Immutep’s FY25 Loss Widens to A$61.4M as Phase III Lung Cancer Trial Progresses

Financial Overview and R&D Investment

Immutep Limited has released its preliminary final report for the fiscal year ended 30 June 2025, revealing a loss after tax of A$61.4 million, a significant increase from the A$42.7 million loss recorded in FY2024. This widening loss primarily reflects a strategic ramp-up in research and development (R&D) and intellectual property expenses, which rose by nearly A$20 million due to intensified clinical trial activities.

Despite the increased expenditure, the company demonstrated prudent financial management, ending the year with a strong cash and term deposit balance of approximately A$129.7 million. This robust liquidity position provides Immutep with a secure operational runway through to the end of calendar year 2026, underpinning its ongoing clinical programs and corporate activities.

Clinical Progress, Pivotal Phase III Trial and Other Programs

A highlight of FY2025 was the advancement of Immutep’s lead immuno-oncology candidate, eftilagimod alfa (efti), into a global registrational Phase III trial (TACTI-004) targeting first-line non-small cell lung cancer (NSCLC). The trial, conducted in collaboration with MSD, commenced dosing its first patient in March 2025 and is designed to evaluate efti in combination with MSD’s KEYTRUDA® (pembrolizumab) and chemotherapy across a broad patient population. Regulatory approvals have been secured in 23 countries, with 88 clinical sites activated as of August 2025, positioning the trial on track for a futility analysis by late 2025 or early 2026.

Complementing this, Immutep reported encouraging data from its Phase IIb TACTI-003 trial in head and neck squamous cell carcinoma (HNSCC), particularly in patients with low PD-L1 expression (CPS <1), where median overall survival reached 17.6 months, substantially exceeding historical standards of care. The company also progressed its autoimmune disease portfolio with IMP761, a first-in-class LAG-3 agonist antibody, demonstrating promising safety and efficacy signals in early Phase I trials.

Strategic Partnerships and Intellectual Property Expansion

Immutep continues to strengthen its position in the LAG-3 immunotherapy space through collaborations with industry leaders such as MSD and Novartis, as well as academic partnerships with Monash University and Cardiff University. The company expanded its patent portfolio with 17 new patents granted across key territories, protecting its core technologies including efti and IMP761. These developments reinforce Immutep’s commitment to innovation and its potential to deliver transformative therapies for cancer and autoimmune diseases.

Corporate Developments and Governance

In governance and leadership, Immutep welcomed the appointment of Dr. Stephan Winckels as permanent Chief Medical Officer and promoted Christian Mueller to Chief Development Officer, both bringing deep expertise critical to advancing clinical programs. The company was also added to the S&P/ASX 300 index in September 2024, reflecting growing investor confidence in its strategic trajectory.

Notably, no dividends were declared during the year, consistent with the company’s focus on reinvesting capital into clinical development. The company also successfully managed its convertible notes, with the last tranche converted to shares post-year-end, further strengthening its equity base.

Outlook

Looking ahead, Immutep is poised for a catalyst-rich FY2026, with ongoing momentum expected from the TACTI-004 Phase III trial, data readouts from multiple oncology studies, and continued progress in autoimmune disease research. The company’s strategic focus remains on delivering clinical validation for efti and expanding its immunotherapy pipeline, aiming to provide meaningful benefits to patients while creating long-term shareholder value.