |
| |
| |
|
Fair value |
| |
| |
| |
| | |
Incremental Fair value | | | | |
|
Equity-settled share-based payment transactions – Restricted Stock Units (“RSU”)
In 2024, 2025 and 2026, each non-executive director was granted “restricted share units” or “RSUs”, whereby each RSU represents the obligation of the relevant non-executive director to subscribe for one new ordinary share of the Company at a subscription price of EUR
The RSUs will be accounted for as an equity-settled share-based payment plan as the Company can issue new shares under the authorized capital.
At June 12, 2024, the Company has granted a total of
At June 11, 2025, the Company has granted a total of
At June 10, 2026, the Company has granted a total of
19
Table of Contents
Equity-settled share-based payment expense
The Company has recognized €
18.Financial Debt
Financial debt mainly consists of recoverable cash advances, EIB finance agreement and synthetic warrants and convertible bond. The related amounts can be summarized as follows:
| As at | |||
| June 30, | | December 31, | |
(in EUR 000) | 2026 | 2025 | ||
Recoverable cash advances - Non-current | | | ||
Recoverable cash advances - Current |
| |
| |
Total Recoverable cash advances |
| |
| |
EIB finance agreement - Non-current | |
| | |
EIB accrued interest - Current | | — | ||
Synthetic warrants - Non-current |
| |
| |
Total EIB |
| |
| |
Convertible bond - Current | | | ||
Total convertible bond | | | ||
Total financial debt |
| |
| |
Non-current |
| |
| |
Current |
| |
| |
18.1. Financial debt related to recoverable cash advances
Recoverable cash advances received
As at June 30, 2026, the details of recoverable cash advances received can be summarized as follows:
Contractual | Advances | Fixed | Variable | |||||
(in EUR 000) | | advances | | received | | reimbursements* | | reimbursements* |
Sleep apnea device (6472) |
| |
| | | | ||
First articles (6839) |
| |
| | | | ||
Clinical trial (6840) |
| |
| | | | ||
Activation chip improvements (7388) |
| |
| | | | ||
Total |
| |
| | | |
*Excluding interests
During the six months ended June 30, 2026, the Company made variable reimbursements but did not receive any new amounts.
20
Table of Contents
Based on expected timing of sales and after discounting, the financial debt related to the recoverable cash advances is as follows:
As at | ||||
| June 30, | | December 31, | |
(in EUR 000) | 2026 | 2025 | ||
Contract 6472 |
| |
| |
Contract 6839 |
| |
| |
Contract 6840 |
| |
| |
Contract 7388 |
| |
| |
Total recoverable cash advances |
| |
| |
Non-current |
| |
| |
Current |
| |
| |
Total recoverable cash advances |
| |
| |
The amounts recorded under “Current” caption correspond to the sales-independent amounts (fixed repayment) and sales-dependent reimbursements (variable repayment) estimated to be repaid to the Walloon Region in the next 12-month period. The estimated sales-independent (fixed repayment) as well as sales-dependent reimbursements (variable repayment) beyond 12 months are recorded under “Non-current” liabilities.
Changes in the recoverable cash advances can be summarized as follows:
(in EUR 000) | | 2026 | | 2025 |
As at January 1 |
| |
| |
Advances reimbursed (excluding interests) |
| ( |
| — |
Interests paid | ( | — | ||
Initial measurement and re-measurement |
| ( |
| ( |
Discounting impact |
| |
| |
As at June 30 |
| |
| |
A sensitivity analysis of the carrying amount of recoverable cash advances has been done to assess the impact of a change in assumptions. The Company tested reasonable sensitivity to changes in revenue projections of +/-
Fair Value of Liabilities (in EUR 000) | Variation of revenue projections | |||||
Variation of discount rates * | | -25% | | 0% | | 25% |
-25% | | | | |||
0% | | | | |||
25% | | | | |||
* | A change of in the discount rates implies that the discount rate used for the fixed part of the recoverable cash advances is |
An increase of
An increase of
18.2. Financial debt related to loan facility agreement and synthetic warrants agreement
On July 3, 2024 the Company has signed a €
21
Table of Contents
The first tranche A for an amount of €
The second tranche B for an amount of €
In connection with the loan facility agreement, and as a condition to drawdown thereunder, the Company also entered into a “synthetic warrant agreement” with the EIB. Under the synthetic warrant agreement, in consideration for the facility, in connection with each tranche of the facility, the EIB will be granted “synthetic warrants” with a duration of
Change in loan facility for Tranche A can be summarized as follows:
(in EUR 000) | | 2026 | | 2025 |
As at January 1 |
| |
| |
Effective interest rate adjustment |
| |
| |
As at June 30 |
| |
| |
Change in synthetic warrants for Tranche A can be summarized as follows:
(in EUR 000) | | 2026 | | 2025 |
As at January 1 |
| |
| |
Fair value adjustment |
| |
| ( |
As at June 30 |
| |
| |
Change in prepayment option for Tranche A can be summarized as follows:
(in EUR 000) | | 2026 | | 2025 |
As at January 1 |
| ( |
| ( |
Fair value adjustment |
| |
| ( |
As at June 30 |
| ( |
| ( |
Change in loan facility for Tranche B can be summarized as follows:
(in EUR 000) | | 2026 |
As at January 1 |
| — |
New debt |
| |
Transaction cost related to loans and borrowings |
| ( |
Separation of non-closely related embedded derivates |
| ( |
Subtotal: Initial recognition |
| |
Effective interest rate adjustment |
| |
As at June 30 |
| |
22
Table of Contents
Change in synthetic warrants for Tranche B can be summarized as follows:
(in EUR 000) | | 2026 |
As at January 1 |
| — |
Separation of non-closely related embedded derivates |
| |
Fair value adjustment |
| |
As at June 30 |
| |
Change in prepayment option for Tranche B can be summarized as follows:
(in EUR 000) | | 2026 |
As at January 1 |
| — |
Separation of non-closely related embedded derivates |
| ( |
As at June 30 |
| ( |
18.3. Financial debt related to Convertible Bond Instrument
On November 13, 2025, the Company entered into a bond subscription agreement with an international financial services firm for the issuance of a Convertible Bond Instrument for an aggregate maximum principal amount of up to €
The Bond Instrument is accounted for as a hybrid financial instrument containing a host financial liability with embedded derivatives that are closely related (Deferred amortized payment) and embedded derivatives that are not closely related (Bond conversion right, Amortization conversion right, Share settlement option and Advanced amortized payment). The entire hybrid contract is designated by management at fair value through profit and loss. The fair value of the hybrid contract is estimated using a Longstaff–Schwartz Monte Carlo approach, in which share prices are simulated forward on a weekly basis over a
The valuation model is dependent on the following significant inputs:
| Per June 30, |
| |
2026 | |||
Coupon (interest) rate |
| | % |
Conversion price |
| | |
Stock price |
| | |
Return dividend |
| | % |
Expected volatility |
| | % |
Discount rate |
| | % |
23
Table of Contents
The expected volatility has been estimated based on the historical share prices of the Company on Euronext (as this is the primary stock exchange as determined in the Bond Subscription Agreement). The discount rate is determined based on a risk-free interest rate, based on the 3-month Euribor rate, plus a credit spread estimated for the Company based on the previous debt instruments and factors such as financial results, liquidity needs that may impact the credit spread of the Company.
The transaction price of the Bond Instrument at initial recognition is the consideration of the first tranche for €
Change in the convertible bond can be summarized as follows:
| Per June 30, | |
(in EUR 000) |
| 2026 |
As at January 1, 2025 |
| |
Fair value adjustment |
| |
Conversion to shares |
| ( |
Total fair value |
| |
Day 1 loss at December 31, 2025 |
| ( |
Amortization |
| |
Total day 1 loss as at June 30 |
| ( |
Total convertible bond as at June 30 |
| |
Per March 2, 2026, the Company has converted the first principal instalment of €
Per May 20, 2026, the Company has converted the second principal instalment of €
The fair value loss for the six months ended June 30, 2026 is mainly resulting from the conversion price reset per June 9, 2026, partly mitigated by the decrease in stock price in 2026. Refer to note 27.
19.Provisions
| As at June 30, | | As at December 31, | |
(in EUR 000) | 2026 | 2025 | ||
Provision for constructive obligation |
| |
| |
Other provisions |
| |
| |
Total provisions |
| |
| |
The Company has a constructive obligation related to the ongoing replenishment of certain consumable components, based on business practices and customer expectations.
On May 30, 2025, the Company was sued in the U.S. District Court of Delaware by Inspire Medical, Inc. (“Inspire”) for the alleged infringement of
On September 15, 2025, the Company has filed a lawsuit against Inspire in the U.S. District Court of Delaware for the alleged infringement of 3 Nyxoah patents (US Patent Nos: 8,700,183, 9,415,215, and 9,415,216). The complaint requests customary remedies for patent infringement, including (i) a judgment that Inspire has infringed and is infringing the Nyxoah Patents, (ii) damages, (iii) attorneys’ fees, (iv) a permanent injunction preventing Inspire from infringing the Company’s patents and (v) costs and expenses.
Given the early stage of this litigation, the Company is unable to predict the likelihood of success of the Inspire claims against the Company or to quantify any risk of loss. Therefore, the Company has not accrued for any potential litigation losses as of June 30, 2026. Legal costs incurred in connection with this matter have been accrued through June 30, 2026, and are recognized in the Selling, General
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and Administrative Expense on the line item “Legal fees”. The company reviews the status of the litigation each quarter going forward for accrual purposes.
20.Trade payables
As at | ||||
| June 30, | | December 31, | |
(in EUR 000) | 2026 | 2025 | ||
Payables |
| |
| |
Invoices to be received |
| |
| |
Total Trade payables |
| |
| |
The decrease in total trade payables of €
21.Income taxes and deferred taxes
For the three months ended | For the six months ended | |||||||
| June 30, | | June 30, | |||||
(in EUR 000) | | 2026 | | 2025 | 2026 | | 2025 | |
Current tax expenses |
| ( | ( | ( |
| ( | ||
Deferred tax income/(expense) |
| ( | ( | ( |
| | ||
Total Income Tax Expense |
| ( | ( | ( |
| ( | ||
For the six months ended June 30, 2026, the current tax expense mainly relates to (i) an increase of income tax payable by certain of the Company’s subsidiaries for an amount of €
The uncertain tax position was recorded following certain public rulings and guidance issued by tax authorities in one of the jurisdictions that the Company operates in. The current tax liability of €
22.Other liabilities
| As at | |||
June 30, | December 31, | |||
(in EUR 000) | | 2026 | | 2025 |
Holiday pay accrual | | | ||
Salary |
| |
| |
Accrued expenses |
| |
| |
VAT Payable |
| |
| |
Other |
| |
| |
Total other liabilities |
| |
| |
The decrease by €
As at June 30, 2026, Other mainly consists of an outstanding liability related to the continued development of the Company’s strategic R&D project.
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23.Foreign currency swaps and forwards
The Company is exposed to currency risk primarily due to the expected future USD, AUD and NIS expenses that will be incurred as part of the ongoing and planned marketing, clinical trials and other related expenses. A financial risk management policy has been approved to i) generate yields on liquidity and ii) reduce the exposure to currency fluctuations with a timeline up to
The Company has entered into several foreign currency forwards for which the notional amounts are detailed in the table below:
As at | ||||
| June 30, | | December 31, | |
(in EUR 000) | 2026 | 2025 | ||
Foreign currency forwards EUR - USD (in EUR) | — | | ||
Foreign currency forwards EUR - USD (in USD) |
| — |
| |
The following table shows the carrying amount of derivative financial instruments measured at fair value in the statement of the financial position including their levels in the fair value hierarchy:
As at June 30, 2026 | ||||||||
(in EUR 000) | | Level I | | Level II | | Level III | | Total |
Financial assets |
| |
| |
| |
| |
Foreign currency forwards |
| |
| |
| |
| |
The fair value is determined by the financial institution and is based on foreign currency swaps and forwards rates and the maturity of the instrument. All foreign currency swaps are classified as current as their maturity date is within the next twelve months.
The change in the balance of the financial assets is detailed as follows:
(in EUR 000) | | 2026 | | 2025 |
Opening value at January 1 |
| |
| |
Fair value adjustments |
| ( |
| |
Closing value at June 30 |
| |
| |
The change in the balance of the financial liabilities is detailed as follows:
(in EUR 000) | | 2026 | | 2025 |
Opening value at January 1 |
| — |
| |
Settled contracts | — | ( | ||
Closing value at June 30 |
| — |
| — |
24.Results of operation
Revenue and cost of goods sold
In the six months ended June 30, 2026, the Company generated revenue for the amount of €
The contract liability included in the consolidated balance sheet is related to revenue attributed to the additional replenishment of disposable patches which is recognized when control of the patches is transferred to the customer or patient quarterly following the patient implants and the revenue attributed to the future deliveries of the patient-related components in the United States. The current contract liability amounts to €
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The sales based on country of customer for the three months ended and six months ended June 30, 2026 and 2025:
For the three months ended June 30 | For the six months ended June 30 | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Sales US |
| |
| — |
| |
| — |
Sales Germany |
| |
| |
| |
| |
Sales UAE |
| |
| — |
| |
| |
Sales England |
| |
| — |
| |
| — |
Sales Switzerland |
| |
| — |
| |
| — |
Sales Netherlands |
| — |
| — |
| |
| — |
Sales Austria |
| |
| |
| |
| |
Sales Spain |
| |
| — |
| |
| — |
Sales Italy |
| |
| — |
| |
| — |
Total sales |
| |
| |
| |
| |
For the six month period ended June 30, 2026, the Company had
For the three month period ended June 30, 2026, the Company had
Cost of goods sold for the three and six months ended June 30, 2026 and 2025:
| For the three months ended | For the six months ended | ||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Purchases of goods and services (*) |
| | | |
| | ||
Inventory movement |
| | ( | |
| ( | ||
Total cost of goods sold |
| | | |
| | ||
(*) | Including purchases of raw material, direct labour allocation, indirect labour allocation, fees of subcontractors, warranty and shipping cost (direct) |
Operating expenses
The tables below detail the operating expenses for the six months ended June 30, 2026 and 2025:
Operating | ||||||
expense for the | ||||||
(in EUR 000) | | Total cost | | Capitalized | | period |
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| |
| ( |
For the six months ended June 30, 2026 |
| |
| ( |
| |
| | | Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| |
| ( |
For the six months ended June 30, 2025 |
| |
| ( |
| |
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The tables below detail the operating expenses for the three months ended June 30, 2026 and 2025:
| | | Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| — |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| |
| |
| |
For the three months ended June 30, 2026 |
| |
| |
| |
| | | Operating | |||
expense for the | ||||||
(in EUR 000) | Total cost | Capitalized | period | |||
Research and development |
| |
| ( |
| |
Selling, general and administrative expenses |
| |
| |
| |
Other income/(expense) |
| ( |
| |
| ( |
For the three months ended June 30, 2025 |
| |
| ( |
| |
Research and Development expenses
| For the three months ended | For the six months ended | ||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Staff costs |
| | | |
| | ||
Consulting and contractors’ fees |
| | | |
| | ||
Q&A regulatory |
| | | |
| | ||
Depreciation and amortization expense |
| | | |
| | ||
Travel |
| | | |
| | ||
Manufacturing and outsourced development |
| | | |
| | ||
Clinical studies |
| | | |
| | ||
IT |
| | | |
| | ||
Rent |
| | | |
| | ||
Other expenses | | | | | ||||
Capitalized costs |
| — | ( | ( |
| ( | ||
Total research and development expenses |
| | | |
| | ||
Before capitalization of €
Research and development expenses decreased by €
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Selling, General and Administrative expenses
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Staff costs |
| | | |
| | ||
Consulting and contractors’ fees |
| | | |
| | ||
Legal fees |
| | | |
| | ||
Rent |
| | | |
| | ||
Depreciation and amortization expense |
| | | |
| | ||
IT |
| | | |
| | ||
Travel |
| | | |
| | ||
Insurance fees |
| | | |
| | ||
Impairment loss on trade receivables |
| | — | |
| — | ||
Other |
| | | |
| | ||
Total selling, general and administrative expenses |
| | | |
| | ||
Selling, general and administrative expenses increased by €
Selling, general and administrative expenses increased by €
Other operating income / ( expenses)
The Company had other operating income of €
The Company had other operating expenses of €
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Recoverable cash advances |
| |
| | ||||
Initial measurement and re-measurement |
| | | |
| | ||
R&D incentives |
| ( | | |
| | ||
Capitalization of R&D incentive |
| ( | ( | ( |
| ( | ||
Other income/(expenses) |
| — | — | — |
| | ||
Total Other Operating Income/(Expenses) |
| ( | | |
| | ||
The other operating income for the six month period ended June 30, 2026, contains the R&D incentive in Australia and as from 2023 the tax incentive in Belgium as well. The incentives to be received relate to development expenses incurred by the subsidiary in Australia and Belgium. For the six month period ended June 30, 2026, €
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25.Employee benefits
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Salaries |
| | | |
| | ||
Social charges |
| | | |
| | ||
Pension charges | | | | | ||||
Share-based payment |
| | | |
| | ||
Other |
| | | |
| | ||
Total employee benefits |
| | | |
| | ||
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Selling, general and administrative expenses |
| | | |
| | ||
Research & Development expenses |
| | | |
| | ||
Total employee benefits |
| | | |
| | ||
26.Financial income
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Interests |
| | | |
| | ||
Exchange differences |
| | | |
| | ||
Fair value adjustment foreign currency swaps and forwards | ( | | — | | ||||
Fair value adjustment synthetic warrants | — | ( | — | | ||||
Fair value adjustment prepayment option | — | ( | — | | ||||
Other |
| | | |
| | ||
Total financial income |
| | | |
| | ||
The financial income decreased from €
For the six month period ended June 30, 2026, exchange gains amount to €
The Company holds both EUR and USD balances, each used to settle expenses in their respective currencies.
While the Company does hedge a few transactions using swap contracts, the Company does not apply hedge accounting. The swap instruments are short-term and mainly used to manage transactional exposures in GBP, ILS, and CHF. Although GBP sales are expected to cover GBP costs going forward, some contracts have been used to address short-term needs. In addition, a few swaps were used to neutralize the currency impact of our USD-denominated T-bills, which were purchased using EUR balances for convenience, in line with the portfolio allocation approved by the board.
The main contributor to the exchange gain is explained by the fact that the majority of the cash held by the Belgian subsidiary is held in USD to cover future USD expenses. As a result, the recent depreciation of the euro, approximately
For the six month period ended June 30, 2026, total interest income amounted to €
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The fair value adjustments of synthetic warrants and prepayment option are related to the EIB loan facility agreement. More information can be found in note 18.
More information on the fair value adjustment on the convertible bond can be found in note 18.3.
More information on the fair value adjustment foreign currency swaps and forwards can be found in note 23.
27.Financial expense
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Fair value adjustment convertible bond |
| | — | |
| — | ||
Amortization day 1 loss convertible bond | | — | | — | ||||
Fair value adjustment synthetic warrants | | — | | — | ||||
Fair value adjustment prepayment option | ( | — | | — | ||||
Recoverable cash advances, Accretion of interest |
| | | |
| | ||
Interest and bank charges |
| | | |
| | ||
Interest on lease liabilities |
| | | |
| | ||
Exchange differences |
| | | |
| | ||
Other |
| | ( | |
| | ||
Total Financial expense |
| | | |
| | ||
The financial expenses increased from €
The exchange losses amounting to €
The discounting impact of the recoverable cash advances is further detailed in note 18 above.
The fair value adjustments the prepayment option are related to the EIB loan facility agreement. More information can be found in note 18.2.
More information on the amortization of the day 1 loss related to the convertible bond can be found in note 18.3.
28.Earnings/ (Loss) Per Share (EPS)
The Basic Earnings Per Share and the Diluted Earnings Per Share are calculated by dividing earnings for the year by the weighted average number of shares outstanding during the year. As the Company is incurring net losses, outstanding warrants have no dilutive effect. As such, there is no difference between the Basic and Diluted EPS.
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EPS for June 2026 has been presented in the income statement taking into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing preferred shares were converted into common shares, and then a share split of
| For the three months ended | For the six months ended | ||||||
June 30, | June 30, | |||||||
2026 | | 2025 | | 2026 | | 2025 | ||
As at June 30, after conversion and share split |
| |
| | ||||
Outstanding common shares at period-end |
| | | |
| | ||
Weighted average number of common shares outstanding |
| | | |
| | ||
Potential number of shares resulting from the exercise of outstanding warrants | | | | | ||||
Potential number of shares resulting from conversion of the bond |
| | — | |
| — | ||
Basic and Diluted EPS for the three and six month period ended June 30, 2026 and 2025 based on weighted average number of shares outstanding after conversion and share split are as follows:
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
| 2026 | | 2025 | | 2026 | | 2025 | |
Loss of year attributable to equity holders (in EUR) |
| ( | ( | ( |
| ( | ||
Weighted average number of common shares outstanding (in units) |
| | | |
| | ||
Basic earnings per share in EUR (EUR/unit) |
| ( | ( | ( |
| ( | ||
Diluted earnings per share in EUR (EUR/unit) |
| ( | ( | ( |
| ( | ||
29.Other commitments
There are
30.Related Party Transactions
Transactions between the Company and its subsidiaries have been eliminated in consolidation and are not disclosed in the notes. Related party transactions are disclosed below.
30.1. Remuneration of Key Management
Key management comprised of the members of executive management which consists of the Chief Executive Officer (CEO), the Chief Financial Officer (CFO), the Chief Commercial Officer (CCO) and the Chief Technology Officer (CTO) of the Company.
For the period ended June 30, 2026 and June 30, 2025, the table below includes the remuneration package of all members of executive management.
For the three months ended | For the six months ended | |||||||
June 30, | June 30, | |||||||
(in EUR 000) | | 2026 | | 2025 | | 2026 | | 2025 |
Short-term remuneration & compensation (1) |
| | | |
| | ||
Post-employment benefits | | | | | ||||
Share based payment (2) |
| | | |
| | ||
Total |
| | | |
| | ||
(1) | Includes base remuneration, fringe benefits, short term (one-year) performance related bonus (i.e. variable remuneration), sign-on bonuses. |
(2) | Warrant expense under IFRS 2. |
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30.2. Relationship and transactions with non-executive directors and holders of more than 3% of our share capital:
For the six months ended | For the six months ended | |||||||
June 30, 2026 | June 30, 2025 | |||||||
Set up of | Board | Set up of | Board | |||||
(in EUR 000) | | Production Line | | Remuneration | | Production line | | Remuneration |
Cochlear |
| — |
| — |
| |
| — |
Robelga SRL |
| — |
| |
| — |
| |
Kevin Rakin |
| — |
| |
| — |
| |
Pierre Gianello |
| — |
| |
| — |
| |
Jurgen Hambrecht |
| — |
| |
| — |
| |
Rita Mills |
| — |
| |
| — |
| |
Giny Kirby | — | | — | | ||||
Wildman Ventures LLC | — | | — | | ||||
Total |
| — |
| |
| |
| |
Amounts outstanding at period-end |
| — |
| |
| — |
| |
| For the three months ended | | For the three months ended | |||||
June 30, 2026 | June 30, 2025 | |||||||
Set up of | | Board | | Set up of | | Board | ||
(in EUR 000) |
| Production Line |
| Remuneration |
| Production line |
| Remuneration |
Cochlear |
| — |
| — |
| — |
| — |
Robelga SRL |
| — |
| |
| — |
| |
Kevin Rakin |
| — |
| |
| — |
| |
Pierre Gianello |
| — |
| |
| — |
| |
Jurgen Hambrecht |
| — |
| |
| — |
| |
Rita Mills |
| — |
| |
| — |
| |
Giny Kirby | — | | — | | ||||
Wildman Ventures LLC | — | | — | | ||||
Total |
| — |
| |
| — |
| |
Amounts outstanding at period-end |
| — |
| |
| — |
| |
For the period ended June 30, 2026, our non-executive directors were: Robelga SRL (permanently represented by Robert Taub), Jürgen Hambrecht, Kevin Rakin, Rita Johnson-Mills, Virigina Kirby, Wildman Ventures, LLC (permanently represented by Daniel Wildman) and Pierre Gianello.
The warrant expense under IFRS 2 related to the warrants that were granted to the non-executive directors amounted to €
The Company and Cochlear Limited, or Cochlear, have entered into a collaboration agreement, dated January 2023, related to the transfer of assets and related support for the setting up of a production line in the U.S. This statement scope of work led to
On September 28, 2023, the Company announced a partnership with ResMed in Germany to increase OSA awareness and therapy penetration in the German market. The Company and ResMed Germany will establish a continuum of care that will educate and guide OSA patients in the German market from diagnosis through treatment. Together, the companies will work to accelerate patient identification and better support patient set-up on the appropriate therapy.
Effective as of October 1, 2024, the Company entered into a collaboration agreement with Man & Science SA to develop a miniaturized injectable neuromodulation device. The Company retains exclusive rights for its use in treating obstructive sleep apnea.
30.3. Relationship and transactions with members of key management
For the period ended June 30, 2026 and June 30, 2025, our key management consisted of the members of executive management: Olivier Taelman (CEO), John Landry (CFO), Scott Holstine (CCO) and Bruno Onkelinx (CTO).
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From August 19, 2024 until September 1, 2025, Olivier Taelman temporarily relocated to the U.S. Since then, he performs his function as CEO of the Company partially on a self-employed basis in accordance with a service agreement between Nyxoah SA and Olivier Taelman and partially as employee of Nyxoah Inc. As from September 1, 2025, Olivier Taelman moved back to Belgium and from that date he is performing his function as CEO of the Company on a self-employed basis in accordance with a service agreement between Nyxoah SA and Olivier Taelman.
In June 2026, Olivier Taelman, together with the Board of Directors, has decided that this is the right moment to transition leadership to a U.S.-based Chief Executive Officer as the Company enters its next phase of U.S.-driven growth and value creation. The Board has formally launched a search process to appoint a new U.S.-based CEO who will lead Nyxoah from within a critical market for the Company’s future growth. He will remain fully engaged during the transition period, continuing to lead the Company’s daily operations and to support a smooth onboarding and successful transition to the future CEO.
Bruno Onkelinx is an employee of Nyxoah SA. John Landry and Scott Holstine are employees of Nyxoah Inc.
Members of our key management were granted warrants during the period ended June 30, 2026 and June 30, 2025.
31.Events after the Balance-Sheet Date
There are no events after the balance-sheet date.
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RESPONSIBILITY STATEMENT
We certify that, to the best of our knowledge,
| a) | the condensed consolidated interim financial statement, prepared in accordance with the applicable standards for financial statements, give a true and fair view of the assets, liabilities, financial position and results of the Company and the undertakings included in the consolidation taken as a whole; and |
| b) | this interim management report provides a true and fair overview of the development, results and the position of the Company and the undertakings included in the consolidation taken as a whole, as well as a description of the principal risks and uncertainties that they face. |
Mont-Saint-Guibert, August 5, 2026.
On behalf of the board of directors
Robelga SRL | | Olivier Taelman |
(permanently represented by Robert Taub) | CEO |
35