UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of August 2021

 

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

 

On August 11, 2021, Nyxoah SA (the “Company”) issued a press release announcing that the Company will (i) release financial results for the first half of 2021 on Tuesday, August 31, 2021 and (ii) host a conference call to discuss financial results on Wednesday, September 1, 2021. Additionally, on August 27, 2021, the Company issued a press release announcing the appointment of Rita Johnson-Mills to the Company’s board of directors. Copies of the press releases are attached hereto as Exhibits 99.1 and 99.2, respectively.

 

The information in the attached Exhibits 99.1 and 99.2 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

 

 

 

 

Exhibits

 

99.1 Press Release, dated August 11, 2021

 

99.2 Press Release, dated August 27, 2021

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  NYXOAH SA
     
Date: August 27, 2021 By: /s/ Fabian Suarez Gonzalez
  Name:

Fabian Suarez Gonzalez,

acting via ActuaRisk Consulting SRL

  Title: Chief Financial Officer

 

 

Exhibit 99.1

 

 

 

Nyxoah to Release First Half 2021 Financial Results on August 31 and

Host Earnings Conference Call on September 1, 2021

 

Mont-Saint-Guibert, Belgium. - August 11, 2021, 10:30 pm CET / 4:30 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), today announced that it will release financial results for the first half of 2021 on Tuesday, August 31, 2021, after the US markets close. Company management will host a conference call to discuss financial results on Wednesday, September 1, 2021, beginning at 3:00 p.m. CET / 9:00 a.m. ET.

 

Investors interested in listening to the conference call may do so by dialing (844) 260-3718 for US, 0800 73264 for Belgium, or (929) 517-0938 for international callers, followed by Conference ID: 7468474. A live and archived webcast of the event will be available on the Company’s investors relations website at https://investors.nyxoah.com/.

 

About Nyxoah

 

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

 

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company has completed the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion and is currently conducting the DREAM IDE pivotal study for FDA approval and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.

 

For more information, please visit http://www.nyxoah.com/.

 

Contacts:

Nyxoah

Fabian Suarez, Chief Financial Officer

corporate@nyxoah.com

+32 (0)10 22 24 55

 

Gilmartin Group

Vivian Cervantes

IR@nyxoah.com

 

 

 

 

Exhibit 99.2

 

 

 

Nyxoah Appoints Rita Johnson-Mills to its Board of Directors

 

Mont-Saint-Guibert, Belgium – August 27, 2021, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that it has appointed Rita Johnson-Mills as an Independent Director to its Board of Directors.

 

Robert Taub, Chairman of the Board of Directors of Nyxoah, commented: “We are delighted to welcome Rita Johnson-Mills to the Nyxoah Board of Directors. Her wealth of knowledge, extensive operating experience and expertise in corporate governance will be invaluable as we navigate the healthcare industry with new and innovative solutions. Rita's addition will also strengthen our US presence and our commitment to Board diversity.”

 

Rita Johnson-Mills added: “Nyxoah is truly unique in the health technology field and I am thrilled to lend my expertise to the Board and the leadership team in identifying ways to positively impact the health and quality of life for those living with the debilitating impact of sleep disordered breathing conditions.”

 

Rita Johnson-Mills is a seasoned former C-suite healthcare executive. Rita's background and experience include a combined 30 years of federal and state government and private industry experience, 15 years of which she was directly responsible for profitability and growth of healthcare organizations. She spent 11 years with UnitedHealthcare including as CEO of UnitedHealthcare Community Plan of Tennessee. Rita currently serves on the Board of Directors of Brookdale Senior Living Inc. and Quest Analytics, LLC. Rita received dual Master's degrees from Ohio State University, Master of Public Policy and Master of Labor/Human Resources. She is also a Hogan certified executive coach and a National Association of Corporate Directors Governance Fellow.

 

The appointment of Rita Johnson-Mills is effective immediately, subject to final appointment by the next shareholders' meeting.

 

About Nyxoah

 

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a CE-validated, patient-centered, next generation hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

 

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company has completed the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion and is currently conducting the DREAM IDE pivotal study for FDA approval and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio® system.

 

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For more information, please 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.

 

Contacts:

 

Nyxoah

Fabian Suarez, Chief Financial Officer

corporate@nyxoah.com

+32 (0)10 22 24 55

 

Gilmartin Group

Vivian Cervantes

IR@nyxoah.com

 

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