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Processa Pharmaceuticals

HQ: Vero Beach, FL source · processapharmaceuticals.com ↗ · Southeast

Clinical Phase 2

Keywords: neurology immunology food allergy chronic spontaneous urticaria multiple sclerosis Necrobiosis Lipoidica Duchenne Muscular Dystrophy Breast Cancer TNBC - Triple-Negative Breast Cancer HER2-negative Breast Cancer Tumor Gastric Metastatic Bladder Cancer Metastatic Pancreatic Cancer Gastroparesis PCS499 RX-3117 HT-100 PCS12852

Location: Vero Beach, FL · source · Oct 15, 2026

Profile checked Oct 10, 2026

$212.0MRaised (2 yrs)10Trials (company is sponsor)

Timeline

  1. Raise Private placement: $200M (total, as published), announced Jul 29, 2026. Source: SEC filing. source ↗
  2. Raise Private placement: amount not published, announced Aug 7, 2025. Source: SEC filing. source ↗
  3. Raise Follow-on offering: $7M (total, as published), announced Jun 17, 2025. Source: SEC filing. source ↗
  4. Raise Follow-on offering: $5M (total, as published), announced Jan 27, 2025. Source: SEC filing. source ↗
  5. Trial start 2: A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer source ↗
  6. Trial start Phase 2: Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis source ↗
  7. Trial start Phase 1: A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors source ↗
  8. Trial start Phase 2: A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica source ↗
  9. Trial start Phase 2: A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica source ↗
  10. Trial start Phase 1: Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects source ↗
  11. Trial start Phase 1/Phase 2: RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer source ↗
  12. Trial start Phase 1/Phase 2: Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies source ↗
  13. Trial start Phase 2: Open Label Extension Study of HT-100 in Patients With DMD source ↗
  14. Trial start Phase 1/Phase 2: Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy source ↗

Funding

Raised: $212.0M. Last 2 years.

Clinical trials (lead sponsor) 10

RecordTitlePhaseStatusStartPrimary completion
NCT06568692A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer2TerminatedOct 2, 2024Jul 29, 2026 (actual)
NCT04861987A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract TumorsPhase 1CompletedJun 18, 2021Jun 12, 2024 (actual)
NCT02030067Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced MalignanciesPhase 1/Phase 2Completed2013-122019-07 (actual)
NCT03189914RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic CancerPhase 1/Phase 2CompletedOct 2, 2017Oct 1, 2019 (actual)
NCT04800562A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis LipoidicaPhase 2TerminatedApr 12, 2021Feb 28, 2023 (actual)
NCT05270460Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe GastroparesisPhase 2CompletedMar 9, 2022Sep 29, 2022 (actual)
NCT03698864A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis LipoidicaPhase 2CompletedNov 7, 2018Feb 25, 2020 (actual)
NCT01847573Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular DystrophyPhase 1/Phase 2Terminated2013-05Mar 30, 2016 (actual)
NCT01978366Open Label Extension Study of HT-100 in Patients With DMDPhase 2Terminated2013-10Apr 30, 2016 (actual)
NCT03836222Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy SubjectsPhase 1CompletedFeb 26, 2018Jun 4, 2018 (actual)
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