Full Press Release Details
INTERIM FINANCIAL REPORT
| Interim financial report | 3 | |
| 1. | Business update | 3 |
| 2. | FINANCIAL HIGHLIGHTS | 4 |
| 3. | 2025 OUTLOOK | 4 |
| 4. | RISK FACTORS | 5 |
| 5. | FORWARD-LOOKING STATEMENTS | 5 |
| Unaudited condensed consolidated interim financial information as at and for the nine months ended September 30, 2025 - Interim consolidated statement of financial position | 6 | |
| Unaudited condensed consolidated interim financial information as at and for the nine months ended September 30, 2025 - Interim consolidated statements of loss and other comprehensive loss | 7 | |
| Unaudited condensed consolidated interim financial information as at and for the nine months ended, September 30 2025 - Interim consolidated statements of changes in equity | 8 | |
| Unaudited condensed consolidated interim financial information as at and for the nine months ended September 30, 2025 - Interim consolidated statements of cash flows | 9 | |
| Notes to the unaudited condensed interim consolidated financial information | 10 | |
| 1. | General information | 10 |
| 2. | Material accounting policies | 10 |
| 3. | Critical accounting estimates and assumptions | 11 |
| 4. | Segment reporting | 12 |
| 5. | Fair Value | 12 |
| 6. | Subsidiaries | 13 |
| 7. | Property, Plant and Equipment | 13 |
| 8. | Intangible assets | 14 |
| 9. | Right of use assets and lease liabilities | 14 |
| 10. | Other long-term receivables | 15 |
| 11. | Inventory | 15 |
| 12. | Trade receivables, Contract assets and Other receivables | 16 |
| 13. | Other current assets | 16 |
| 14. | Cash and cash equivalents | 17 |
| 15. | Financial assets | 17 |
| 16. | Share Capital, Share Premium, Reserves | 17 |
| 17. | Share-Based compensation | 19 |
| 18. | Financial Debt | 22 |
| 19. | Provisions | 25 |
| 20. | Trade payables | 25 |
| 21. | Income taxes and deferred taxes | 26 |
| 22. | Other liabilities | 26 |
| 23. | Foreign currency swaps and forwards | 26 |
| 24. | Results of operation | 27 |
| 25. | Employee benefits | 31 |
| 26. | Financial income | 32 |
| 27. | Financial expense | 32 |
| 28. | Earnings/(Loss) Per Share (EPS) | 33 |
| 29. | Other commitments | 33 |
| 30. | Related Party Transactions | 33 |
| 31. | Events after the Balance-Sheet Date | 35 |
| Responsibility statement | 36 |
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
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 (see below).
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
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 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 enrollment 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 enrollment
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.
During the first nine months of 2025, Nyxoah recognized
a total revenue of 4.4 million, primarily in Germany. 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 full time employees as of September, 30th
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
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 centers, onboarding sites, shipping initial systems to hospitals/ambulatory surgery centers, and completing surgeon training.
During Q3 2025, Nyxoah recognized a total revenue of 231,000 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 enroll 229 patients (with a minimum of
160 evaluable patients).
Revenue was 4.4 million for the nine
months ending September 30, 2025, compared to 3.3 million for the nine months ending September 30, 2024.
Cost of goods sold was 1.7 million
for the nine months ending September 30, 2025, compared to cost of goods sold of 1.2 million for the nine months ending
Selling, general and administrative expenses increased
by 15.4 million or 75.4% from 20.4 million for the nine months ended September 30, 2024
to 35.8 million for the nine months ended September 30, 2025, due to an increase in costs to support
commercialization of the Genio system in the U.S. following FDA approval in August 2025 and the Company's broader scale-up
of commercial operations.
Before capitalization of 1.8 million
for the nine months ended September 30, 2025 and 3.8 million for the nine months ended September 30, 2024, research
and development expenses increased by 7.3 million or 27.8%, from 26.4 million for the nine months ended September 30,
2024, to 33.7 million for the nine months ended September 30, 2025. The increase is the result of higher R&D activities, offset by a decrease in clinical study expenses. 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 1.6 million for the nine months ending September 30, 2025 primarily driven by the exchange rate depreciation of the
U.S. dollar versus the Euro and interest expense on the term loan entered into in July 2024. This compares to a net negative financial
result of 0.9 million for the nine months ended September 30, 2024.
Nyxoah realized a net loss of 66.6 million
for the nine months ended September 30, 2025, compared to a net loss of 42.1 million for the nine months ended September 30,
Cash and cash equivalents
On September 30, 2025, cash and cash equivalents
and financial assets totalled 22.5 million, compared to 85.6 million on December 31, 2024. The decrease in financial
assets is due to the use of proceeds from the sale of term deposits to support operating activities.
The Company expects to continue ramping up sales
in Germany as well as in other European countries where we are already present and in select European and Middle East markets, subject
to the receipt of favorable reimbursement for the Company's product in those markets.
In the US, the Company's Pre-Market Approval (PMA)
application for the Genio system was approved by the FDA on August 8, 2025 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 began its commercial efforts in the US market on August 11, 2025.
We refer to the description of risk factors in
the Company's 2024 annual report, pp. 76-98, as well as to the risk related to lawsuit that Inspire Medical, Inc. filed against us
in May 2025 for the alleged infringement of three Inspire patents. 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.
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