1. Preliminary Phase 2 data shows promising safety and efficacy for NGC-Cap. 2. NGC-Cap increases cancer-killing metabolite exposure without severe side effects. 3. Formal interim analysis expected in early 2026 with comprehensive data. 4. Capecitabine combined with PCS6422 shows reduced toxicity and improved therapeutic profile. 5. Management sees NGC-Cap as a key value driver for Processa.
FAQ
Why Bullish?
The positive trial results may lead to increased investor interest, similar to prior biotech successes. Historical examples include companies with promising trial data seeing stock rallies.
How important is it?
The advancements in cancer treatment and patient outcomes are crucial factors, potentially leading to increased market capitalization due to future earnings potential.
Why Long Term?
While interim results are positive, full analysis due in 2026 will determine sustained impact. Past biotech firms such as Moderna had significant long-term gains following positive trial results.
Processa Pharmaceuticals Announces Positive Clinical Update for NGC-Cap in Metastatic Breast Cancer
VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical firm focused on Next Generation Cancer (NGC) therapies, has released an update on its ongoing Phase 2 study of NGC-Cap. This innovative treatment combines PCS6422 and capecitabine to target advanced or metastatic breast cancer.
Encouraging Early Findings from Phase 2 Study
Initial data from the first 16 of 19 patients indicate that NGC-Cap significantly enhances the exposure to capecitabine's cancer-fighting metabolites while maintaining comparable safety profiles to the standard monotherapy capecitabine (Mono-Cap). This promising result implies potential advancements in clinical efficacy without compromising patient safety, which remains a cornerstone of Processa's NGC platform.
The comprehensive interim analysis, which is anticipated early in 2026, will include efficacy and safety data from all 20 patients enrolled in this pivotal study.
Comments from Leadership
Dr. David Young, President of Research and Development at Processa, stated, “These emerging data continue to validate the central premise of our Next Generation Cancer strategy. NGC-Cap appears to increase exposure to the capecitabine metabolites responsible for killing cancer cells, while simultaneously reducing exposure to the toxic catabolites associated with adverse side effects such as hand-foot syndrome (HFS).”
George Ng, Chief Executive Officer of Processa Pharmaceuticals, added, “As we proceed towards our planned interim analysis, we believe NGC-Cap shows a differentiated pharmacologic profile that could meaningfully enhance the therapeutic index of capecitabine-based therapy. This program represents a key value driver for PCSA and an essential opportunity for patients facing advanced or metastatic breast cancer.”
Clinical Observations and Safety Profile
Out of the 19 patients randomized, 10 patients were administered NGC-Cap (150 mg twice daily), while others received standard-dose Mono-Cap (1,000 mg/m² twice daily). The evaluation from the initial 16 patients indicated that those receiving NGC-Cap experienced higher exposure to active cancer-killing metabolites. However, importantly, the severity of side effects remained comparable to those undergoing Mono-Cap treatment.
- The NGC-Cap group demonstrated up to ten times lower exposure to the toxic catabolite metabolite FBAL compared to Mono-Cap.
- Incidence of hand-foot syndrome was similar across groups, but NGC-Cap patients experienced only mild symptoms, while Mono-Cap patients reported more severe effects.
Dr. Young emphasized, “The distribution and severity of side effects we are observing align closely with our pharmacologic expectations, confirming enhanced exposure to active metabolites and reduced formation of toxic catabolites, including FBAL.”
Looking Ahead: Upcoming Clinical Milestones
Processa anticipates completing the enrollment of the final patient for the formal interim analysis of this Phase 2 study by the end of the first quarter of 2026, adhering to the trial protocol. This analysis aims to shed light on both safety and efficacy outcomes for NGC-Cap.
About Processa Pharmaceuticals, Inc.
Processa Pharmaceuticals is focused on developing Next Generation Cancer (NGC) drugs that enhance safety and efficacy. By modifying existing FDA-approved oncology therapies, Processa aims to improve the therapeutic index of cancer treatments. The company combines its innovative drug pipeline with proven cancer-fighting molecules to create improved therapy options for patients.
For more information, visit www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking statements that involve risks and uncertainties. Actual outcomes may differ from those expressed. Investors are encouraged to refer to Processa Pharmaceuticals' filings with the SEC, particularly its recent reports on Forms 10-K and 10-Q, for more information on risk factors affecting current results.
Contact Information
For company inquiries, contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
For investor relations, contact:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com