Exhibit 99.1
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): June 1, 2020
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)) |
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
| Common | PCSA | OTC |
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 May 24, 2020, Processa Pharmaceuticals, Inc. (“Processa”) entered into a License Agreement with Aposense, LTD., (“Aposense”), pursuant to which Processa to license in the patent rights and the know-how to develop and commercialize their next generation irinotecan cancer drug, ATT-11T.
The licensing agreement is a Condition Precedent Agreement. Subject to the terms of the Agreement and upon satisfaction of the conditions, Aposense will grant Processa an exclusive, royalty-bearing right and license, including the right to sublicense. Under the terms of the Agreement, Aposense could receive up to a maximum of $128M in potential development and sales milestones, as well as royalties of 7% based on net sales.
| Exhibit No. | Exhibit Description | |
|
99.1
|
License Agreement dated 05242020
|
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| 99.2 | Press Release dated 06012020 | |
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 June 1, 2020.
| PROCESSA PHARMACEUTICALS, INC. | ||
| Registrant | ||
| By: | /s/ David Young | |
| David Young | ||
| Chief Executive Officer | ||
Exhibit 99.1
Exhibit 99.2
| FOR IMMEDIATE RELEASE | For More Information: | |
| Investor Relations: Patrick Lin | ||
| plin@processapharma.com | ||
| 925-683-3218 |
PROCESSA PHARMACEUTICALS ANNOUNCES THAT IT HAS
ENTERED INTO AN AGREEMENT WITH APOSENSE, LTD TO LICENSE
IN THE NEXT GENERATION IRINOTECAN DRUG
HANOVER, MD – June 1, 2020 – Processa Pharmaceuticals, Inc. (OTCQB: PCSA) announced today that it has signed an agreement with Aposense, LTD. to license in the patent rights and the know-how to develop and commercialize their next generation irinotecan cancer drug, ATT-11T.
Irinotecan metabolizes to SN-38, the active anti-cancer moiety, and is used as first and second line therapy in many types of cancer (e.g., metastatic colorectal, small cell lung, pancreatic). Although irinotecan has a narrow therapeutic window and dose limiting adverse effects, including a FDA “Black Box” warning for both neutropenia and severe diarrhea, irinotecan achieved peak annual sales of US$1.1 billion.
ATT-11T is a novel lipophilic anti-cancer pro-drug that is being developed for the treatment of the same solid tumors as prescribed for irinotecan. This pro-drug is a conjugate of a specific proprietary Aposense molecule connected to SN-38, the active metabolite of irinotecan. The proprietary Aposense molecule on ATT-11T allows ATT-11T to bind to cell membranes to form an inactive pro-drug depot on the cell with SN-38 preferentially accumulating in the membrane of tumors cells and the tumor core. This unique characteristic is expected to make the therapeutic window of ATT-11T wider than irinotecan such that the anti-tumor effect of ATT-11T will occur at a much lower dose than irinotecan with a milder adverse effect profile than irinotecan. The wider therapeutic window will likely lead to more patients responding with less side effects when on ATT-11T compared to irinotecan.
“The licensing of this product from Aposense fits with our strategy to continue to bring innovative products to patients with an unmet medical need condition. With the addition of this product to our pipeline, the Processa team is excited about moving into the cancer arena,” said Dr. David Young, Chief Executive Officer of Processa.
The licensing agreement is a Condition Precedent License Agreement conditioned upon: (i) Processa’s closing of the Satisfactory Financing Round and the listing of the Company’s shares on the NASDAQ or NYSE and (ii) Aposense obtaining the approval of the Israel Innovation Authority for the consummation of the transactions set forth in the agreement. Subject to the terms of the Agreement and upon satisfaction of the conditions, Aposense will grant Processa a worldwide (excluding China), royalty-bearing right and license, including the right to sublicense. Under the terms of the License Agreement, Aposense will receive shares in Processa with an aggregate value of $2.5 M and could receive up to $125 M in potential development and sales milestones, as well as royalties of 7% based on net sales.
Additional information and updates are available on the company’s website: http://www.processapharma.com
About Processa Pharmaceuticals, Inc.
The mission of Processa is to develop products where existing clinical evidence of efficacy already exists in unmet medical need conditions, medical conditions where patients need treatment options that will improve survival and/or quality of life. The Company has assembled a proven regulatory science development team, management team, and Board of Directors. The Processa development team has been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and 100 FDA meetings.
About Aposense, LTD.
Aposense is a highly innovative Israeli bio-pharmaceutical company, specializing in development of novel drugs, utilizing membrane electrical forces. Among others, Aposense developed a universal platform technology entitled Molecular Nano-Motors (MNMs) for the delivery of genetic drugs, such as siRNA, into cells.
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 which could cause actual results to differ from those contained in the forward-looking statements.
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