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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): October 2, 2024

 

Commission file number 001-39531

 

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))

 

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

 

Title of each class   Trading symbol(s)   Name of each exchange on which registered
Common stock: Par value $.0001   PCSA   Nasdaq Capital Market

 

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 Event.

 

On October 2, 2024, Processa Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the dosing of a patient in a Phase 2 clinical trial of NGC-Cap which satisfies the diligence milestone under the Company’s license agreement for PCS6422 with Elion Oncology, Inc. Multiple trial sites have been established and are now recruiting patients. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference.

 

The Company has now timely satisfied all of the Company’s diligence obligations, as enumerated in Article V, in its license agreement with Elion Oncology, Inc. The Company has previously referred to the Condition Precedent Satisfaction Date for its diligence obligations as October 2, 2024, but has determined that such statements should have been October 6, 2024 which is the anniversary of the funding event that triggers the calculation of the Condition Precedent Satisfaction Date.

 

Safe Harbor Statement

 

Information provided in this Current Report on Form 8-K contain forward-looking statements. The statements in this Current Report on Form 8-K that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Although the Company believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, the Company can give no assurance these expectations will be attained, and it is possible actual results may differ materially from those indicated by these forward-looking statements due to a variety of risks and uncertainties. Please refer to the documents filed by the Company with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

 

These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as and to the extent required by law.

 

Item 9.01. Financial Statements and Exhibits.

 

Exhibit No.   Exhibit Description
     
99.1   Press Release dated October 2, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
 

 

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, 2024.

 

  PROCESSA PHARMACEUTICALS, INC.
  Registrant
     
  By:  /s/ George Ng                           
    George Ng
    Chief Executive Officer