Core Insights - Processa Pharmaceuticals is focusing on oncology assets with strong differentiation and commercial opportunity to enhance shareholder value [4][9] - The company is actively enrolling patients in a Phase 2 clinical trial for its lead oncology asset, PCS6422, targeting metastatic breast cancer, with initial data expected in the second half of 2025 [2][7] - Processa has signed a binding term sheet with Intact Therapeutics for PCS12852, which could yield up to $454 million in milestone payments and a 12% royalty on future sales [7] Company Updates - The company is streamlining its development pipeline and optimizing capital allocation to focus on programs with the highest potential for clinical success [2][4] - A new adaptive pivotal Phase III study for PCS499 is being designed, following preliminary positive results in kidney disease [7] - Processa has terminated the license agreement for PCS3117 due to high costs and time requirements, returning rights to the original licensor [7] Financial and Strategic Developments - Processa has strengthened its balance sheet with a $7 million capital infusion [6] - The company is establishing a dedicated subsidiary for PCS499 to enhance strategic flexibility in capital raising and partnership exploration [7] - An investor webinar is scheduled for July 9, 2025, to discuss the company's strategic pipeline realignment and milestones [5]

Core Viewpoint - Processa Pharmaceuticals has entered into a binding term sheet with Intact Therapeutics for the exclusive option to license PCS12852, a 5-HT4 receptor agonist aimed at treating gastroparesis and other gastrointestinal motility disorders [1][3]. Financial Terms - Processa is set to receive a $2.5 million option exercise fee, up to $20 million in development and regulatory milestone payments, and over $432.5 million in commercial milestone payments based on net product sales [2][8]. - Intact will pay Processa a double-digit royalty on worldwide net sales of licensed products, excluding South Korea, and provide an equity stake of 3.5% in Intact upon closing [2][8]. Clinical Significance - PCS12852 has shown a favorable safety and efficacy profile in clinical studies, particularly in a Phase 2a trial for diabetic gastroparesis, a condition with limited treatment options [3][4]. - The drug is designed to restore normal gastric emptying without the cardiovascular and central nervous system side effects associated with older agents in this class [3]. Strategic Partnership - The partnership is expected to unlock the value of Processa's non-oncology assets while focusing on developing next-generation cancer therapies [3]. - Intact Therapeutics aims to address significant unmet clinical needs in gastrointestinal diseases, enhancing patient quality of life through innovative therapies [3][5]. Company Background - Intact Therapeutics is a clinical-stage biopharmaceutical company focused on next-generation therapies for gastrointestinal diseases, leveraging proprietary thermal hydrogel technology [5]. - Processa Pharmaceuticals specializes in developing next-generation cancer drugs with improved safety and efficacy, modifying existing FDA-approved oncology therapies [7].

As filed with the U.S. Securities and Exchange Commission on January 19, 2024 Registration No. 333-276308 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 45-1539785 (I.R.S. Employer Id ...

As filed with the U.S. Securities and Exchange Commission on December 29, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 45-1539785 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 738 ...