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CytoDyn

HQ: Vancouver, WA source · cytodyn.com ↗ · West Coast

Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: HIV HIV-1-infection Coronavirus Disease 2019 HIV Infections Human Immunodeficiency Virus Metastatic Colorectal Cancer TNBC TNBC - Triple-Negative Breast Cancer Triple Negative Breast Neoplasms Metastatic Triple-Negative Breast Carcinoma Graft Vs Host Disease Nonalcoholic Steatohepatitis CCR5 Microsatellite Stable Metastatic Colorectal Cancer PRO 140 Leronlimab leronlimab (PRO 140) PRO 140 350 PRO 140 525 PRO 140 700 PRO 140 (humanized monoclonal antibody to CCR5)

24Trials (company is sponsor)

Funding and NIH signals

Job counts as of Oct 18, 2026. All funding and NIH signals

Raises and deals from press releases

Raises announced in these releases: $34M disclosed.

From the company’s own releases; this list is partial. All raises and deals

Timeline

  1. Raise Undisclosed round · $16.5M source ↗
  2. Raise Undisclosed round · $17.5M source ↗
  3. Trial start Phase 2: CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen source ↗
  4. Trial start Phase 2: Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer source ↗
  5. Trial start Phase 2: Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 source ↗
  6. Trial start Phase 2: Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis source ↗
  7. Trial start Phase 2: Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors source ↗
  8. Trial start Phase 2: Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 source ↗
  9. Trial start Phase 2: Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19 source ↗
  10. Trial start Phase 1/Phase 2: Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBC source ↗
  11. Trial start Phase 2/Phase 3: PRO 140 in Treatment-Experienced HIV-1 Subjects source ↗
  12. Trial start Phase 2/Phase 3: An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study source ↗
  13. Trial start Phase 2: A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation source ↗
  14. Trial start Phase 2/Phase 3: Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection source ↗
  15. Trial start Phase 2/Phase 3: An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label Study source ↗
  16. Trial start Phase 2: An Extension of Protocol PRO 140_CD01 Study source ↗
  17. Trial start Phase 2: Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection source ↗
  18. Trial start Phase 1: Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers source ↗
  19. Trial start Phase 2/Phase 3: Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140 source ↗
  20. Trial start Phase 2: A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Use source ↗
  21. Trial start —: Observational Study of Blood Treated With Cytolin source ↗
  22. Trial start Phase 2: Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection source ↗
  23. Trial start Phase 2: PRO 140 by IV Administration in Adults With HIV-1 Infection source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 24

RecordTitlePhaseStatusStartPrimary completion
NCT06699836CLOVER - CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched RegimenPhase 2Active, not recruitingJun 16, 20252028-01 (estimated)
NCT07536815An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)Not listedAvailableNot listedNot listed
NCT02859961Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 InfectionPhase 2/Phase 3CompletedDec 7, 2016Sep 16, 2020 (actual)
NCT04504942Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid TumorsPhase 2CompletedMay 1, 2020Nov 7, 2021 (actual)
NCT02990858An Extension Protocol for Subjects Who Successfully Completed PRO140_CD02 or PRO140_CD02_Open Label StudyPhase 2/Phase 3TerminatedNov 3, 20162022-06 (actual)
NCT05271370An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 StudyPhase 2/Phase 3TerminatedAug 29, 2017Jun 20, 2022 (actual)
NCT04347239Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19Phase 2CompletedApr 16, 2020Oct 24, 2021 (actual)
NCT02355184An Extension of Protocol PRO 140_CD01 StudyPhase 2TerminatedNov 18, 20142022-06 (actual)
NCT03902522PRO 140 in Treatment-Experienced HIV-1 SubjectsPhase 2/Phase 3CompletedJun 25, 2018May 18, 2020 (actual)
NCT03838367Leronlimab (PRO 140) Combined With Carboplatin in Patients With Cytokine Chemokine Receptor 5 Positive (CCR5+) mTNBCPhase 1/Phase 2TerminatedApr 22, 2019Jul 15, 2022 (actual)
NCT04313075A Compassionate Use Study of Leronlimab in Breast CancerNot listedNo longer availableNot listedNot listed
NCT04678830Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19Phase 2CompletedMar 1, 2021Jun 5, 2021 (actual)
NCT02737306A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell TransplantationPhase 2TerminatedMay 14, 2017Apr 14, 2021 (actual)
NCT02175680Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 InfectionPhase 2CompletedApr 16, 2014Feb 2, 2015 (actual)
NCT00110591Safety and Tolerability of PRO 140 in HIV Uninfected Male VolunteersPhase 1CompletedApr 16, 2004Nov 7, 2005 (actual)
NCT04521114Leronlimab (PRO 140) in Patients With Nonalcoholic SteatohepatitisPhase 2CompletedDec 1, 2020Dec 29, 2021 (actual)
NCT05730673Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal CancerPhase 2WithdrawnSep 20, 2022May 27, 2023 (estimated)
NCT04343651Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19Phase 2CompletedApr 1, 2020Jul 21, 2020 (actual)
NCT02483078Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140Phase 2/Phase 3Completed2015-102018-02 (actual)
NCT02759042An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 StudyNot listedNo longer availableNot listedNot listed
NCT01272258A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor AdherencePhase 2Withdrawn2013-122017-01 (estimated)
NCT00613379PRO 140 by IV Administration in Adults With HIV-1 InfectionPhase 2Completed2007-122008-08 (actual)
NCT00642707Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 InfectionPhase 2Completed2008-032008-11 (actual)
NCT01048372Observational Study of Blood Treated With CytolinNot listedCompleted2010-012011-01 (actual)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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