IMMUTEP Ltd

Immutep Ltd. provided its Quarterly Activities Report and Appendix 4C for Q1 FY27. The company is focusing its clinical development of efti on HNSCC and neoadjuvant STS, with new trials targeted for H2 CY27. IMP761, an antibody for autoimmune diseases, is now a co-priority. A root cause analysis for the TACTI-004 discontinuation identified manufacturing scale differences, leading to a new 200 L scale efti run. Immutep received significant R&D tax incentives and reported A$48.50M in cash and term deposits, expecting runway into H1 CY28. The company also adjusted its ADS ratio to regain Nasdaq compliance.

Immutep Ltd reported its Q4 FY26 activities, ending the quarter with A$68.87 million in cash, cash equivalents, and term deposits, extending its cash runway into H1 CY28. The company provided updates on its clinical programs, including positive pooled analysis data for eftilagimod alfa (efti) showing a 7.7-month median overall survival benefit and encouraging Phase I results for IMP761. However, the investigation into the futility outcome of the TACTI-004 Phase III trial is ongoing, and Novartis terminated its out-license agreement for ieramilimab. The company also initiated cost-reduction measures and reported net cash used in operating activities of A$38.891 million, which included a A$14.092 million repayment to Dr. Reddy's.

Immutep provided a quarterly update, highlighting a pooled analysis of five efti trials that demonstrated a 7.7-month median overall survival benefit in biological responders. The company also reported positive first-in-human Phase I results for IMP761, meeting its primary safety endpoint and showing significant pharmacodynamic activity. However, the Phase III TACTI-004 trial was discontinued due to a futility outcome, with a root cause analysis ongoing. Immutep remains well-funded with A$68.87 million in cash and expects its cash runway to extend into H1 CY28 due to cost-reduction measures.

Immutep announced positive mature Overall Survival (mOS) data from its INSIGHT-003 Phase I trial for eftilagimod alfa (efti) in 1st line non-small cell lung cancer (NSCLC). The trial showed a mOS of 30.9 months in the overall population and in patients with low PD-L1 expression, comparing favorably to historical benchmarks. The company also provided an update on the ongoing root cause analysis for the discontinued TACTI-004 Phase III trial, noting preliminary immune monitoring data indicated a different immune activation profile compared to previous studies. Additional results from the TACTI-004 analysis are expected in Q3 CY2026.

Immutep Ltd. announced positive mature overall survival (mOS) data from its investigator-initiated INSIGHT-003 Phase I trial for eftilagimod alfa in combination with KEYTRUDA and chemotherapy for 1st line advanced non-small cell lung cancer (NSCLC). The trial demonstrated a mOS of 30.9 months in the overall population (N=51) and in patients with low PD-L1 expression (TPS <50%, N=47), comparing favorably to historical benchmarks of 22.0 months. No new safety signals were identified. The company also provided an update on the ongoing root cause analysis for the discontinued TACTI-004 Phase III trial, noting preliminary immune monitoring data indicating a different immune activation profile compared to previous studies, with additional results expected in Q3 CY2026.

Immutep announced positive interim Phase I data for its lead autoimmune candidate, IMP761, at the EULAR 2026 Congress. The first-in-human study met its primary endpoint, demonstrating favorable safety and tolerability in healthy volunteers. IMP761 also showed statistically significant pharmacodynamic activity at 7 mg/kg, supporting further clinical investigation in autoimmune diseases. Additional trial updates are expected in H2 CY2026.

Immutep announced positive first-in-human Phase I clinical data for its lead autoimmune candidate, IMP761, presented at the EULAR Congress. The study met its primary endpoint, demonstrating favorable safety and tolerability in healthy volunteers. IMP761 showed statistically significant pharmacodynamic activity at 7 mg/kg, including reduced inflammatory responses and attenuated T-cell activity, supporting further clinical investigation in autoimmune diseases.

Immutep announced the discontinuation of its TACTI-004 Phase III trial for first-line non-small cell lung cancer (1L NSCLC) following an independent data monitoring committee's recommendation due to futility. The eftilagimod alfa arm unexpectedly underperformed the control arm, leading to an orderly wind-down of the study. A root cause analysis is underway to understand the outcome and its implications for the broader eftilagimod alfa development program. Despite this setback, the company's IMP761 Phase I trial for autoimmune diseases is progressing with a favorable safety profile, and other efti trials continue. Immutep reported a strong cash position of A$110.6 million as of March 31, 2026, providing an expected cash reach into H1 CY2028, though it faces a US$10 million payment obligation to Dr. Reddy's related to the trial discontinuation and has initiated cost reduction measures.

Immutep Limited announced that an abstract detailing clinical and translational data for its lead product candidate, eftilagimod alfa (efti), has been selected for a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data demonstrates that efti, an APC activator, induces rapid and sustained lymphocyte activation, which was associated with improved overall survival outcomes in patients with metastatic cancer across multiple late-stage studies. This presentation highlights the clinical relevance of efti's mechanism of action.

Immutep announced that the FDA has granted Orphan Drug Designation (ODD) for its drug eftilagimod alfa ("efti") for the treatment of Soft Tissue Sarcoma (STS). This designation provides significant benefits, including regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval. The ODD is supported by encouraging data from the Phase II EFTISARC-NEO trial, which demonstrated a median tumor hyalinization/fibrosis of 51.5%, surpassing the pre-specified target of 35%. The company views this as a potential direct path to a late-stage study in the neoadjuvant setting for STS.