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

 

November 20, 2019
Date of Report (Date of earliest event reported)

 

AEVI GENOMIC MEDICINE, INC.
(Exact name of registrant as specified in its charter)

 

Delaware 1-35112 98-0217544
(State or other jurisdiction of
incorporation or organization) 		(Commission File Number) (I.R.S. Employer
Identification No.)

 

435 Devon Park Drive, Suite 715

Wayne, Pennsylvania 19087

(Address of principal executive offices, zip code)

 

(610) 254-4201
(Registrant’s telephone number, including area code)

 

Not Applicable
(Former name or former address, if changed since last report)

 

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 per share GNMX Nasdaq Capital Market


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))

 

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 (§240.12b-2 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. ¨

 

 

 

 

 

 

Item 8.01.    Other Events.

  

On November 20, 2019, Aevi Genomic Medicine, Inc. dosed the first patient with AEVI-002 in a Phase Ib clinical trial (MDGN-002-CD-101 TRaCKLIGHT) for patients with moderate to severe active Crohn’s Disease.

 

AEVI-002 is a potential first-in-class anti-LIGHT monoclonal antibody being developed for use in Pediatric Onset Crohn’s disease. The 8-week Phase Ib, open-label, multi-center, dose-escalation proof-of-concept study has been initiated and is currently recruiting and enrolling patients.

  

 

 

 

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.

 

  AEVI GENOMIC MEDICINE, INC.  
     
     
  By:  /s/ Michael F. Cola  
    Name: Michael F. Cola  
    Title: President and Chief Executive Officer  

Date: November 22, 2019

 

 

 

 

 

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