Processa Pharmaceuticals, Inc. Common - PCSA STOCK NEWS

Processa Pharmaceuticals (Nasdaq: PCSA) has announced the dosing of the first patient in a Phase 2 clinical trial for NGC-Cap, targeting advanced or metastatic breast cancer. The trial (NCT06568692) is a global, multicenter, open-label study comparing two doses of NGC-Cap to FDA-approved monotherapy capecitabine in 60-90 patients.

Key points:

• The trial aims to evaluate NGC-Cap's safety-efficacy profile and determine optimal dosage regimens.
• Interim analysis results are expected in mid-2025.
• Three clinical trial sites have received approval, with plans to activate approximately 30 sites worldwide.
• Breast cancer is the second most common cancer globally, with over 2 million cases diagnosed in 2022.
• The five-year survival rate for metastatic breast cancer is approximately 30%.

Processa Pharmaceuticals (Nasdaq: PCSA) has announced its participation in two major conferences this September. The company will attend the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. Management will conduct one-on-one investor meetings and deliver a company presentation, which will be available on-demand from September 9th at 7:00 am Eastern time on Processa's website.

Additionally, Processa will participate in the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona from September 13-17, 2024. During this event, management will meet with clinicians, researchers, industry key opinion leaders, and potential partners. These conferences provide Processa with valuable opportunities to showcase their developments and network within the pharmaceutical and investment communities.

Processa Pharmaceuticals (Nasdaq: PCSA) provides updates on its product pipeline and financials for Q2 2024. Key highlights include:

1. NGC-Cap: Phase 2 trial initiated in metastatic breast cancer with initial data expected mid-2025. Phase 1b showed favorable safety and preliminary anti-tumor activity.

2. NGC-Gem: Evaluating potential in pancreatic and other cancers. FDA meeting planned for late 2024/early 2025.

3. NGC-Iri: Preclinical studies showed greater tumor accumulation of SN-38 compared to irinotecan and Onivyde®.

4. Q2 2024 financials: R&D expenses $1.7M, G&A expenses $1.4M, net loss $3.0M ($1.01/share). Cash position $5.6M as of June 30, 2024.

Processa Pharmaceuticals (Nasdaq: PCSA) announces positive preclinical data for NGC-Iri, a next-generation irinotecan prodrug. Studies in human melanoma xenograft mouse models show NGC-Iri delivers more cancer-killing SN-38 to tumors than FDA-approved treatments irinotecan and Onivyde®. Key findings include:

1. Higher tumor-to-muscle SN-38 ratio (200 for NGC-Iri vs <15 for others)
2. Greater tumor-to-plasma SN-38 ratio (10 for NGC-Iri vs <7 for others)
3. Lower muscle-to-plasma SN-38 ratio (<0.10 for NGC-Iri vs >0.4 for others)

These results suggest NGC-Iri may offer improved efficacy and fewer side effects compared to existing treatments. Processa is currently defining the regulatory path for NGC-Iri, including target patient population and cancer type for FDA presentation.

Processa Pharmaceuticals (Nasdaq: PCSA) has received FDA clearance for its Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), paving the way for a Phase 2 clinical trial in advanced or metastatic breast cancer. The open-label study, set to begin enrollment in Q3 2024, will compare two doses of NGC-Cap to FDA-approved monotherapy capecitabine in 60-90 patients. Initial data is expected mid-2025.

NGC-Cap demonstrated 5-10 times more 5-fluorouracil exposure to cancer cells in a Phase 1b study, potentially offering greater efficacy with a similar or better safety profile than existing capecitabine treatments. The trial aims to evaluate NGC-Cap's safety-efficacy profile, determine optimal dosage regimens, and explore personalized therapy options for breast cancer patients.

Processa Pharmaceuticals (Nasdaq: PCSA) has appointed Russell L. Skibsted as its new Chief Financial Officer (CFO), effective immediately. Skibsted, with nearly 30 years of experience in the pharmaceutical industry, succeeds James Stanker, who is retiring but will stay on in an advisory role to assist with the transition.

Skibsted brings expertise in financial management, global business development, capital markets, investor relations, and operations. He has worked with public and private life sciences companies at various stages of development. His most recent role was as Senior Vice President and CFO of Alimera Sciences, a publicly traded global ophthalmic pharmaceuticals company.

CEO George Ng expressed confidence in Skibsted's ability to contribute to Processa's advancement of its pipeline through clinical trials, citing his proven record in finance and capital markets, combined with a deep understanding of life sciences complexities.

Processa Pharmaceuticals has announced positive results from their Phase 1b trial of NGC-Cap in gastrointestinal cancer patients. The trial involved 12 patients, with 66.7% achieving progression-free survival (PFS) ranging from 5 to 11 months. At the highest dose, all patients showed PFS, with two partial responses and one stable disease. Compared to monotherapy capecitabine, 5-FU exposure was greater, and FBAL exposure was lower, with better or similar side effects. These promising results support further development, with a Phase 2 trial in breast cancer slated for the third quarter of 2024.

Processa Pharmaceuticals, Inc. (PCSA) will participate in the EF Hutton Annual Global Conference on May 15, 2024, in New York City. The company aims to develop advanced chemotherapeutic drugs for improved efficacy and safety.

Processa Pharmaceuticals, Inc. appointed Dr. Steven Cha as Senior Vice President of Clinical Research. Dr. Cha brings extensive experience in oncology drug development, having guided multiple oncology therapies through all phases of development, including regulatory approval and commercialization. His leadership will be important as Processa advances its oncology programs, with plans to initiate a Phase 2 trial in breast cancer.