Processa Hits Key Milestone in Next-Gen Breast Cancer Drug Trial

VERO BEACH, Fla. – January 05, 2026 – Processa Pharmaceuticals announced today it has completed enrollment and dosing for a critical interim analysis in its Phase 2 study of NGC-Cap, a novel therapy for advanced or metastatic breast cancer. This achievement marks a pivotal moment for the clinical-stage biopharmaceutical company (Nasdaq: PCSA) and brings a potential new treatment paradigm one step closer for patients who have exhausted other options.

The study reached its target of 20 patients required for a formal review of NGC-Cap, a proprietary combination treatment designed to enhance the efficacy and reduce the debilitating side effects of a widely used chemotherapy, capecitabine. The results of this analysis, expected in the first quarter of 2026, will provide the first randomized, controlled data comparing the novel combination against the current standard of care.

“This is an important milestone because it allows us to assess whether NGC-Cap can demonstrate a meaningful improvement over capecitabine monotherapy in both safety and efficacy for patients who have already undergone multiple prior cancer treatments,” stated George Ng, Chief Executive Officer of Processa Pharmaceuticals, in the company's press release.

A New Strategy for an Old Foe

For decades, capecitabine (marketed as Xeloda) has been a cornerstone of treatment for various cancers, including breast cancer. As an oral chemotherapy, it offers patients the convenience of at-home administration. However, its benefits are often shadowed by severe, dose-limiting side effects. Chief among these are hand-foot syndrome—a painful condition causing redness, swelling, and blistering on the palms and soles—as well as severe diarrhea and mouth sores. These toxicities can force doctors to lower doses or stop treatment altogether, compromising its effectiveness.

Processa's NGC-Cap aims to fundamentally re-engineer how the body processes capecitabine. The therapy combines a standard dose of capecitabine with PCS6422, an irreversible inhibitor of an enzyme called dihydropyrimidine dehydrogenase (DPD). In a typical patient, DPD rapidly breaks down about 80% of capecitabine's active form, 5-fluorouracil (5-FU), into metabolites, or catabolites, that are primarily responsible for side effects, not killing cancer. Only the remaining 20% is converted into cancer-fighting anabolites.

By blocking the DPD enzyme, PCS6422 is designed to flip that ratio. It dramatically reduces the creation of toxic catabolites while redirecting the drug's metabolism to produce more of the cancer-killing anabolites. The goal is a more potent and more tolerable therapy.

This scientific premise is backed by promising data from the company’s Phase 1b trial. Those results demonstrated that NGC-Cap delivered two to ten times greater exposure to the key cancer-fighting metabolite compared to capecitabine alone. Crucially, it also showed lower exposure to the metabolite associated with side effects and a significantly lower incidence of hand-foot syndrome than historically expected, along with early signs of anti-tumor activity.

Navigating a Crowded and Urgent Field

The landscape of metastatic breast cancer treatment is evolving rapidly, with a host of new targeted therapies and antibody-drug conjugates (ADCs) like Enhertu showing remarkable efficacy. However, a significant unmet need persists. Metastatic breast cancer remains incurable, with a five-year survival rate lingering below 30%. Many patients eventually develop resistance to newer therapies and must cycle through multiple lines of treatment, each with its own burden of toxicity.

It is for this heavily pre-treated population—the patients in the current Phase 2 study have undergone a median of two to three prior regimens—that an improved version of a trusted therapy like capecitabine could be transformative. Rather than introducing an entirely new and complex biologic, Processa's strategy is to optimize a well-understood, accessible oral drug. If successful, NGC-Cap could offer an effective treatment that enhances quality of life, a critical factor for patients living with advanced disease.

High Stakes for a Clinical-Stage Biotech

For Processa Pharmaceuticals, the upcoming data represents a major inflection point. The company's stock (PCSA) has experienced significant volatility, reflecting the high-risk, high-reward nature of biopharmaceutical development. After a prolonged downturn over the past year, the stock surged in December 2025 on the heels of positive early data and saw another jump on today's enrollment news.

Analysts have maintained a generally bullish outlook, with several “Buy” ratings and price targets suggesting substantial upside. However, like most clinical-stage companies, Processa remains unprofitable, and its future valuation is heavily dependent on clinical success. The Q1 2026 interim analysis is arguably the most significant catalyst in the company's near-term history. Positive results could validate its entire Next Generation Cancer platform, attract potential partners, and unlock significant shareholder value. Conversely, disappointing data could pose a major setback.

The formal interim analysis will compare safety and early efficacy signals between patients receiving NGC-Cap and those receiving standard capecitabine. According to Dr. David Young, President of Research and Development, the findings will be instrumental in shaping the trial's future.

“The interim analysis is designed to evaluate early signals of clinical benefit and to guide potential optimization of dose selection and overall study design,” Dr. Young noted. “These data will be critical as we determine the most appropriate path forward to maximize the therapeutic potential of NGC-Cap.”

Based on the results, the company may decide to add a new dosing arm to the study or adjust the total number of patients enrolled to ensure the trial is powered for success. This data-driven approach aligns with the FDA's Project Optimus initiative, which encourages drug developers to identify an optimal dose rather than simply the maximum tolerated one.

For the thousands of patients battling advanced breast cancer, the scientific and corporate milestones are secondary to a more fundamental question: will this new therapy work better and feel better? The data expected in the coming months will provide the first clear answer and determine whether NGC-Cap is poised to become a vital new tool in the fight against this relentless disease.