Immutep(IMMP) - 2025 Q2 - Quarterly Report

Results for Announcement to the Market Financial Performance Summary The company's total revenue and other income rose 77% to A$7.28 million, though net loss increased 5% to A$22.38 million due to higher R&D expenses Key Financial Metrics (Half-Year Ended 31 Dec 2024 vs 31 Dec 2023) | Metric | Change | Value (A$) | | :--- | :--- | :--- | | Other Income | up 77% | 7,276,004 | | Total revenue and other income | up 77% | 7,276,004 | | Loss after tax attributable to members | up 5% | (22,377,429) | Net Tangible Assets per Share | Date | Cents | | :--- | :--- | | As at 31 December 2024 | 11.30 | | As at 31 December 2023 | 8.99 | - The increase in net loss was primarily driven by a A$4.89 million rise in R&D and intellectual property expenses, partially offset by increased interest and grant income[4] Directors' Report Principal Activities The company is a clinical-stage biotechnology firm developing novel immunotherapies related to the LAG-3 protein for cancer and autoimmune diseases - The company's core focus is on developing LAG-3 related immunotherapies for both cancer and autoimmune diseases[10] Review of Operations The company initiated its TACTI-004 Phase III trial, reported positive data from other trials, and advanced its autoimmune disease program TACTI-004: Phase III trial in 1L NSCLC Immutep commenced its registrational TACTI-004 Phase III trial for efti in combination with KEYTRUDA® and chemotherapy for 1L NSCLC patients - The TACTI-004 trial is a global, randomized, double-blind Phase III study with dual primary endpoints of progression-free survival and overall survival, enrolling ~750 patients[15] TACTI-003: Phase IIb trial in 1L HNSCC The TACTI-003 trial reported positive new data, showing superior performance for the efti and KEYTRUDA combination in both PD-L1 positive and negative patients - In PD-L1 positive (CPS ≥1) patients, the combination showed a durable response of 17.5 months, with the largest outperformance in the CPS ≥20 subgroup[16] - In PD-L1 negative (CPS <1) patients, the combination achieved a 35.5% ORR, a 12.9% complete response rate, and a 12-month OS rate of 67%[18][19] AIPAC-003: Phase II/III trial in Metastatic Breast Cancer Patient enrollment was completed for the randomized Phase II portion of the AIPAC-003 trial evaluating efti with chemotherapy in metastatic breast cancer - Patient enrollment was completed in October 2024 for the 65-patient randomized Phase II portion of the trial, which is evaluating two doses of efti (30mg vs 90mg) with chemotherapy[21] Other Phase I and II Studies with Eftilagimod Alpha Other efti studies continued to yield positive results, including impressive overall survival in NSCLC and significant efficacy in soft tissue sarcoma - In the TACTI-002 trial (Part A), median OS reached 35.5 months in 1L NSCLC patients with PD-L1 expression (TPS ≥1%)[23] - The EFTISARC-NEO trial in soft tissue sarcoma demonstrated a median 50% tumor hyalinization/fibrosis, a threefold increase over the historical median from radiotherapy alone[24] IKF INSIGHT Clinical Trial Platform The investigator-initiated INSIGHT platform generated promising data, with the INSIGHT-003 trial showing significant survival benefits in NSCLC - Mature data from the INSIGHT-003 trial (N=21) in NSCLC showed a median OS of 32.9 months, median PFS of 12.7 months, and a 24-month OS rate of 81.0%[32] - The INSIGHT-003 trial completed its enrollment target of approximately 50 evaluable patients in January 2025[30] Autoimmune Disease Clinical Development The company advanced its autoimmune pipeline by initiating a Phase I trial for IMP761 and regaining all rights to IMP731 from GSK - The Phase I trial for IMP761, a first-in-class LAG-3 agonist for autoimmune diseases, began dosing in August 2024 with favorable initial safety data[34] - All development and commercialization rights for the LAG-3 depleting antibody IMP731 have been restored to Immutep from GSK[35] Intellectual Property Immutep strengthened its intellectual property portfolio by securing ten new patents across various territories for its key product candidates - The company was granted ten new patents for its key assets: efti, IMP761, and the out-licensed LAG525 (licensed to Novartis)[46][47][49][50] Corporate Summary & Financial Performance The company joined the S&P/ASX 300 index and maintained a strong financial position with A$159.26 million in cash, ensuring a runway to late 2026 - The company was added to the S&P/ASX 300 index, recognizing its growth and increasing market visibility[52] Financial Performance Highlights (A$) | Metric | H1 FY25 | H1 FY24 | | :--- | :--- | :--- | | Total Revenue & Other Income | 7.28 million | 4.11 million | | R&D and IP Expenses | 25.33 million | 20.44 million | | Corporate Administrative Expenses | 4.23 million | 4.80 million | | Loss After Tax | (22.38 million) | (21.23 million) | - The company is well-funded with a cash, cash equivalent, and term deposit balance of approximately A$159.26 million, providing an expected cash runway to the end of calendar year 2026[59] Outlook The company's focus is on advancing the TACTI-004 Phase III trial for efti, which provides a clear path to potential marketing approval - The initiation of the TACTI-004 Phase III trial has transformed Immutep, providing a visible pathway to marketing approval for its lead product, efti[60] Auditor's Independence Declaration Declaration The lead auditor confirmed no contraventions of auditor independence requirements under the Corporations Act 2001 - The auditor, PricewaterhouseCoopers, declared that there were no contraventions of auditor independence requirements or any applicable code of professional conduct during their review[64][66] Half-Year Financial Report Consolidated Statement of Comprehensive Income The company reported a net loss of A$22.38 million for the half-year, an increase from the prior period's A$21.23 million loss Consolidated Statement of Comprehensive Income (A$) | Line Item | 31 December 2024 | 31 December 2023 | | :--- | :--- | :--- | | Total revenue and other income | 7,276,004 | 4,110,397 | | R&D and IP expenses | (25,330,664) | (20,436,458) | | Corporate administrative expenses | (4,233,642) | (4,802,183) | | Loss for the half-year | (22,377,429) | (21,228,191) | | Other comprehensive income/(loss) | 5,074,247 | (600,632) | | Total comprehensive loss | (17,303,182) | (21,828,823) | | Basic and diluted loss per share (Cents) | (1.54) | (1.79) | Consolidated Balance Sheet The company's balance sheet reflects a strong liquidity position with A$173.76 million in current assets and net assets of A$172.47 million Consolidated Balance Sheet Summary (A$) | Line Item | 31 December 2024 | 30 June 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | 73,886,442 | 161,790,147 | | Short-term investments | 85,374,520 | 20,086,308 | | Total current assets | 173,764,061 | 191,350,442 | | Total assets | 182,328,516 | 201,579,281 | | Total liabilities | 9,856,310 | 12,057,539 | | Net assets | 172,472,206 | 189,521,742 | Consolidated Statement of Changes in Equity Total equity decreased to A$172.47 million, primarily due to the period's net loss, partially offset by positive foreign currency translation Movement in Total Equity (A$) | Description | Amount | | :--- | :--- | | Balance at 1 July 2024 | 189,521,742 | | Loss for the half-year | (22,377,429) | | Other comprehensive income | 5,074,247 | | Employee Share based payments | 253,646 | | Balance at 31 December 2024 | 172,472,206 | Consolidated Statement of Cash Flows Net cash outflow from operations was A$28.55 million, with cash and equivalents decreasing to A$73.89 million after investing activities Consolidated Statement of Cash Flows Summary (A$) | Line Item | 31 December 2024 | 31 December 2023 | | :--- | :--- | :--- | | Net cash outflows from operating activities | (28,546,264) | (18,450,440) | | Net cash outflows in investing activities | (62,815,234) | (419,121) | | Net cash outflows in financing activities | (427,170) | (431,859) | | Net increase in cash and cash equivalents | (91,788,668) | (19,301,420) | | Cash and cash equivalents at end of period | 73,886,442 | 103,734,981 | Notes to the Consolidated Financial Statements The notes confirm the company's going concern status, its single operating segment, and details of an outstanding convertible note - The financial statements have been prepared on a going concern basis, as the directors believe the Group's total cash and short-term investment balance of A$159.26 million is sufficient to pay its debts for at least the next 12 months[83][84] - The Group operates in a single operating segment: Cancer Immunotherapy[88] - As of the reporting date, a 2015 convertible note with a notional amount of A$1.10 million remains outstanding, maturing on August 4, 2025[99][100] Directors' Declaration Declaration Statement The directors declared the financial statements provide a true and fair view and that the company can meet its financial obligations - The directors declared that the financial statements give a true and fair view of the group's financial position and performance, and that the company is a going concern[125] Independent Auditor's Review Report Auditor's Conclusion The auditor's review found no matter suggesting the financial report does not comply with the Corporations Act 2001 - The auditor's review concluded that nothing came to their attention to suggest the half-year financial report does not comply with the Corporations Act 2001, including giving a true and fair view of the Group's financial position and performance[126][127] - The auditor clarified that a review is substantially less in scope than an audit and, accordingly, they do not express an audit opinion[132]