6-K
Nyxoah SA (NYXH)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TORULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2024
Commission File Number: 001-40552
NYXOAH SA
(Translation of registrant’s name into English)
Rue Edouard Belin 12, 1435 Mont-Saint-Guibert,Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
DREAM U.S. Pivotal Study
On September 27, 2024, Nyxoah SA (the “Company”) announced that data from its DREAM U.S. pivotal study were presented in an oral session at the International Surgical Sleep Society (“ISSS”) 2024 Educational Update.
In particular, additional data were presented for Apnea-Hypopnea Index (“AHI”) reduction in supine and non-supine positions. Genio bilateral stimulation resulted in a clinically meaningful 71.0% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12-month AHI reduction of 70.8% across all sleeping positions.
With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality-of-life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.
The presentation included previously announced data demonstrating that the study achieved its co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (“ODI”) responder rate, both on an Intent-To-Treat (“ITT”) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001). Safety results were in line with other neuromodulation therapies, with 11 serious adverse events (“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 information included under the heading “DREAM U.S. Pivotal Study” of this report on Form 6-K shall be deemed to be incorporated by reference into the registrationstatements on Form S-8 (Registration Numbers 333-261233 and 333-269410) and Form F-3 (Registration Number 333-268955) of the Company(including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this reportis filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Press Releases
On September 27, 2024, the Company issued two press releases, copies of which are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively.
Additionally, on September 27, 2024, the Company issued a press release announcing that data from its DREAM U.S. pivotal study were presented in an oral session at the ISSS 2024 Educational Update. A copy of the press release is attached hereto as Exhibit 99.3.
The information in the attached Exhibits 99.1.99.2 and 99.3 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities ExchangeAct of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemedincorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, exceptas otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.
Exhibits
| 99.1 | Press Release, dated September 27, 2024 |
|---|---|
| 99.2 | Press Release, dated September 27, 2024 |
| 99.3 | Press Release, dated September 27, 2024 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NYXOAH SA | ||
|---|---|---|
| Date: September 27, 2024 | By: | /s/ Loic Moreau |
| Name: | Loic Moreau | |
| Title: | Chief Financial Officer |
Exhibit 99.1
Publication relating to transparency notifications
September 27, 2024
REGULATED INFORMATION
Publication relating to transparency notifications
Mont-Saint-Guibert (Belgium), September 27,2024, 8.00am CET / 2.00am ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below.
BlackRock, Inc.
On September 24, 2024, Nyxoah received a transparency notification from BlackRock, Inc. and related persons indicating that BlackRock Advisors, LLC went below the 3% threshold on September 20, 2024. As of such date, BlackRock, Inc. (together with its controlled undertakings) held 1,116,421 voting rights, consisting of 1,043,221 shares and 73,200 equivalent financial instruments, representing 3.25% of the total number of voting rights on September 20, 2024 (34,373,015).
The notification dated September 23, 2024 contains the following information:
| · | Reason for the notification: acquisition or disposal<br>of voting securities or voting rights | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · | Notification by: a parent undertaking or a controlling<br>person | |||||||||||
| --- | --- | |||||||||||
| · | Persons subject to the notification requirement: | |||||||||||
| --- | --- | |||||||||||
| · | BlackRock, Inc. (with address at 50 Hudson Yards, New York,<br>NY, 10001, U.S.A.) | |||||||||||
| --- | --- | |||||||||||
| · | BlackRock Advisors, LLC (with address at 50 Hudson Yards, New<br>York, NY, 10001, U.S.A.) | |||||||||||
| --- | --- | |||||||||||
| · | BlackRock Fund Advisors (with address at 400 Howard Street,<br>San Francisco, CA, 94105, U.S.A.) | |||||||||||
| --- | --- | |||||||||||
| · | BlackRock Investment Management (UK) Limited (with address at<br>12 Throgmorton Avenue, London, EC2N 2DL, U.K.) | |||||||||||
| --- | --- | |||||||||||
| · | BlackRock Investment Management, LLC (with address at 1 University<br>Square Drive, Princeton, NJ, 8540, U.S.A.) | |||||||||||
| --- | --- | |||||||||||
| · | Date on which the threshold was crossed: September 20,<br>2024 | |||||||||||
| --- | --- | |||||||||||
| · | Threshold that is crossed: 3% | |||||||||||
| --- | --- | |||||||||||
| · | Denominator: 34,373,015 | |||||||||||
| --- | --- | |||||||||||
| · | Notified details: | |||||||||||
| --- | --- | |||||||||||
| A) Voting rights | Previous | After the transaction | **** | |||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| notification | ||||||||||||
| # of voting rights | # of voting rights | % of voting rights | ||||||||||
| Holders of voting | Linked to | Not linked to the | Linked to | Not linked to | ||||||||
| rights | securities | securities | securities | the securities | ||||||||
| BlackRock, Inc. | 0 | 0 | 0.00 | % | ||||||||
| BlackRock Advisors, LLC | 1,071,561 | 1,016,861 | 2.96 | % | ||||||||
| BlackRock Fund Advisors | 46 | 46 | 0.00 | % | ||||||||
| BlackRock Investment Management (UK) Limited | 1,080 | 1,080 | 0.00 | % | ||||||||
| BlackRock Investment Management, LLC | 25,242 | 25,234 | 0.07 | % | ||||||||
| Subtotal | 1,097,929 | 1,043,221 | 3.03 | % | ||||||||
| TOTAL | 1,043,221 | 0 | 3.03 | % | 0.00 | % | ||||||
| B)<br> Equivalent financial instruments | After<br> the transaction | |||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |||
| Holders<br> of<br><br> equivalent financial<br><br> instruments | Type<br> of financial<br><br> instrument | Expiration<br> date | Exercise<br> period<br><br> or date | #<br> of voting<br><br> rights that may<br><br> be acquired if<br><br> the instrument<br><br> is exercised | %<br> of voting<br><br> rights | Settlement | ||||||
| BlackRock Advisors,<br> LLC | Securities Lent | 72,300 | 0.21 | % | physical | |||||||
| BlackRock Fund Advisors | Securities<br> Lent | 900 | 0.00 | % | physical | |||||||
| TOTAL | 73,200 | 0.21 | % | |||||||||
| # of voting rights | % of voting rights | |||||||||||
| TOTAL (A<br> & B) | 1,116,421 | 3.25 | % | |||||||||
| · | Full chain of controlled undertakings through which the holding<br>is effectively held: | |||||||||||
| --- | --- |
BlackRock, Inc.
Trident Merger, LLC
BlackRock Investment Management, LLC
BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock International Holdings, Inc.
BR Jersey International Holdings L.P.
BlackRock Holdco 3, LLC
BlackRock Cayman 1 LP
BlackRock Cayman West Bay Finco Limited
BlackRock Cayman West Bay IV Limited
BlackRock Group Limited
BlackRock Finance Europe Limited
BlackRock Investment Management (UK) Limited
BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Holdco 4, LLC
BlackRock Holdco 6, LLC
BlackRock Delaware Holdings Inc.
BlackRock Fund Advisors
BlackRock, Inc.
BlackRock Holdco 2, Inc.
BlackRock Financial Management, Inc.
BlackRock Capital Holdings, Inc.
BlackRock Advisors, LLC
| · | Additional information: The disclosure obligation arose<br>due to voting rights attached to shares for BlackRock Advisors, LLC going below 3%. |
|---|
*
* *
Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com
Attachment
| · | 2024<br> 09 26 PR Transparency notifications 2024 09 (BlackRock) (ENG) |
|---|
Exhibit 99.2
Information on the total number of voting rights and shares
September 27, 2024
REGULATED INFORMATION
Information on the total number of voting rights and shares
Mont-Saint-Guibert (Belgium), September 27,2024, 08:05 am CET / 2:05 am ET – In accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publishes the below information following the issue of new shares.
| · | Share capital: EUR 5,907,711.21 |
|---|---|
| · | Total number of securities carrying voting rights: 34,389,015<br>(all ordinary shares) |
| --- | --- |
| · | Total number of voting rights (= denominator): 34,389,015 (all<br>relating to ordinary shares) |
| --- | --- |
| · | Number of rights to subscribe to securities carrying voting<br>rights not yet issued: 2,040,231 (all granted subscription rights; this number excludes 643,394 subscription rights that were issued<br>but not yet granted) |
| --- | --- |
*
* *
Contact:
Nyxoah
Loic Moreau, CFO
IR@nyxoah.com
Attachment
| · | 2024 09 26 - Press release - Number of shares (ENG) |
|---|
Exhibit 99.3
DREAM Pivotal Study Data Presented at the InternationalSurgical Sleep Society 2024 Educational Update
Additional clinical data on patients sufferingfrom Obstructive Sleep Apnea (OSA) demonstrate a clinically significant 71.0% median reduction in Apnea-Hypopnea index (AHI) while sleepingsupine
at 12 months compared with baseline.
82.0% of patients who completed a polysomnographyat 12 months had an AHI below 15, and 67.4% of patients who completed a polysomnography at 12 months had an AHI below 10.
Mont-Saint-Guibert, Belgium – September27, 2024, 10:30pm CET / 4:30pm 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, announced that data from the DREAM U.S. pivotal study were presented in an oral session at the International Surgical Sleep Society (ISSS) 2024 Educational Update, taking place from September 26 -27 in Miami, Florida.
Additional data were presented for AHI reduction in supine and non-supine positions. Genio bilateral stimulation resulted in a clinically meaningful 71.0% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12-month AHI reduction of 70.8% across all sleeping positions.
With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality-of-life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.
The presentation included previously announced data demonstrating that the study achieved its co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent-To-Treat (ITT) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio^®^ implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001). Safety results were in line with other neuromodulation therapies, with 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.
*An AHI responder, per the Sher criteria, is defined as a subject with an AHI reduction of at least 50% from baseline and an AHI score of less than 20 events per hour on the 12-month PSG. An ODI responder is defined as a subject which demonstrates an ODI reduction of at least 25% from baseline on the 12-month PSG.
“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea. Clinically significant improvements in primary and secondary endpoints were observed,” said B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM study. “Genio has the potential of helping us advance neuromodulation therapy for the treatment of OSA.”
“Achieving meaningful AHI reductions regardless of sleep position is a clinical validation of our patient-centric approach,” said Olivier Taelman, CEO of Nyxoah. “Genio bilateral stimulation also enabled more than 80% of patients to hit 12 months with an AHI below 15, positively impacting their overall quality of life and reducing sleepiness. Nyxoah is now entering the final regulatory phase and is progressing toward FDA approval. This will be a huge milestone in our mission to make Genio available to OSA patients in the US.”
About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio^®^, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.
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 for FDA and U.S. commercialization approval.
For more information, please see the Company’s annual report for the financial year 2023 and visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
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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 and ongoing clinical studies of the Genio^®^ system; the potential advantages of the Genio^®^ system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio^®^ system; the utility of clinical data in potentially obtaining FDA approval of the Genio^®^ system; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com
For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
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