Processa Pharmaceuticals (PCSA) Stock News

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.

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.

Processa Pharmaceuticals (Nasdaq: PCSA) announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, was accepted for poster presentation at ASN Kidney Week 2025 in Houston, Nov 5–9, 2025.

The poster is scheduled in the session “Glomerular Clinical Trials: From Data to Impact” on Nov 7, 2025, 10:00–12:00 CT (board FR-PO0829). PCS499 is an analog of a pentoxifylline metabolite that has shown a favorable safety profile versus PTX, potentially allowing higher dosing for greater benefit in rare kidney diseases like FSGS. Processa will discuss an adaptive Phase 2/3 design with the FDA later in 2025 to optimize dosing and accelerate development.

Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage biopharmaceutical company focused on Next Generation Cancer therapies, has announced two strategic initiatives: securing an undisclosed strategic investment and exploring cryptocurrency treasury strategies.

The company is evaluating blockchain-based assets as a potential avenue to diversify its capital base and enhance financial flexibility while funding clinical development programs. This approach aims to reduce shareholder dilution and position Processa at the biotech-fintech intersection.

To implement its cryptocurrency treasury strategy, Processa has engaged LifeSci Capital, LLC as an advisor.

Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage pharmaceutical company, has provided significant updates on its product pipeline and business developments. The company has signed a binding term sheet with Intact Therapeutics for PCS12852, potentially worth up to $454 million in milestone payments plus 12% royalties and a 3.5% equity stake.

The company's lead oncology asset, PCS6422 (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer, with interim analysis expected in H2 2025. For PCS499, Processa is designing a new adaptive pivotal Phase III study for rare kidney diseases and establishing a dedicated subsidiary to enhance strategic flexibility.

In portfolio optimization moves, Processa has terminated the PCS3117 license agreement, while continuing to explore development strategies for PCS11T, their preclinical oncology asset. The company has also strengthened its balance sheet with a $7 million capital infusion.

Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on Next Generation Cancer therapies, has announced a $7 million public offering. The company is offering 28,000,000 shares of common stock (or pre-funded warrants) along with common warrants at $0.25 per share. The common warrants have a $0.25 exercise price and a 5-year expiration period. The offering, expected to close around June 18, 2025, is managed by H.C. Wainwright & Co. as exclusive placement agent. Processa plans to use the proceeds to fund its Phase 2 clinical trial for NCG-Cap and for working capital purposes.

Processa Pharmaceuticals (PCSA) has entered into a binding term sheet with Intact Therapeutics for an exclusive option to license PCS12852, a 5-HT4 receptor agonist targeting gastroparesis treatment. The deal includes $452.5M in total milestone payments, comprising a $2.5M option exercise fee, up to $20M in development/regulatory milestones, and $432.5M in commercial milestones. Intact will pay double-digit royalties on worldwide net sales (excluding South Korea) and provide Processa with a 3.5% equity stake. PCS12852, which completed Phase 2a trials showing strong safety and efficacy in diabetic gastroparesis patients, aims to restore normal gastric emptying without cardiovascular and CNS side effects. Processa must share 60% of cash payments with its licensor, excluding the equity stake. The agreement allows Processa to focus on oncology while monetizing non-oncology assets.

Processa Pharmaceuticals (NASDAQ: PCSA) announced its participation in the 2025 BIO International Convention in Boston from June 16-19, 2025. CEO Georg Ng and President R&D Dr. David Young will conduct one-on-one meetings with potential partners and investors to discuss the company's strategic direction and clinical developments. The meetings will focus on their Next Generation Cancer (NGC) platform, particularly their lead asset NGC-Cap, which is in Phase 2 trials for metastatic breast cancer. The BIO International Convention is the biotechnology industry's largest gathering, attracting over 20,000 global leaders for networking and collaboration opportunities.

Processa Pharmaceuticals announced the acceptance of three abstracts for presentation at the 2025 ASCO Annual Meeting. The presentations focus on their Next Generation Cancer drug candidates PCS6422 and PCS11T. The main presentation features their Phase 2 adaptive design trial of PCS6422 (eniluracil) combined with capecitabine for advanced/metastatic breast cancer. Two additional online-only abstracts cover: (1) Phase 1b trial results defining MTD and RP2DR for NGC-Cap, showing improved safety and anti-tumor activity, and (2) preclinical Project Optimus dose escalation study of PCS11T, a tumor-targeted SN-38 pro-drug designed to increase tumor drug concentration while reducing systemic toxicity.