INSIDE INFORMATION
REGULATED INFORMATION

Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio

Financings are comprised of equity investments, including from Cochlear, Resmed and Nyxoah’s Chairman and Management, and a convertible bond.

Mont–Saint–Guibert, Belgium – November 13, 2025, 2025, 10:11pm CET / 4:11 pm 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) through neuromodulation, today announced a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a €17 million registered direct offering combined with a convertible bond financing of up to €45 million.

The private placement consists of the issuance of 5,481,678 new ordinary shares at a subscription price per share of €4.00 (approximately U.S. $4.6304 at current exchange rates) with gross proceeds totaling €22 million (approximately U.S. $25 million at current exchange rates). The closing of the private placement is expected to occur on or about November 17, 2025, subject to customary closing conditions. Degroof Petercam acted as the sole book runner for this private placement.

The ordinary shares are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Additionally, the registered direct offering consists of the issuance of 1,215,964 new ordinary shares at a price per share of U.S. $4.6304 with gross proceeds totaling approximately U.S. $5,6 million. The closing of the registered direct offering is expected to occur on or about November 18, 2025, subject to customary closing conditions.

The registered direct offering is being made pursuant to an effective shelf registration statement on Form F–3 (File No. 333– 268955) which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 6, 2023. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov.

Additionally, the Company entered into a subscription agreement with an international financial services firm for the issuance of convertible bonds for an aggregate maximum principal amount of up to €45 million (approximately U.S. $52 million at current exchange rate). The financing consists of a first tranche of up to €22.5 million with an option to issue a second tranche of €22.5 million at Nyxoah’s discretion, during the 30 days beginning seven months from the closing date subject to certain conditions. The closing for the first tranche of bonds is expected to occur in December 2025, subject to customary closing conditions. The first tranche of bonds will be issued at 92 per cent of their principal amount and carry an interest rate of 6.5 per cent per annum, payable every quarter in arrears. The bonds have a three–year maturity from issuance with quarterly amortization payments of principal and interest. The default conversion price for the first tranche of bonds, which can be modified on a downward basis, shall be equal to EUR 5.00, which represents 125 per cent of the placement price of the Shares being issued pursuant to the private placement.

The net proceeds from the convertible bonds together with the net proceeds of the private placement, will be used (i) to support commercialization activities in the United States and advance the commercialization of the Genio system in the Company’s initial target markets outside the United States; (ii) to continue gathering clinical data and to support physician–initiated clinical research projects related to OSA patient treatments; (iii) to further finance research and development activities related to Genio system upgrades, re–designing the Company’s products for manufacturability and cost reduction initiatives; (iv) to continue to build a pipeline of new technologies and explore potential collaboration opportunities in the field of monitoring and diagnostics for OSA; and (v) for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should the Company choose to pursue any, and collaborations.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

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 Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription–only device.

ADDITIONAL INFORMATION

The following information is provided pursuant to article 7:97 of the Belgian Code on companies and associations. The investors that have participated in the private placement include, among others, (either directly or through entities controlled by them) Robert Taub, who is the chairman of the board of directors, Jürgen Hambrecht and Daniel Wildman (permanent representative of Wildman Ventures LLC), who are independent directors, Olivier Taelman, CEO and director of the Company, John Landry, CFO of the Company and Scott Holstine, Chief Commercial Officer of the Company. Together, these investors have subscribed to 356,250 new shares for EUR 1.425 million in gross proceeds at an issue price equal to EUR 4.00.

As Robert Taub, Jürgen Hambrecht, Daniel Wildman, Olivier Taelman, John Landry and Scott Holstine qualify as related parties of the Company, the board of directors applied the related parties procedure of article 7:97 of the Belgian Code on companies and associations in connection with the participation of the aforementioned related parties in the private placement. Within the context of the aforementioned procedure, prior to resolving on the private placement, a committee of three independent directors of the Company consisting of Rita Johnson–Mills, Virginia Kirby and Kevin Rakin (the “Committee”) issued an advice to the board of directors in which the Committee assessed the participation of the six aforementioned investors in the private placement. In its advice to the board of directors, the Committee concluded the following: “Based on the information provided, the Committee considers that the proposed Transaction is in line with the strategy pursued by the Company, will be done on market terms, and is unlikely to lead to disadvantages for the Company and its shareholders (in terms of dilution) that are not sufficiently compensated by the advantages that the Transaction offers the Company”.

The Company’s board of directors approved the principle of the private placement and did not deviate from the Committee's advice.

IMPORTANT INFORMATION

THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW. THIS ANNOUNCEMENT IS FOR GENERAL INFORMATION ONLY AND DOES NOT FORM PART OF ANY OFFER TO SELL OR PURCHASE, OR THE SOLICITATION OF ANY OFFER TO SELL OR PURCHASE, ANY SECURITIES. THE DISTRIBUTION OF THIS ANNOUNCEMENT AND THE OFFER, SUBSCRIPTION, SALE AND PURCHASE OF SECURITIES DESCRIBED IN THIS ANNOUNCEMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW. ANY PERSONS READING THIS ANNOUNCEMENT SHOULD INFORM THEMSELVES OF AND OBSERVE ANY SUCH RESTRICTIONS.

Forward–looking statements

Certain statements, beliefs and opinions in this press release are forward–looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the closings of the private placement, the registered direct offering and the convertible bond financing; 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; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the satisfaction of the closing conditions required for the closing of each of the private placement, the registered direct offering and the convertible bond financing and the consummation of the respective closings, 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward–looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward– looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

Attachment

• Financing PR

GLOBENEWSWIRE (Distribution ID 1001138771)

REGULATED INFORMATION

Nyxoah Reports Third Quarter 2025 Financial and Operating Results

US launch off to a strong start. First commercial Genio implants completed with widespread payer coverage drives initial revenue.

Mont–Saint–Guibert, Belgium – November 13, 2025, 10:10pm CET / 4:10 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2025.

Recent Financial and Operating Highlights

• Completed the first commercial implants of U.S. patients, and generated first U.S. revenue as early as September
• Reimbursement secured with Medicare and private payers, achieving 100% approval rate on prior authorization submissions from United Healthcare, Blue Cross Blue Shield, and Anthem. In all these approvals, the CPT code 64568 was accepted
• Revenue for the third quarter of 2025 was €2.0 million, representing 56% year over year growth, compared to €1.3 million in the third quarter of 2024
• Cash, cash equivalents and financial assets were €22.5 million on September 30, 2025, compared to €43.0 million at the end of June 30, 2025.

“The first weeks post FDA approval have been a huge success. We already completed the first implants in September. The response from physicians has been overwhelmingly positive, driven by the excitement of finally having real optionality in hypoglossal nerve stimulation for OSA patients,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We also secured reimbursement and generate the first U.S. revenue within the first month post FDA approval. The financing transaction announced today will support our sustained growth in the U.S. market. The momentum and enthusiasm couldn’t be greater.”

Strong Initial U.S. Commercial Launch

The Company is executing its focused two–pronged launch strategy, targeting high–volume hypoglossal nerve stimulation implanting centers while developing strong referral networks with sleep physicians. The first commercial Genio devices were implanted at Townsend Memorial Health System in Houston, Texas, where the surgeon completed five procedures in the first week.

As of October 31, the Company has trained 111 surgeons on the Genio system, and 9 accounts implanted Genio. The Company has completed 102 value analysis committee submissions, with 35 approvals received, and has submitted 63 prior authorizations through their Genio Access Program (GAP), of which 21 approvals have been received. These metrics reflect the strong early traction the Company is seeing in the market and demonstrate the execution of its focused launch strategy.

Reimbursement Progress

The Company continues to make significant progress towards widespread reimbursement coverage with major payor policy updates and strategic partnerships that streamline patient access to the Genio system. Health Care Service Corporation (HCSC) operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan have updated their hypoglossal nerve stimulation medical policies to include CPT Code 64568 as a referenced procedure code. While coverage for hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payors, which the Company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across six states.

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

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)

Revenue
Revenue was €2.0 million for the third quarter ending September 30, 2025, compared to €1.3 million for the third quarter ending September 30, 2024, representing a 56% year over year increase.

Cost of Goods Sold
Cost of goods sold was €0.8 million for the third quarter ending September 30, 2025, representing a gross profit of €1.2 million, or gross margin of 60.5%. This compares to cost of goods sold of €482,000 in the third quarter ending September 30, 2024, for a gross profit of €0.8 million, or gross margin of 62.0%.

Research and Development
For the third quarter ending September 30, 2025, research and development (“R&D”) expenses were €12.9 million, versus €7.9 million for the third quarter ending September 30, 2024. The increase in research and development expenses was primarily due to higher 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.

Selling, General and Administrative
For the third quarter ending September 30, 2025, selling, general and administrative expenses were €12.7 million, versus €8.0 million for the third quarter ending September 30, 2024. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system and the Company’s overall scale–up preparations for the commercialization of the Genio® system in the U.S. following receipt of FDA approval.

Operating Loss
Total operating loss for the third quarter ending September 30, 2025, was €24.4 million, versus €15.0 million in the third quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, including the Company’s overall scale–up preparations for the commercialization of the Genio system in the US in connection with the receipt of FDA approval, and increased R&D and manufacturing activities, in addition to higher depreciation and amortization expenses.

Cash Position
As of September 30, 2025, cash, cash equivalents and financial assets totaled €22.5 million, compared to €43.0 million at the end of June 30, 2025.

Third Quarter 2025
Nyxoah’s financial report for the third quarter of 2025, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, November 13, 2025, 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 Q3 2025 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah's Q3 2025 Earnings Call Q&A Line. required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

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

About Nyxoah

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

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

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 managements’ 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; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward–looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward– looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

Attachment

• ENGLISH_Q3 2025 Earnings PR

GLOBENEWSWIRE (Distribution ID 1001138769)

REGULATED INFORMATION

Nyxoah Reports Third Quarter 2025 Financial and Operating Results

US launch off to a strong start. First commercial Genio implants completed with widespread payer coverage drives initial revenue.

Mont–Saint–Guibert, Belgium – November 13, 2025, 10:10pm CET / 4:10 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2025.

Recent Financial and Operating Highlights

• Completed the first commercial implants of U.S. patients, and generated first U.S. revenue as early as September
• Reimbursement secured with Medicare and private payers, achieving 100% approval rate on prior authorization submissions from United Healthcare, Blue Cross Blue Shield, and Anthem. In all these approvals, the CPT code 64568 was accepted
• Revenue for the third quarter of 2025 was €2.0 million, representing 56% year over year growth, compared to €1.3 million in the third quarter of 2024
• Cash, cash equivalents and financial assets were €22.5 million on September 30, 2025, compared to €43.0 million at the end of June 30, 2025.

“The first weeks post FDA approval have been a huge success. We already completed the first implants in September. The response from physicians has been overwhelmingly positive, driven by the excitement of finally having real optionality in hypoglossal nerve stimulation for OSA patients,” commented Olivier Taelman, Nyxoah's Chief Executive Officer. “We also secured reimbursement and generate the first U.S. revenue within the first month post FDA approval. The financing transaction announced today will support our sustained growth in the U.S. market. The momentum and enthusiasm couldn’t be greater.”

Strong Initial U.S. Commercial Launch

The Company is executing its focused two–pronged launch strategy, targeting high–volume hypoglossal nerve stimulation implanting centers while developing strong referral networks with sleep physicians. The first commercial Genio devices were implanted at Townsend Memorial Health System in Houston, Texas, where the surgeon completed five procedures in the first week.

As of October 31, the Company has trained 111 surgeons on the Genio system, and 9 accounts implanted Genio. The Company has completed 102 value analysis committee submissions, with 35 approvals received, and has submitted 63 prior authorizations through their Genio Access Program (GAP), of which 21 approvals have been received. These metrics reflect the strong early traction the Company is seeing in the market and demonstrate the execution of its focused launch strategy.

Reimbursement Progress

The Company continues to make significant progress towards widespread reimbursement coverage with major payor policy updates and strategic partnerships that streamline patient access to the Genio system. Health Care Service Corporation (HCSC) operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico, and Montana. HCSC and Blue Cross Blue Shield of Michigan have updated their hypoglossal nerve stimulation medical policies to include CPT Code 64568 as a referenced procedure code. While coverage for hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payors, which the Company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across six states.

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

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)

Revenue
Revenue was €2.0 million for the third quarter ending September 30, 2025, compared to €1.3 million for the third quarter ending September 30, 2024, representing a 56% year over year increase.

Cost of Goods Sold
Cost of goods sold was €0.8 million for the third quarter ending September 30, 2025, representing a gross profit of €1.2 million, or gross margin of 60.5%. This compares to cost of goods sold of €482,000 in the third quarter ending September 30, 2024, for a gross profit of €0.8 million, or gross margin of 62.0%.

Research and Development
For the third quarter ending September 30, 2025, research and development (“R&D”) expenses were €12.9 million, versus €7.9 million for the third quarter ending September 30, 2024. The increase in research and development expenses was primarily due to higher 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.

Selling, General and Administrative
For the third quarter ending September 30, 2025, selling, general and administrative expenses were €12.7 million, versus €8.0 million for the third quarter ending September 30, 2024. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system and the Company’s overall scale–up preparations for the commercialization of the Genio® system in the U.S. following receipt of FDA approval.

Operating Loss
Total operating loss for the third quarter ending September 30, 2025, was €24.4 million, versus €15.0 million in the third quarter 2024, respectively. This was driven by an increase in selling, general and administrative expenses to support commercialization of the Genio system, including the Company’s overall scale–up preparations for the commercialization of the Genio system in the US in connection with the receipt of FDA approval, and increased R&D and manufacturing activities, in addition to higher depreciation and amortization expenses.

Cash Position
As of September 30, 2025, cash, cash equivalents and financial assets totaled €22.5 million, compared to €43.0 million at the end of June 30, 2025.

Third Quarter 2025
Nyxoah’s financial report for the third quarter of 2025, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Thursday, November 13, 2025, 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 Q3 2025 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah's Q3 2025 Earnings Call Q&A Line. required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

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

About Nyxoah

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

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

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 managements’ 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; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward–looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward– looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

Attachment

• ENGLISH_Q3 2025 Earnings PR

GLOBENEWSWIRE (Distribution ID 1001138769)

INFORMATIONS RÉGLEMENTÉES

Nyxoah Présente ses Résultats Financiers et d’Exploitation
pour le Troisième Trimestre 2025

Lancement réussi aux États–Unis. Les premières implantations commerciales de Genio, largement prises en charge par les organismes payeurs, génèrent les premiers revenus.

Mont–Saint–Guibert, Belgique – 13 novembre 2025, 22h10 CET / 16h10 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques révolutionnaires pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a rapporté aujourd’hui ses résultats financiers et d’exploitation pour le troisième trimestre 2025.

Temps Forts Financiers et d’Exploitation

• Réalisation des premières implantations commerciales chez des patients américains et génération des premiers revenus aux États–Unis dès le mois de septembre
• Remboursement sécurisé auprès de Medicare et des assureurs privés, avec un taux d'approbation de 100 % des demandes d'autorisation préalable soumises à United Healthcare, Blue Cross Blue Shield et Anthem. Dans toutes ces approbations, le code CPT 64568 a été accepté
• Le chiffre d'affaires du troisième trimestre 2025 s'est élevé à 2,0 millions d'euros, soit une croissance de 56 % par rapport à l'année précédente, contre 1,3 million d'euros au troisième trimestre 2024
• La trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 22,5 millions d'euros au 30 septembre 2025, contre 43,0 millions d'euros à la fin du 30 juin 2025.

“Les premières semaines qui ont suivi l'autorisation de la FDA ont été couronnées de succès. Nous avons déjà réalisé les premières implantations en septembre. Les réactions des médecins ont été extrêmement positives, motivées par l'enthousiasme suscité par la possibilité d'avoir enfin une véritable option en matière de stimulation du nerf hypoglosse pour les patients atteints d'AOS”, a commenté Olivier Taelman, CEO de Nyxoah. “Nous avons également obtenu le remboursement et généré les premiers revenus aux États–Unis dès le premier mois suivant l'autorisation de mise sur le marché délivrée par la FDA. L'opération de financement annoncée aujourd'hui soutiendra notre croissance durable sur le marché américain. La dynamique et l'enthousiasme ne pourraient être plus grands.”

Lancement Commercial Initial Solide aux États–Unis
La Société met en œuvre sa stratégie de lancement à deux volets, ciblant les centres d'implantation de stimulateurs du nerf hypoglosse à grand volume tout en développant de solides réseaux de référents auprès des médecins spécialistes du sommeil. Les premiers dispositifs Genio ont été implantés au Townsend Memorial Health System à Houston, au Texas, où le chirurgien a réalisé cinq interventions au cours de la première semaine.

Au 31 octobre, la Société avait formé 111 chirurgiens au système Genio et 9 établissements avaient implanté Genio. La Société a soumis 102 demandes auprès de comités d'analyse de la valeur (Value Analysis Committee – “VAC”), dont 35 ont été approuvées, et a soumis 63 autorisations préalables dans le cadre de son programme Genio Access Program (GAP), dont 21 ont été approuvées. Ces chiffres reflètent la forte traction initiale que la Société observe sur le marché et démontrent la bonne exécution de sa stratégie de lancement ciblée.

Progrès en Matière de Remboursement

La Société continue de réaliser des progrès significatifs en matière de couverture de remboursement généralisée grâce à des mises à jour importantes des politiques des principaux payeurs et à des partenariats stratégiques qui rationalisent l'accès des patients au système Genio. Health Care Service Corporation (HCSC) gère les régimes Blue Cross Blue Shield dans l'Illinois, au Texas, en Oklahoma, au Nouveau–Mexique et au Montana. HCSC et Blue Cross Blue Shield of Michigan ont mis à jour leurs politiques médicales en matière de stimulation du nerf hypoglosse afin d'inclure le code CPT 64568 comme code de procédure de référence. Bien que la couverture de la stimulation du nerf hypoglosse était déjà établie, l'inclusion de ce code apporte une clarification supplémentaire pour les prestataires et les payeurs, ce qui, selon la Société, contribuera à réduire les obstacles administratifs et à rationaliser l'accès des patients. HCSC et BCBS of Michigan représentent plus de 26 millions de membres dans six États.

ÉTATS CONSOLIDÉS DES PERTES ET AUTRES ÉLÉMENTS DU RÉSULTAT GLOBAL

(non audités) (en milliers)

ÉTAT DE LA SITUATION FINANCIÈRE CONSOLIDÉ (non audité) (en milliers)

Revenus
Le chiffre d'affaires s'est élevé à 2,0 millions d'euros pour le troisième trimestre clos le 30 septembre 2025, contre 1,3 million d'euros pour le troisième trimestre clos le 30 septembre 2024, soit une augmentation de 56 % en comparaison annuelle.

Coût des marchandises vendues
Le coût des marchandises vendues s'est élevé à 0,8 million d'euros pour le troisième trimestre clos le 30 septembre 2025, ce qui représente une marge brute de 1,2 million d'euros, soit une marge brute de 60,5 %. À titre de comparaison, le coût des marchandises vendues s'élevait à 482 000 € au troisième trimestre clos le 30 septembre 2024, pour une marge brute de 0,8 million d'euros, soit une marge brute de 62,0 %.

Recherche et développement
Pour le troisième trimestre clos le 30 septembre 2025, les dépenses de recherche et développement (« R&D ») se sont élevées à 12,9 millions d'euros, contre 7,9 millions d'euros pour le troisième trimestre clos le 30 septembre 2024. L'augmentation des dépenses de recherche et développement est principalement due à l'intensification des activités de R&D. En outre, à la suite de l'autorisation de mise sur le marché délivrée par la FDA en août 2025, l'amortissement des actifs incorporels associés a commencé, entraînant une augmentation des charges d'amortissement.

Frais commerciaux, généraux et administratifs
Pour le troisième trimestre clos le 30 septembre 2025, les frais commerciaux, généraux et administratifs se sont élevés à 12,7 millions d'euros, contre 8,0 millions d'euros pour le troisième trimestre clos le 30 septembre 2024. L'augmentation des frais de vente, généraux et administratifs est principalement due à une augmentation des coûts liés à la commercialisation du système Genio® et aux préparatifs généraux de la Société en vue de la commercialisation du système Genio® aux États–Unis après l'obtention de l'autorisation de la FDA.

Perte d'exploitation
La perte d'exploitation totale pour le troisième trimestre clos le 30 septembre 2025 s'est élevée à 24,4 millions d'euros, contre 15,0 millions d'euros au troisième trimestre 2024. Cette augmentation s'explique par la hausse des frais commerciaux, généraux et administratifs liés à la commercialisation du système Genio, notamment les préparatifs généraux de la Société en vue de la commercialisation du système Genio aux États–Unis suite à l'obtention de l'autorisation de la FDA, ainsi que par l'intensification des activités de R&D et de fabrication, en plus de la hausse des charges d'amortissement.

Position de trésorerie

Au 30 septembre 2025, la trésorerie, les équivalents de trésorerie et les actifs financiers s'élevaient à 22,5 millions d'euros, contre 43,0 millions d'euros à la fin du 30 juin 2025.

Troisième trimestre 2025

Le rapport financier de Nyxoah pour troisième trimestre 2025, y compris les détails des résultats consolidés, sont disponibles sur la page investisseurs du site web de Nyxoah (https://investors.nyxoah.com/financials).

Conférence téléphonique et webcast

Le management de la Société organisera une conférence téléphonique pour discuter ses résultats financiers le même jour, à 22h30 CET / 16h30 ET.

La retransmission de la conférence téléphonique sera accessible sur la page Investor Relations du site web de Nyxoah ou par le biais de ce lien : Nyxoah's Q3 2025 Earnings Call Webcast. Pour ceux qui n'ont pas l'intention de poser une question au Management, la Société recommande d'écouter la webdiffusion.

Si vous avez l'intention de poser une question, veuillez utiliser le lien suivant : Nyxoah's Q3 2025 Earnings Call. Après l'inscription, un courriel sera envoyé, comprenant les détails de la connexion et un code d'accès unique à la conférence téléphonique nécessaire pour rejoindre l'appel en direct. Pour s'assurer que vous êtes connecté avant le début de la conférence, la Société suggère de s'inscrire au moins 10 minutes avant le début de l'appel.

Le webcast archivé pourra être réécouté peu après la clôture de la conférence.

A propos de Nyxoah

Nyxoah opère dans le secteur des technologies médicales. Elle se concentre sur le développement et la commercialisation de solutions innovantes destinées à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS). La principale solution de Nyxoah est le système Genio®, une thérapie de neurostimulation du nerf hypoglosse sans sonde et sans batterie qui a reçu le marquage CE, centrée sur le patient et destinée à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS), le trouble respiratoire du sommeil le plus courant au monde. Ce dernier est associé à un risque accru de mortalité et des comorbidités, dont les maladies cardiovasculaires. La vision de Nyxoah est que les patients souffrant de SAOS doivent pouvoir profiter de nuits réparatrices et vivre pleinement leur vie.

À la suite de la finalisation probante de l’étude BLAST OSA, le système Genio® a reçu le marquage européen CE en 2019. Nyxoah a réalisé avec succès deux IPO : l’une sur Euronext Bruxelles en septembre 2020 et l’autre sur le NASDAQ en juillet 2021. Grâce aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu le marquage CE pour l’extension de ses indications thérapeutiques aux patients souffrant de collapsus concentrique complet (CCC), pour lesquels les thérapies concurrentes sont actuellement contre–indiquées. En outre, la Société a annoncé les résultats positifs de l'étude pivot DREAM IDE et l'obtention de l'autorisation de la FDA pour un sous–groupe de patients adultes atteints d'AOS modérée à sévère avec un IAH supérieur ou égal à 15 et inférieur ou égal à 65.

Pour plus d’informations, visitez www.nyxoah.com

Attention – Marquage CE depuis 2019. Approuvé par la FDA en août 2025 en tant que dispositif disponible uniquement sur prescription médicale.

Déclarations Prospectives

Certaines déclarations, convictions et opinions contenues dans ce communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la Société ou, le cas échéant, de ses administrateurs ou de sa direction concernant le système Genio ; les études cliniques prévues et en cours sur le système Genio ; les avantages potentiels du système Genio ; les objectifs de Nyxoah en matière de développement, de parcours réglementaire et d'utilisation potentielle du système Genio ; la stratégie de commercialisation de la société et son entrée sur le marché américain ; et les résultats d'exploitation, la situation financière, la liquidité, les performances, les perspectives, la croissance et les stratégies de la société. De par leur nature, les déclarations prospectives comportent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou événements réels diffèrent sensiblement de ceux exprimés ou sous–entendus dans les déclarations prospectives. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence défavorable sur les résultats et les effets financiers des plans et événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2024, déposé auprès de la Securities and Exchange Commission (« SEC ») le 20 mars 2025, et dans les rapports ultérieurs que la Société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent considérablement de toute évolution prévue. Les déclarations prospectives contenues dans le présent communiqué de presse concernant les tendances ou activités passées ne constituent pas des garanties de performances futures et ne doivent pas être interprétées comme une indication que ces tendances ou activités se poursuivront à l'avenir. En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements ne sont pas nécessairement indicatifs des résultats ou développements futurs. Aucune déclaration ni garantie n'est faite quant à l'exactitude ou à l'équité de ces déclarations prospectives. Par conséquent, la Société décline expressément toute obligation ou engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement dans les attentes ou d'un changement dans les événements, les conditions, les hypothèses ou les circonstances sur lesquels ces déclarations prospectives sont fondées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni aucun des dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs, et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans le présent communiqué de presse ou à la réalisation effective des développements prévus. Vous ne devez pas vous fier indûment aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contact :

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

Pièce jointe

• FRENCH_Q3 2025 Earnings PR

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