Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer

Rhea-AI Summary

Processa Pharmaceuticals (Nasdaq: PCSA) provided a Phase 2 clinical update for NGC-Cap (PCS6422 + capecitabine) on Dec 17, 2025. Preliminary analysis of the first 16 of 19 randomized patients indicates NGC-Cap increases exposure to capecitabine's active, cancer-killing metabolites while maintaining comparable severity of side effects versus standard capecitabine monotherapy.

Key measured facts: NGC-Cap dosing was 150 mg BID vs Mono-Cap 1,000 mg/m² BID, and exposure to the catabolite FBAL was reduced by up to 10-fold. A formal interim analysis of the first 20 patients is expected in early 2026 with final enrollment targeted by end of Q1 2026.

Positive

• Increased exposure to active capecitabine metabolites observed
• FBAL catabolite exposure reduced by up to 10-fold
• Severity of side effects similar between NGC-Cap and Mono-Cap
• Formal interim analysis of 20 patients planned in early 2026

Negative

• Higher number of active-metabolite–related side effects per NGC-Cap patient
• Preliminary analysis based on only 16 of 19 randomized patients

News Market Reaction – PCSA

+122.30% 19.5x vol

41 alerts

+122.30% News Effect

+82.5% Peak Tracked

-25.5% Trough Tracked

+$11M Valuation Impact

$20M Market Cap

19.5x Rel. Volume

On the day this news was published, PCSA gained 122.30%, reflecting a significant positive market reaction. Argus tracked a peak move of +82.5% during that session. Argus tracked a trough of -25.5% from its starting point during tracking. Our momentum scanner triggered 41 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $11M to the company's valuation, bringing the market cap to $20M at that time. Trading volume was exceptionally heavy at 19.5x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients with data: 16 of 19 patients Randomized patients: 19 patients NGC‑Cap dose: 150 mg twice daily +5 more

8 metrics

Patients with data 16 of 19 patients Preliminary Phase 2 NGC‑Cap metastatic breast cancer analysis

Randomized patients 19 patients Phase 2 NGC‑Cap vs Mono‑Cap study population so far

NGC‑Cap dose 150 mg twice daily PCS6422+capecitabine arm dosing regimen

Mono‑Cap dose 1,000 mg/m² twice daily Standard capecitabine monotherapy comparator

Interim analysis size 20 patients Planned formal Phase 2 interim safety and efficacy readout

FBAL reduction up to ten times less NGC‑Cap FBAL exposure vs Mono‑Cap

HFS severity NGC‑Cap Grade 1 Hand‑foot‑syndrome severity in NGC‑Cap arm

HFS severity Mono‑Cap up to Grade 2 Hand‑foot‑syndrome severity in capecitabine monotherapy

Market Reality Check

Price: $1.94 Vol: Volume 6,992,990 is 3.45x...

high vol

$1.94 Last Close

Volume Volume 6,992,990 is 3.45x the 20-day average of 2,027,313, signaling elevated trading interest before this update. high

Technical At $0.1202, shares trade well below the $0.28 200-day MA, 90.15% under the 52-week high and only 9.77% above the 52-week low.

Peers on Argus

PCSA fell 15.05% while closest peers showed modest, mixed moves (e.g., BOLT +1.8...

PCSA fell 15.05% while closest peers showed modest, mixed moves (e.g., BOLT +1.87%, CYCCP -5.61%), pointing to a stock-specific reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Nov 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 05	Clinical poster update	Positive	-1.7%	PCS499 Phase 2/3 poster acceptance at ASN Kidney Week 2025.
Aug 07	Strategic investment	Positive	+1.6%	Strategic investment and exploration of cryptocurrency treasury strategy.
Jul 01	Portfolio update	Positive	-2.4%	Portfolio optimization, PCS12852 term sheet and <b>$7M</b> capital infusion.
Jun 17	Equity offering	Negative	+15.5%	<b>$7M</b> public offering to fund NGC‑Cap Phase 2 and working capital.
Jun 17	Clinical licensing deal	Positive	+15.5%	PCS12852 licensing option with up to <b>$452.5M</b> milestones and royalties.

Pattern Detected

News flow often positive but price reactions are mixed, with several divergences on clinical and financing updates.

Recent Company History

Over the last six months, Processa reported multiple pipeline and financing developments. A June 2025 term sheet for PCS12852 with milestones up to $452.5M and a separate $7M public offering supported its oncology focus, including NGC‑Cap. A July 2025 portfolio update highlighted PCS6422’s Phase 2 enrollment and a $7M capital infusion. Later, a PCS499 Phase 2/3 poster was announced for ASN Kidney Week. Today’s NGC‑Cap Phase 2 update extends this sequence of oncology‑focused clinical progress.

Market Pulse Summary

The stock surged +122.3% in the session following this news. A strong positive reaction would have a...

Analysis

The stock surged +122.3% in the session following this news. A strong positive reaction would have aligned with prior sizable moves on clinical and deal news, where average clinical-trial headlines moved shares 8.62%. Investors might focus on the improved metabolite profile and reduced FBAL exposure, but sustainability would still depend on later-phase efficacy data, funding visibility beyond early 2026, and how the market weighs earlier dilution from the 2025 offerings.

Key Terms

phase 2, metastatic, pharmacologic, pharmacokinetic, +3 more

7 terms

phase 2 medical

"provided a clinical update on its ongoing Phase 2 study of NGC-Cap"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

metastatic medical

"NGC-Cap ... in patients with advanced or metastatic breast cancer."

Metastatic describes cancer that has spread from its original spot to other organs or tissues, like weeds moving from one garden bed into several others. For investors, metastatic disease matters because it often requires more complex, long-term treatments, larger clinical trials, and can drive demand for specialized drugs and diagnostics—factors that affect a drug’s development costs, regulatory risk, market size, and potential revenue.

pharmacologic medical

"a differentiated pharmacologic profile that could meaningfully improve the therapeutic index"

Pharmacologic describes anything related to drugs — how a medicine works in the body, the effects it produces, and the dose needed to get those effects. For investors, pharmacologic details matter because they indicate a treatment’s likely benefits, side effects, and how easy it will be to use or approve; think of it as whether a key fits a lock and how well it turns, which affects a drug’s real-world value and commercial potential.

pharmacokinetic medical

"Key Safety and Pharmacokinetic Observations 19 patients have been randomized"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

catabolite metabolites medical

"also broken down into catabolite metabolites, including FBAL, which are associated"

Catabolite metabolites are the chemical pieces produced when a body or cell breaks down larger molecules—such as drugs, nutrients, or other compounds—into smaller parts. Investors care because these breakdown products can change a treatment’s effectiveness, create side effects, alter how long a drug stays in the body, or trigger regulatory scrutiny, much like car exhaust can reveal whether an engine runs cleanly or has hidden problems.

hand-foot-syndrome (hfs) medical

"catabolite metabolites, including FBAL, which are associated with certain side effects such as HFS."

Hand-foot syndrome (HFS) is a painful skin reaction that causes redness, swelling, numbness, tingling or blisters on the palms of the hands and soles of the feet, often likened to a severe localized sunburn. It commonly occurs as a side effect of certain cancer drugs and can force dose reductions, treatment delays or additional supportive care, making it important to investors because it can affect a drug’s safety profile, patient adherence and commercial value.

therapeutic index medical

"profile that could meaningfully improve the therapeutic index of capecitabine-based therapy"

The therapeutic index is a measure of a drug’s safety margin—the gap between the dose that produces a desired effect and the dose that causes harmful effects. For investors, a larger therapeutic index means a wider safety cushion, lower risk of dangerous side effects, smoother regulatory review and broader market acceptance, all of which can reduce clinical and commercial risk and affect a drug developer’s valuation.

AI-generated analysis. Not financial advice.

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine

Company on track to conduct formal interim analysis in early 2026

VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.

Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy (Mono-Cap). This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa’s NGC platform.

The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.

“These emerging data continue to validate the central premise of our Next Generation Cancer strategy,” said Dr. David Young, President of Research and Development at Processa. “NGC-Cap (capecitabine combined with PCS6422) appears to meaningfully increase exposure to the capecitabine metabolites responsible for killing cancer cells, while reducing exposure to the catabolite metabolites associated with dose-limiting toxicity such as hand-foot-syndrome (HFS), a profile that is difficult to achieve with conventional Mono-Cap dosing.”

“As we approach our planned interim analysis, we believe NGC-Cap continues to demonstrate a differentiated pharmacologic profile that could meaningfully improve the therapeutic index of capecitabine-based therapy,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “We view this program as a key value driver for the Company and an important opportunity for patients with advanced or metastatic breast cancer.”

Preliminary Phase 2 study findings suggest that NGC-Cap may allow patients to receive greater exposure to the most effective cancer-killing components of therapy while avoiding increased severity of side effects commonly associated with standard treatment. The Company believes this balance between potential efficacy and tolerability is central to improving outcomes in patients with advanced breast cancer.

Key Safety and Pharmacokinetic Observations

19 patients have been randomized to receive either NGC-Cap (150 mg twice daily) or a standard-dose Mono-Cap (1,000 mg/m² twice daily). The evaluation of safety data from the first 16 patients provides preliminary findings consistent with higher exposure to active cancer-killing metabolites in the NGC-Cap arm. The data from all 19 patients were not available for this preliminary analysis.

As expected with increased exposure to active metabolites, a greater proportion of patients receiving NGC-Cap experienced side effects related to these capecitabine cancer-killing metabolites, and the total number of such side effects per patient was higher compared to patients receiving capecitabine alone. Importantly, the severity of these side effects was similar between treatment arms, indicating that the increased activity did not translate into more severe toxicity.

In addition to forming active metabolites, capecitabine is also broken down into catabolite metabolites, including FBAL, which are associated with certain side effects such as HFS. Patients receiving NGC-Cap demonstrated substantially lower exposure to FBAL — up to ten times less than with Mono-Cap.

Consistent with this reduced exposure, the number of patients reporting HFS was similar between treatment groups, but patients in the NGC-Cap arm experienced only mild (Grade 1) symptoms, while patients receiving capecitabine monotherapy experienced symptoms of greater severity (up to Grade 2).

“What we are seeing in patients aligns closely with our pharmacologic expectations,” added Dr. Young. “The distribution and severity of observed side effects are consistent with enhanced exposure to active cancer-killing metabolites and reduced formation of catabolites, including FBAL.”

Upcoming Clinical Milestone

Processa anticipates completing enrollment of the final patient in the formal 20-patient interim analysis of Phase 2 safety and efficacy study by the end of the first quarter of 2026, in accordance with the trial protocol.

About PCS6422+Cap (NGC-Cap)

NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy.

About Processa Pharmaceuticals, Inc.

Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value.

For more information, visit our website at www.processapharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com

Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com

FAQ

What did Processa announce about PCSA Phase 2 NGC-Cap on December 17, 2025?

Processa reported preliminary data showing NGC-Cap increased active metabolite exposure while maintaining comparable side-effect severity versus capecitabine monotherapy.

How many patients were included in the preliminary PCSA Phase 2 analysis?

The preliminary analysis covered the first 16 of 19 randomized patients; the formal interim analysis will include 20 patients.

What dosing was used for PCSA NGC-Cap versus Mono-Cap in the study?

NGC-Cap dosing was 150 mg twice daily for PCS6422 with capecitabine; Mono-Cap was 1,000 mg/m² twice daily.

What change in the catabolite FBAL did Processa report for PCSA NGC-Cap?

Patients receiving NGC-Cap showed up to 10-times lower exposure to the FBAL catabolite versus Mono-Cap.

When will Processa complete the interim analysis that may affect PCSA shareholders?

The company expects the formal interim analysis of the first 20 patients in early 2026 and aims to finish enrollment by the end of Q1 2026.