Recent Updates — PRRUF

Immutep Limited has received a cash payment of €1.36 million (approximately A$2.16 million) from the French Government under its Crédit d’Impôt Recherche (CIR) research tax incentive program. The refund covers eligible R&D expenditure for calendar year 2025 conducted by Immutep’s French subsidiary, Immutep S.A.S. This funding follows a recent A$0.86 million rebate from the Australian Government and supports current development of product candidates eftilagimod alfa and IMP761. The non-dilutive capital contributes to an expected cash runway extending into the first half of 2028. Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases.

Immutep announced a focused development strategy for its lead candidate eftilagimod alfa following the early discontinuation of the TACTI-004 study. A root cause analysis identified structural differences, specifically in N-glycan structure, between the drug manufactured at 2,000 L scale used in TACTI-004 and the 200 L scale used in prior successful trials. The company has contracted a new manufacturing run at 200 L scale to address these discrepancies. Future registration-directed development will target head and neck squamous cell carcinoma (HNSCC) in patients with CPS < 1, where efti holds Fast Track designation, and the neoadjuvant setting of soft tissue sarcoma (STS), which received Orphan Drug Designation in April 2026. Preparations for new clinical trials have commenced, with a study start targeted for the second half of calendar year 2027. Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases.

Immutep Limited announced the discontinuation of its Phase III TACTI-004 trial in first-line non-small cell lung cancer following an Independent Data Monitoring Committee recommendation based on a futility analysis showing inferior objective response rates compared to control. The company repaid US$10 million to licensing partner Dr. Reddy’s Laboratories and is conducting a root cause analysis expected to conclude in Q3 CY26. Concurrently, Immutep reported positive first-in-human Phase I results for IMP761, a LAG-3 agonist antibody for autoimmune diseases, meeting primary safety endpoints with significant pharmacodynamic activity. The company holds A$68.87 million in cash and has initiated cost-reduction measures to extend its runway into H1 CY28. Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases.