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): September 4, 2019

 

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. [  ]

 

 

 

     

 

 

Item 1.01. Entry into a Material Definitive Agreement.

 

License Agreement

 

On August 29, 2019, Processa Pharmaceuticals, Inc. (“Processa”) entered into a License Agreement with Akashi Therapeutics, Inc. (“Akashi”), pursuant to which Processa obtained an exclusive worldwide license to develop and commercialize products compromising or containing HT-100.

 

Under the License Agreement, Processa made a nominal upfront payment and has agreed to future Development and Regulatory Milestone, and Sales Milestone payments along with royalties as set forth in the License Agreement.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit No.   Exhibit Description
     
99.1   License Agreement dated 08/29/2019
99.2   Press Release dated 09/03/2019

 

     

 

 

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 September 4, 2019.

 

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

 

     

 

 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

PROCESSA PHARMACEUTICALS ANNOUNCES THE LICENSING OF AN ANTI-FIBROTIC, ANTI-INFLAMMATORY DRUG FOR THE TREATMENT OF MULTIPLE UNMET MEDICAL NEED CONDITIONS

 

HANOVER, MD – September 3, 2019 – Processa Pharmaceuticals, Inc. (OTCQB: PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have a high unmet medical need condition, announced today that they have signed an exclusive worldwide license agreement with Akashi Therapeutics to develop and commercialization Akashi’s lead drug, HT-100.

 

HT-100 is an orally available anti-fibrotic, anti-inflammatory drug that also promotes healthy muscle fiber regeneration. In previous clinical trials in Duchenne Muscular Dystrophy (DMD), HT-100 showed promising improvement in the muscle strength of non-ambulant pediatric patients. Although FDA placed a clinical hold on the DMD trial after a serious adverse event in a pediatric patient, FDA has removed the drug off of clinical hold and defined how HT can resume clinical trials in DMD.

 

Processa plans to begin developing HT-100 in rare adult fibrotic related diseases such as focal segmental glomerulosclerosis (FSGS), idiopathic pulmonary fibrosis (IPF) or Scleroderma, where there are still few therapeutic options. The company will revisit potential pediatric indications, such as DMD, at a later time.

 

“Processa needs to learn more about the safety and dose response of HT-100 while we determine the best way to clinically manage patients on this anti-fibrotic drug,” said Dr. Sian Bigora, Chief Development Officer at Processa Pharmaceuticals. “In early 2020 we hope to begin to define, in collaboration with the FDA, an efficient way to develop HT-100 for all those patients who would benefit from this drug.”

 

Dr. David Young, Chief Executive Officer at Processa, added, “The Processa strategy is to add drugs to our portfolio which already have some clinical evidence of efficacy. This enables our team to efficiently develop these drugs for patients with a high unmet medical need condition while the risk of failure associated with the clinical trials is decreased. This strategy was implemented when PCS-499 was acquired and will now be implemented for HT-100. Since the quality of life for these patients is so often impaired given the lack of treatment options, the more efficiently we can develop these products, the sooner patients will experience the positive impact of these drugs on their lives.”

 

Additional information and updates are available on our website: http://www.processapharma.com

 

 
 

 

About Processa Pharmaceuticals, Inc.

 

Processa Pharmaceuticals, Inc. was founded in 2017 in Hanover, Maryland, with a mission to develop products that can improve the survival and/or quality of life for patients who have a high unmet medical need. The Company has assembled a proven regulatory science development team, management team, and Board of Directors. The Processa drug development team members have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and 100 FDA meetings. For more information, please visit http://www.processapharma.com.

 

Forward-Looking Statements

 

This release contains forward-looking statements. The statements in this press release 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. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.

 

For More Information:

Investor Relations: Patrick Lin

plin@processapharma.com

925-683-3218

 

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