Overview of the Company

Processa Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing improved versions of existing chemotherapy drugs, called Next Generation Chemotherapy (NGC). The company aims to improve cancer survival and quality of life for patients.

Processa has three NGC drug candidates in development:

• NGC-Cap: A combination drug including PCS6422 and a lower dose of the approved cancer drug capecitabine. In early testing, NGC-Cap has been significantly more potent, up to 50 times more than capecitabine alone. A Phase 1b trial identified promising dosage regimens with improved safety and efficacy over existing chemotherapy. A Phase 2 trial in breast cancer patients will begin in Q3 2024.

• NGC-Gem: A modified form of the chemo drug gemcitabine, which may be safer and more effective for some patients. Planning for Phase 2 trials is underway.

• NGC-Iri: An analog of the chemo drug irinotecan, with potential for better safety and efficacy. Processa plans to conduct further preclinical studies in 2024.

Financial Highlights

• In Q1 2024, Processa used net cash of $2 million in operating activities and had a net loss of $2.7 million. Research and development expenses were $1.5 million.

• As of March 31, 2024, Processa had $8.9 million in cash and cash equivalents, which will fund operations into early 2025 based on current plans.

• In January 2024, Processa raised $7 million in a public stock offering, providing funding for the NGC-Cap Phase 2 trial and other pipeline development.

Q1 2024 Financial Results

Research and development expenses decreased 14% from Q1 2023 to $1.5 million. This was driven by having only one active clinical trial in early 2024 compared to two trials last year. General and administrative costs decreased 49% from Q1 2023 to $1.3 million, primarily due to non-recurring costs in 2023 for a consultant warrant.

Processa reported a net loss of $2.7 million in Q1 2024 compared to a $4 million net loss in Q1 2023. The reduced net loss was due to lower operating expenses.

Future Outlook

As Processa initiates the Phase 2 breast cancer trial for NGC-Cap and continues pipeline development, research costs are expected to increase. The company will need to raise additional funding in 2024 to advance its programs.

The recent public offering provided capital expected to fund operations into early 2025. However, future funding will be needed to complete clinical trials and bring an NGC drug to market.

Processa’s goal is to develop NGC drugs that improve patient survival and quality of life by enhancing the safety and efficacy of chemotherapies. The pipeline aims to address unmet needs for cancer patients.