Processa Pharmaceuticals Announces Q3 Business Highlights and Financial Results

Processa Pharmaceuticals Inc., a clinical-stage pharmaceutical company dedicated to advancing next-generation chemotherapy drugs with enhanced efficacy and safety, has provided a comprehensive update on its product pipeline, projected milestones, and business activities, along with its financial results for the three and nine months ending September 30, 2024.

George Ng, Chief Executive Officer of Processa Pharmaceuticals, expressed optimism about the progress of their programs, highlighting the dosing of the first patient in their Phase 2 clinical trial of NGC-Cap for metastatic breast cancer. This open-label trial is expected to yield initial data in the second half of 2025. Ng emphasized the company's commitment to improving cancer patients' lives through innovative oncology therapeutics.

Processa Pharmaceuticals aims to transform widely used FDA-approved chemotherapies by modifying their metabolic and distribution pathways to enhance patients' survival and quality of life. The company employs a Regulatory Science Approach, incorporating FDA’s Project Optimus Oncology initiative in developing its next-generation chemotherapy (NGC) drugs to achieve a more favorable benefit-risk profile.

**Key Program Updates**

1. **NGC-Cap (PCS6422 and Capecitabine)**:
NGC-Cap combines PCS6422 with capecitabine, an oral prodrug of the cancer drug 5-fluorouracil (5-FU). By altering the metabolism of 5-FU, PCS6422 enhances its distribution to cancer cells. The first patient in the Phase 2 clinical trial has been dosed, with the study comparing two doses of NGC-Cap to monotherapy capecitabine in advanced or metastatic breast cancer patients. The trial, involving around 60 to 90 participants, aims to evaluate the safety and efficacy of NGC-Cap, determine optimal dosage regimens as per FDA Project Optimus, and explore personalized NGC-Cap therapy. Interim data is expected in the latter half of 2025.

2. **NGC-Gem (PCS3117)**:
NGC-Gem is an oral analogue of gemcitabine (Gemzar®) that is metabolized by a different enzyme system, potentially benefiting patients resistant to or who acquire resistance to gemcitabine. Processa is exploring the efficacy of NGC-Gem in pancreatic and other cancers and means to identify patients more responsive to NGC-Gem than to gemcitabine alone. The company plans to discuss potential trial designs with the FDA.

3. **NGC-Iri (PCS11T)**:
NGC-Iri is an analogue of SN-38, the active metabolite of irinotecan, and is expected to exhibit an improved safety-efficacy profile in various cancers. Preclinical studies in a human melanoma xenograft mouse model showed that NGC-Iri led to greater SN-38 accumulation in tumors compared to tissues, suggesting enhanced efficacy and a more favorable side effect profile versus irinotecan and Onivyde®. Processa is currently finalizing the manufacturing process and potential approval pathways, with IND-enabling toxicology studies slated for 2025.

**Financial Results for Third Quarter 2024**

Research and development expenses reached $2.3 million in Q3 2024, up from $1.2 million in the same period of 2023. General and administrative expenses were $1.1 million, slightly up from $1.0 million in Q3 2023. The net loss for Q3 2024 was $3.4 million, or $1.03 per share, compared to $2.1 million, or $1.54 per share, in Q3 2023. The company had a cash balance of $2.9 million as of September 30, 2024.

**About Processa Pharmaceuticals, Inc.**

Processa Pharmaceuticals is focused on developing Next Generation Chemotherapy (NGC) drugs that improve the safety and efficacy of existing FDA-approved oncology therapies. By modifying the metabolism and distribution pathways of these drugs, Processa aims to enhance their therapeutic outcomes while maintaining their cancer-killing mechanisms. The company combines its innovative oncology pipeline with solid scientific principles to offer better treatment options for cancer patients, aiming for a more efficient regulatory path.

Processa Pharmaceuticals continues to push forward with its various oncology programs, striving to make a significant impact in cancer treatment through scientific innovation and a patient-focused approach.