Immutep (IMM) H2 2025 earnings summary

Executive summary

• Transitioned to a Phase III biotechnology company, advancing lead candidate efti into a global registrational Phase III trial for 1L NSCLC, with first patient dosed in March 2025 and regulatory approvals in 23 countries as of August 2025.

• Reported strong clinical progress across oncology and autoimmune pipelines, including positive Phase IIb and Phase I results in HNSCC, metastatic breast cancer, soft tissue sarcoma, and autoimmune disease.

• Maintained a robust cash and term deposit balance of A$129.7 million at year-end, providing a cash runway through CY2026.

• Added to the S&P/ASX 300 Index in September 2024, reflecting increased market confidence.

Financial highlights

• Total revenue and other income rose to A$10.33 million in FY2025, up from A$7.84 million in FY2024, driven by higher interest income and grant receipts.

• Research and development and intellectual property expenses increased to A$61.41 million (FY2024: A$41.55 million), reflecting expanded clinical trial activity.

• Corporate administrative expenses were A$8.64 million, slightly down from A$8.85 million in FY2024.

• Loss after tax for FY2025 was A$61.43 million, compared to A$42.72 million in FY2024, mainly due to planned increases in R&D spending.

• Basic and diluted loss per share was 4.22 cents (FY2024: 3.56 cents).

Outlook and guidance

• TACTI-004 Phase III trial in 1L NSCLC is a key milestone, with futility analysis readout expected by end of CY2025/Q1 CY2026.

• Multiple ongoing trials in oncology (INSIGHT-003, TACTI-003, EFTISARC-NEO, AIPAC-003) and autoimmune disease (IMP761) position the company for several catalysts in FY2026.

• Focus remains on clinical execution, advancing efti and IMP761, and maintaining financial discipline.