Immutep (ASX:IMM) is entering an important phase of its development journey, as rising research spending and expanding clinical trials are reshaping both its financial results and its strategic outlook.
For the six months to December 2025, the company reported a net loss of $44.9 million, largely reflecting a sharp increase in clinical trial activity and associated staffing costs. The jump in expenditure highlights the company's investment in its immunotherapy pipeline, particularly its lead candidate eftilagimod alfa, known as efti.
Immutep’s leadership frames the period as one of operational momentum. The company is now advancing efti through a pivotal Phase 3 trial targeting first-line treatment for advanced non-small cell lung cancer. The study is designed to evaluate whether the therapy, used alongside MSD's KEYTRUDA (pembrolizumab) and chemotherapy, can improve survival outcomes and potentially redefine treatment standards.
Recruitment for the trial is progressing steadily, with hundreds of patients already enrolled and regulatory approvals secured across multiple countries. Management expects several milestones during 2026, including interim analyses and continued enrolment expansion, making the trial a central driver of investor attention and long-term value.
Beyond lung cancer, the company continues to broaden its clinical footprint. Additional studies are underway in head and neck cancer, breast cancer, and soft tissue sarcoma, while a separate program is exploring autoimmune disease treatment through another candidate, IMP761. Early safety and immune-response data from this program have been encouraging, the company said, reinforcing its ambition to develop therapies that both activate and suppress immune responses depending on the disease context.
Strategic partnerships are also becoming more central to the company’s growth model. During the reporting period, Immutep entered a licensing and collaboration agreement with Dr. Reddy’s Laboratories covering development and commercialisation of efti in markets outside North America, Europe, Japan and Greater China. The deal includes upfront funding, potential milestone payments, and future royalties, offering both financial support and validation of the drug’s commercial prospects.
Financially, the company remains well capitalised despite rising costs. At the end of December, Immutep held roughly $99 million in cash and term deposits, with additional funds received shortly after the period from its licensing agreement. This liquidity provides runway to continue its clinical programmes while pursuing regulatory milestones and partnership opportunities.