Processa Pharmaceuticals issues letter to shareholders

Processa Pharmaceuticals announces that CEO George Ng has issued a letter to shareholders. “Earlier in 2023, the strategic decision was made to focus on development of the Company’s Next Generation Chemotherapy agents. That will not change under my direction, and much of my experience is in oncology and leading business transactions. Even with the advent of immuno-oncology and other oncology drugs and treatments, chemotherapy drugs still remain an important and viable treatment option. However, many issues and limitations are associated with the use of chemotherapy…. I think Processa can address these shortcomings with chemotherapy by providing patients with potentially safer and more effective chemotherapy treatments through the pursuit of our Next Generation Chemotherapies… Our current pipeline consists of three separate NGCs in development: NGC-Capecitabine – targeted at colorectal, pancreatic, and other solid tumor cancers; NGC-Gemcitabine – targeted at pancreatic, gall bladder, and non-small cell tumor cancers; NGC-Irinotecan – targeted at pancreatic, ovarian, lung, colorectal, and other cancers. It is important to recognize that each of the respective underlying chemotherapy agents in each NGC candidate are already approved, are on the market, and are used across multiple cancer indications, with each generating between $500 million – $1 billion in worldwide revenue… The current status and upcoming near-term potential milestones for each of our NGCs is follows: NGC-Capecitabine: Phase 1b study enrollment is expected to be completed by early 2024; Assessment of the safety profile of NGC-Cap in totality across all cohorts is expected to be completed by mid 2024; Discussion with FDA to determine Phase 2 study design expected by year-end 2023; With FDA feedback, dose regimen to be used in Phase 2 study is expected to be finalized by mid-2024; Filing of Phase 2 study to the IND is expected by mid-2024; Start of patient enrollment in Phase 2 study is expected in mid-2024. NGC-Gemcitabine: Analysis of existing Phase 2 data from patients with pancreatic cancer under the Project Optimus framework is expected to be completed in early 2024; Discussion with the FDA to determine Phase 2b/3a study design expected in the first half of 2024. NGC-Irinotecan: Analysis of existing pre-clinical data in animals to develop a drug development roadmap is expected to be completed in early 2024; Initiate sourcing of drug substance and product manufacturing sites expected in 2024; Stable Financial Affairs and Business Development Opportunities. … In conclusion, given our Forward Looking Vision, Experienced Team, De-Risked and Diversified Pipeline, Stable Financial Affairs and Business Development Opportunities, I feel that Processa is well-positioned for success and is uniquely positioned to disrupt and expand current chemotherapy and oncology therapeutics.”