Processa Pharmaceuticals Completes Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study

Processa Pharmaceuticals (Nasdaq: PCSA) completed enrollment and dosing of the 20 patients required for the planned formal interim analysis in its randomized Phase 2 study of NGC-Cap (PCS6422 + capecitabine) in advanced or metastatic breast cancer.

Rhea-AI Summary

Processa Pharmaceuticals (Nasdaq: PCSA) completed enrollment and dosing of the 20 patients required for the planned formal interim analysis in its randomized Phase 2 study of NGC-Cap (PCS6422 + capecitabine) in advanced or metastatic breast cancer.

The formal interim analysis will compare safety and preliminary efficacy versus capecitabine monotherapy and is expected to be completed in Q1 2026. Key interim objectives include evaluating comparative safety/efficacy, deciding whether to add a higher or lower NGC-Cap dose as a third arm, and assessing whether to adjust overall sample size.

Enrolled patients had a median of 2–3 prior treatment regimens. NGC-Cap dosing: single PCS6422 dose one day before capecitabine; capecitabine schedule: 150 mg twice daily, seven days on/seven days off. Mono-Cap dosing: 1,000 mg/m² twice daily, 14 days on/7 days off.

Positive

• Formal interim analysis enabled by 20 patients enrolled
• Interim readout expected in Q1 2026
• Clear randomized design comparing NGC-Cap vs Mono-Cap

Negative

• Possible addition of a third dose arm may expand study scope
• Interim could prompt an overall sample-size adjustment affecting timelines

Argus Jan 5 session

+10.24% close to close Open Argus

Details

News Market Reaction – PCSA

On Jan 5, the day this news came out, PCSA closed 10.24% above the previous close.

Data tracked by StockTitan Argus for the Jan 5 session.

Key Figures

Interim analysis patients: 20 patients Prior regimens median: 2–3 prior treatments NGC-Cap capecitabine dose: 150 mg twice daily +4 more

Interim analysis patients

20 patients

Required for formal Phase 2 interim analysis in metastatic breast cancer

Prior regimens median

2–3 prior treatments

Median number of prior treatment regimens for enrolled patients

NGC-Cap capecitabine dose

150 mg twice daily

Capecitabine dose in NGC-Cap arm, 7 days on / 7 days off

NGC-Cap schedule

7 days on, 7 days off

Capecitabine treatment cycle in NGC-Cap arm

Mono-Cap dose

1,000 mg/m² twice daily

Capecitabine dose in monotherapy arm, 14 days on

Mono-Cap schedule

14 days on, 7 days off

Standard monotherapy capecitabine treatment cycle

Interim data timing

Q1 2026

Planned timing to report interim safety and efficacy data

Historical Context

3 past events · Latest: Dec 17

3 events

1. Dec 17

   NGC-Cap trial update

   24h Move

   +122.3%

   Phase 2 data showing higher active metabolite exposure with reduced FBAL catabolite.

2. Nov 05

   PCS499 trial poster

   24h Move

   -1.7%

   Acceptance of PCS499 Phase 2/3 poster and planned FDA design discussions.

3. Aug 07

   Strategic investment/crypto

   24h Move

   +1.6%

   Strategic investment and exploration of cryptocurrency treasury to diversify capital base.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, metastatic, randomized, monotherapy, +3 more

7 terms

phase 2 regulatory

"The randomized, FDA-recommended Phase 2 study is designed to compare 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

"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.

randomized medical

"The randomized, FDA-recommended Phase 2 study is designed to compare"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

monotherapy medical

"standard-of-care capecitabine monotherapy (Mono-Cap, Arm C) in patients"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

standard-of-care medical

"compare NGC-Cap (Arm A) with standard-of-care capecitabine monotherapy"

The standard-of-care is the widely accepted medical treatment or procedure that doctors typically use for a particular illness, based on current evidence and clinical practice. For investors it matters because new drugs or devices must beat or match this baseline to be adopted, reimbursed and widely sold—think of it as the default recipe a market expects; a new product must prove it’s tastier, cheaper, or faster to replace it.

catabolites medical

"while decreasing the formation of metabolites associated primarily with side effects (catabolites)."

Catabolites are the small molecules produced when larger biological compounds—like drugs, nutrients, or proteins—are broken down by the body or by microbes. For investors, catabolites matter because their identity, amount and persistence affect a drug’s safety, how long it works, regulatory approval and manufacturing waste controls—think of them like the ash left after burning fuel: what remains can reveal efficiency, safety risks and cleanup costs that influence a company’s value.

interim analysis medical

"for the planned formal interim analysis in its ongoing Phase 2 clinical study"

An interim analysis is an early review of a project or process before it is fully completed. For investors, it provides a snapshot of progress or performance, helping to identify whether things are on track, need adjustment, or should be stopped early. Think of it as a progress report that can influence decisions before the final outcome is known.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Interim safety and efficacy data to be reported in Q1

VERO BEACH, Fla., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa’s proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.

“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.,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals.

Study Design and Patient Characteristics

The randomized, FDA-recommended Phase 2 study is designed to compare NGC-Cap (Arm A) with standard-of-care capecitabine monotherapy (Mono-Cap, Arm C) in patients with advanced or metastatic breast cancer. Patients enrolled in the study were required to have received at least one prior cancer treatment, with a median of two to three prior treatment regimens across the enrolled population.

NGC-Cap consists of a single dose of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on treatment and seven days off. The Mono-Cap arm consists of capecitabine administered at 1,000 mg/m² twice daily for 14 days followed by seven days off treatment.

PCS6422 is designed to re-engineer capecitabine metabolism by increasing the formation of cancer-killing metabolites (anabolites) while decreasing the formation of metabolites associated primarily with side effects (catabolites).

Formal Interim Analysis Objectives

The formal interim analysis will compare safety and preliminary efficacy outcomes between the NGC-Cap and Mono-Cap treatment arms and is expected to be completed in the first quarter of 2026. Key objectives of the interim analysis include:

• Evaluating the comparative safety and efficacy of NGC-Cap versus Mono-Cap
• Determining whether a higher or lower dose of NGC-Cap should be added as a third study arm
• Assessing whether the overall sample size of the Phase 2 study should be adjusted based on interim findings
  

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

About NGC-Cap (PCS6422+Capecitabine)

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone did Processa (PCSA) announce on January 5, 2026?

Processa completed enrollment and dosing of the 20 patients required for the formal interim analysis in its Phase 2 NGC-Cap breast cancer study.

When is the PCSA Phase 2 interim analysis for NGC-Cap expected?

The formal interim analysis is expected to be completed in Q1 2026.

What will the Processa (PCSA) interim analysis compare?

It will compare the safety and preliminary efficacy of NGC-Cap (PCS6422 + capecitabine) versus capecitabine monotherapy.

How many prior treatments did patients in the PCSA study have?

Enrolled patients had a median of two to three prior treatment regimens.

What dosing regimens are used in the PCSA Phase 2 NGC-Cap study?

NGC-Cap: single PCS6422 dose one day before capecitabine (150 mg twice daily, 7 days on/7 off). Mono-Cap: capecitabine 1,000 mg/m² twice daily, 14 days on/7 off.

Could the interim analysis change the PCSA trial design?

Yes; objectives include deciding whether to add a higher or lower NGC-Cap dose arm and whether to adjust overall sample size.