Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [4] Financial Results Announcement - Nyxoah will release its financial results for the first quarter of 2025 on May 14, 2025 [1] - A conference call to discuss these results will take place on the same day at 2:00 PM CET / 8:00 AM ET [1] Webcast Information - A webcast of the earnings call will be available on the Investor Relations page of Nyxoah's website [2] - For participants wishing to ask questions, registration is required to receive dial-in details and a unique access code [3] Product Development and Regulatory Milestones - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5] - Positive outcomes were also announced from the DREAM IDE pivotal study [5]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Nyxoah S.A. and its officers or directors [1] Group 1: Company Developments - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [3] - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [3] - Following the announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [3] Group 2: Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the FDA announcement [4]

Core Points - Nyxoah SA announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs [3] - The total number of ordinary shares that can be sold and issued under the Company's ATM has increased to 5,662,694, which includes 662,694 shares remaining from a previous issuance decision made on December 22, 2022 [3][4] - The shares may be sold at prevailing USD market prices on the Nasdaq Global Market at the time of sale [4]

Core Viewpoint - Nyxoah is nearing full FDA approval for its Genio system, with expectations to meet final requirements in the second quarter of 2025 [1][4]. Group 1: FDA Approval Process - On March 26, 2025, the FDA issued an Approvable Letter for Nyxoah's Pre-Market Approval (PMA) application for the Genio system [2]. - The Approvable Letter indicates that the application substantially meets FDA requirements, pending satisfactory completion of a review of manufacturing facilities and methods [3]. - Nyxoah is addressing one remaining item related to the validation of a process at its U.S. manufacturing site, which is expected to be completed soon [4]. Group 2: Company Background and Product Information - Nyxoah specializes in developing innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation, with the Genio system being a leadless and battery-free hypoglossal neurostimulation therapy [6]. - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7]. - The company has conducted successful IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and has expanded its therapeutic indications based on positive study outcomes [7].

Core Viewpoint - The Schall Law Firm is investigating Nyxoah S.A. for potential violations of securities laws related to misleading statements and undisclosed information regarding the FDA's approval process for the Genio® system [1][2]. Group 1: Investigation Details - The investigation centers on whether Nyxoah issued false or misleading statements or failed to disclose critical information to investors [2]. - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [2]. - Analysts noted that this announcement may lead to a delay in the commercial launch of the Genio® system, resulting in a significant drop of over 21.3% in Nyxoah's share price the following day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who have suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Nyxoah S.A. and its officers or directors [1] Company Developments - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [3] - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [3] - Following this announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [3] Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the news [4]

Core Viewpoint - Nyxoah S.A. is under investigation for possible securities fraud following a significant stock price decline after the FDA's Approvable Letter regarding its Genio® system [1][4]. Group 1: Company Announcement - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially met regulatory requirements [3]. - Final approval from the FDA is pending a satisfactory review of Nyxoah's manufacturing facilities, methods, and controls [3]. Group 2: Market Reaction - Following the FDA announcement, analysts predicted a delay in the commercial launch of the Genio® system, leading to a stock price decline of $2.42 per share, or 21.36%, closing at $8.91 on March 26, 2025 [4]. Group 3: Legal Actions - The Portnoy Law Firm has initiated an investigation into Nyxoah for possible securities fraud and may file a class action on behalf of investors who incurred losses [1]. - Investors are encouraged to contact the law firm for a complimentary case evaluation and to discuss options for recovering their losses [2][5].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Nyxoah S.A. and its officers or directors, following a significant stock price drop after the FDA's Approvable Letter regarding the Genio® system [1][2][3]. Group 1: Company Developments - On March 25, 2025, Nyxoah announced that the FDA issued an Approvable Letter for its Pre-Market Approval application for the Genio® system, indicating that the application substantially meets regulatory requirements [2]. - The FDA's approval is contingent upon satisfactory completion of a review of manufacturing facilities, methods, and controls [2]. - Following the announcement, analysts projected a delay in the commercial launch of the Genio system pending further FDA review [2]. Group 2: Market Reaction - Nyxoah's stock price fell by $2.42 per share, or 21.36%, closing at $8.91 per share on March 26, 2025, in response to the FDA announcement [3].

Core Insights - The FDA has issued an Approvable Letter for Nyxoah's Genio® system, indicating that the application substantially meets the necessary requirements for marketing in the U.S. [3][4] - The approval is contingent upon the satisfactory completion of a review of manufacturing facilities, methods, and controls [4][5] - Nyxoah's CEO expressed confidence in the approval process, noting that there were no further questions regarding clinical data or biocompatibility [5] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA) through neuromodulation [6] - The Genio® system is a leadless, battery-free hypoglossal neurostimulation therapy designed for OSA patients [6] - The company aims to improve the quality of life for OSA patients, who face increased mortality risk and cardiovascular issues [6] Regulatory and Market Position - The Genio® system received its European CE Mark in 2019 and has been approved for both Complete Concentric Collapse (CCC) and non-CCC patients [7] - Nyxoah has successfully completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [7] - The company has reported positive outcomes from clinical studies, including the BETTER SLEEP study and the DREAM IDE pivotal study [7]

PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section outlines the principal risks associated with the company's business, financial position, product development, commercialization, and regulatory compliance, including a history of losses, dependence on the Genio system's success, regulatory hurdles, and identified material weaknesses in internal financial controls [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) This subsection details the company's limited operating history, reliance on the Genio system, regulatory challenges, and internal control weaknesses - The company has a limited operating history, has incurred losses since inception, and its future performance is highly dependent on the commercial acceptance of its sole product, the Genio system[29](index=29&type=chunk) - Nyxoah has identified material weaknesses in its internal control over financial reporting for the year ended December 31, 2024, which could lead to failure in meeting reporting obligations or result in material misstatements[31](index=31&type=chunk)[288](index=288&type=chunk) - The company faces significant regulatory risks, including the need to obtain and maintain marketing authorizations in key markets like the United States, and is subject to extensive government oversight[29](index=29&type=chunk)[31](index=31&type=chunk) [Information on the Company](index=94&type=section&id=Item%204.%20Information%20on%20the%20Company) Nyxoah is a medical technology company focused on developing and commercializing the Genio system, an innovative hypoglossal neurostimulation (HGNS) therapy for Obstructive Sleep Apnea (OSA), pursuing FDA approval in the U.S. and expanding its commercial infrastructure in select European markets [History and Development of the Company](index=94&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) This section traces Nyxoah's corporate history from its incorporation to its public listings and outlines its capital expenditure focus - Nyxoah SA was incorporated in Belgium on July 15, 2009, becoming publicly listed on Euronext Brussels in September 2020 and on The Nasdaq Global Market in July 2021[298](index=298&type=chunk) Capital Expenditures (in millions) | Year | Capital Expenditure (€) | | :--- | :--- | | 2024 | 5.9 million | | 2023 | 10.5 million | | 2022 | 16.3 million | - Principal capital expenditures in 2023 and 2024 were focused on capitalized development expenses, establishing a U.S. production line, and investments in new clean rooms and laboratory equipment[301](index=301&type=chunk)[302](index=302&type=chunk) [Business Overview](index=94&type=section&id=B.%20Business) This section details Nyxoah's flagship product, the Genio system, its market differentiation, and progress in clinical trials and market authorization - Nyxoah's lead product is the Genio system, a CE-Marked, minimally invasive hypoglossal neurostimulation (HGNS) therapy for moderate to severe Obstructive Sleep Apnea (OSA)[303](index=303&type=chunk) - The DREAM pivotal trial, designed to support U.S. marketing authorization, met its primary endpoints, with an announcement made on March 19, 2024, and the company expects to be commercially available in the U.S. in the first quarter of 2025[303](index=303&type=chunk)[310](index=310&type=chunk)[318](index=318&type=chunk) Estimated Annual Total Addressable Market (TAM) | Region | Target Patients | Estimated Annual Market Opportunity | | :--- | :--- | :--- | | Europe | 515,000 | ~$10 billion | | United States | 510,000 | ~$10 billion | - The Genio system is differentiated by its battery-free, leadless, single-incision implant design that provides bilateral stimulation, potentially treating a broader patient population, including those with Complete Concentric Collapse (CCC)[306](index=306&type=chunk)[308](index=308&type=chunk)[315](index=315&type=chunk) [Organizational Structure](index=160&type=section&id=C.%20Organizational%20Structure) This section outlines the company's corporate structure, including its significant subsidiaries and their respective activities Significant Subsidiaries | Name | Country | Activity | Holding | | :--- | :--- | :--- | :--- | | Nyxoah Ltd | Israel | Medical Technology R&D | 100% | | Nyxoah Pty Ltd | Australia | Medical Technology R&D | 100% | | Nyxoah, Inc. | United States | Medical Technology R&D; pre-commercialization | 100% | | Nyxoah GmbH | Germany | Commercialization of medical devices | 100% | [Property, Plant and Equipment](index=160&type=section&id=D.%20Property%2C%20Plant%20and%20Equipment) This section describes the company's property arrangements, noting that all facilities are leased across various locations - The company leases all of its properties, including its corporate headquarters in Mont-Saint-Guibert, Belgium, manufacturing facilities in Milmort, Belgium, R&D facilities in Tel Aviv, Israel, and offices in Summit, New Jersey, USA[530](index=530&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk)[533](index=533&type=chunk)[534](index=534&type=chunk) [Operating and Financial Review and Prospects](index=161&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) Nyxoah's financial performance reflects its stage as a growing medical technology company, with revenue increasing to **€4.5 million** in 2024, but net losses widening to **€59.2 million** due to significant investments in R&D, clinical trials, and commercial infrastructure, with liquidity supported by recent capital raises expected to fund operations through mid-2026 [Operating Results](index=161&type=section&id=A.%20Operating%20Results) This section analyzes the company's financial performance, highlighting revenue growth and increased operating losses due to strategic investments - The company's financial strategy is focused on obtaining regulatory approval in new markets (especially the U.S.), growing its commercial organization, investing in clinical support and product innovation, and securing third-party payor reimbursement[540](index=540&type=chunk)[542](index=542&type=chunk)[543](index=543&type=chunk)[545](index=545&type=chunk)[546](index=546&type=chunk) Comparison of Operations (Year Ended Dec 31) | (In Thousands €) | 2024 | 2023 | YoY Change | YoY % Change | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | 4,521 | 4,348 | 173 | 4% | | **Gross Profit** | 2,969 | 2,692 | 277 | 10% | | **R&D Expenses** | (34,325) | (26,651) | (7,674) | 29% | | **SG&A Expenses** | (28,461) | (21,687) | (6,774) | 31% | | **Operating Loss** | (58,809) | (45,102) | (13,707) | 30% | | **Loss for the period** | (59,236) | (43,212) | (16,024) | 37% | - Revenue for 2024 increased by **4% to €4.5 million**, driven by growing commercialization of the Genio system in Europe, including expansion into Italy and the UK[561](index=561&type=chunk) - The operating loss widened by **30% in 2024**, primarily due to a **€7.6 million (29%) increase in R&D expenses** and a **€6.8 million (31%) increase in SG&A expenses** to support clinical trials, product development, and commercial scale-up[564](index=564&type=chunk)[571](index=571&type=chunk)[576](index=576&type=chunk) [Liquidity and Capital Resources](index=174&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) This section details the company's cash position, capital raises, and projected liquidity runway - As of December 31, 2024, the company had cash and cash equivalents of **€34.2 million** and financial assets of **€51.4 million**[600](index=600&type=chunk) - The company believes its current cash position is sufficient to fund operations for at least 12 months from the report date and through the middle of 2026, supported by capital raises totaling **€110.6 million in 2024**[550](index=550&type=chunk)[600](index=600&type=chunk)[612](index=612&type=chunk) Cash Flow Summary (Year Ended Dec 31, in thousands €) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (49,226) | (44,778) | | Net cash from (used in) investing activities | (16,325) | 32,011 | | Net cash from financing activities | 77,439 | 16,858 | [Directors, Senior Management and Employees](index=178&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the composition of the company's leadership and workforce, providing biographies for executive officers and non-executive directors, outlining compensation structure, and describing board practices and committee compositions, with a significant increase in personnel to support R&D and commercial activities as of year-end 2024 [Directors and Senior Management](index=178&type=section&id=A.%20Directors%20and%20Senior%20Management) This section introduces the executive team and non-executive board members, highlighting key leadership changes and their expertise - The executive team is led by CEO Olivier Taelman, with key additions and changes in 2024 including John Landry as CFO (replacing Loic Moreau) and Scott Holstine as CCO[618](index=618&type=chunk)[619](index=619&type=chunk)[620](index=620&type=chunk)[622](index=622&type=chunk) - The non-executive board is chaired by founder Robert Taub (represented by Robelga SRL) and includes members with extensive experience in life sciences, medical devices, and finance from companies like HighCape Capital, Cochlear, and BASF[618](index=618&type=chunk)[623](index=623&type=chunk)[624](index=624&type=chunk)[626](index=626&type=chunk) [Compensation](index=181&type=section&id=B.%20Compensation) This section details the compensation structure for the CEO, executive management, and non-executive directors, including salaries, bonuses, and equity awards CEO Compensation (2024) | Component | Amount (€) | | :--- | :--- | | Base salary | 424,283 | | Performance bonus | 298,029 | | Pension contributions | 19,860 | | Fringe benefits | 18,381 | - In 2024, CEO Olivier Taelman was granted **420,000 warrants**, while other executive management team members received an aggregate base salary of **€693,546** and performance bonuses of **€348,138**[650](index=650&type=chunk)[651](index=651&type=chunk) - Non-executive directors receive an annual fixed fee (**€45,000** for directors, **€82,000** for the Chairman) plus additional fees for committee service, and in 2024, all non-executive directors were also granted **14,806 Restricted Share Units (RSUs)** each[634](index=634&type=chunk)[636](index=636&type=chunk) [Board Practices](index=193&type=section&id=C.%20Board%20Practices) This section describes the company's governance structure, board committees, and deviations from Nasdaq listing rules as a foreign private issuer - The company has a one-tier governance structure and has established four board committees: Audit, Remuneration, Nomination, and Science & Technology[670](index=670&type=chunk)[679](index=679&type=chunk) - As a foreign private issuer, Nyxoah follows certain Belgian corporate governance practices in lieu of Nasdaq requirements, such as not having a majority of independent directors on the full board and different composition rules for its Remuneration and Nomination committees[666](index=666&type=chunk)[882](index=882&type=chunk) - The company deviates from the Belgian Corporate Governance Code by granting share-based incentives (warrants and RSUs) to non-executive directors, arguing it is necessary to attract top talent in the life sciences industry and align their interests with shareholders[698](index=698&type=chunk) [Employees](index=202&type=section&id=D.%20Employees) This section provides an overview of the company's workforce size and its growth across different functions Full-Time Equivalents (FTEs) by Function | Function | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Sales, General & Administration | 56.5 | 40.4 | 34.9 | | Research & Development | 127.1 | 106.4 | 102.6 | | **Total** | **183.6** | **146.8** | **137.5** | - The company's workforce grew to **183.6 FTEs in 2024** from **146.8 in 2023**, with significant growth in both R&D and SG&A functions to support clinical trials and commercial expansion[701](index=701&type=chunk) [Major Shareholders and Related Party Transactions](index=204&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies the company's major shareholders, with significant stakes held by Cochlear Investments Pty Ltd (**15.1%**), founder Robert Taub (**10.7%**), Vestal Point Capital, LP (**8.0%**), and entities affiliated with Gilde Healthcare (**7.8%**), and details related party transactions, including compensation for directors and executives [Major Shareholders](index=204&type=section&id=A.%20Major%20Shareholders) This section lists the company's principal shareholders and their respective ownership percentages Beneficial Ownership (as of March 1, 2025) | Shareholder | Ownership % | | :--- | :--- | | Cochlear Investments Pty Ltd | 15.1% | | Robert Taub | 10.7% | | Vestal Point Capital, LP | 8.0% | | TOGETHER Partnership | 7.9% | | Entities affiliated with Gilde Healthcare | 7.8% | | Resmed Inc. | 4.6% | | FMR LLC | 4.5% | | Jürgen Hambrecht | 3.7% | - As of March 1, 2025, all current directors and executive management as a group beneficially own **17.0%** of the company's ordinary shares[710](index=710&type=chunk) [Related Party Transactions](index=207&type=section&id=B.%20Related%20Party%20Transactions) This section outlines transactions with related parties, including executive compensation and board member participation in offerings - CEO Olivier Taelman performs his duties under a service agreement and, as of August 2024, also as an employee of Nyxoah Inc. following a temporary relocation to the U.S[717](index=717&type=chunk)[718](index=718&type=chunk) - Board Chairman Robert Taub participated in the May 2024 underwritten public offering, an action approved by the board under the related parties procedure[719](index=719&type=chunk) [Financial Information](index=209&type=section&id=Item%208.%20Financial%20Information) This section confirms that the detailed consolidated financial statements are provided elsewhere in the report, states that the company has never paid dividends and does not anticipate doing so, intending to retain all earnings for business operation and expansion, and notes no significant changes have occurred since the balance sheet date of December 31, 2024 - The company has never declared or paid cash dividends and does not intend to in the foreseeable future, retaining all funds for business expansion[723](index=723&type=chunk) - Dividend distributions are subject to Belgian law, requiring sufficient distributable profits and the allocation of **5% of annual net profit** to a legal reserve until it reaches **10% of share capital**[724](index=724&type=chunk)[725](index=725&type=chunk) - There have been no significant changes to the company's financial condition since December 31, 2024[726](index=726&type=chunk) [Additional Information](index=213&type=section&id=Item%2010.%20Additional%20Information) This section covers key corporate and tax information, confirming no material contracts outside the ordinary course of business and no Belgian exchange controls limiting payments to U.S. residents, and providing a detailed summary of material U.S. and Belgian tax considerations for shareholders, including potential PFIC classification and the **30%** Belgian withholding tax on dividends [Taxation](index=213&type=section&id=E.%20Taxation) This section provides an overview of U.S. and Belgian tax implications for shareholders, including PFIC status and dividend withholding tax - For U.S. holders, the company does not expect to be classified as a Passive Foreign Investment Company (PFIC) for the current taxable year, but this is an annual determination and cannot be assured[256](index=256&type=chunk)[754](index=754&type=chunk) - Dividends paid by the company are generally subject to a **30% Belgian withholding tax**, which may be reduced under applicable tax treaties, such as the U.S.-Belgium Tax Treaty[768](index=768&type=chunk)[795](index=795&type=chunk) - A Belgian tax on stock exchange transactions of **0.35%** (capped at **€1,600 per transaction**) applies to the sale and purchase of shares on the secondary market if carried out through a Belgian intermediary or by a Belgian investor[811](index=811&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=237&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign exchange risk and credit risk, with credit risk considered low, and foreign exchange risk stemming from expenses denominated in USD, NIS, and AUD, where a **5%** strengthening of the USD against the Euro in 2024 would have increased the net loss by **€87,000**, and the company does not currently hedge its currency risk exposure - The company's main market risks are credit risk and foreign exchange risk, with credit risk considered minimal as it arises from reputable institutions and governments[846](index=846&type=chunk)[847](index=847&type=chunk) - Foreign exchange risk is primarily from expenses in U.S. dollars (USD), Israeli new shekel (NIS), and Australian dollars (AUD), and the company does not generally hedge this exposure[848](index=848&type=chunk)[850](index=850&type=chunk) Foreign Exchange Risk Sensitivity (2024) | Currency Change vs. Euro | Impact on Net Loss (€) | | :--- | :--- | | +5% USD Strength | €87,000 higher | | -5% USD Strength | €79,000 lower | | +5% NIS Strength | €35,000 higher | | -5% NIS Strength | €32,000 lower | | +5% AUD Strength | €22,000 higher | | -5% AUD Strength | €20,000 lower | PART II [Controls and Procedures](index=240&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that as of December 31, 2024, the company's disclosure controls and procedures and its internal control over financial reporting were not effective due to continued material weaknesses related to insufficient accounting personnel and inadequate documentation of control procedures, with remediation efforts underway but not complete by year-end - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024, due to ongoing material weaknesses in internal control over financial reporting[862](index=862&type=chunk) - Material weaknesses identified relate to: 1) Insufficient accounting and supervisory personnel with the appropriate technical experience and training 2) Insufficient documented evidence of control procedures, including IT General Controls, preventing validation of their operating effectiveness[865](index=865&type=chunk)[866](index=866&type=chunk) - Remediation actions are in progress, including formalizing a risk assessment, designing an internal control framework within a GRC tool, and engaging an external advisor to validate design effectiveness, however, these efforts had not fully resolved the weaknesses by year-end[866](index=866&type=chunk)[867](index=867&type=chunk)[871](index=871&type=chunk) - Despite the material weaknesses, management believes the consolidated financial statements for the period are fairly presented in all material respects[869](index=869&type=chunk) [Other Information](index=243&type=section&id=Item%2016.%20Other%20Information) This section covers various governance and compliance topics, identifying Kevin Rakin as the Audit Committee Financial Expert, confirming the adoption of a Code of Ethics, detailing principal accountant fees to EY totaling **€758,000** in 2024, outlining the company's adherence to Belgian governance practices as a foreign private issuer, and describing its board-overseen cybersecurity risk management strategy, with no material cybersecurity incidents reported [Principal Accountant Fees and Services](index=244&type=section&id=Item%2016C.%20Principal%20Accountant%20Fees%20and%20Services) This section details the fees paid to the principal accountant, EY, for audit and tax services Accountant Fees (in thousands €) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | 748 | 526 | | Tax Fees | 10 | 20 | | **Total** | **758** | **546** | - All services provided by the principal accountant, EY, were pre-approved by the Audit Committee[877](index=877&type=chunk) [Corporate Governance](index=244&type=section&id=Item%2016G.%20Corporate%20Governance) This section explains how the company, as a foreign private issuer, aligns its corporate governance with Belgian practices rather than certain Nasdaq rules - As a foreign private issuer, the company follows Belgian corporate governance practices in lieu of certain Nasdaq listing rules, including those related to shareholder meeting quorum, compensation/nomination committee composition, and the requirement for a majority of independent directors on the board[881](index=881&type=chunk)[882](index=882&type=chunk) [Cybersecurity](index=247&type=section&id=Item%2016K.%20Cybersecurity) This section outlines the company's cybersecurity risk management strategy, board oversight, and confirms no material incidents - The company's cybersecurity program is based on recognized frameworks like NIST and is overseen by the Board of Directors, with day-to-day management led by the Chief Financial Officer[885](index=885&type=chunk)[891](index=891&type=chunk)[893](index=893&type=chunk) - The company's strategy includes regular monitoring, vulnerability assessments, employee training, and an incident response plan to manage cybersecurity threats[886](index=886&type=chunk)[887](index=887&type=chunk) - The company has not experienced any material cybersecurity incidents, and related expenses have been immaterial[890](index=890&type=chunk) PART III [Financial Statements](index=249&type=section&id=Item%2018.%20Financial%20Statements) The consolidated financial statements for Nyxoah SA cover the three years ended December 31, 2024, showing total assets grew to **€158.4 million** in 2024 from **€124.2 million** in 2023, primarily funded by increased equity from capital raises, with a net loss of **€59.2 million** for 2024, widening from a **€43.2 million** loss in 2023 due to increased R&D and SG&A spending, and significant cash used in operations (**€49.2 million**) and investing activities (**€16.3 million**) offset by **€77.4 million** from financing activities Consolidated Balance Sheet Highlights (in thousands €) | Account | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **158,406** | **124,157** | | Cash and cash equivalents | 34,186 | 21,610 | | Financial assets | 51,369 | 36,138 | | Intangible assets | 50,381 | 46,608 | | **Total Liabilities** | **45,152** | **26,135** | | **Total Equity** | **113,254** | **98,022** | Consolidated Statement of Loss Highlights (in thousands €) | Account | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Revenue | 4,521 | 4,348 | 3,084 | | Gross profit | 2,969 | 2,692 | 1,934 | | Operating loss | (58,809) | (45,102) | (32,499) | | **Loss for the period** | **(59,236)** | **(43,212)** | **(31,225)** | Consolidated Statement of Cash Flow Highlights (in thousands €) | Account | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (49,226) | (44,778) | (28,756) | | Net cash from / (used in) investing activities | (16,325) | 32,011 | (89,946) | | Net cash from financing activities | 77,439 | 16,858 | (983) | [Exhibits](index=249&type=section&id=Item%2019.%20Exhibits) This section lists all exhibits filed as part of the annual report, including the company's Articles of Association, material contracts such as the Cochlear Collaboration Agreement and the EIB Loan Facility Agreement, various warrant plans, certifications by the CEO and CFO, and the consent of the independent registered public accounting firm - Key exhibits filed include the Articles of Association, Description of Securities, various material contracts (Cochlear, Man & Science, EIB), and multiple warrant plans (2020, 2021, 2022, 2024)[898](index=898&type=chunk)[900](index=900&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906 are included as exhibits[900](index=900&type=chunk)