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EX-99.1 - Processa Pharmaceuticals, Inc.ex99-1.htm

 

 

 

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): October 2, 2018

 

Commission file number 333-184948

 

PROCESSA PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in its Charter)

 

Delaware   45-1539785

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification Number)

 

7380 Coca Cola Drive, Suite 106, Hanover, Maryland 21076
(Address of Principal Executive Offices, Including Zip Code)

 

(443) 776-3133
(Registrant’s Telephone Number, Including Area Code)

 

 
(Former Name or Former Address, if Changed Since Last Report)

 

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 [X]

 

  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. [X]

 

 

 

   
 

 

Item 8.01 Other Event.

 

On October 2, 2018, Processa Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) has granted Processa clearance to proceed with a Phase 2 clinical trial of PCS-499 in patients with Necrobiosis Lipoidica under a recently submitted Investigational New Drug (IND) application.

 

A press release announcing the FDA clearance is filed as Exhibit 99.1 hereto.

 

Item 9.01 Exhibits and Financial Statements

 

Exhibit No.   Exhibit Description
     
99.1   Press Release, dated October 2, 2018.

 

   
 

 

SIGNATURE

 

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, on October 2, 2018.

 

  PROCESSA PHARMACEUTICALS, INC.
  Registrant
     
  By: /s/ David Young                            
    David Young
    Chief Executive Officer