Immutep Limited reported a doubling of its half-year loss to A$44.9 million amid expanded clinical trial activity and secured a USD 20 million upfront payment from a strategic licensing deal with Dr. Reddy’s Laboratories.
- Half-year loss doubles to A$44.9 million driven by increased R&D and clinical expenses
- Strategic collaboration with Dr. Reddy’s Laboratories yields USD 20 million upfront payment
- Pivotal Phase III trial TACTI-004 for non-small cell lung cancer progressing with strong enrolment
- Multiple oncology and autoimmune trials advancing with encouraging data and regulatory feedback
- Robust cash position of approximately A$99.1 million supports ongoing development
Financial Results Reflect Investment in Growth
Immutep Limited has revealed a significant increase in its half-year loss for the period ending 31 December 2025, with a net loss after tax of A$44.86 million, more than double the A$22.38 million loss recorded in the previous corresponding period. This widening loss primarily reflects a substantial rise in research and development (R&D) and intellectual property expenses, which surged by A$21.3 million due to heightened clinical trial activity and increased staff costs.
Corporate expenses also rose by A$1.2 million, largely attributable to share-based payment expenses. Despite the higher loss, the company’s total revenue and other income increased modestly by 6% to A$7.74 million, bolstered by a new licensing revenue stream from its collaboration partner Dr. Reddy’s Laboratories.
Strategic Collaboration with Dr. Reddy’s Laboratories
A key highlight of the half-year was the announcement of a strategic collaboration and licensing agreement with Dr. Reddy’s Laboratories, covering the development and commercialisation of Immutep’s lead immunotherapy candidate, eftilagimod alfa (efti), in all countries outside North America, Europe, Japan, and Greater China. This partnership generated an upfront payment of USD 20 million (approximately A$29.9 million), received shortly after the reporting period, with potential milestone payments of up to USD 349.5 million and royalties on future sales.
Immutep retains manufacturing rights globally (except limited rights in Greater China) and commercial rights in major pharmaceutical markets, positioning the company to capitalise on efti’s global potential while leveraging Dr. Reddy’s regional expertise.
Clinical Trial Progress and Regulatory Engagement
Immutep continues to advance its clinical pipeline aggressively. The pivotal Phase III TACTI-004 trial in first-line advanced or metastatic non-small cell lung cancer (1L NSCLC) has enrolled the required number of patients for its upcoming futility analysis, expected in early 2026, with full enrolment anticipated by Q3 2026. The trial spans over 150 sites in more than 25 countries, including recent site activations in the United States following FDA approvals.
Other oncology trials, including TACTI-003 for head and neck cancer, AIPAC-003 for metastatic breast cancer, and EFTISARC-NEO for soft tissue sarcoma, have reported encouraging clinical data and regulatory feedback. Notably, the FDA has provided positive guidance on efti’s development path in head and neck cancer, including potential accelerated approval pathways.
In autoimmune disease, Immutep’s first-in-human Phase I trial of IMP761, a novel LAG-3 agonist antibody, has demonstrated positive safety and immunosuppressive effects, supporting continued development.
Strong Cash Position and Financial Management
Immutep maintains a robust cash and short-term investment balance of approximately A$99.1 million as of 31 December 2025, including cash equivalents and term deposits. This liquidity is supported by licensing revenue, government grants, and prudent cash management, including deferral of a significant vendor payment of around A$30 million related to future biologics license application readiness.
The company’s financial strategy aims to sustain its clinical development momentum while preserving flexibility for future funding needs.
Outlook for 2026
Looking ahead, Immutep is focused on delivering key milestones, particularly the TACTI-004 futility analysis and completion of patient enrolment. The company anticipates multiple catalysts from ongoing trials across oncology and autoimmune indications throughout 2026. Its expanding intellectual property portfolio and manufacturing capabilities underpin confidence in advancing efti toward potential commercialisation.
With the strategic collaboration with Dr. Reddy’s now in place, Immutep is well positioned to extend its global reach and enhance shareholder value as clinical data and regulatory progress unfold.
Bottom Line?
Immutep’s intensified clinical activity and strategic partnerships set the stage for pivotal milestones in 2026, but investors will watch closely as trial outcomes and milestone realisations unfold.
Questions in the middle?
- When will the results of the TACTI-004 futility analysis be released, and how might they impact Immutep’s valuation?
- What are the timelines and likelihood for milestone payments beyond the upfront USD 20 million from Dr. Reddy’s?
- How will Immutep manage its cash flow and vendor payment deferrals as clinical programs scale?