Immutep Quarterly Activities Report Q2 FY25

Core Viewpoint - Immutep Limited has made significant advancements in its clinical programs, particularly with the initiation of the Phase III trial for eftilagimod alfa (efti) in first-line metastatic non-small cell lung cancer (1L NSCLC), marking its transition into a Phase III biotechnology company [3][4][8]. Clinical Development Updates - The TACTI-004 Phase III trial for efti in 1L NSCLC commenced in December 2024, following regulatory approval from the Australian Therapeutic Goods Administration [3][4]. - Positive results from the TACTI-003 (KEYNOTE-C34) Phase IIb trial were reported, showing a 67% 12-month overall survival (OS) rate and a promising progression-free survival (PFS) of 5.8 months for patients with PD-L1 negative tumors [5][6]. - The AIPAC-003 trial in metastatic breast cancer completed patient enrollment in October 2024, with 65 patients randomized to receive different doses of efti in combination with paclitaxel [7][9]. - The INSIGHT-003 trial reported a median OS of 32.9 months and a 24-month OS rate of 81.0% for patients with advanced or metastatic non-squamous NSCLC [10][11][12]. - The EFTISARC-NEO trial demonstrated a greater than three-fold increase in tumor hyalinization compared to historical data, indicating significant efficacy in soft tissue sarcoma [13][14][15]. Product Development and Research - IMP761, a first-in-class agonist LAG-3 antibody for autoimmune diseases, reported favorable initial safety data from its Phase I study [16][17]. - Collaboration with Monash University led to new findings on the binding of LAG-3 to MHC Class II, enhancing the understanding of LAG-3 therapeutics [18]. Intellectual Property - Immutep was granted three new patents for efti and IMP761 in various territories, including Brazil and Japan, enhancing its intellectual property portfolio [19][20]. Financial Overview - As of December 31, 2024, Immutep reported a strong cash position of approximately A$159.26 million, expected to fund operations until the end of CY2026 [23]. - The net cash used in R&D activities during Q2 FY25 was A$16.2 million, reflecting increased clinical trial activities [25]. - Total cash flow used in investing activities for the quarter was A$30.4 million, primarily due to an increase in short-term investments [26].