Processa Pharmaceuticals Offers Update on Product Pipeline and Financial Performance
Phase 2 trial with NGC-Cap for breast cancer is currently in progress
The Phase 1b trial of NGC-Cap showed a favorable safety profile along with preliminary signs of anti-tumor activity
Preclinical studies indicate that NGC-Iri delivers a higher concentration of cancer-fighting SN-38 molecules to tumors compared to irinotecan or Onivyde
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company dedicated to creating the next generation of chemotherapeutic drugs with enhanced efficacy and safety, has provided updates regarding its product pipeline, upcoming milestones, and business activities, along with its financial results for the three and six months ending June 30, 2024.
“We have made substantial progress in advancing our three development programs this year, with a special emphasis on our lead candidate NGC-Cap,” stated George Ng, Chief Executive Officer of Processa Pharmaceuticals. “After receiving FDA approval for our NGC-Cap IND application, we launched a Phase 2 clinical trial in metastatic breast cancer. We anticipate enrolling patients in this multicenter, open-label study and expect to release initial data by mid-2025.”
Updates on Key Programs
Processa is committed to developing next-generation chemotherapies (NGC) by enhancing widely used FDA-approved oncology drugs to improve patient survival rates and quality of life. This is accomplished by modifying the metabolism and distribution of these drugs in the body, particularly their delivery to cancer cells. Furthermore, Processa employs its Regulatory Science Approach, which incorporates principles from the FDA’s Project Optimus Oncology initiative, to optimize the benefit-risk profile of its NGC drug products.
NGC-Cap (PCS6422)
NGC-Cap combines PCS6422 with capecitabine, the oral prodrug of the cancer medication 5-fluorouracil (5-FU). PCS6422 enhances the metabolism of 5-FU, resulting in improved distribution to cancer cells. In July 2024, the FDA granted approval for the Company’s IND application to conduct a Phase 2 trial with NGC-Cap in metastatic breast cancer. Following this approval, Processa initiated the Phase 2 study, a global, multicenter, open-label, adaptive design trial that will compare two doses of NGC-Cap to FDA-approved capecitabine in approximately 60 to 90 patients.
The Phase 1b study of NGC-Cap demonstrated that 66.7% of evaluable patients who received one dose of PCS6422 along with seven days of capecitabine showed partial responses or stable disease, indicating promising anti-tumor activity.
PCS3117: Next-Generation Gemcitabine (NGC-Gem)
NGC-Gem is an oral analog of gemcitabine (Gemzar) that is processed by a different enzyme system, targeting patients who are intrinsically resistant to or develop resistance against gemcitabine. Processa is evaluating NGC-Gem's potential effectiveness against pancreatic and other cancers and plans to engage in discussions with the FDA regarding trial designs, including advancements in the Project Optimus initiative.
PCS11T: Next-Generation Irinotecan (NGC-Iri)
NGC-Iri is designed as an improved formulation of SN-38, the active metabolite of irinotecan, aimed at enhancing both safety and efficacy. Recent studies have shown that NGC-Iri results in a significant accumulation of SN-38 in tumors while minimizing exposure in non-cancerous tissues, which could lead to better efficacy and a more favorable side effect profile compared to conventional treatments.
Financial Results for the Second Quarter
In the second quarter of 2024, Processa reported research and development expenses of $1.7 million, which remained unchanged from the same quarter in 2023. However, general and administrative expenses rose to $1.4 million compared to $1.0 million in the second quarter of the previous year, primarily due to increased professional fees.
The net loss for the quarter was $3.0 million, translating to a loss of $1.01 per share, compared to a net loss of $2.6 million or $1.94 per share in the second quarter of 2023. As of June 30, 2024, cash and cash equivalents stood at $5.6 million.
About Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals is focused on developing Next Generation Chemotherapy (NGC) drugs that provide enhanced safety and efficacy. The Company aims to modify existing FDA-approved oncology therapies to change how drugs are metabolized and distributed while preserving their cancer-fighting capabilities. By leveraging a strong oncology pipeline along with effective regulatory strategies, Processa seeks to offer better therapeutic options for cancer patients.
Frequently Asked Questions
What is the current status of Processa's NGC-Cap trial?
Processa is actively conducting a Phase 2 clinical trial for NGC-Cap in metastatic breast cancer, with initial data expected to be available in mid-2025.
What financial results did Processa report for Q2 2024?
For Q2 2024, Processa announced a net loss of $3.0 million, and as of June 30, 2024, cash and cash equivalents totaled $5.6 million.
What are NGC drugs?
NGC drugs refer to next-generation chemotherapies designed to improve the efficacy and safety of existing cancer treatments by modifying their metabolism and distribution within the body.
What other drugs is Processa working on?
In addition to NGC-Cap, Processa is developing NGC-Gem, an oral analog of gemcitabine, and NGC-Iri, which aims to enhance the safety and efficacy of irinotecan treatments.
How does Processa handle regulatory science?
Processa utilizes a Regulatory Science Approach that incorporates principles from initiatives like the FDA’s Project Optimus to ensure a favorable benefit-risk profile for its drug candidates.
