Processa Pharmaceuticals Inc

a) As previously reported, on August 23, 2020, we entered into a condition precedent License Agreement with Elion (and as subsequently amended, the “Elion License Agreement”), pursuant to which we acquired an exclusive license to develop, manufacture and commercialize PCS6422 globally. The terms of the Elion License Agreement require us to use commercially reasonable efforts, at our sole cost and expense, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that include dosing a first patient with a product in a Phase 2 or 3 clinical trial on or before October 2, 2024. We are currently conducting pre-trial activities and planning to dose the first patient in our Phase 2 trial before the conclusion of the third quarter of 2024 and ahead of the required diligence milestone.

The foregoing summary of the Elion License Agreement is qualified in its entirety by reference to the full text of the Elion License Agreement, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on August 27, 2020, and is incorporated by reference herein.

On May 7, 2024, the Company received notification from Elion purporting to terminate the Elion License Agreement as a result of the Company’s alleged breach of the Elion License Agreement. The Company believes that Elion’s claims are without merit and disputes that the Elion License Agreement has been validly terminated.

On May 10, 2024, the Company filed a complaint for declaratory judgment and other claims against Elion in New York State Court. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it determines are appropriate.

b) None.

c) During the three months ended March 31, 2024, none of our directors or officers adopted orterminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.