Processa Pharmaceuticals, Inc. reiterated the strategic prioritization of its pipeline of proprietary oncology drugs, defined as Next Generation Chemotherapies (NGCs). Previous studies with these NGCs suggest potential improvement in the safety-efficacy profile will significantly differentiate these NGCs from their three presently widely used counterparts - capecitabine, gemcitabine, and irinotecan. Much of oncology research and drug development focuses on the search for a new or different way to treat cancer.

Processa's approach is to modify and improve three different, widely used chemotherapy treatments with a proven history of successfully treating many cancer patients but also having a high rate of non-responders and a significant number of patients who must decrease the dose or discontinue treatment because of adverse events. The NGCs have been modified using a proprietary approach such that they are metabolized and/or distributed differently in the body than their approved counterpart drugs, while still maintaining the same mechanism of killing the cancer cells. Each of the Company's pipeline of three NGC treatments is briefly described: (1) NGC-Capecitabine is a combination of PCS6422 and capecitabine.

PCS6422 alters the metabolism of capecitabine without having any clinically meaningful biological effect itself. In clinical trials, NGC-Capecitabine has been shown to be greater than fifty times more potent with an improved safety profile over capecitabine. Like capecitabine, NGC-Capecitabine could be used to treat patients with cancers, such as metastatic colorectal, gastrointestinal, breast, and pancreatic.

2) NGC-Gemcitabine (PCS3117) is an oral analog of gemcitabine that is converted to its active metabolite by a different enzyme system than gemcitabine resulting in a positive response in gemcitabine patients as well as some gemcitabine treatment-resistant patients. Like gemcitabine, NGC-Gemcitabine could be used to treat patients with cancers such as pancreatic, lung, ovarian, and breast. We estimate at least 275,000 patients in the United States were diagnosed in 2022 with pancreatic, lung, ovarian, and breast cancer.

We plan to meet with the FDA in 2023 to discuss potential study designs, including the implementation of the FDA's Project Optimus Oncology initiative and the recent Oncology Guidance as part of the design. The Phase 2B protocol will be submitted to the existing IND in the second half of 2023 with the initiation of the trial, subject to funding requirements, occurring soon after the submission to the IND. (3) NGC-Irinotecan (PCS11T) is a prodrug of the active metabolite of irinotecan (SN-38).

The chemical structure of PCS11T influences the uptake of NGC-Irinotecan into cancer cells resulting in more NGC-Irinotecan entering cancer cells than normal cells in mice. These levels were significantly greater than those seen with irinotecan, resulting in lower doses of NGC-Irinotecan having greater efficacy than Irinotecan and improved safety in animal models. Like irinotecan, NGC-Irinotecan could be used to treat patients with cancers such as lung, colorectal, gastrointestinal, and pancreatic cancer.

We estimate at least 200,000 patients in the United States were diagnosed in 2022 with lung, colorectal, gastrointestinal, and pancreatic cancer. We plan to conduct IND enabling and toxicology studies in 2023 and 2024, subject to funding.