Overview

Processa Pharmaceuticals is a clinical-stage biopharmaceutical company developing a pipeline of Next Generation Cancer (NGC) therapies. Their risk-mitigated strategy is to identify existing cancer therapies with well-understood mechanisms of action but high toxicity, and then devise technologies to improve the therapeutic effect and reduce toxicity.

Next Generation Cancer Therapy Pipeline

Processa has three NGC therapies in development:

• PCS6422 (NGC-Cap): A combination of PCS6422 and a lower dose of capecitabine, which is used to treat solid tumors like breast and colon cancer. NGC-Cap has shown a better safety profile than capecitabine alone.

• PCS3117 (NGC-Gem): A cytidine analog similar to gemcitabine, but designed to be effective in patients resistant or refractory to gemcitabine.

• PCS11T (NGC-Iri): An analog of SN38, the active metabolite of irinotecan, designed to increase uptake into cancer cells while reducing accumulation in normal tissues, potentially improving the safety profile.

Processa also has two other drug candidates in development:

• PCS12852 is a 5HT4 agonist in Phase 2B development for diabetic gastroparesis.

• PCS499 is being evaluated for use in primary glomerular diseases like focal segmental glomerulosclerosis (FSGS) and IgA nephropathy.

Recent Developments

In January 2025, Processa raised $4.5 million in net proceeds from a public offering. They also have an at-the-market (ATM) offering program that generated $1.5 million in net proceeds during 2024.

Results of Operations

Processa had no revenue in 2024 or 2023, as they are still in the clinical development stage. Research and development expenses increased by $1.5 million in 2024 to $7.3 million, primarily due to costs for the NGC-Cap Phase 1B and Phase 2 trials. General and administrative expenses decreased by $875,000 to $4.8 million.

Processa incurred net losses of $11.9 million in 2024 and $11.1 million in 2023, which they expect to continue as they advance their pipeline.

Liquidity

As of December 31, 2024, Processa had $1.2 million in cash and cash equivalents. The January 2025 public offering provided an additional $4.5 million in net proceeds. Based on current plans, Processa believes these funds will satisfy their capital needs into mid-2025.

However, Processa will need to raise additional capital in the future to fully implement their business plan and advance their drug candidates through clinical development and potential commercialization. Their future capital requirements will depend on the progress and costs of their clinical trials, regulatory approvals, and other R&D activities.