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Adlai Nortye Group Ltd. (ANL)

Adlai Nortye Ltd. (ANL) is a clinical-stage biotechnology firm dedicated to the research and development of innovative pharmaceutical products. Their flagship compound, AN2025, a pan-phosphoinositide 3-kinase inhibitor, is currently undergoing Phase III clinical trials. It is being investigated as a potential treatment for recurrent or metastatic head and neck squamous cell carcinomas. The company's pipeline also features AN0025, a small molecule prostaglandin E receptor 4 antagonist designed to modulate the tumor microenvironment. This candidate is in Phase Ib clinical trials, exploring its efficacy in treating various conditions, including: recurrent non-small cell lung cancer; urothelial cancer (post-anti-PD-1/PD-L1 treatments); recurrent triple-negative breast cancer; microsatellite stable colorectal cancer; and cervical cancer (following standard-of-care treatments). Additionally, ANL is developing AN4005, an oral small-molecule PD-L1 inhibitor. This drug, which is in Phase I clinical trials, aims to induce and stabilize PD-L1 dimerization to disrupt the interaction between PD-1 and PD-L1. Beyond their clinical programs, Adlai Nortye has early-stage research candidates such as AN8025, a multifunctional antibody that acts as a modulator of T cells and antigen-presenting cells, and AN9025, an oral small molecule pan-KRAS inhibitor. Established in 2004, the company's headquarters are situated in Grand Cayman, Cayman Islands.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Adlai Nortye Ltd. logo

Adlai Nortye Ltd.

NASDAQ:ANLHealthcare
-7.10%$9.55
AH$9.55+0.00%vs close
Mkt Cap$615M
Float47.26M
O/S64.4M
Vol
$ Vol
RVOL
Inst Own41.1%
SI10.8%
Earnings
Dilution
Phase Distribution
10 lead-sponsored trials·4 active·4 completed
Phase 19
Phase 31
(1 more as collaborator)
Status Overview
Recruiting4
Completed4
Stopped1
Unknown1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

    Buparlisib & Paclitaxel

    Head and Neck Cancer

    Enrollment
    487
    Start
    Dec 2020
    Primary Completion
    Nov 2025
    Completion
    Nov 2025
    NCT04338399
  • Phase 1
    Completed

    Preoperative Radiotherapy and E7046 in Rectum Cancer

    E7046, capecitabine

    Neoadjuvant Therapy in Rectal Cancer

    Enrollment
    29
    Start
    May 2017
    Primary Completion
    Aug 2021
    Completion
    Sep 2021
    NCT03152370
  • Phase 1
    Unknown status

    AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

    AN0025, Pembrolizumab

    Triple-negative Breast Cancer, NSCLC, Squamous or Non-Squamous +3

    Enrollment
    63
    Start
    Aug 2020
    Primary Completion
    May 2024
    Completion
    Jan 2025est.
    NCT04432857
  • Phase 1
    Completed

    Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors

    AN2025, AN0025

    Locally Advanced Solid Tumor

    Enrollment
    47
    Start
    Sep 2021
    Primary Completion
    Jan 2025
    Completion
    Jan 2025
    NCT04975958
  • Phase 1
    Recruiting

    First in Human, Dose Escalation Study of AN4005

    AN4005-dose level 0, AN4005-dose level 1

    Advanced Solid Tumor, Advanced Lymphoma

    Enrollment
    31
    Start
    Sep 2021
    Primary Completion
    Nov 2026est.
    Completion
    Dec 2026est.
    NCT04999384
  • Phase 1
    Suspended

    AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

    AN0025

    Esophageal Cancer

    Enrollment
    32
    Start
    Jan 2022
    Primary Completion
    Dec 2025est.
    Completion
    Dec 2025est.
    NCT05191667
  • Phase 1
    Completed

    Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

    Pelareorep

    Advanced or Metastatic Breast Cancer

    Enrollment
    15
    Start
    Oct 2021
    Primary Completion
    Sep 2022
    Completion
    May 2023
    NCT05519059
  • Phase 1
    Recruiting

    Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

    AN9025 oral capsule

    Solid Tumors (Phase 1), RAS Mutation

    Enrollment
    118
    Start
    Jan 2026
    Primary Completion
    Jan 2028est.
    Completion
    Jun 2028est.
    NCT07252479
  • Phase 1
    Recruiting

    An Initial Evaluation of AN8025 in Solid Tumors

    AN8025 is a multifunctional antibody fusion protein

    Advanced Solid Tumor (Phase 1)

    Enrollment
    91
    Start
    Nov 2025
    Primary Completion
    Jul 2027est.
    Completion
    Jan 2028est.
    NCT07639047
  • Phase 1
    Recruiting

    A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression

    Intravenous AN4035, Intravenous AN4035 followed by intravenous EGFR Inhibitor.

    Solid Tumor (Phase I), RAS Mutation +1

    Enrollment
    228
    Start
    Sep 2026
    Primary Completion
    Dec 2028est.
    Completion
    Dec 2028est.
    NCT07686445