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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): July 1, 2021

 

IMMUNIC, INC.

(Exact name of registrant as specified in its charter)

 

Delaware 001-36201 56-2358443
(State or other jurisdiction
of incorporation)
(Commission File Number) (IRS Employer Identification No.)

 

1200 Avenue of the Americas, Suite 200

New York, NY 10036

USA

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (332) 255-9818

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of exchange on which registered
Common Stock, par value $0.0001 IMUX The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes No

 

 

 

Item 8.01. Other Events

 

On July 1, 2021, Immunic, Inc. (the “Company”) issued a press release and presentation announcing U.S. Food and Drug Administration clearance of (i) its Investigational New Drug (“IND”) application for the phase 3 ENSURE program of IMU-838, the Company’s selective oral DHODH inhibitor, in patients with relapsing-remitting multiple sclerosis, and (ii) a separate IND application for the supportive phase 2 CALLIPER trial of IMU-838 in patients with progressive multiple sclerosis.

 

The press release and presentation are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits

 

Exhibit Description
   
99.1 Press Release, dated July 1, 2021.
99.2 Presentation, dated July 1, 2021.
104 Cover Page to this Current Report on Form 8-K in Inline XBRL.

 

 

 

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, hereunto duly authorized.

 

Dated:  July 1, 2021 Immunic, Inc.
   
  By:   /s/ Daniel Vitt
    Daniel Vitt
    Chief Executive Officer
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